“IKAR Holdings and Insense Health Tech Company Join Forces to Provide Innovative Technology to Epilepsy Patients”

“IKAR Holdings and Insense Health Tech Company Join Forces to Provide Innovative Technology to Epilepsy Patients”
Mario Diel, Chairman and Founder, IKAR Holdings, Ulas Kayacan, Chairman and CEO Insense Health Tech

Mario Diel, Chairman and Founder IKAR Holdings, Ulas Kayacan, Chairman and CEO Insense Health Tech Inc.

Executive Board, IKAR Holdings, Sertan Aycicek, Group President IKAR Holdings, Ulas Kayacan, Chairman and CEO, Insense Health Tech Inc.

Executive Board, IKAR Holdings, Sertan Aycicek, Group President, IKAR Holdings, Ulas Kayacan, Chairman and CEO Insense Helath Tech Inc.

IKAR Holdings, has announced a partnership with Turkish Insense Overall health Tech to globally offer their engineering solution covering the demands of epilepsy people.

LONDON, UNITED KINGDOM, April 4, 2023/EINPresswire.com/ — The partnership between IKAR Holdings and Insense Wellness Tech Inc. will offer a complete resolution to the needs of epilepsy people. The technologies product or service created by Insense Health and fitness Tech is a detailed technique that screens the patient’s health and fitness and gives actual-time details to the patient’s medical professional / patient.

The process is built to detect the onset of an epileptic seizure and notify the patient’s medical professional / affected individual in real-time. This will enable the medical doctor to offer timely healthcare support to the client.

The engineering products formulated by Insense Overall health Tech Organization is a innovative product that will revolutionize the way epilepsy sufferers are monitored and treated.

IKAR Holdings, which will maintain its fairness shares by way of its operational Keeping, Adelfi Ventures Confined, London, is psyched to lover with Insense Health Tech to offer this ground breaking technological know-how to epilepsy individuals close to the world. This partnership will support to increase the quality of lifetime for epilepsy individuals and supply them with the best possible care.

IKAR Holdings and Insense Overall health Tech are dedicated to delivering the very best attainable treatment to epilepsy people and are self-assured that this partnership will assist to make a change in the life of those people influenced by this issue.

The parties agreed on a 30 Million Euro valuation of Insense Wellbeing Tech Inc.

IKAR Holdings is a multi-tiered entrepreneurial team, with a present-day in general portfolio of 40 firms. The group has a vertical tactic, which is structured into three operational Holdings, covering functions across a broad wide range of industries:

IKAR Industries is targeted on matured industries such as electricity, sports, true belongings, cyber stability, aviation, defense, products and services, and building. IKAR Worldwide is centered on affect functions ranging from media, to technology, to finance and instruction and is at this time in the process of developing its individual University. The 3rd holding, Adelfi Ventures, is centered on startup and proven firms and has currently a portfolio of more than 10 firms covering overall health tech, production, investing, telecommunication and many others.

Insense is a health technological know-how firm, based in Istanbul, co-founded by health care medical doctors and tech-business owners. The business offers technological solutions in the wellbeing sector. These alternatives contain software program used for ailment prognosis and treatment, medical imaging software package, individual info administration techniques and a lot of much more. Insense utilizes reducing-edge technological know-how to make health care companies much more successful and successful and develops custom made software program to meet the desires of its buyers.

Aaruni Kumar – Chief Working Officer
IKAR Holdings Restricted, London
press@ikarholdings.com

Rapid access to innovative medicinal products while ensuring relevant health technology assessment. Position of the French National Authority for Health

Rapid access to innovative medicinal products while ensuring relevant health technology assessment. Position of the French National Authority for Health

The challenge of accelerated clinical developments

In France, decisions for reimbursement taken by the Ministry of Health are based on appraisal by an independent Health Technology Assessment body (HTAb): the ‘Haute Autorité de santé’ (HAS). HAS grades the clinical added value of any medicinal product for which a manufacturer seeks reimbursement. This appraisal considers different types of clinical and patient-centred outcomes, including patient-reported ones. Under certain conditions, a concomitant economic assessment which accounts for patients’ preferences in the form of utility values is also performed.

As providing fast access to breakthrough therapies is a critical expectation from patients, clinicians and health policy makers, the European Medicines Agency and the Food and Drug Administration have established various accelerated approval pathways. These procedures lead to conditional approvals frequently based on uncontrolled (ie, single arm) pivotal trials.1–4 Approvals based on uncontrolled trials are also motivated by randomisation sometimes being considered unfeasible or unethical, or because the pathophysiological rationale is assumed to be important when proving effectiveness (eg, a treatment with molecular target in oncology).5 6

However, expected benefits based on uncontrolled trials as evidence are frequently not confirmed. The results of meta-epidemiological studies illustrate that appraisals based on such evidence entail a high level of uncertainty leading to ethical concerns.7 8 For patients, this may have deleterious consequences such as the use of products for which the benefits remain unknown,9 10 the overestimation of benefits with no further confirmation11 12 or the increased risks of adverse events.12 13 This high level of uncertainty may also impact health system sustainability.

While ensuring rapid access to valuable treatments is of utmost importance to patients, maintaining an adequate balance with the performance of relevant HTA in this context is highly challenging. Thus, the French Minister of Health requested HAS to provide recommendations. A consultation of patient associations, academics, manufacturers and various institutions was conducted from October 2021 to January 2022. With the support of an expert committee, a qualitative summary of the consultation has led to the prioritisation of recommendations, which are developed below (details on the consultation process are available in an online supplemental appendix 1).

Need for evidence from comparative designs allowing causal interpretation of treatment effect estimation

Performing relevant HTA requires that an unbiased estimate of the treatment effect is available. Thus, the additional effect must be disentangled beyond effects due to the natural course of the medical condition, the placebo effect, various sources of bias and the effect of alternative(s). To produce such an estimate, the simplest and most consensual methodological choice is a comparison of the treatment of interest to a control by conducting a randomised controlled trial (RCT). Randomising treatment allocation balances both known and unknown confounders between groups, which enables the causal attribution of an observed effect to the investigated treatment. Other characteristics such as blinding and intention to treat analysis principles reduce the risk of bias and thereby lead to an estimation of treatment effect with the highest certainty of results.

Therefore, RCTs should still be systematically considered by manufacturers during clinical development.

Accelerating rapid access to innovative treatments by adapting the traditional RCT design

While RCTs are the gold standard for producing clinical evidence, HAS acknowledges that the strict adherence to the traditional fixed-sample RCT design can lead to long delays before patients access treatments. Several alternatives to the traditional design, such as adaptative designs, platform trials, seamless trials, pragmatic trials or cross-over designs, can be better suited choices for accelerating clinical developments. An overview of main strengths and methodological points of attention is described in table 1. All these adaptations are considered compatible with the principles of RCT design and can produce evidence with high certainty of results.

Table 1

Adaptation of randomised controlled designs leading to good enough certainty of results that can accelerate treatment access to patients

They should, therefore, be encouraged first when considering the issue of balancing rapid access to beneficial medicinal products to patients while performing relevant HTA.

Increasing the certainty of results when uncontrolled trials are pivotal studies

Apart from the exceptional condition where an unequivocal response on a patient-centred outcome for almost all patients compared with an otherwise certain pejorative evolution is observed, the value of uncontrolled trials alone is strongly limited when estimating the effect of a treatment. Nonetheless, market approval relying on uncontrolled trials is prevalent,14 as is the number of dossiers submitted for HTA based on these trials. Thus, HAS proposes points of attention that should be considered providing a manufacturer wants to submit a dossier based on uncontrolled trial(s) only. They are summarised below and are detailed in box 1. Any deviation from these points of attention will further impair the certainty of results.

Box 1

Methodological points of attention HAS should consider when assessing an external comparison between an uncontrolled trial and an external control

  1. Justification of the lack of randomisation

  2. Study design

    • Early planning during clinical development and before the conduct of the uncontrolled trial of the treatment of interest.

    • A priori definition of the clinical question, study population, intervention, comparator and outcomes in a protocol and statistical analysis plan.

    • An emulation of a target trial can enhance eliciting the appropriate clinical question (estimand) and designing the external comparison.

  3. Search and selection of relevant sources of data

    • Well-performed systematic review identifying relevant prognostic variables, confounders and effect modifiers.

    • Well-performed systematic review (with eligibility criteria defined a priori) identifying relevant sources for external control.

  4. Choice of the external control

    • The comparator and external source(s) of data has been chosen independently of the results of the uncontrolled trial, fit best the clinical question (does not arbitrarily favour the treatment of interest) and correspond to standard of care.

  5. Analysis of the results

    • The study protocol, statistical analysis plan and report allow a transparent and appropriate assessment of the study.

    • A model for causal inference controlling an appropriate set of confounders and targeting the predefined estimand has been properly specified and estimated.

    • The model is preferably based on a method using individual patient data only such as propensity scores, g-computation or doubly robust estimation.

    • Underlying assumptions have been explored and seems to be met (such as positivity, sufficient overlap and sufficient balance for propensity scores).

    • If ‘trimming’ (ie, excluding patients in areas of the propensity score without overlap) have been performed, the resulting target population for which results can apply is described.

    • Residual confounding has been explored with analyses such as the use of negative and positive controls, consistency in results when using other external controls, or quantitative bias analysis and excludes a conclusion of no treatment effect.

    • Study characteristics of the uncontrolled trial and external control are sufficiently similar for excluding other sources of bias such as selection bias, attrition bias, measurement bias.

    • Safety can be properly documented for both groups.

  6. Grading the clinical added value

Justifying the suitability of the data generation programme

Lack of randomisation is a major deviation from evidence-based medicine principles and should remain an exceptional option. Therefore, a rationale for the lack of randomisation must be provided by the manufacturer. They are invited to discuss the suitability of the evidence data package during European joint scientific consultations or national early dialogues.

Gathering source(s) of data for external comparison

Performing an adequate comparison vs an external control, using for example data from cohorts or other clinical trials, can be an option for mitigating uncertainties in the absence of RCTs. Availability of external controls may be scarce (eg, in case of targeted therapies for very rare mutation(s) in oncology). Real-world data generation should therefore be anticipated by the manufacturer during the early stages of the clinical development if no pre-existing data set has been identified for the comparison.

Performing transparent and appropriate analyses

To follow an hypothetico-deductive approach, external comparison must be planned as early as possible during clinical development. The framework of the emulation of a target trial can help to define the appropriate estimand, eligibility criteria as well as exposition and outcome(s) of the targeted (ie, ideal) RCT that the external comparison tries to emulate.15 It also helps to avoid the occurrence of immortal-time bias that results from a failure to align start of follow-up.

To avoid a post hoc selection, the choice of an external control must be done prior to conducting the trial, after a well-performed systematic search. It must fit the standard of care. The retained external source of data must be chosen because it fits best the research question and not because it would arbitrarily favour the treatment of interest.

When performing an external comparison, the attribution of the observed effect to the treatment (causal statement) supposes the absence of any confounders. It requires a well performed causal inference analysis, suing appropriate methods. Approaches based on the use of individual patient data only are preferred (eg, propensity scores analysis, g-computation, doubly robust estimation). Indeed, population-based adjusted methods using individual patient data from an uncontrolled trial and aggregate statistics from external data are sometimes considered. However, they rely on the assumption of the conditional constancy of absolute effects (ie, the absolute treatment effects are assumed constant at any given level of the effect modifiers and prognostic variables),16 which is unlikely to be met. To select the appropriate set of covariables to use for conditioning the statistical analyses, a well-performed systematic search of prognosis variables, confounders and effect modifiers must be conducted.

The possibility of residual confounding must be discussed. All methods assume exhaustivity of the confounders considered, a property that will ultimately remain unverifiable. This discussion should not be based on expert opinion only and should be documented, for example, using either negative or positive controls, or a quantitative bias analysis. Sources of bias (eg, selection bias, measurement bias) due to the characteristics of the trial and external control(s) must be discussed.

Safety must be properly documented, including for the external control.

Discussion of cross-cutting implications

This paper delineates proposals for an adequate balance between fast access to valuable medicinal products and performing relevant HTA. RCT, as the simplest and most consensual design for allowing causal reasoning, must be systematically considered for clinical development. However, various adaptations of its design, as proposed in table 1, may accelerate clinical development and are encouraged whenever appropriate.

Conducting uncontrolled trials is regularly justified by arguing that randomisation is deemed unfeasible, or that there is a conflict between individual and collective ethics because there is no other alternative than best supportive care. However, results from meta-epidemiological studies showed that RCTs are regularly conducted when investigating rare diseases, even vs placebo, providing clinical equipoise (ie, the genuine uncertainty regarding the benefit of a new treatment) is appropriately explained to patients.17 Urgent response to an emergent disease, or a strong pathophysiological rationale, are also frequently argued to justify the absence of RCTs. But, randomising the first patients when an emergent disease occurs has been considered ethically appropriate for decades, as it leads to the quickest generation of evidence with the highest certainty of results.18 A strong pathophysiological rationale does not necessarily translate into clinical value and what is considered an ‘innovative’ treatment should be based on clinical evidence. Therefore, HAS cannot propose a definitive list of conditions where absence of randomisation would be de facto acceptable.

To some extent, HAS acknowledges that exceptional conditions may exist that make it unreasonable to conduct an RCT. From the HAS perspective, evidence must, however, still comply to a hypothetico-deductive approach allowing causal reasoning. Should an uncontrolled trial with a comparison vs an external control be provided, the methodological points of attention HAS should consider are described in box 1 to reduce uncertainty. Most of these points of attention (sections 2–5 of box 1) allow assessing factual elements according to good clinical and statistical principles. As such, they could be proposed as consistent points of attention applicable by different HTAbs when assessing external comparisons. However, the acceptance of the rationale justifying the lack of randomisation, as well as some elements leading to the appraisal of clinical added value (eg, relevance and magnitude of treatment effect, impact on public health), are relative to the organisation of health systems and must be assessed considering the national context.

A consequence of relying increasingly on uncontrolled trials as pivotal evidence would be a shift in demonstrating the effectiveness of medicinal products during clinical development towards post-approval. In this context, the use of real-world data, as primary or complementary source of data, is a possible way to address remaining uncertainties. Regardless of the source of data, quality of study design is a cornerstone for certainty of results. To close evidence gap quickly, appropriate studies must thus be anticipated and not limited to uncontrolled designs.19 Usage of real-world data and compliance to RCT design should not be seen as antinomic. When appropriate, the conduct of RCTs can be facilitated by collecting some of the necessary data from pre-existing databases (see table 1). In addition, HAS calls for greater transparency in the whole process of generating evidence through initiatives such as registered report publications, data and clinical study reports sharing.20

Finally, HAS will remain attentive to emerging methods to reduce evidence gaps and accelerate clinical developments. In particular, the increasing use of artificial intelligence, in silico trials and disease modelling, might become a complementary path to optimising clinical development, as illustrated by CRESIM in helping to choose the best design in rare diseases.21 22

Conclusion

Decisions for reimbursement in France are based on an assessment and appraisal process performed by an independent HAS committee which includes healthcare providers, methodologists and patients’ representatives. Members of HAS and especially this committee are eager to secure rapid patient access to valuable medicinal products and that must be weighed against the duty to propose treatment with a clear demonstration of their clinical added value. As evidence-based medicine is an impartial decision model for coverage authorisations and as causal reasoning is essential for continuous improvement of care, HAS reaffirms the importance of RCTs to establish the value of new treatments. However, to balance rapid access for patients with evidential uncertainties, the traditional fixed-sample RCT design can be adapted. Moreover, properly conducted external comparisons as detailed in this paper may represent reasonable alternatives under exceptional conditions.

Ethics statements

Patient consent for publication

The World’s Most Innovative Medical Device Companies in 2023

The World’s Most Innovative Medical Device Companies in 2023

For the 2nd consecutive yr, Quickly Firm has regarded 10 clinical product firms as aspect of its once-a-year Most Progressive Businesses Checklist.

“The pandemic underscored the importance of overall health and how a deficiency of it can shut down the world as we know it,” Rapid Firm’s Shalene Gupta writes. “Even amid overburdened hospital systems and burned-out employees, there has been no lack of corporations seeking to enable mature the abilities of clinicians by means of revolutionary equipment.”

1. Scopio Labs

The magazine recognized Tel Aviv, Israel-based Scopio Labs, “for planning a more clever way to count blood cells.”

Scopio has produced an synthetic intelligence platform to automate analyzing peripheral blood smear (PBS) assessments as opposed to an analyst with a microscopt counting the cells manually. The firm obtained Food and drug administration clearance in June 2022 for its X100HT system with PBS application. Coupling higher throughput capabilities with the maximum resolution for hematological evaluation, the X100HT (proven on the suitable in the photograph under) caters to significant health care facilities and labs across the globe.

Picture courtesy of Scorpio LabsNamed one of Fast Company's most innovative medical device companies in the world, Scorpio Labs has developed an AI platform for counting blood cells.

In handbook microscopy, people should opt for in between a big subject of look at or superior resolution. Scopio’s devices reduce that tradeoff completely, capturing big scan parts at 100X magnification. Holding 30 slides and processing up to 40 samples an hour, Scopio’s X100HT can meet up with the higher throughput needs of huge hospitals and labs, when entirely supporting distant evaluation capabilities, enabling a new subfield of telehematology. Hospital and lab networks can now operate seamlessly throughout a number of amenities of all sizes, with workload balancing, remote consultations, addressing personnel shortages and additional.

2. Professional medical Microinstruments

Pisa, Italy-centered Health-related Microinstruments produced the Symani Surgical Method to permit microsurgery and expand the industry of supermicrosurgery. 

Microsurgery is the manipulation or suturing of very tiny anatomy this kind of as arteries, veins, ducts, or nerves. These procedures demand large visible magnification and specialised precision instruments as very well as innovative good motor abilities. Supermicrosurgery is microsurgery on an even smaller sized scale. Symani is intended to enable this fragile get the job done by including precision that not each and every surgeon can attain, even with substantial education, when manually suturing really tiny vessels.

Picture courtesy of Health-related MicroinstrumentsMedical Microinstruments, developer of devices for microsurgery and super microsurgery, has been named one of the most innovative medical device companies in the world by Fast Company.

Currently, throughout Europe, the Symani Surgical Program is getting applied in reconstructive plastic surgeries, lymphatic surgeries, orthopedic surgeries and head and neck surgeries. The organization claimed it is doing work to extend indications and to assist ongoing commercialization initiatives for the Symani Surgical Procedure in Europe, the place it acquired CE mark certification in 2019.

Last calendar year, Health-related Microinstruments secured 12 new patents and raised $75 million in funding, Quickly Firm famous.

3. Xenco Healthcare

Extending the scope of its health care improvements to incorporate digitally-driven technologies that have amplified the impression of its surgical systems, San Diego, CA-primarily based Xenco Professional medical released the first WiFi-enabled surgical vending machines for true-time inventory monitoring of Xenco Medical’s implant systems as very well as the world’s initially glasses-cost-free holographic surgical simulation platform (demonstrated in the photo below), enabling surgeons to simulate holographic spine operation employing digital spinal implants dependent on Xenco Medical’s precise implants in open, holographic space. Maximizing the operational efficiency of outpatient medical procedures centers across the country as a result of its streamlined Multilevel CerviKit, Xenco said its logistics-optimized spinal devices have boosted surgical turnover moments by eradicating the will need for the sterilization and reprocessing of metal-based mostly spinal units amongst surgical procedures. The company’s portfolio of sterile-packaged spinal implants pre-attached to disposable, composite polymer supply instruments and suite of novel, software package-based technologies have heralded a price-based technique to healthcare. The enterprise built the record of most ground breaking healthcare device businesses “for slicing backbone surgical procedures periods in fifty percent,” Fast Business mentioned.

Picture courtesy of Xenco HealthcareXenco Medical was named one of the most innovative medical device companies in 2023 by Fast Company

4. Bigfoot Biomedical

Chosen as a single of the most ground breaking health care unit providers “for inventing a smarter way to manage diabetes,” Milpitas, CA-primarily based Bigfoot Biomedical has extensive been a most loved of MD+DI readers. The firm was our reader’s choice for 2017 Medtech Corporation of the Yr.

“The hopes of thousands and thousands of diabetics are waiting on them,” one particular MD+DI reader wrote. “They have a individual connection which motivates them product and price tag-clever, and they made a great choice to switch from DexCom to Freestyle Libre as the constant glucose keep an eye on for their system, delaying the release by going with a superior item. That’s what businesses who Treatment do.”

A lot of audience that calendar year also cited Bigfoot’s affected individual target as a reason for their selection.

“In the location of diabetic issues, there are numerous firms functioning to build this ‘artificial pancreas.’ What a lot of of them you should not comprehend is that their answers are not easy for clients and their caregivers to control. They include several units and complicated technologies,” one more MD+DI reader wrote. “Bigfoot Biomedical is working difficult to make their alternative easy to use, as nicely as correct and trustworthy.”

Bigfoot was also a winner in the 2022 Clinical Structure Excellence Awards for its Bigfoot Unity technique for diabetic issues administration (pictured underneath). According to the business, the Bigfoot Unity reimagines cure for individuals with diabetic issues with a holistic alternative that includes first-of-its-kind wise insulin pen caps providing on-demand from customers dose suggestions built-in with a cloud-based system that seamlessly connects patients to their clinicians to empower proactive, remote care with simplicity, effectiveness, and ease.

Graphic courtesy of Bigfoot BiomedicalBigfoot Biomedical's Bigfoot Unity diabetes management system.

5. Integrum

Mölndal, Sweden-based mostly Integrum was selected by Speedy Firm as just one of the most progressive professional medical machine companies “for generating prosthetics that stay on far better.”

Integrum developed a bone-anchored three-piece OPRA Implant Technique, in which the prosthetic is screwed on to an anchor. After a 12-year-very long scientific demo approach, OPRA gained Fda approval in December 2020, Rapidly Business famous. Previous year, the organization concentrated on introducing OPRA to hospital companions in the United States. Also, earlier this month, Integrum received an EU Health care Unit Regulation certification for the OPRA system.

6. Tivic Overall health

In accordance to Rapid Enterprise, Tivic Health’s ClearUp gadget is intended to carefully encourage nerves making use of low-level electricity to do away with sinus ache, sinus headaches, and congestion. Last 12 months, Tivic Health acquired the Reliefband merchandise line for nausea cure and all related property from Reliefband Technologies.

7. Circadia Well being

London, England-based Circadia has created a contactless radar sensor built to allow for 24/7, continuous, non-invasive essential signs measurement, without any enter needed by medical personnel, Rapidly Corporation observed. In 2020, Circadia received expedited Fda clearance for Contactless Respiration Amount (CResp) monitoring owing to COVID-19. The C100 System uses radar to perception wirelessly, from up to 4 ft absent in adult individuals. Steady CResp will help clinicians and conserve affected individual lives, by predicting and protecting against respiratory complications as a result of early warning scores, enabling timely interventions. The C100 characteristics a radar sensor, proprietary radar Sign Evaluation Engineering, and cloud-primarily based software for early detection of affected person deterioration to augment scientific conclusion creating, Circadia noted.

8. Freespira

Freespira has developed a sensor that actions respiratory charges and CO2 ranges and displays them on a tablet so people can visualize their breathing styles. The company built the listing of most innovative clinical product companies “for giving PTSD people respiratory room,” Fast Business famous. Using this technique, Freespira helps patients normalize their respiration and minimize worry assaults and PTSD signs.

9. BrainsWay

Speedy Business named BrainsWay one of the most innovative health care system companies “for utilizing magnetic stimulation to take care of depression.”

The Jerusalem, Israel-primarily based firm has created a treatment that utilizes magnetic waves to promote nerve cells in the brain. In 2018, BrainsWy received de novo clearance from Food and drug administration for its deep transcranial magnetic stimulation procedure for the cure of OCD in grown ups. Last August, Fda cleared the company’s H7 coil for nervous despair and melancholy, Fast Company described.

10. Ceribell

In 2019, Mountain Perspective, CA-based Ceribell took dwelling the top prize at the Professional medical Design and style Excellence Awards ceremony. The business received ideal-in-display that 12 months for the Ceribell Fast Reaction EEG. The machine is made up of a disposable headband and a cell recorder that acquires and transmits facts to a HIPAA compliant cloud portal for a expert to evaluate the patient’s EEG from any place. Ceribell created Quickly Company’s list of most progressive medical system organizations this 12 months “for planning a extra powerful way to detect seizures.”

In September, the enterprise pushed the technique even even more into the mainstream, Rapidly Corporation pointed out, obtaining a breakthrough device designation from Fda for delirium detection.

‘I’m grateful my son is not wasting away’: Jamaica’s innovative approach to mental healthcare | Global development

‘I’m grateful my son is not wasting away’: Jamaica’s innovative approach to mental healthcare | Global development

“JamaiCAN,” reads a mural at one of the entrance gates to Bellevue, Jamaica’s only psychiatric hospital. The name of the old powder-pink building near Kingston’s upmarket waterfront is recognisable to any Jamaican and is shrouded in stigma.

An illustration about the mental health campaign, You are not alone, Together we CAN, JamaiCan, from Bellevue psychiatric hospital, Kingston.
A mural announces the mental health campaign ‘JamaiCan’ at Bellevue psychiatric hospital, Kingston. Photograph: Courtesy of Bellevue psychiatric hospital

Built as a colonial lunatic asylum in the 19th century, it had been a tool of political repression, serving as prison for Rastafarian luminaries, forefathers of pan-Africanism, and other Jamaicans who challenged British racial oppression. After independence, media coverage of Bellevue was dominated by stories of poor treatment of patients and threadbare facilities.

Staff and directors are today determined to transform the hospital into a modern treatment centre, building on decades of Jamaica’s pioneering mental health policies. But one barrier keeps emerging: resources.

“It’s really challenging to get focus on non-communicable diseases, and mental health is a fraction of the focus on non-communicable diseases,” says Ishtar Govia, a member of Bellevue’s board of directors and a researcher at the University of the West Indies.

Quick Guide

A common condition

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The human toll of non-communicable diseases (NCDs) is huge and rising. These illnesses end the lives of approximately 41 million of the 56 million people who die every year – and three quarters of them are in the developing world.

NCDs are simply that; unlike, say, a virus, you can’t catch them. Instead, they are caused by a combination of genetic, physiological, environmental and behavioural factors. The main types are cancers, chronic respiratory illnesses, diabetes and cardiovascular disease – heart attacks and stroke. Approximately 80{08cd930984ace14b54ef017cfb82c397b10f0f7d5e03e6413ad93bb8e636217f} are preventable, and all are on the rise, spreading inexorably around the world as ageing populations and lifestyles pushed by economic growth and urbanisation make being unhealthy a global phenomenon.

NCDs, once seen as illnesses of the wealthy, now have a grip on the poor. Disease, disability and death are perfectly designed to create and widen inequality – and being poor makes it less likely you will be diagnosed accurately or treated.

Investment in tackling these common and chronic conditions that kill 71{08cd930984ace14b54ef017cfb82c397b10f0f7d5e03e6413ad93bb8e636217f} of us is incredibly low, while the cost to families, economies and communities is staggeringly high.

In low-income countries NCDs – typically slow and debilitating illnesses – are seeing a fraction of the money needed being invested or donated. Attention remains focused on the threats from communicable diseases, yet cancer death rates have long sped past the death toll from malaria, TB and HIV/Aids combined.

‘A common condition’ is a Guardian series reporting on NCDs in the developing world: their prevalence, the solutions, the causes and consequences, telling the stories of people living with these illnesses.

Tracy McVeigh, editor

Thank you for your feedback.

Up to 80{08cd930984ace14b54ef017cfb82c397b10f0f7d5e03e6413ad93bb8e636217f} of people with mental disorders live in low and middle-income countries. And while mental health has received increased attention after the Covid pandemic, this has not been reflected in global funding for psychiatric health, says Rebecca Gribble from Georgetown University.

According to her research, only 0.3{08cd930984ace14b54ef017cfb82c397b10f0f7d5e03e6413ad93bb8e636217f} of global health development funding is dedicated solely to mental health projects.

“Donors like to put their money towards things that get quantifiable results,” Gribble says. “With mental health that is more difficult to measure than with viruses, for example.”

However Jamaica, unlike many low and middle-income countries, has been at the forefront of mental health innovation over the past 50 years. After gaining independence in 1962, Jamaica became one of the first countries in the world to take decisive steps to deinstitutionalise its mental health system and integrate it into primary healthcare, despite limited resources.

Today, up to 80{08cd930984ace14b54ef017cfb82c397b10f0f7d5e03e6413ad93bb8e636217f} of Jamaicans with chronic mental illness are not hospitalised in Bellevue but receive treatment in local health centres or at home, thanks to mobile teams made up of psychiatrists and specially trained nurses.

This approach provides a useful task-sharing model for countries looking to restructure their mental health services, says André van Rensburg from the University of KwaZulu-Natal in South Africa, who has been researching deinstitionalisation in low and middle-income countries.

Prof Frederick Hickling, the senior medical officer at Bellevue in the 1970s and 1980s, led the shift away from the custodial approach to mental healthcare inherited from Britain.
Prof Frederick Hickling, the senior medical officer at Bellevue in the 1970s and 1980s, led the shift away from the custodial approach to mental healthcare inherited from Britain. Photograph: Handout

The Jamaican model was introduced by the late Professor Frederick Hickling, who was the senior medical officer at Bellevue throughout the 1970s and 1980s – the highest psychiatric post in the country.

Hickling was determined to move the country away from the custodial treatment style inherited from Britain, whereby mentally ill patients were detained in hospitals against their will – as is still the case in many low and middle-income countries.

“Post independence we had limited financial resources and a population traumatised by colonialism and the legacy of slavery,” says Geoffrey Walcott from the Caribbean Institute of Mental Health and Substance Abuse, founded by Hickling. “We had to find novel ways to restructure our system.”

By allowing patients to receive healthcare without being committed to Bellevue, Hickling hoped to avoid the shame associated with mental illness while making treatment more accessible and cost-effective. Nearly half of Jamaicans live in rural areas, a costly journey away from Kingston’s Bellevue, while fewer than 10{08cd930984ace14b54ef017cfb82c397b10f0f7d5e03e6413ad93bb8e636217f} own a car.

Hickling also sought to minimise involuntary treatment.

Dr Geoffrey Walcott, from the Caribbean Institute of Mental Health and Substance Abuse, says: If patients are part of the decision-making process and accept treatment, they are more likely to recover. and remain well.’
Dr Geoffrey Walcott says: ‘If patients are part of the decision-making process and accept treatment, they are more likely to recover and remain well.’ Photograph: Mary Fowles/The Guardian

“What we found is that if patients are part of the decision-making process and accept treatment, they are more likely to recover and remain well over a long-term period,” says Walcott, a former student of Hickling. “The biggest cause of relapse, especially for patients with schizophrenia, is non-compliance with treatment. When a patient is onboard with their medication, the relapse rate can be cut from 50{08cd930984ace14b54ef017cfb82c397b10f0f7d5e03e6413ad93bb8e636217f} to 3{08cd930984ace14b54ef017cfb82c397b10f0f7d5e03e6413ad93bb8e636217f}.”

Walcott recalls attending to a mentally ill man, armed with a knife and a machete, who had been apprehended by the police. “We opted not to take him involuntarily to a hospital and, while keeping his machete and his knife, he accepted treatment,” Walcott says.

After three weeks of treatment the man was lucid enough to cooperate with Bellevue’s social work team. “The team was able to find his brother and within six months the man was reintegrated into his family while taking long-acting injectables to manage his condition. Today, deinstutionalisation is baked into our healthcare model.”

But while Jamaica has found innovative ways to deliver mental healthcare to its citizens, this has not meant the end of challenges for the island as resources remain scarce.

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“I am grateful that my son is not wasting away in some hospital,” says Yvonne McKenzie, whose son Andrew, 39, has bipolar disorder. “But I don’t feel supported by the system. I feel alone.”

For McKenzie, the mental healthcare model which centres on family and community cooperation means that, in the face of limited resources, the responsibility for managing illness can disproportionately fall on women.

Yvonne McKenzie at her home in St Thomas. Her 39-year-old son has bipolar disorder and is being treated by Dr Walcott.
Yvonne McKenzie at her home in St Thomas, Surrey, Jamaica. Her 39-year-old son has bipolar disorder and is being treated by Dr Walcott. Photograph: Mary Fowles/The Guardian

“I have seen my son’s psychiatrist more times than I can count, but I don’t think Andrew’s dad has spoken to him once,” McKenzie says. “Andrew was diagnosed in his late teens. Since then, I have been journeying with that diagnosis single-handedly.

“What I fear the most”, she says, “is what will happen to him after I am gone.”

Inge Petersen, a professor of public mental health at University of KwaZulu-Natal, says: “To help patients live in the community families need to be offered support. Often in low and middle-income countries the money does not follow the patient after they are discharged from hospital.”

In 2016, 95{08cd930984ace14b54ef017cfb82c397b10f0f7d5e03e6413ad93bb8e636217f} of the mental health expenditure of the Jamaican health ministry was dedicated to Bellevue hospital, although the facility offered treatment to only 22{08cd930984ace14b54ef017cfb82c397b10f0f7d5e03e6413ad93bb8e636217f} of Jamaica’s mental health patients, according to an internal audit.

The policy commitment to deinstitutionalisation is further undermined by 2020 WHO data, which shows that more than 61{08cd930984ace14b54ef017cfb82c397b10f0f7d5e03e6413ad93bb8e636217f} of Jamaicans hospitalised for mental illness had been in hospital for more than five years.

Finding a way to reintegrate long-term residents into the community, some of whom have lived at the hospital for more than 30 years, is now Bellevue’s priority.

“It’s not possible to rehome every single resident,” Govia says. “We are working to create a transitional adult care facility.”

However, the hospital relies on NGO cooperation. “We may have the best of intentions”, Govia says, “but we really need to get the buy-in from third-sector organisations to be able to realise them.”

“Countries can have wonderful policies,” says Petersen. “But what is really required is technical support for governments in low and middle-income countries to implement successful deinstitionalisation.”

Posters at Bellevue remember musician Bob Marley, who died in 1981, and Prof Hickling, who died in 2020.
Posters at Bellevue hospital remember musician Bob Marley, who died in 1981, and Prof Hickling, who died in 2020. Photograph: Mary Fowles/The Guardian

Petersen would like to see a pool of global funding dedicated to implementing efficient mental health policies, similar to the resources available for treatment of HIV.

Govia’s long-term hopes for Bellevue include a world-class neurocognitive psychiatric facility. She also hopes that the hospital will become an example of successful transformation.

“I would love it if, in the next 50 years, Bellevue would provide insight into how to transform effective long-term care,” she says. “In Jamaica, the resource constraints have led us to find creative and cross-sectoral solutions. Even if the fruits are not fully visible yet, the insight and experience Jamaican psychiatrists can provide are important.”

CareCloud to Unveil Innovative EHR Therapy Platform at

CareCloud to Unveil Innovative EHR Therapy Platform at

CareCloud will showcase how its new therapy-targeted EHR model can strengthen affected person treatment, results and the base line for therapy methods

SOMERSET, N.J., Jan. 26, 2023 (Globe NEWSWIRE) — CareCloud, Inc. (Nasdaq: CCLD, CCLDP, CCLDO), a chief in healthcare technology remedies for medical procedures and overall health techniques nationwide, now declared it will unveil a new model of an digital wellbeing history (EHR) system that has been personalized to include attributes distinct to bodily therapy at the upcoming American Actual physical Remedy Association’s (APTA) Merged Sections Meeting (CSM). The firm will exhibit in booth 2444 at the event, which will consider location February 23-25 in San Diego, California.

The improved model of CareCloud’s talkEHR, anticipated to be produced later on in the 1st quarter of 2023, incorporates features tailored to actual physical remedy methods and provides therapists with a detailed and uncomplicated-to-use tool for taking care of affected person info and tracking development. It was built to be built-in and included with a treatment-focused electronic overall health solution called CareCloud Remote, launched early in 2022. Remote, which has obtained good evaluations from CareCloud leading therapy consumers, can integrate with other market-main therapy EHR methods. It is a tested digital wellbeing alternative that will help competent household-care practices realize operational excellence. Distant offers utmost business flexibility and drives efficiencies in profits cycle management, referral administration and credentialing, individual communications, tracking and scheduling, and client feedback.

“We’re thrilled to be participating at the APTA CSM and to showcase how our new EHR adaptation strengthens CareCloud Distant and can boost affected person care, outcomes and the base line for therapy tactics,” stated CareCloud Senior Vice President of Technique Alfonso Nardi, who will be onsite at the APTA CSM function. “CareCloud Distant has by now served elevate organizations’ workflow administration by employing a focused staff of gurus to streamline referral management, and a proprietary developed-in algorithm with spot monitoring to get clinicians to sufferers on time. Distant also provides know-how-enabled revenue cycle administration driven by automation that can simplify administrative procedures, enhance workflows, and enhance the affected individual experience. With the addition of our new EHR version, CareCloud customers can now leverage the simplicity of our conclusion-to-end remedy option, which we think satisfies the wants of the therapy marketplace greater than any other system accessible.”

For more details about CareCloud’s comprehensive suite of technologies-enabled expert services and solutions, take a look at carecloud.com/options, or cease by the CareCloud booth in the course of the APTA CSM.

About CareCloud
CareCloud (Nasdaq: CCLD, CCLDP, CCLDO) provides disciplined innovation to the enterprise of healthcare. Our suite of technological innovation-enabled solutions allows consumers enhance financial and operational performance, streamline scientific workflows and increase the client practical experience. Far more than 40,000 providers count on CareCloud to strengthen individual treatment, when minimizing administrative burdens and functioning costs. Discover a lot more about our products and services, like earnings cycle management (RCM), observe administration (PM), digital well being data (EHR), organization intelligence, individual practical experience administration (PXM) and electronic wellbeing, at www.carecloud.com.

Follow CareCloud on LinkedIn, Twitter and Facebook.

Ahead-Searching Statements

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Our operations entail pitfalls and uncertainties, a lot of of which are outside our regulate, and any a person of which, or a mix of which, could materially influence our effects of operations and whether or not the ahead-wanting statements finally confirm to be proper. Forward-searching statements in this press launch include, without limitation, statements reflecting management’s anticipations for long term money functionality and operating expenditures, envisioned expansion, profitability and business enterprise outlook, the effects of the Covid-19 pandemic on our economic general performance and organization functions, and the envisioned results from the integration of our acquisitions.

These forward-on the lookout statements are neither historic details nor assurances of potential functionality. Rather, they are only predictions, are uncertain and include sizeable identified and mysterious challenges, uncertainties and other variables which may perhaps induce our (or our industry’s) true results, amounts of action or general performance to be materially various from any long run results, concentrations of action or performance expressed or implied by these ahead-looking statements. New threats and uncertainties arise from time to time, and it is not doable for us to predict all of the hazards and uncertainties that could have an influence on the ahead-looking statements, such as without the need of limitation, threats and uncertainties relating to the Company’s capacity to control progress, migrate newly acquired prospects and retain new and present shoppers, manage price tag-helpful world operations, raise operational efficiency and cut down working expenses, predict and effectively alter to alterations in reimbursement and other market polices and trends, retain the solutions of key personnel, build new technologies, upgrade and adapt legacy and obtained technologies to get the job done with evolving industry requirements, contend with other companies’ products and products and services competitive with ours, and other vital dangers and uncertainties referenced and talked about below the heading titled “Risk Factors” in the Company’s filings with the Securities and Trade Commission. In addition, there is uncertainty about the spread of the Covid-19 virus and the effect it might have on the Company’s functions, the need for the Company’s companies, and financial exercise in typical.

The statements in this press release are produced as of the day of this press release, even if subsequently manufactured accessible by the Firm on its web-site or otherwise. The Company does not believe any obligations to update the ahead-seeking statements delivered to reflect occasions that come about or situations that exist immediately after the day on which they were being manufactured.

SOURCE CareCloud

Company Get in touch with:
Invoice Korn
Main Monetary Officer
CareCloud
bkorn@carecloud.com

Trader Make contact with:
Asher Dewhurst
ICR Westwicke
CareCloudIR@westwicke.com

Media Inquiries:
Alexis Feinberg
ICR Westwicke
CareCloudPR@westwicke.com

MaineHealth Partners with Roux Institute at Northeastern University on Innovative Founder Residency

MaineHealth Partners with Roux Institute at Northeastern University on Innovative Founder Residency

Make contact with: Caroline Cornish
caroline.cornish@mainehealth.org

PORTLAND, Maine – MaineHealth is earning a $500,000 financial investment in overall health-tech innovation above the following 3 yrs by partnering with the Roux Institute at Northeastern College and Northern Light Wellbeing in The Upcoming of Health care Founder Residency. This initial-of-its-kind software aims to provide 30 early-phase well being-tech companies to Maine over the subsequent 3 many years, offering them with cash, pro tips, and clinical environments to exam their strategies.

Founders get a $50,000 investment and invest 12 months operating out of the Roux Institute at Northeastern University to produce, vet and demo artistic methods to complicated complications facing Maine’s healthcare industry. MaineHealth will not only provide some of the funding but also its wellbeing treatment experience and obtain to clinical areas wherever founders can trial their strategies. MaineHealth people will reward from early obtain to chopping-edge care, and MaineHealth will have an equity stake in profitable companies.

“Innovation is a core benefit for MaineHealth and important to supporting our eyesight of doing work alongside one another so our communities are the healthiest in The us,” claimed Susan Ahern, Vice President of Innovation at MaineHealth. “We are thrilled to assistance all those seeking for tomorrow’s novel answers to intricate difficulties our care crew faces just about every day.”

The very first cohort of Founders will start their residency in Spring 2023. Discover much more about the system.

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About MaineHealth:
MaineHealth is a not-for-income built-in overall health program whose vision is “Working alongside one another so our communities are the healthiest in America.” It is made up of nine local wellbeing programs, a extensive behavioral health care community, diagnostic services, house health companies, and 1,700 utilized suppliers performing together by means of the MaineHealth Professional medical Team. With somewhere around 22,000 staff members, MaineHealth delivers preventive care, analysis and therapy to 1.1 million residents in Maine and New Hampshire. It consists of Franklin Memorial Hospital/Franklin Neighborhood Wellness Network in Farmington, LincolnHealth in Damariscotta and Boothbay Harbor, Maine Behavioral Healthcare in South Portland, MaineHealth Care at Residence in Saco, Maine Healthcare Middle in Portland, Memorial Clinic in North Conway, N.H., Mid Coast-Parkview Health in Brunswick, NorDx in Scarborough, Pen Bay Clinical Middle and Waldo County General Clinic in Rockport and Belfast, Southern Maine Health Treatment in Biddeford and Sanford, Spring Harbor Healthcare facility in Westbrook and Stephens Memorial Hospital/Western Maine Wellness Treatment in Norway. MaineHealth Affiliates incorporate Maine Typical Health in Augusta and Waterville, New England Rehabilitation Healthcare facility in Portland and St. Mary’s Regional Medical Middle in Lewiston. It is also a sizeable stakeholder in the MaineHealth Accountable Treatment Organization in Portland.

About the Roux Institute at Northeastern College
The Roux Institute in Portland, Maine is made as an engine of innovation, talent–building, and economic growth for Portland, Maine, and northern New England. Partnerships set the design of graduate training and investigate apart. With major organizations and nonprofit companies at the desk from working day one particular, the Roux Institute generates programs that are planning the workforce to continue to be agile and prosper in a competitive landscape driven by artificial intelligence. The Roux Institute, as an R1 international investigate college, is nurturing an surroundings for substantial-affect investigation and innovation in laptop or computer and facts science, electronic engineering, the sophisticated life sciences and medicine, and other tech fields. And the Roux allows entrepreneurs launch firms focused on and powered by technological innovation. Together, with our companions, we are creating an innovation corridor that will stretch from Boston to Portland and outside of. For more facts: www.roux.northeastern.edu/