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chloesunit4 · 8 months

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Facts of disability:

Disability is an essential component of the human experience. It is caused by the combination of health disorders such as dementia, blindness, or spinal cord damage, as well as a variety of environmental and personal circumstances. Today, an estimated 1.3 billion individuals, or 16% of the world population, have a major impairment. This figure is rising due to an increase in noncommunicable illnesses and individuals living longer lives. Persons with disabilities are a varied population, and characteristics such as gender, age, gender identity, sexual orientation, religion, colour, ethnicity, and economic condition all have an impact on their life experiences and health requirements. People with impairments die younger, have lower health, and have greater limits in daily functioning than others.

An estimated 1.3 billion people experience significant disability. This represents 16% of the world’s population, or 1 in 6 of us.

Some persons with disabilities die up to 20 years earlier than those without disabilities.

Persons with disabilities have twice the risk of developing conditions such as depression, asthma, diabetes, stroke, obesity or poor oral health.

Persons with disabilities face many health inequities.

Persons with disabilities find inaccessible and unaffordable transportation 15 times more difficult than for those without disabilities.

Health inequities arise from unfair conditions faced by persons with disabilities, including stigma, discrimination, poverty, exclusion from education and employment, and barriers faced in the health system itself.

Factors contributing to health inequities

Health inequities arise from unfair conditions faced by persons with disabilities.

Structural factors: Persons with disabilities experience ableism, stigma and discrimination in all facets of life, which affects their physical and mental health. Laws and policies may deny them the right to make their own decisions and allow a range of harmful practices in the health sector, such as forced sterilization, involuntary admission and treatment, and even institutionalization.

Social determinants of health: Poverty, exclusion from education and employment, and poor living conditions all add to the risk of poor health and unmet health care needs among persons with disabilities. Gaps in formal social support mechanisms mean that persons with disabilities are reliant on support from family members to engage in health and community activities, which not only disadvantages them but also their caregivers (who are mostly women and girls).

Risk factors: Persons with disabilities are more likely to have risk factors for non-communicable diseases, such as smoking, poor diet, alcohol consumption and a lack of physical activity. A key reason for this is that they are often left out of public health interventions.

Health system: Persons with disabilities face barriers in all aspects of the health system. For example, a lack of knowledge, negative attitudes and discriminatory practices among healthcare workers; inaccessible health facilities and information; and lack of information or data collection and analysis on disability, all contribute to health inequities faced by this group.

Referencing:

Brennan, C.S., Disability Rights During the Pandemic: A Global Report on Findings of the COVID-19 Disability Rights Monitor. 2020, COVID-19 Disability Rights Monitor.

Williamson, E.J., et al., Risks of COVID-19 hospital admission and death for people with learning disability: population based cohort study using the OpenSAFELY platform. BMJ, 2021. 374: p. n1592.

Baksh, R.A., et al., Understanding inequalities in COVID-19 outcomes following hospital admission for people with intellectual disability compared to the general population: a matched cohort study in the UK. BMJ Open, 2021. 11(10): p. e052482 Dunkle, K., et al., Disability and violence against women and girls. 2018, UKaid: London.

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o-behave · 5 years

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OPTIMISING PLACEBOS AND MINIMISING NOCEBOS

LESSONS FROM BEHAVIOURAL SCIENCE

By Chloe Hutchings-Hay, Analyst at Ogilvy Consulting’s Behavioural Science Practice

Placebo Effect

The placebo effect was first established when Henry Beecher, a World War II doctor, ran out of morphine, and decided to give his patients a salt-water injection instead. He was surprised to learn that many of his patients (around a third) responded as though they had actually received morphine.

Since then, the benefits of placebo have been observed in treatments for illnesses as disparate as depression and Parkinson’s disease. One study even found that sham shoulder surgeries were as effective at improving symptoms as the real surgery itself (Schroder et al., 2017).

Whilst initially these benefits were thought of as ‘fake’, and those who experienced placebo effects were deemed suggestible, growing evidence suggests that there are real neurobiological mechanisms underpinning placebo effects. Supporting this is the mounting evidence from open-label placebo studies, where improvement has still been observed even when patients know they are receiving a placebo (BMJ, 2018), suggesting that conditioning alone can bring about the placebo effect. What’s more, personality factors are shown to be less important in determining response to placebo than factors determined by the broader context, like expectancy effects and the quality of the doctor-patient relationship.

The understanding that the context is crucial in eliciting the placebo response lends itself to the use of behavioural nudges to optimise the placebo response. Doctors already routinely prescribe placebos in their practices (Howick et al., 2013). Understanding how to best optimise the placebo response is important for medicine generally, as the success of conventional treatments is also bolstered via the placebo effect.

How Can We Optimise the Placebo Effect?

1. Priming: Placebos need to look legitimate, with branding and pricing being especially important. One study found higher-priced painkillers to be more effective than discounted painkillers (Waber et al., 2008); higher prices anchor expectations upwards. The colour of pills is important too, with learned associations having an impact on how we respond to drugs. We associated blue pills with sedation, yellow pills with mood enhancement and white pills with pain relief (Cohen, 2014). Setting the scene with good branding, thoughtful design and realistic pricing is key.

2. Affect: Creating a positive therapeutic relationship between patient and doctor is vital in eliciting the placebo response; our expectations about the efficacy of the medication are largely set in this interaction. The placebo effect is enhanced when doctors are more empathetic, have a warmer approach and spend longer with their patients (Benedetti, 2013). An initial positive interaction can improve the expectation that treatment is going to work and helps to ease anxiety.

Nocebo Effect

Sometimes thought of as the ‘evil twin’ of the placebo effect is the nocebo effect, referring to the development of side-effects following exposure to a sham substance. Evidence for the nocebo effect also abounds, with sham medication leading to increased side-effect reporting for conditions including hypertension and cancer (Enck et al., 2013). Systematic reviews find that around half of placebo groups in clinical trials experience adverse effects that are attributed to the drug (Howick et al. 2018).

The nocebo effect is often observed during public health outbreaks, putting huge pressure onto health providers. For example, in 1985 ‘radioactive caesium 137’ was scavenged from a disused hospital site in Goiânia, Brazil. 120,000 people subsequently sought screening for radioactive contamination at health facilities, however of the first 60,000 people screened, only 5,000 were symptomatic. This begs the question; why do people sometimes think they are unwell when they haven’t been exposed to anything harmful?

People sometimes believe they are unwell because they re-interpret pre-existing common symptoms in light of information about the health outbreak, like fatigue or headaches. Anxiety about a health outbreak can also be sufficient in and of itself to also generate physical symptoms.

Aside from these influences, the nocebo effect can also have a very real influence on generating harmful side-effects, in the same way that placebo effects can have a tangible positive influence on the body. Expectancy, rather than conditioning, is the crucial mechanism underpinning the nocebo effect. One study found that verbal suggestion alone was sufficient to make low-level electric shocks be experienced as highly painful (Colloca, Sigaudo & Benedetti, 2008).

How Can We Minimise the Nocebo Effect?

1. Positive Framing: At present, we are often all too aware of the possible side-effects that may come about as a result of trying a new medication. Even mere mentions of such side-effects can be sufficient to generate expectations of such symptoms (Colloca, Sigaudo & Benedetti, 2008). These potential negative outcomes can weigh more heavily in our minds than the possible benefits.

Changing the conversation to make it more positive may subsequently lessen the experience of side-effects, with patients having greater expectancy that the treatment will be effective. Positive framing is needed in the doctor-patient interaction, but also on information leaflets and drug packaging, which at present tend to focus on the riskiness of medication, rather than the benefits.

2. Reducing Salience of Side-Effect Information: Research suggests that a particularly effective strategy to ward against nocebo effects is to omit information about side-effects altogether (Webster & Rubin, 2019), which poses something of an ethical dilemma. However, given that we know that people can experience side-effects just because they expect to experience them, it makes sense to be reporting on the potential for adverse experiences in a responsible way.

One example of this going wrong comes from press coverage over side-effects associated with statins. In 2013; it was estimated that 200,000 people in the UK stopped taking statins as a result. Expectancy of side-effects seemed to be sufficient for many people to change their perception of their experience of taking statins. As a result, it is predicted that the incidence of cardiovascular disease will rise by an additional 2000 cases over the next decade (Horton, 2016).

Tackling medical consent therefore poses something of a thorny issue: how do we adequately warn people of possible risks without inadvertently creating negative outcomes? There has been discussion over the idea of contextualised consent: where adverse effects are presented as more of a ‘grey area’, instead of a definite likelihood, and where doctors can withhold certain pieces of information in the best interest of the patient (Chamsi-Pasha, Albar & Chamsi-Pasha, 2017).

The use of placebos provides a cost-effective way to create tangible improvements in patients’ lives. Behavioural science is key to maximising the benefits from placebos, in part through limiting the likelihood of developing side-effects from taking them.

References

Benedetti, F. (2013). Placebo and the new physiology of the doctor-patient relationship. Physiological reviews, 93(3), 1207-1246.

Chamsi-Pasha, M., Albar, M. A., & Chamsi-Pasha, H. (2017). Minimizing nocebo effect: Pragmatic approach. Avicenna Journal of Medicine, 7(4), 139-143.

Cohen, T. F. (2014, October 13). The Power of Drug Color. Retrieved from: https://www.theatlantic.com/health/archive/2014/10/the-power-of-drug-color/381156/

Colloca, L., Sigaudo, M., & Benedetti, F. (2008). The role of learning in nocebo and placebo effects. Pain, 136(1-2), 211-218.

De Pascalis, V., Chiaradia, C., & Carotenuto, E. (2002). The contribution of suggestibility and expectation to placebo analgesia phenomenon in an experimental setting. Pain, 96 (3), 393-402. Enck, P., Bingel, U., Schedlowski, M., & Rief, W. (2013). The placebo response in medicine: minimize, maximize or personalize?Nature reviews Drug discovery,12(3), 191.

Horton, R. (2016). Offline: Lessons from the controversy over statins. The Lancet, 388(10049), 1040.

Howick, J., Bishop, F. L., Heneghan, C., Wolstenholme, J., Stevens, S., Hobbs, F. R., & Lewith, G. (2013). Placebo use in the United Kingdom: results from a national survey of primary care practitioners. PLoS One, 8(3), e58247.

Howick, J. (2018, October 1). Is back pain really all in the mind?Retrieved from: https://www.pressreader.com/uk/the-daily- telegraph/20181001/281509342121606

Howick, J., Webster, R., Kirby, N., & Hood, K. (2018). Rapid overview of systematic reviews of nocebo effects reported by patients taking placebos in clinical trials. Trials, 19(1), 674.

Kaptchuk, T. J., & Miller, F. G. (2018). Open label placebo: can honestly prescribed placebos evoke meaningful therapeutic benefits?. British Medical Journal, 363, k3889.

Schrøder, C. P., Skare, Ø., Reikerås, O., Mowinckel, P., & Brox, J. I. (2017). Sham surgery versus labral repair or biceps tenodesis for type II SLAP lesions of the shoulder: a three-armed randomised clinical trial. Br J Sports Med, 51(24), 1759-1766.

Waber, R. L., Shiv, B., Carmon, Z., & Ariely, D. (2008). Commercial features of placebo and therapeutic efficacy. Jama, 299(9), 1016-7.

Webster, R. K., Weinman, J., & Rubin, G. J. (2016). A systematic review of factors that contribute to nocebo effects. Health Psychology, 35(12), 1334.

Webster, R., & Rubin, G. J. (2019). Influencing side-effects to medicinal treatments: A systematic review of brief psychological interventions. Frontiers in Psychiatry, 9, 775.

#placebo #nocebo #medicine #behavioural science #priming #affect #positive framing #salience #0319

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atintintintin · 2 years

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Early detection of Australian Aboriginal and Torres Strait Islander infants at high risk of adverse neurodevelopmental outcomes at 12 months corrected age: LEAP-CP prospective cohort study protocol

BMJ Open. 2022 Jan 7;12(1):e053646. doi: 10.1136/bmjopen-2021-053646.

ABSTRACT

INTRODUCTION: Neurodevelopmental disorders (NDD), including cerebral palsy (CP), autism spectrum disorder (ASD) and foetal alcohol spectrum disorder (FASD), are characterised by impaired development of the early central nervous system, impacting cognitive and/or physical function. Early detection of NDD enables infants to be fast-tracked to early intervention services, optimising outcomes. Aboriginal and Torres Strait Islander infants may experience early life factors increasing their risk of neurodevelopmental vulnerability, which persist into later childhood, further compounding the health inequities experienced by First Nations peoples in Australia. The LEAP-CP prospective cohort study will investigate the efficacy of early screening programmes, implemented in Queensland, Australia to earlier identify Aboriginal and Torres Strait Islander infants who are 'at risk' of adverse neurodevelopmental outcomes (NDO) or NDD. Diagnostic accuracy and feasibility of early detection tools for identifying infants 'at risk' of a later diagnosis of adverse NDO or NDD will be determined.

METHODS AND ANALYSIS: Aboriginal and/or Torres Strait Islander infants born in Queensland, Australia (birth years 2020-2022) will be invited to participate. Infants aged <9 months corrected age (CA) will undergo screening using the (1) General Movements Assessment (GMA); (2) Hammersmith Infant Neurological Examination (HINE); (3) Rapid Neurodevelopmental Assessment (RNDA) and (4) Ages and Stages Questionnaire-Aboriginal adaptation (ASQ-TRAK). Developmental outcomes at 12 months CA will be determined for: (1) neurological (HINE); (2) motor (Peabody Developmental Motor Scales 2); (3) cognitive and communication (Bayley Scales of Infant Development III); (4) functional capabilities (Paediatric Evaluation of Disability Inventory-Computer Adaptive Test) and (5) behaviour (Infant Toddler Social and Emotional Assessment). Infants will be classified as typically developing or 'at risk' of an adverse NDO and/or specific NDD based on symptomology using developmental and diagnostic outcomes for (1) CP (2) ASD and (3) FASD. The effects of perinatal, social and environmental factors, caregiver mental health and clinical neuroimaging on NDOs will be investigated.

ETHICS AND DISSEMINATION: Ethics approval has been granted by appropriate Queensland ethics committees; Far North Queensland Health Research Ethics Committee (HREC/2019/QCH/50533 (Sep ver 2)-1370), the Townsville HHS Human Research Ethics Committee (HREC/QTHS/56008), the University of Queensland Medical Research Ethics Committee (2020000185/HREC/2019/QCH/50533) and the Children's Health Queensland HHS Human Research Ethics Committee (HREC/20/QCHQ/63906) with governance and support from local First Nations communities. Findings from this study will be disseminated via peer-reviewed publications and conference presentations.

TRIAL REGISTRATION NUMBER: ACTRN12619000969167.

PMID:34996793 | DOI:10.1136/bmjopen-2021-053646

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#IFTTT #autism

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your-dietician · 3 years

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Long-Term CRYSVITA® ▼ (burosumab) Treatment Reduces the Burden of Disease in Adults With X-Linked Hypophosphataemia (XLH), a Rare Genetic Metabolic Bone Disease

New Post has been published on https://depression-md.com/long-term-crysvita-%e2%96%bc-burosumab-treatment-reduces-the-burden-of-disease-in-adults-with-x-linked-hypophosphataemia-xlh-a-rare-genetic-metabolic-bone-disease/

Long-Term CRYSVITA® ▼ (burosumab) Treatment Reduces the Burden of Disease in Adults With X-Linked Hypophosphataemia (XLH), a Rare Genetic Metabolic Bone Disease

TOKYO–(BUSINESS WIRE)–Kyowa Kirin Co., Ltd. (TSE:4151, Kyowa Kirin) today announced the publication of new data highlighting the sustained benefits of treatment with CRYSVITA® (burosumab) in adults with X-linked hypophosphataemia (XLH), a rare genetic metabolic bone disease. The data show that adults with XLH experience substantial pain, stiffness, fatigue and impairment in physical and ambulatory function. Treatment with CRYSVITA was associated with a significant improvement from baseline after 96 weeks.1

The data are from a randomised, double-blind, placebo-controlled, phase 3 study with an open-label extension to assess the efficacy and safety of CRYSVITA in adults with XLH.2 The study met its primary endpoint, showing a statistically significant effect in increasing serum phosphorus concentrations at 24 weeks, compared to placebo.3 After 24 weeks, all patients were switched to CRYSVITA treatment and data was collected on metabolic and biochemical markers, patient reported outcomes (PROs) and measures of mobility up to 96 weeks. This new publication focuses on the results from the PRO analysis and mobility scores.1

At week 96, the study showed statistically significant improvements in PROs, including the Western Ontario and the McMaster Universities Osteoarthritis Index (WOMAC), Brief Pain Inventory–Short Form (BPI-SF) and Brief Fatigue Inventory (BFI), compared to baseline.1 Statistically significant improvements in ambulatory function, measured by the 6-minute walk test (6MWT), were also seen at 96 weeks compared to baseline.1 Data previously published at 48 weeks also showed improvements in some PROs, including stiffness and pain, as well as fracture healing.3

Lead author Pr Karine Briot, Hôpital Cochin, Paris, France said: “The study highlights the many physical challenges faced by adult patients with XLH, including pain, stiffness, fatigue and difficulty walking or physical function. Burosumab treatment has previously been shown to improve phosphate homeostasis in adult XLH patients, compared to placebo. This new analysis suggests that, despite the long-term complications and physical impairment associated with XLH in adults, treatment with burosumab can also improve the physical function and quality of life of adults with XLH over the longer term.”

Tomohiro Sudo, Executive Officer, Head of Global Product Strategy Department of Kyowa Kirin, said: “Kyowa Kirin is committed to improving the lives of people with XLH and their families. One of our areas of focus is to generate new data that improve our understanding of how best to manage and treat XLH. These important new data highlight the many physical challenges that people living with XLH face every day, how their needs could be better met and how Kyowa Kirin is delivering on its purpose, to make people smile.”

The data were published today in the BMJ journal RMD Open, Rheumatic and Musculoskeletal Diseases.1 CRYSVITA is licensed in Europe for the treatment of XLH in children and adolescents aged 1 to 17 years with radiographic evidence of bone disease, and in adults.4

▼This medicinal product is subject to additional monitoring.

About X-linked hypophosphataemia

X-linked hypophosphataemia (XLH) is a rare, genetic disease that causes abnormalities in the bones, muscles, and joints.5,6 XLH is not life-threatening, but its burden is life-long and progressive, and it may reduce a person’s quality of life.7

People with XLH have a genetic defect on the X-chromosome, which causes an excessive loss of phosphate through the urine and poor absorption from the gut due to excess of a hormone known as fibroblast growth factor-23 (FGF23), resulting in chronically low levels of phosphate in the blood.4,8 Phosphate is a key mineral needed for maintaining the body’s energy levels, muscle function, and the formation of healthy bones and teeth.9,10 While there is no cure for XLH, therapies aimed at helping to restore and maintain phosphate to normal levels within the body may help to improve the progression of disease symptoms.2

XLH is the most common form of hereditary rickets.11 It can sometimes appear in individuals with no family history of the disease but is usually passed down from a parent who carries the defective gene.12

About CRYSVITA® (burosumab)

CRYSVITA (burosumab) was created and developed by Kyowa Kirin and is a recombinant fully human monoclonal IgG1 antibody against the phosphaturic hormone fibroblast growth factor 23 (FGF23). FGF23 is a hormone that reduces serum levels of phosphate by regulating phosphate excretion and active vitamin D production by the kidney. Phosphate wasting and resulting hypophosphataemia in X-linked hypophosphataemia (XLH) is caused by excess FGF23. CRYSVITA is designed to bind to, and thereby inhibit, the biological activity of FGF23. By blocking excess FGF23 in patients, CRYSVITA is intended to increase phosphate reabsorption from the kidney and increase the production of active vitamin D, which enhances intestinal absorption of phosphate and calcium.

CRYSVITA has been available for clinical use since 2018. The first approval came from the European Commission, that granted a conditional marketing authorisation for CRYSVITA for the treatment of XLH with radiographic evidence of bone disease in children one year of age and older and adolescents with growing skeletons. In 2020, this authorisation was subsequently expanded to include older adolescents and adults.2

CRYSVITA is approved by the US Food and Drug Administration (FDA) for patients with XLH aged 6 months and older and by Health Canada for patients with XLH aged one year and older.13,14

In 2019, CRYSVITA received approval from Japan’s Ministry of Health, Labour and Welfare for the treatment of FGF23-related hypophosphataemic rickets and osteomalacia. In 2020, CRYSVITA was reimbursed by National Health Insurance (NHI) in Japan as a self-injection presentation for the treatment of FGF23-related hypophosphataemic rickets and osteomalacia.

In January 2020, Swissmedic approved CRYSVITA for the treatment of adults, adolescents and children (one year of age and older) with XLH.15

In June 2020, the U.S. Food and Drug Administration (FDA) approved CRYSVITA for patients aged two and older with tumour-induced osteomalacia (TIO), a rare disease that is characterised by the development of tumours that cause weakened and softened bones.16

Kyowa Kirin and Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE: Ultragenyx) have been collaborating in the development and commercialisation of CRYSVITA globally, based on the collaboration and licence agreement between Kyowa Kirin and Ultragenyx.

About Kyowa Kirin

Kyowa Kirin strives to create and deliver novel medicines with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company with a more than 70-year heritage, the company applies cutting-edge science including an expertise in antibody research and engineering, to address the needs of patients and society across multiple therapeutic areas including Nephrology, Oncology, Immunology/Allergy and Neurology. Across our four regions – Japan, Asia Pacific, North America and EMEA/International – we focus on our purpose, to make people smile, and are united by our shared values of commitment to life, teamwork/Wa, innovation, and integrity. You can learn more about the business of Kyowa Kirin at: https://www.kyowakirin.com/

Kyowa Kirin International

http://www.international.kyowa-kirin.com / www.kyowakirin.com

Galabank Business Park

Galashiels, TD1 1QH

United Kingdom

References

1 Briot K, Portale AA, Brandi ML, et al. RMD Open 2021;7:e001714. doi: 10.1136/rmdopen-2021-001714.

2 Insogna KL, Rauch F, Kamenický P, et al. Burosumab improved histomorphometric measures of osteomalacia in adults with X-linked hypophosphatemia: a Phase 3, single-arm, international trial. J Bone Miner Res. 2019;34:2183-2191.

3 Portale AA, Carpenter TO, Brandi ML, et al. Calcif Tissue Int 2019;105:271–84.

4 European Medicines Agency. CRYSVITA EPAR product information. Summary of Product Characteristics. Available at: Crysvita, INN-burosumab; (europa.eu). Last updated: June 2021. Last accessed: July 2021.

5 Linglart A, Biosse-Duplan M, Briot K, et al. Therapeutic management of hypophosphatemic rickets from infancy to adulthood. Endocr Connect. 2014;3:R13-30.

6 Haffner D, Emma F, Eastwood DM, et al. Consensus Statement. Evidence-based guideline. Clinical practice recommendations for the diagnosis and management of X-linked hypophosphatemia. Nat Rev Nephrol. 2019;15;435-455.

7 Skrinar A, Dvorak-Ewell M, Evins A, et al. The lifelong impact of X-linked hypophosphatemia: Results from a burden of disease survey. J Endocr Soc. 2019;3:1321-1334.

8 Beck-Nielsen SS, Mughal Z, Haffner D, et al. FGF23 and its role in X-linked hypophosphatemia-related morbidity. Orphanet J Rare Dis. 2019;14:58.

9 Pesta D, Tsirigotis DN, Befroy DE, et al. Hypophosphatemia promotes lower rates of muscle ATP synthesis. The FAESB Journal. 2016;39:3378-3387.

10 Unnanuntana A, Rebolledo BJ, Khair MM, et al. Diseases affecting bone quality: beyond osteoporosis. Clin Orthop Relat Res. 2011;469:2194-2206.

11 Carpenter TO, Imel EA, Holm IA, et al. A clinician’s guide to X-linked hypophosphatemia. J Bone Miner Res. 2011;26:1381-8.

12 National Center for Advancing Translational Sciences. X-linked hypophosphatemia. Available at: https://rarediseases.info.nih.gov/diseases/12943/x-linked-hypophosphatemia. Last updated: February 2018. Last accessed: July 2021.

13 Health Canada. Regulatory Decision Summary – CRYSVITA. Available at: https://hpr-rps.hres.ca/reg-content/regulatory-decision-summary-detail.php?linkID=RDS00463. Last updated: April 2020. Last accessed: April 2021.

14 Available at : https://www.kyowakirin.com/media_center/news_releases/2019/e20190930_01.html. Last accessed: July 2021

15 Swissmedic. Crysvita, injektionslösung (burosumabum). Available at: https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/authorisations/new-medicines/vrysvita-injektionsloesung_burosumabum.html. Last updated: January 2020. Last accessed: July 2021.

16 FDA. Available at: FDA Approves First Therapy for Rare Disease that Causes Low Phosphate Blood Levels, Bone Softening | FDA. Last accessed: July 2021

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lauramalchowblog · 4 years

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Managing Surgical Wait Times in the Intra-COVID-19 World

Finding the Right Prioritization Model

By JUSTIN SPECTOR

Restrictions on elective surgical volume in hospitals across the United States are causing a dilemma heretofore unseen in the American healthcare system. Surgeons across services have large and growing backlogs of elective surgeries in an environment where operating room (OR) capacity is restricted due to availability of inpatient beds, personal protective equipment (PPE), staffing, and many other constraints. Fortunately, the U.S. is not the first country to experience and deal with this situation; for many countries, this is the normal state of medicine.

By combining the accumulated experience of health systems around the world with cutting-edge technologies, it is possible to make this crisis manageable for perioperative leadership and, potentially, to improve upon the preexisting models for managing OR time.

The first step in creating an equitable system that can garner widespread buy-in is to agree upon a method for categorizing cases into priority levels. Choosing a system with strong academic backing will help to reduce the influence of intra-hospital politics from derailing the process before it can begin.

Why Cases Should Be Prioritized

If your hospital has a mix of surgeons who perform highly time-sensitive cases — cases where patient quality of life is substantially impacted — as well as cases with minor health or quality of life outcomes, it is important to make sure there will be enough capacity to get the higher urgency cases done within a reasonable amount of time. This allows cases in the backlog to be balanced against new cases that are yet to be scheduled and will help to optimize the flow of patients through the OR.

Case Prioritization Best Practices

The most important feature of a prioritization model is for it to be something your hospital, surgeons and schedulers will be able to understand and be willing to use. For this reason, we have excluded systems that are difficult to implement, such as that used by the Department of Veterans Affairs. The models included, with one exception, have long track records of success, and any hospital should be able to implement them.

Another important consideration in prioritization is what factors you want to consider. These can be broken into three major categories: clinical urgency, risk to the patient, and risk to the hospital. Risk to the patient would include factors such as ASA score, age and any complicating conditions that would make the patient especially at risk if infected with SARS-CoV-2. Clinical urgency — the rate at which the patient’s condition is worsening and the patient’s ability to wait for surgery — is the most straightforward. Finally, risk to the hospital takes into account many factors such as the risk of the patient spreading infection to hospital staff and other patients, their likelihood of needing an ICU bed and blood, and the amount of PPE needed for the case. Each hospital will need to place a different amount of emphasis on each category.

Four Prominent Case Prioritization Models

Descriptive – Surgical Waiting List Info System (SWALIS): SWALIS is a system based on the Italian government’s case prioritization guidelines that solely take into account clinical urgency to assign a case one of five levels, and each priority level is associated with a maximum time before treatment (MTBT). This model is easy to understand and requires minimal administrative oversight, but it does not take into account other factors such as equipment needs and risk to the patient and hospital. Because of the ease of implementation and clarity of the segmentation, this is a favored model.

A model to prioritize access to elective surgery on the basis of clinical urgency and waiting time

Prescriptive – British Columbia Ministry of Health Surgical Patient Registry (SPR): The model used in British Columbia, Canada, is similar to the Italian model in that it divides cases into groups by clinical urgency. However, instead of the surgeon subjectively determining the priority level, this model prescribes a level based on the procedure. This system is especially effective if it will be difficult to instruct your clinics on the prioritization methodology but requires a lot of decisions to be made centrally to determine the priority for each procedure and any modifiers that need to be considered.

Patient Prioritization Codes: Overview

Surgical Wait Time Strategy

Surgical Wait Times – Procedures A-Z

Dental Surgery ‐ Adult – BC List of Patient Condition and Diagnosis Descriptions

Qualitative Patient Need – General Surgery Prioritization Tool (GSPT): New Zealand was one of the first countries to implement clinical priority assessment criteria (CPAC) nationwide. One CPAC tool being used is the GSPT. It uses a 0-100 scale for each case based on aspects of the impact on the patient’s quality of life and health to determine a relative priority. (See Appendix)

General Surgery Prioritization Tool: a pilot study

Qualitative Multifactor – Medically Necessary, Time-Sensitive (MeNTS): Published in the Journal of the American College of Surgeons, this system uses a mix of subjective and objective scores in different categories to create a cumulative score between 21 and 105. Higher scores equate to a greater risk to reward for the procedure. The process of scoring each case requires 21 factors to be rated on a scale of 1 to 5, making this best suited to systems with strong admin staff who can complete these evaluations for each case.

Medically Necessary, Time-Sensitive Procedures: Scoring System to Ethically and Efficiently Manage Resource Scarcity and Provider Risk During the COVID-19 Pandemic

Choosing the Right Model

The two most important factors when designing a prioritization model for your hospital or system are consistency and compliance. It is important that across surgeons and service lines there is an understanding of what priority level is appropriate and that those are in line with leadership’s intent. It is also important to consider the ease of use as models that require too much work per individual case may be ignored or half-heartedly complied with.

As there has been little national or state-level guidance on this subject, each hospital organization has a great deal of leeway to choose a method that fits their unique needs.

Other Considerations

If your hospital is constrained on beds, PPE, blood or any other surgical input, consider adding these as factors in your prioritization system. For example, if PPE is a constraint, it’s important to balance case lengths as shorter cases result in more PPE use throughout a surgery day. Similarly, if inpatient beds are limited, you may want to set a threshold on the total number of cases that require greater than six hours of in-bed recovery time. This is an area where web-based tools excel due to their ability to leverage sophisticated packing algorithms.

Translating Priority Scores Into Surgery Dates

In the American healthcare system, surgical schedules are built around block allocation. This means that each case’s score is not enough to determine when it should be performed since the surgeons will not be coming in to do just one case. Each surgeon or department’s entire backlog should be considered to determine how surgical time should be distributed.

The challenge is to balance priority against wait time and overall backlog volume. While certain service lines may only have low- to medium-priority cases, if their caseload is sufficient, then they should be given time even within the first few weeks of opening up elective booking. Using a scoring system for each case that takes into account wait time, along with determining the MTBT for each priority category, it is possible to formulate how much time each surgeon or service should receive each week. Because surgeons’ waitlists are constantly changing, it is useful to repeat this exercise at a weekly or biweekly cadence to ensure optimal distribution.