research projects in health care

Research Topics & Ideas: Healthcare

100+ Healthcare Research Topic Ideas To Fast-Track Your Project

Finding and choosing a strong research topic is the critical first step when it comes to crafting a high-quality dissertation, thesis or research project. If you’ve landed on this post, chances are you’re looking for a healthcare-related research topic , but aren’t sure where to start. Here, we’ll explore a variety of healthcare-related research ideas and topic thought-starters across a range of healthcare fields, including allopathic and alternative medicine, dentistry, physical therapy, optometry, pharmacology and public health.

NB – This is just the start…

The topic ideation and evaluation process has multiple steps . In this post, we’ll kickstart the process by sharing some research topic ideas within the healthcare domain. This is the starting point, but to develop a well-defined research topic, you’ll need to identify a clear and convincing research gap , along with a well-justified plan of action to fill that gap.

If you’re new to the oftentimes perplexing world of research, or if this is your first time undertaking a formal academic research project, be sure to check out our free dissertation mini-course. In it, we cover the process of writing a dissertation or thesis from start to end. Be sure to also sign up for our free webinar that explores how to find a high-quality research topic.

Overview: Healthcare Research Topics

• Allopathic medicine
• Alternative /complementary medicine
• Veterinary medicine
• Physical therapy/ rehab
• Optometry and ophthalmology
• Pharmacy and pharmacology
• Public health
• Examples of healthcare-related dissertations

Allopathic (Conventional) Medicine

• The effectiveness of telemedicine in remote elderly patient care
• The impact of stress on the immune system of cancer patients
• The effects of a plant-based diet on chronic diseases such as diabetes
• The use of AI in early cancer diagnosis and treatment
• The role of the gut microbiome in mental health conditions such as depression and anxiety
• The efficacy of mindfulness meditation in reducing chronic pain: A systematic review
• The benefits and drawbacks of electronic health records in a developing country
• The effects of environmental pollution on breast milk quality
• The use of personalized medicine in treating genetic disorders
• The impact of social determinants of health on chronic diseases in Asia
• The role of high-intensity interval training in improving cardiovascular health
• The efficacy of using probiotics for gut health in pregnant women
• The impact of poor sleep on the treatment of chronic illnesses
• The role of inflammation in the development of chronic diseases such as lupus
• The effectiveness of physiotherapy in pain control post-surgery

Topics & Ideas: Alternative Medicine

• The benefits of herbal medicine in treating young asthma patients
• The use of acupuncture in treating infertility in women over 40 years of age
• The effectiveness of homoeopathy in treating mental health disorders: A systematic review
• The role of aromatherapy in reducing stress and anxiety post-surgery
• The impact of mindfulness meditation on reducing high blood pressure
• The use of chiropractic therapy in treating back pain of pregnant women
• The efficacy of traditional Chinese medicine such as Shun-Qi-Tong-Xie (SQTX) in treating digestive disorders in China
• The impact of yoga on physical and mental health in adolescents
• The benefits of hydrotherapy in treating musculoskeletal disorders such as tendinitis
• The role of Reiki in promoting healing and relaxation post birth
• The effectiveness of naturopathy in treating skin conditions such as eczema
• The use of deep tissue massage therapy in reducing chronic pain in amputees
• The impact of tai chi on the treatment of anxiety and depression
• The benefits of reflexology in treating stress, anxiety and chronic fatigue
• The role of acupuncture in the prophylactic management of headaches and migraines

Topics & Ideas: Dentistry

• The impact of sugar consumption on the oral health of infants
• The use of digital dentistry in improving patient care: A systematic review
• The efficacy of orthodontic treatments in correcting bite problems in adults
• The role of dental hygiene in preventing gum disease in patients with dental bridges
• The impact of smoking on oral health and tobacco cessation support from UK dentists
• The benefits of dental implants in restoring missing teeth in adolescents
• The use of lasers in dental procedures such as root canals
• The efficacy of root canal treatment using high-frequency electric pulses in saving infected teeth
• The role of fluoride in promoting remineralization and slowing down demineralization
• The impact of stress-induced reflux on oral health
• The benefits of dental crowns in restoring damaged teeth in elderly patients
• The use of sedation dentistry in managing dental anxiety in children
• The efficacy of teeth whitening treatments in improving dental aesthetics in patients with braces
• The role of orthodontic appliances in improving well-being
• The impact of periodontal disease on overall health and chronic illnesses

Tops & Ideas: Veterinary Medicine

• The impact of nutrition on broiler chicken production
• The role of vaccines in disease prevention in horses
• The importance of parasite control in animal health in piggeries
• The impact of animal behaviour on welfare in the dairy industry
• The effects of environmental pollution on the health of cattle
• The role of veterinary technology such as MRI in animal care
• The importance of pain management in post-surgery health outcomes
• The impact of genetics on animal health and disease in layer chickens
• The effectiveness of alternative therapies in veterinary medicine: A systematic review
• The role of veterinary medicine in public health: A case study of the COVID-19 pandemic
• The impact of climate change on animal health and infectious diseases in animals
• The importance of animal welfare in veterinary medicine and sustainable agriculture
• The effects of the human-animal bond on canine health
• The role of veterinary medicine in conservation efforts: A case study of Rhinoceros poaching in Africa
• The impact of veterinary research of new vaccines on animal health

Topics & Ideas: Physical Therapy/Rehab

• The efficacy of aquatic therapy in improving joint mobility and strength in polio patients
• The impact of telerehabilitation on patient outcomes in Germany
• The effect of kinesiotaping on reducing knee pain and improving function in individuals with chronic pain
• A comparison of manual therapy and yoga exercise therapy in the management of low back pain
• The use of wearable technology in physical rehabilitation and the impact on patient adherence to a rehabilitation plan
• The impact of mindfulness-based interventions in physical therapy in adolescents
• The effects of resistance training on individuals with Parkinson’s disease
• The role of hydrotherapy in the management of fibromyalgia
• The impact of cognitive-behavioural therapy in physical rehabilitation for individuals with chronic pain
• The use of virtual reality in physical rehabilitation of sports injuries
• The effects of electrical stimulation on muscle function and strength in athletes
• The role of physical therapy in the management of stroke recovery: A systematic review
• The impact of pilates on mental health in individuals with depression
• The use of thermal modalities in physical therapy and its effectiveness in reducing pain and inflammation
• The effect of strength training on balance and gait in elderly patients

Topics & Ideas: Optometry & Opthalmology

• The impact of screen time on the vision and ocular health of children under the age of 5
• The effects of blue light exposure from digital devices on ocular health
• The role of dietary interventions, such as the intake of whole grains, in the management of age-related macular degeneration
• The use of telemedicine in optometry and ophthalmology in the UK
• The impact of myopia control interventions on African American children’s vision
• The use of contact lenses in the management of dry eye syndrome: different treatment options
• The effects of visual rehabilitation in individuals with traumatic brain injury
• The role of low vision rehabilitation in individuals with age-related vision loss: challenges and solutions
• The impact of environmental air pollution on ocular health
• The effectiveness of orthokeratology in myopia control compared to contact lenses
• The role of dietary supplements, such as omega-3 fatty acids, in ocular health
• The effects of ultraviolet radiation exposure from tanning beds on ocular health
• The impact of computer vision syndrome on long-term visual function
• The use of novel diagnostic tools in optometry and ophthalmology in developing countries
• The effects of virtual reality on visual perception and ocular health: an examination of dry eye syndrome and neurologic symptoms

Topics & Ideas: Pharmacy & Pharmacology

• The impact of medication adherence on patient outcomes in cystic fibrosis
• The use of personalized medicine in the management of chronic diseases such as Alzheimer’s disease
• The effects of pharmacogenomics on drug response and toxicity in cancer patients
• The role of pharmacists in the management of chronic pain in primary care
• The impact of drug-drug interactions on patient mental health outcomes
• The use of telepharmacy in healthcare: Present status and future potential
• The effects of herbal and dietary supplements on drug efficacy and toxicity
• The role of pharmacists in the management of type 1 diabetes
• The impact of medication errors on patient outcomes and satisfaction
• The use of technology in medication management in the USA
• The effects of smoking on drug metabolism and pharmacokinetics: A case study of clozapine
• Leveraging the role of pharmacists in preventing and managing opioid use disorder
• The impact of the opioid epidemic on public health in a developing country
• The use of biosimilars in the management of the skin condition psoriasis
• The effects of the Affordable Care Act on medication utilization and patient outcomes in African Americans

Topics & Ideas: Public Health

• The impact of the built environment and urbanisation on physical activity and obesity
• The effects of food insecurity on health outcomes in Zimbabwe
• The role of community-based participatory research in addressing health disparities
• The impact of social determinants of health, such as racism, on population health
• The effects of heat waves on public health
• The role of telehealth in addressing healthcare access and equity in South America
• The impact of gun violence on public health in South Africa
• The effects of chlorofluorocarbons air pollution on respiratory health
• The role of public health interventions in reducing health disparities in the USA
• The impact of the United States Affordable Care Act on access to healthcare and health outcomes
• The effects of water insecurity on health outcomes in the Middle East
• The role of community health workers in addressing healthcare access and equity in low-income countries
• The impact of mass incarceration on public health and behavioural health of a community
• The effects of floods on public health and healthcare systems
• The role of social media in public health communication and behaviour change in adolescents

Examples: Healthcare Dissertation & Theses

While the ideas we’ve presented above are a decent starting point for finding a healthcare-related research topic, they are fairly generic and non-specific. So, it helps to look at actual dissertations and theses to see how this all comes together.

Below, we’ve included a selection of research projects from various healthcare-related degree programs to help refine your thinking. These are actual dissertations and theses, written as part of Master’s and PhD-level programs, so they can provide some useful insight as to what a research topic looks like in practice.

• Improving Follow-Up Care for Homeless Populations in North County San Diego (Sanchez, 2021)
• On the Incentives of Medicare’s Hospital Reimbursement and an Examination of Exchangeability (Elzinga, 2016)
• Managing the healthcare crisis: the career narratives of nurses (Krueger, 2021)
• Methods for preventing central line-associated bloodstream infection in pediatric haematology-oncology patients: A systematic literature review (Balkan, 2020)
• Farms in Healthcare: Enhancing Knowledge, Sharing, and Collaboration (Garramone, 2019)
• When machine learning meets healthcare: towards knowledge incorporation in multimodal healthcare analytics (Yuan, 2020)
• Integrated behavioural healthcare: The future of rural mental health (Fox, 2019)
• Healthcare service use patterns among autistic adults: A systematic review with narrative synthesis (Gilmore, 2021)
• Mindfulness-Based Interventions: Combatting Burnout and Compassionate Fatigue among Mental Health Caregivers (Lundquist, 2022)
• Transgender and gender-diverse people’s perceptions of gender-inclusive healthcare access and associated hope for the future (Wille, 2021)
• Efficient Neural Network Synthesis and Its Application in Smart Healthcare (Hassantabar, 2022)
• The Experience of Female Veterans and Health-Seeking Behaviors (Switzer, 2022)
• Machine learning applications towards risk prediction and cost forecasting in healthcare (Singh, 2022)
• Does Variation in the Nursing Home Inspection Process Explain Disparity in Regulatory Outcomes? (Fox, 2020)

Looking at these titles, you can probably pick up that the research topics here are quite specific and narrowly-focused , compared to the generic ones presented earlier. This is an important thing to keep in mind as you develop your own research topic. That is to say, to create a top-notch research topic, you must be precise and target a specific context with specific variables of interest . In other words, you need to identify a clear, well-justified research gap.

Need more help?

If you’re still feeling a bit unsure about how to find a research topic for your healthcare dissertation or thesis, check out Topic Kickstarter service below.

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15 Comments

I need topics that will match the Msc program am running in healthcare research please

Hello Mabel,

I can help you with a good topic, kindly provide your email let’s have a good discussion on this.

Can you provide some research topics and ideas on Immunology?

Thank you to create new knowledge on research problem verse research topic

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can you provide me with a research topic on healthcare related topics to a qqi level 5 student

Please can someone help me with research topics in public health ?

Hello I have requirement of Health related latest research issue/topics for my social media speeches. If possible pls share health issues , diagnosis, treatment.

I would like a topic thought around first-line support for Gender-Based Violence for survivors or one related to prevention of Gender-Based Violence

Please can I be helped with a master’s research topic in either chemical pathology or hematology or immunology? thanks

Can u please provide me with a research topic on occupational health and safety at the health sector

Good day kindly help provide me with Ph.D. Public health topics on Reproductive and Maternal Health, interventional studies on Health Education

may you assist me with a good easy healthcare administration study topic

May you assist me in finding a research topic on nutrition,physical activity and obesity. On the impact on children

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Codex Health

Risk stratification & prediction.

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National ai steering committee.

Advising GBMF on the purpose and structure of a national coordinating center and grant program to advance the implementation and prospective evaluation of AI/ML diagnostic decision support tools to improve patient care and diagnostic outcomes

Omada Health

Remote patient monitoring evaluation.

Collaborating with  Omada Health  on a pragmatic trial testing the hypothesis that commercial patient-facing digital care platforms can be intentionally and effectively paired with health systems to augment the primary care of patients with chronic conditions such as hypertension, diabetes, and depression

Predicta Med

Early detection of autoimmune disease.

Validating a machine learning tool for identifying patients with an undiagnosed autoimmune disease one year prior to first recorded diagnosis with Predicta Med

Quadrant Technologies

Reimagining patient portals with ai .

Designing and building an AI-powered system to automate the sorting and routing of patient messages as a first step towards reimagining patient portals and reducing the burden of the inbox on clinicians

Predicting and Preventing Harm in the Hospital

Retrospectively validating a suite of AI-enabled tools predicting infections and other adverse events in the inpatient setting (e.g. sepsis and falls with injury) to prepare for a prospective pilot and evaluation of the impact on patient outcomes and provider workflows

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Studied the feasibility and acceptability of a conversational AI for pre-visit medical interviews with SOAP Health

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Telemedicine education.

Developed a national telemedicine curriculum for medical students, residents, and teaching clinicians as part of STFM 's National Telemedicine Task Force

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Data and technology to support diagnostic excellence.

Developed a whitepaper with CLIIR that investigates potential investments in artificial intelligence to advance diagnostic excellence for the Gordon and Betty Moore Foundation

Medical Device Innovation

Collaborating with Verily on multi-site investigational studies assessing the feasibility of new investigational devices designed to estimate blood pressure and cardiac filling pressure

Stanford Collaborations

Center for artificial intelligence in medicine & imaging (aimi), closing gaps in healthcare ai.

Identifying and addressing gaps and barriers in the field of healthcare AI with the goal of accelerating and streamlining the translation of AI tools for clinical applications with AIMI

Center for Automotive Research (CARS)

Detecting providers' stress levels.

Assessed the feasibility and efficacy of detecting stress in family medicine practitioners through desktop computer interactions with CARS

Center for Biomedical Informatics Research (BMIR)

Enabling advance care planning discussions.

Implemented a predictive mortality model to enable patient selection for end of life advance care planning discussions and increased the incidence of documented conversations at Stanford Health Care with BMIR

AI-Driven Order Recommendations

Developing AI-driven clinical order recommendations for primary care physicians to tee up appropriate and efficient specialty care consultations

Center for Digital Health (CDH)

Ai in hypertension management.

Consulting on CDH 's development of an AI-powered hypertension management algorithm for cardiologists and primary care physicians

Clinical Excellence Research Center (CERC)

Computer vision depression screening.

Studying the feasibility of developing an AI algorithm that can predict depression and anxiety based on audio and visual cues captured from a recording of the person with  CERC

Insulin-Dependent Diabetes Management

Advising a project assessing the feasibility and acceptability of leveraging at-home voice applications to assist patients with insulin-dependent diabetes management remotely

Evaluation Sciences Unit (ESU)

Ai in pre-visit planning.

Completed a comprehensive environmental scan, a literature review, and key informant interviews to explore the use of AI in pre-visit planning with the ESU

Master of Science in Clinical Informatics Management (MCiM)

Master of science in clinical informatics management.

Collaborating with MCiM - a master's program for working professionals seeking to harness the power of digital innovations in healthcare - to provide a management-focused educational experience and foster digitally-driven excellence in healthcare

Research IT

Clinical identification tools.

Developing high-performance open source clinical identification tools that enable researchers around the world to use clinical text for AI-driven applications while preserving patient privacy with Research IT

Stanford Health Care

Detecting inpatient clinical deterioration.

Implementing a predictive model for clinical deterioration in the inpatient acute care setting to reduce unexpected escalations to the intensive care units and mortality at Stanford Health Care and Valley Care

Stanford Institute for Human-Centered AI (HAI)

Ai + healthcare global conference.

Co-designed sessions for the Stanford AI + Health Global Conference covering topics related to AI applied research, academic partnership with industry, as well as equity and community engagement in health AI

Stanford Medicine Center for Improvement (SMCI)

Improvement across stanford medicine.

Collaborating with SMCI  as active affiliate faculty and guest lecturers in order to foster a culture of continuous improvement across Stanford Medicine

Stanford Prevention Research Center (SPRC)

Remote patient monitoring and ai health coaching.

Designing a large pragmatic trial of a comprehensive digital care platform versus usual care for the treatment of hypertension with  SPRC

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Reimagining patient portals with ai.

Partnering with WellMD & WellPhD to develop an AI-powered system to automate the sorting and routing of patient messages as a first step towards reimagining patient portals and reducing the burden of the inbox on clinicians

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In this research in Nature , we demonstrated how artificial intelligence could accurately predict acute kidney injuries (AKI) in patients up to 48 hours earlier than it is currently diagnosed. Notoriously difficult to spot, AKI affects up to one in five hospitalized patients in the US and UK, and deterioration can happen quickly. Read the article

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Protecting patients from medication errors

Research shows that 2% of hospitalized patients experience serious preventable medication-related incidents that can be life-threatening, cause permanent harm, or result in death. Published in Clinical Pharmacology and Therapeutics , our best-performing AI model was able to anticipate physician’s actual prescribing decisions 75% of the time, based on de-identified electronic health records and the doctor’s prescribing records. This is an early step towards testing the hypothesis that machine learning can support clinicians in ways that prevent mistakes and help to keep patients safe. Read the article

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12 Innovations That Will Change Health Care and Medicine in the 2020s

P ocket-size ultrasound devices that cost 50 times less than the machines in hospitals (and connect to your phone). Virtual reality that speeds healing in rehab. Artificial intelligence that’s better than medical experts at spotting lung tumors. These are just some of the innovations now transforming medicine at a remarkable pace.

No one can predict the future, but it can at least be glimpsed in the dozen inventions and concepts below. Like the people behind them, they stand at the vanguard of health care. Neither exhaustive nor exclusive, the list is, rather, representative of the recasting of public health and medical science likely to come in the 2020s.

David Abney: Drone-delivered medical supplies

Since March, UPS has been conducting a trial program called Flight Forward, using autonomous drone deliveries of critical medical samples including blood or tissue between two branches of a hospital in Raleigh, N.C., located 150 yards apart. A fleet-footed runner could cover the distance almost as fast as the drones, but as a proof-of-concept program, it succeeded, and in October the FAA granted the company approval to expand to 20 hospitals around the U.S. over the next two years. “We expect UPS Flight Forward to one day be a very significant part of our company,” says UPS CEO David Abney of the service, which will deliver urine, blood and tissue samples, and medical essentials like drugs and transfusable blood. UPS is not alone in pioneering air deliveries. Wing, a division of Google’s parent company Alphabet, received similar, but more limited, FAA approval to make deliveries for both Walgreens and FedEx. And in Ghana and Rwanda, drones operated by Silicon Valley startup Zipline are already delivering medical supplies to rural villages. —Jeffrey Kluger

Christine Lemke: The biggest Big Data

There are 7.5 billion humans, and tens of millions of us track our health with wearables like smart watches, as well as with more traditional devices like blood-pressure monitors. If there were a way to aggregate all that data from even a few million of us and make it all anonymous but searchable, medical researchers would have a powerful tool for drug development, lifestyle studies and more. California-based Big Data firm Evidation has developed just such a tool, with information from 3 million volunteers providing trillions of data points. Evidation partners with drug manufacturers like Sanofi and Eli Lilly to parse that data; that work has led to dozens of peer-reviewed studies already, on subjects ranging from sleep and diet to cognitive-health patterns. For founder Christine Lemke, one of Evidation’s ongoing projects, to see if new technologies can effectively measure chronic pain, is personal: Lemke has a rare genetic disease that causes frequent back pain. Evidation is partnering with Brigham and Women’s Hospital on the project. —Jeffrey Kluger

Doug Melton: A stem-cell cure for diabetes

Type 1 diabetes affects 1.25 million Americans, but two in particular got Harvard biologist Doug Melton’s attention: his daughter Emma and son Sam. Treatment can involve a lifetime of careful eating, insulin injections and multiple daily blood-glucose tests. Melton has a different approach: using stem cells to create replacement beta cells that produce insulin. He started the work over 10 years ago, when stem-cell research was raising hopes and controversy. In 2014 he co-founded Semma Therapeutics—the name is derived from Sam and Emma—to develop the technology, and this summer it was acquired by Vertex Pharmaceuticals for $950 million. The company has created a small, implantable device that holds millions of replacement beta cells, letting glucose and insulin through but keeping immune cells out. “If it works in people as well as it does in animals, it’s possible that people will not be diabetic,” Melton says. “They will eat and drink and play like those of us who are not.” —Don Steinberg

Abasi Ene-Obong: A more diverse global bio bank

A major limitation threatens to hamper the era of personalized medicine: people of Caucasian descent are a minority in the global population yet make up nearly 80% of the subjects in human-genome research, creating blind spots in drug research. Dr. Abasi Ene-Obong, 34, founded 54gene to change that. Named for Africa’s 54 countries, the Nigeria-based startup is sourcing genetic material from volunteers across the continent, to make drug research and development more equitable. 54gene is conscious of the ugly history of colonial exploitation in Africa. If companies are going to profit by developing marketable drugs based on the DNA of African people, Africa should benefit: so, when partnering with companies, 54gene prioritizes those that commit to including African countries in marketing plans for any resulting drugs. “If we are part of the pathway for drug creation, then maybe we can also become part of the pathway to get these drugs into Africa,” Ene-Obong says. —Corinne Purtill

Sean Parker: A disruptive approach to cancer research

One of the original disrupters of the new economy is bringing his approach to medical research. The Parker Institute for Cancer Immunotherapy, established by Napster co-founder and former Facebook president Sean Parker, is a network of top institutions including Memorial Sloan Kettering, Stanford, the MD Anderson Cancer Center and more. Its goal is to identify and remove obstacles to innovation in traditional research. For example, all of the participating institutes have agreed to accept an approval decision by any of their respective Institutional Review Boards, which “allows us to get major clinical trials off the ground in weeks rather than years,” says Parker, and at lower costs. Perhaps most important, Parker wants to infuse the project with his market sensibility: “We follow the discoveries coming from our researchers and then put our money behind commercializing them,” he says, either by licensing a product or spinning it out into a company. Since its founding in 2016, the institute has brought 11 projects to clinical trials and supported some 2,000 research papers.

Thomas Reardon: A wristband that can read your mind

A man wearing what looks like a chunky black wristwatch stares at a tiny digital dinosaur leaping over obstacles on a computer screen before him. The man’s hands are motionless, but he’s controlling the dinosaur—with his brain. The device on his wrist is the CTRL-kit, which detects the electrical impulses that travel from the motor neurons down the arm muscles and to the hand almost as soon as a person thinks about a particular movement. “I want machines to do what we want them to do, and I want us to not be enslaved by the machines,” says Thomas Reardon, CEO and co-founder of CTRL-Labs, the device maker. The hunched-over posture and fumbling keystrokes of the smartphone era represent “a step backward for humanity,” says Reardon, a neuroscientist who, in a past life, led the development of Microsoft’s Internet Explorer. The technology could open up new forms of rehabilitation and access for patients recovering from a stroke or amputation, as well as those with Parkinson’s disease, multiple sclerosis and other neurodegenerative conditions, Reardon says. —Corinne Purtill

Jonathan Rothberg: An ultrasound in your pocket

There are more than 4 billion people globally who don’t have access to medical imaging—and could benefit from Butterfly iQ, a handheld ultrasound device. Jonathan Rothberg, a Yale genetics researcher and serial entrepreneur, figured out how to put ultrasound technology on a chip, so instead of a $100,000 machine in a hospital, it’s a $2,000 go-anywhere gadget that connects to an iPhone app. It went on sale last year to medical professionals. “Our goal is to sell to 150 countries that can pay for it. And [the Gates Foundation] is distributing it in 53 countries that can’t,” Rothberg says. The device isn’t as good as the big machines are and won’t replace them in prosperous parts of the world. But it could make scanning more routine. “There was a time when the thermometer was only used in a medical setting, when a blood-pressure cuff was only used in a medical center,” Rothberg says. “Democratizing [health] happens on multiple dimensions.” —Don Steinberg

Shravya Shetty: Cancer-diagnosing artificial intelligence

Symptoms of lung cancer usually don’t appear until its later stages, when it’s difficult to treat. Early screening of high-risk populations with CT scans can reduce the risk of dying, but it comes with risks of its own. The U.S. National Institutes of Health found that 2.5% of patients who received CT scans later endured needlessly invasive treatments—-sometimes with fatal results—after radiologists erroneously diagnosed false positives. Shravya Shetty believes artificial intelligence may be the solution. Shetty is the research lead of a Google Health team that in the past two years built an AI system that outperforms human radiologists in diagnosing lung cancer. After being trained on more than 45,000 patient CT scans, Google’s algorithm detected 5% more cancer cases and had 11% fewer false positives than a control group of six human radiologists. The early results are promising, but “there’s a pretty big gap between where things are and where they could be,” says Shetty. “It’s that potential impact that keeps me going.” —Corinne Purtill

Joanna Shields: AI to read every science paper

Every year, more than 2 million peer-reviewed research papers are published—far too many for any individual scientist to digest. Machines, however, don’t share this human limitation. BenevolentAI has created algorithms that scour research papers, clinical trial results and other sources of biomedical information in search of previously overlooked relationships between genes, drugs and disease. BenevolentAI CEO Joanna Shields was an executive at companies such as Google and Facebook, and then the U.K.’s Minister for Internet Safety and Security, before joining BenevolentAI. A frequent critic of the tech industry’s lapses in protecting young people from exploitation and abuse online, Shields sees BenevolentAI as an opportunity to harness technology’s power for good. “All of us have family members, friends who are diagnosed with diseases that have no treatment,” she says. “Unless we apply the scaling and the principles of the technology revolution to drug discovery and development, we’re not going to see a change in that outcome anytime soon.” —Corinne Purtill

Sean Slovenski: Walmart-ification of health care

Whenever the world’s biggest retailer aims its gigantic footprint at a new market, the ground shakes. In September, Walmart opened its first Health Center, a medical mall where customers can get primary care, vision tests, dental exams and root canals; lab work, X-rays and EKGs; counseling; even fitness and diet classes. The prices are affordable without insurance ($30 for an annual physical; $45 for a counseling session), and the potential is huge. In any given week, the equivalent of half of America passes through a Walmart. “When I first started here … [I] thought, That can’t be true,” says Sean Slovenski, a former Humana exec who joined Walmart last year to lead its health care push. If the concept spreads, repercussions await in every direction. Like Walmart’s merchandise suppliers, doctors and other medical pros may need to adjust to the retailer’s everyday low prices. Still, cautions Moody’s analyst Charles O’Shea: “Health care is multiple times harder than selling food.” —Don Steinberg

Charles Taylor: 3-D digital hearts

For too many people with suspected heart problems, invasive catheterization is necessary to diagnose blocked or narrowed arteries. Doctors must then choose the best method for improving blood flow from a handful of options, including balloon angioplasty and stenting. Charles Taylor, a former Stanford professor, started HeartFlow to help patients avoid invasive diagnostic procedures and improve treatment outcomes. The company’s system creates personalized 3-D models that can be rotated and zoomed into, so doctors can simulate various approaches on screens. In some cases, it can help avoid invasive procedures entirely. “By adding the HeartFlow … to our available resources for diagnosing stable coronary disease, we are able to provide patients with better care as we evaluate risk,” said Duke University cardiologist Manesh Patel, at the American College of Cardiology’s annual meeting in March. —Jeffrey Kluger

Isabel Van de Keere: Rehab in virtual reality

Isabel Van de Keere was at work one day in 2010 when a steel light fixture pulled loose from the ceiling and fell on her. The accident left Van de Keere, a Belgian-born Ph.D. in biomedical engineering, with a cervical spine injury and severe vertigo that required three years of intense neurological rehabilitation. She practiced the same tedious exercises dozens of times in a row, with progress so slow it seemed undetectable. Now 38, she’s the founder and CEO of Immersive Rehab, a London-based startup whose goal is to change the neurological-rehab experience using virtual reality. By expanding the range and type of exercises patients can try, VR creates more opportunities to harness the brain’s plasticity and repair neural pathways; increases the amount of data caregivers can use to measure progress and adapt programs; and improves the monotonous, frustrating experience of rehab. Feedback from volunteer patients and therapists has been promising; the company is now preparing to run clinical trials in the U.S. and Europe. —Corinne Purtill

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Leading Change in Cancer Clinical Research, Because Our Patients Can’t Wait

May 31, 2024 , by W. Kimryn Rathmell, M.D., Ph.D., and Shaalan Beg, M.D.

Greater use of technologies that can increase participation in cancer clinical trials is just one of the innovations that can help overcome some of the bottlenecks holding up progress in clinical research. 

Thanks to advances in technology, data science, and infrastructure, the pace of discovery and innovation in cancer research has accelerated, producing an impressive range of potential new treatments and other interventions that are being tested in clinical studies . The extent of the innovative ideas that might help people live longer, improve our ability to detect cancer early, or otherwise transform care is staggering. 

Our understanding of tumor biology is also evolving, and those gains in knowledge are being translated into the continued discovery of targets for potential interventions  and the development of novel types of treatments. Some of these therapies are producing unprecedented clinical responses  in studies, including in traditionally difficult-to-treat cancers. 

These advances have contributed to a record number of Food and Drug Administration (FDA) approvals in recent years with, arguably, the most notable approvals being those for drugs that can be used for any cancer, regardless of where it is in the body . 

In some instances, the activity of new agents has been so profound that clinical investigators are having to rethink their criteria for implementation in patient care and their definitions of treatment response. 

For example, although HER2 has been a known therapeutic target in breast cancer for many decades, the new antibody-drug conjugates  (ADCs) that target HER2 have proven to be vastly more effective than the original HER2-targeted therapies. This has forced researchers to rethink fundamental questions about how these ADCs are used in patient care: Can they be effective in people whose tumors have lower expression of HER2 than we previously thought was needed ? And, if so, do we need to redefine how we classify HER2-positive cancer? 

As more innovative therapies like ADCs hit the clinic at a far more rapid cadence than ever before, the research community is being inundated with such fundamentally important questions.

However, the remarkable progress we're experiencing with novel new therapies is tempered by a critical bottleneck: the clinical research infrastructure can’t be expected to keep pace in this new landscape. 

Currently, many studies struggle to enroll enough participants. At the same time, there are patients who don’t have ready access to studies from which they might benefit. Furthermore, ideas researchers have today for studies of innovative new interventions might not come to fruition for 2 or 3 years, or even longer—years that people with cancer don’t have. 

The key to overcoming this bottleneck is to invite innovation to help reshape our clinical trials infrastructure. And here’s how we plan to accomplish that.

Testing Innovation in Cancer Clinical Trials

A transformation in cancer clinical research is already underway. That transformation has been led in part by the success of novel precision oncology approaches, such as those tested in the NCI-MATCH trial .

This innovative study ushered in novel ways of recruiting participants and involving oncologists at centers big and small. And NCI-MATCH has spawned several successor studies that are incorporating and building on its innovations and achievements.

An innovation that emerged from the COVID pandemic was the increase of remote work, even in the clinical trials domain. Indeed, staffing shortages have caused participation in NCI-funded trials to decline. In response, NCI is piloting a Virtual Clinical Trials Office to offer remote support staff to participating study sites. This support staff includes research nurses, clinical research associates, and data specialists, all of whom will help NCI-Designated Cancer Centers and community practices engaged in clinical research activities.

Such technology-enabled services can allow us to reimagine how clinical trials are designed and run. This includes developing technologies and processes for remotely identifying clinical trial participants, shipping medications to participants at home, having imaging performed in the health care settings where our patients live, and empowering local physicians to participate in clinical trials.

We also need mechanisms to test and implement innovations in designing and conducting clinical studies. 

For example, NCI recently established the Clinical Trials Innovation Unit (CTIU) to pressure test a variety of innovations. One of the first trials to emerge from the CTIU’s initial efforts was the Pragmatica-Lung Cancer Treatment Trial , a phase 3 study designed to be easy to launch, enroll, and interpret its results. 

The CTIU, which includes leadership from FDA and NCI’s National Clinical Trials Network , is already working on future innovations, including those that will streamline data collection and apply innovative approaches for other cancers, all with the goal of making cancer clinical studies less burdensome to run and easier for patients to participate.

Data-Driven Solutions

The era of data-driven health care is here, providing still more opportunities to transform cancer clinical research. 

The emergence of artificial intelligence (AI) solutions, large language models, and informatics brings real potential for wholesale changes in how we match patients to clinical studies, assess side effects, and monitor events like disease progression. 

Recognizing this potential, NCI is offering funding opportunities and other resources that will fuel the development of AI tools for clinical research, allow us to carefully test their usefulness, and ultimately deploy them across the oncology community. 

Creating Partnerships and Expanding Health Equity

To be sure, none of this will be, or can be, done by NCI alone. All these innovations require partnerships. We will increase our engagement with partners in the public- and private-sectors, including other government agencies and nonprofits. 

That includes high-level engagement with the Office of the National Coordinator for Health Information Technology (ONC), with input from FDA, Centers for Medicare & Medicaid Services, and Centers for Disease Control and Prevention.

Dr. W. Kimryn Rathmell, M.D., Ph.D.

NCI Director

One example of such a partnership is the USCDI+ Cancer program . Conducted under the auspices of the ONC, this program will further the aims of the White House's reignited Cancer Moonshot SM by encouraging the adoption and utilization of interoperable cancer health IT standards, providing resources to support cancer-specific use cases, and promoting alignment between federal partners. 

And just as importantly, the new partnerships we create must include those with patients, advocates, and communities in ways we have never considered before.

A central feature of this community engagement must involve intentional efforts to expand health equity, to create study designs that are inclusive and culturally appropriate. Far too many marginalized communities and populations today are further harmed by studies that fail to provide findings that apply to their unique situations and needs.

Very importantly, the future will require educating our next generation of clinical investigators and empowering them with the tools that enable new ways of managing clinical studies. By supporting initiatives spearheaded by FDA and professional groups like the American Society of Clinical Oncology, NCI is making it easier for community oncologists to participate in clinical trials and helping clarify previously misunderstood regulatory requirements. 

These efforts must also ensure that we have a clinical research workforce that is representative of the people it is intended to serve. Far too many structural barriers have prevented this from taking place in the past, and it’s time for that to change. 

Expanding our capacity doesn’t mean doing more of the same, it means challenging ourselves to work differently. This will let us move forward to a new state, one in which clinical research is integrated in everyday practice. It is only with more strategic partnerships and increased inclusivity that we can open the doors to seeing clinical investigation in new ways, with new standards for success.

A Collaborative Effort

Shaalan Beg, M.D.

Senior Advisor for Clinical Research

To make the kind of progress we all desire, we have to recognize that our clinical studies system needs to evolve.

There was a time when taking years to design, launch, and complete a clinical trial was acceptable. It isn’t acceptable anymore. We are in an era where we have the tools and the research talent to make far more rapid progress than we have in the past. 

And we can do that by engaging with many different communities and stakeholders in unique and dynamic ways—making them partners in our effort to end cancer as we know it.

Together, our task is to capitalize on this work so we can move faster and enable cutting-edge research that benefits as many people as possible. 

We also know that there are more good ideas in this space, and part of this transformation includes grass roots efforts to drive systemic change. So, we encourage you to share your ideas on how we can transform clinical research. Because achieving this goal can’t be done by any one group alone. We are all in this together. 

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HHS research arm looks to boost hospital cyber defenses with $50M project

The new project comes amid sustained Congressional attention on HHS's role in overseeing healthcare cybersecurity in the wake of the Change Healthcare incident.

Amid relentless targeting of the health sector by ransomware attacks, the Department of Health and Human Services research arm says it will invest more than $50 million in advanced healthcare cybersecurity tools.

HHS’s Advanced Research Projects Agency for Health (ARPA-H) on Monday announced a “Universal PatchinG and Remediation for Autonomous DEfense” (UPGRADE) program. The goal is to build tools that help hospitals and healthcare systems more easily find and fix cyber vulnerabilities in their systems.

In a statement, HHS Deputy Secretary Andrea Palm said the new program would help build on the HHS cybersecurity strategy for the healthcare sector.

“We continue to see how interconnected our nation’s health care ecosystem is and how critical it is for our patients and clinical operations to be protected from cyberattacks,” Palm said. “Today’s launch is yet another example of HHS’ continued commitment to improving cyber resiliency across our health care system.”

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UPGRADE program manager Andrew Carney said a major challenge is modeling the complexities in the myriad software used in any given healthcare facility, leaving many open to ransomware attacks.

“With UPGRADE, we want to reduce the effort it takes to secure hospital equipment and guarantee that devices are safe and functional so that health care providers can focus on patient care,” Carney said in a statement.

A special notice announcing the new project details how ARPA-H envisions the new program developing a “revolutionary new cybersecurity platform for hospitals and health systems.” The idea is to help hospital IT teams manage the “massive complexity” of many health IT environments.

“UPGRADE envisions a semiautonomous cyber-threat mitigation platform that promotes proactive, scalable, and synchronized security updates, adaptable to any hospital environment, and across a wide array of the most vulnerable equipment classes,” the special notice states.

“This software platform will contain a suite of tools that enable real-time evaluation of potential vulnerabilities, and how corresponding security updates might impact hospital operations,” the notice continues. “This will empower hospital decision makers to deploy security remediations without risking the real-world operational downtime that threatens the continuity of patient care.”

ARPA-H detailed how the program will focus on four distinct technical areas, including creating the vulnerability mitigation software platform; developing “high-fidelity” digital twins of hospital systems; automatically detecting cyber vulnerabilities; and “auto-developing” custom cyber defenses.

The research agency said it plans to make multiple awards under the UPGRADE program. It will hold a proposers day on June 20.

ARPA-H’s new project comes amid sustained attention on health sector cybersecurity in the wake of the Change Healthcare ransomware attack. The February cyber incident took down the systems of the major health transactions provider, crippling the operations of hospitals and health systems across the country for weeks.

         Read more: Cybersecurity

In addition to investigating the response by United Healthcare, Change Healthcare’s parent company, lawmakers have been probing the response of HHS, which is responsible for overseeing the cybersecurity of the healthcare sector.

“We must also assess the response of the federal government, which plays a critical role in these efforts,” Sen. Mike Crapo (R-Idaho) said during a May 17 Senate Finance Committee hearing on the Change Healthcare breach. “HHS has a responsibility to serve as a central hub for coordination, convening insights from other branches of government and the private sector to deploy timely information about active threats, as well as best practices to deter intrusions and resources should an attack occur.”

HHS officials say they are elevating the role of the Administration for Strategic Preparedness and Response (ASPR) to serve as a hub for the agency’s sector cybersecurity efforts, which span multiple components and offices.

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Wednesday, September 27, 2023

NIH launches community-led research program to advance health equity

Awards to community organizations will enable examination of structural drivers of health.

The National Institutes of Health is funding a first-of-its-kind community-led research program to study ways to address the underlying structural factors within communities that affect health, such as access to safe spaces, healthy food, employment opportunities, transportation, and quality health care. Through the NIH Common Fund Community Partnerships to Advance Science for Society (ComPASS) program, NIH made 26 awards to community organizations and a coordinating center, totaling approximately $171 million over five years, pending the availability of funds. Through these awards, ComPASS will enable research into sustainable solutions that promote health equity to create lasting change in communities across the nation.

NIH is directly funding research projects led by community organizations. Leaders from the organizations will work in collaboration with their research partners at academic institutions and other organizations in all phases of the research process. ComPASS projects study social determinants of health — the social, physical, and economic conditions where people are born, grow, live, work, age, and play — that contribute to health inequities.

"The ComPASS research model harnesses diverse perspectives and expertise to examine systemic factors that impact the health of individuals, communities, and populations," said NIH Acting Director Lawrence Tabak, D.D.S., Ph.D. “We are excited to see how results from these awards exemplify the transformative power of community-driven research."

The projects will examine underlying conditions and environments that influence health outcomes by enabling the development, implementation, and assessment of structural interventions. Structural interventions are meant to alter social determinants of health by changing factors that create differences in opportunities to achieve optimal health.

Each award will foster the design of strategies to improve health outcomes through innovative structural interventions to address community concerns, such as economic development, social and community context, neighborhood characteristics, health care access and quality, and nutrition and food environment. Community organizations and their research partners will work together to develop a structural intervention, launch it within their communities, and then assess whether the intervention improves health outcomes. Several examples of ComPASS-supported research projects, which focus on populations that experience health disparities , include:

• Supporting access to healthy food in underserved rural communities through the delivery of food boxes to local stores and individuals, and facilitating local food harvesting, processing, and distribution in the community. The project will measure whether these interventions reduce hunger, improve diet quality, promote healthy weight, and protect people against chronic diseases such as diabetes and cardiovascular disease.
• Assessing whether early childcare strategies improve mental health for children and their parents and guardians. This project will develop and examine community strategies that increase access to public early childcare, education, and programming to support young children and families in areas with limited access to childcare.
• Enhancing access to health care through individualized travel information and resources along with a transportation stipend for health care and related trips. The project will assess whether improved transportation access can reduce emergency department readmissions and secondary infections, decrease hospital costs, and improve disease management.
• Improving access to quality health care for older adults from sexual and gender minority populations by creating culturally appropriate and inclusive protocols in the local health system. The project will measure how these changes in the local health system affect overall physical and mental health.
• Assessing whether enhancing telehealth models in rural communities can improve preventative screening and disease management for cancer, depression, diabetes, high blood pressure, and other chronic diseases among agricultural workers. The project will improve telehealth by transforming the workers' access to affordable, reliable high-speed broadband internet.

NIH will gain valuable experience and insight into how to support successful future community-led health research. Each project will also contribute valuable data to a growing body of knowledge about social determinants of health and structural inequities.  

The ComPASS program is funded by the NIH Common Fund and managed collaboratively by NIH staff from the Common Fund; National Cancer Institute; National Institute of Mental Health; National Institute on Minority Health and Health Disparities; National Institute of Nursing Research; National Heart, Lung, and Blood Institute; and NIH Office of Research on Women's Health, with many of the NIH Institutes Centers and Offices providing input and participating in program development and management. More information is available on the ComPASS program website: https://commonfund.nih.gov/compass .  

To learn more about ComPASS, watch this brief video:  https://www.youtube.com/watch?v=PVQVYQBh6KM

About the NIH Common Fund:  The NIH Common Fund encourages collaboration and supports a series of exceptionally high-impact, NIH-wide programs. Common Fund programs are managed by the Office of Strategic Coordination in the Division of Program Coordination, Planning, and Strategic Initiatives in the NIH Office of the Director in partnership with the NIH Institutes, Centers, and Offices.  More information is available at the Common Fund website:  https://commonfund.nih.gov .

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov .

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2024 Research & Scholarship Forum Showcases Pharmacist’s Role in Interprofessional Healthcare Team

May 13, 2024

The MCW School of Pharmacy’s 2024 Research & Scholarship Forum exhibited the work of students, residents, fellows, preceptors, faculty, staff and affiliated partners. The poster showcase featured the findings of 42 projects, which aimed to improve patient care and medication outcomes.

“Providing a research and scholarship forum allows participants to learn about the evolving role of pharmacists, particularly in an interprofessional environment, to discover advancements in the pharmacy profession, engage in peer reflection and identify opportunities for future collaboration,” said Kristin Busse, PharmD, BCPS , assistant professor in the MCW School of Pharmacy  and research oversight program director in the Office of Research.

Of the 42 poster presenters, three award winners gave platform presentations. For Best Student Project, lead author Carter White, BS, 2027 MD candidate from the MCW Medical School, presented the project “Release Characteristics of Partial Patch Clonidine Transdermal System for Pediatric Patients.” The other authors include Sophia Schulte, 2025 PharmD candidate, and MCW School of Pharmacy faculty Jesse Cramer, PharmD, and Abhay Chauhan, PhD, MPharm.

“I hope my presentation demonstrated how pharmacy research can directly enhance patient care,” said White. “I was eager to show attendees that some clinical challenges can be met with straightforward, effective solutions.”

For Best Resident Project, lead author Emily VanOtterloo, PharmD, resident pharmacist with Froedtert & the Medical College of Wisconsin, presented the project “Optimal Duration of Home Blood Pressure Monitoring Protocol in Adults with Hypertension.” The other authors include Zachary Hovis, PharmD, BCACP, assistant professor in the MCW School of Pharmacy, Michelle Mack, BBA, of Froedtert & MCW, Ryan Hanson, MS, of Froedtert & MCW and Erin DeJarlais, PT, MBA, DPT, of Inception Health.

“The Digital Care Monitoring Program at Froedtert and the Medical College of Wisconsin demonstrated sustained effectiveness in maintaining blood pressure control three to six months after patients were disenrolled from the program,” said Dr. VanOtterloo. “These findings highlight the potential value of integrating home blood pressure monitoring with digital engagement tools and pharmacist follow-up in hypertension management.”

For Best Abstract Overall, lead author Mark Hawi, BS, research technologist with the MCW School of Pharmacy, presented the project “HPLC Determination of Pharmaceutical Strength of Expired Oral Hypoglycemics Containing Alogliptin, Metformin and Pioglitazone.” The other authors include Anna Little, 2025 PharmD candidate, Carter White, 2027 MD candidate and Ehab Abourashed, PhD, MS, BPharm, professor and assistant dean for academic and curricular affairs with the MCW School of Pharmacy.

Hawi hoped his presentation ignited interest and curiosity about expired medications. “I want to show that the findings of our study have real, practical applications in terms of free clinic physicians using the data collected to aid in their judgment when using expired medications, plus how our study contributes to the advancement of knowledge about expired hypoglycemic formulations,” said Hawi.

The project receiving honorable mention was “A Prescription to Change Enhancing Pharmacy Student Cultural Intelligence” by Ariane Aidedji and Liliana Galvan, both 2025 PharmD candidates, and Lana Minshew, PhD, assistant professor with the MCW School of Pharmacy.

The event also included a Celebration of Teaching and Learning, which recognized the following 2023-2024 instructor and preceptor award winners:

Outstanding Guest Instructor s

• Caitlin Dunn, MHA (Froedtert &MCW)
• Kristin Hanson, MS (Froedtert &MCW)
• Mark Lodes, MD (Froedtert &MCW)
• Taylor Mancuso, PharmD (Froedtert &MCW)
• Chris Viesselmann, PharmD, BCCCP (Froedtert &MCW)

Patient Care Lab

• John Harter, PharmD (Children’s Wisconsin)
• Angela Paul, PharmD, BCPS (ProHealth Care)
• Rodney Ramos (MATC)
• Claire Solofra, PharmD (St. Luke’s)
• Kathryn Wierer, PharmD, BCPPS, BCCPS (Children’s Wisconsin)

Pharmaceutics

• James Cruikshank, PharmD (Froedtert &MCW)
• Brooke Fraser, PharmD (Froedtert &MCW)

Interdisciplinary Colleague of the Year

• Amy Turner, MS – Director of Operations and Innovation, RPRD Diagnostics
• Ashley Derezinski, BS – Clinical Lab Supervisor, RPRD Diagnostics

IPPE Preceptor of the Year

• Michelle Mitchell, PharmD – Pharmacy Manager, Walgreens

APPE Preceptor of the Year

• Steven Finkenbinder, PharmD, AE-C – Internal Medicine Clinical Pharmacy Specialist, Clement J. Zablocki VA Medical Center

Faculty Preceptor of the Year

• Matthew Stanton, PharmD, BCPS, DABAT – Emergency Pharmacist, Froedtert Hospital; Clinical Assistant Professor, MCW School of Pharmacy; Clinical Toxicologist, WI Poison Center

Didactic Instructors of the Year

Biopharmaceutical Sciences Faculty

• Abir El-Alfy, PhD – Assistant Dean for Student Affairs, Professor (Selected by PY1 and PY2 students)

Clinical Sciences Faculty

• Michael DeBisschop, PharmD – Professor (Selected by PY1 students)
• Matthew Stanton, PharmD, BCPS, DABAT – Clinical Assistant Professor (Selected by PY2 students)

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• v.30(1); Winter 2020

Exploring the challenges of ethical conduct in quality improvement projects

Introduction.

Quality improvement (QI) and clinical research projects both play increasingly important roles in healthcare to improve and enhance patient care. Quality improvement projects in healthcare are critical for improving internal organizational systems and processes to enhance outcomes and deliver safer, cost-effective, and efficient healthcare ( Hagen et al., 2007 ; Newhouse, Pettit, Poe, & Rocco, 2006 ). Clinical research projects use the scientific method to systematically investigate a health-related problem or phenomenon to lead to generalizable knowledge and potentially lead to new discoveries to impact patient care and healthcare systems. As rigorous QI projects and clinical research projects become the norm in driving healthcare improvements, the binary of research versus QI has become less clear ( Newhouse et al., 2006 ). The intent to publish is no longer sufficient for determining whether a QI activity is research ( Casarett, Karlawish, & Sugarman, 2000 ).

A common question for clinicians and researchers is whether or not authorization from a research ethics board (REB) is required prior to conducting their project with participants. The role of the REBs is to ensure research is planned and conducted in a manner that protects the rights and welfare of a project’s participants ( Page & Nyeboer, 2017 ). Research ethics boards make recommendations and provide direction for the ethical conduct of a research project. In Canada, the Tri-Council Policy Statement (TCPS) establishes fundamental ethical principles and dictates standard ethical conduct for research ( Ezzat et al., 2010 ). Tri-Council Policy Statement guidelines clearly indicate that REB approval is required when conducting research and is not required when executing QI or program evaluation projects (Research, 2005). Therefore, there is a gap in the literature regarding the ethical oversight of QI projects ( Ezzat et al., 2010 ). Health researchers are often left without clear guidelines about the approaches warranted to protect QI participants. A debate exists in the literature as to whether or not ethical oversight is necessary in QI projects and, if so, how it should be provided and who should guide this process ( Fiscella, Tobin, Carroll, He, & Ogedegbe, 2015 ; Layer, 2003 ; Lynn, 2007 ; Nerenz, Stoltz, & Jordan, 2003 ; Thurston, Vollman, & Burgess, 2003 ).

The purposes of this paper are to (1) describe how to determine if a project is QI or research, and (2) describe the minimum considerations to ensure the ethical oversight of QI projects.

DISTINGUISHING QI FROM RESEARCH

Research and QI have previously been considered to be fundamentally different activities ( Mold, 2005 ). However, they have become increasingly difficult to distinguish. Not all clinical issues and questions are amenable to research ( Beyea & Nicoll, 1998 ), and both QI and research may address clinical, administrative or educational problems ( Shirey et al., 2011 ). “QI” is a generic term for activities that have the desired effect of improving an aspect of the healthcare process ( Nerenz et al., 2003 ), and QI protocols have typically been informal and subject to change throughout a project ( Shirey et al., 2011 ). An example of this is the Plan, Do, Study, Act (PDSA) cycle, wherein interpretation and implementation of data into practice is an ongoing evaluative process ( Shirey et al., 2011 ). Research is defined as a scientific process that generates new knowledge or validates and refines existing knowledge ( Mold, 2005 ; Shirey et al., 2011 ), and adheres to strict research protocols to control for extraneous variables. To add further complexity, some are hybrid projects, which are research projects on the QI process and are recognized to be a legitimate means of generating new knowledge across clinical settings, as it is a direct route to improving outcomes and delivery of services ( Mormer & Stevans, 2019 ).

One distinguishing criterion used to decipher the difference between QI or research is to review the project’s purpose. If the project aims to generate new knowledge that would be relevant to future beneficiaries such as patients, families, staff, or to the broader scientific community, it would be classified as research. If the intent is to improve current work-flow processes and enhance efficiency within an organization, it is considered QI ( Beyea & Nicoll, 1998 ; Shirey et al., 2011 ).

A second distinguishing feature to consider is the type of question underlying the study. Research uses systematic problem-solving approaches that are inquiry-driven; QI also uses a systematic, problem-solving approach, but is data-driven, rather than inquiry-driven ( Shirey et al., 2011 ). The third distinguishing feature is the data collection process. Whereas QI projects collect data in iterative, short, rapid cycles to provide immediate improvements, research projects rely on controlled data collection approaches, as detailed in research protocols. Quality improvement projects are typically conducted with patients who are inducted into the study with few or no eligibility restrictions to enhance external validity ( Layer, 2003 ; Duke University, 2016 ). In contrast, research participants often must meet inclusion and exclusion criteria to be eligible to enter the study. A number of algorithms are available to facilitate this distinction. However, few provide guidance on how to maintain ethical conduct (see Table 1 ).

QI versus Research Distinguishing Tools

ETHICAL CONDUCT IN QI

Upholding the ethical principles of autonomy, beneficence, non-maleficence, and justice in QI projects should be as stringent as what is expected in clinical research. Whether intentional or unintentional, QI projects can expose participants to risk or burden, may present an unequal distribution of benefit across participants, and can present conflicts of interest in the prioritization of projects ( Duke University, 2016 ). Although the TCPS lacks clear guidelines for maintaining ethical conduct in QI projects, some guidance exists in the literature ( Hagen et al., 2007 ; Government of Canada, 2005 ). In essence, the ethical principle of non-maleficence (protecting patients from harm) must be observed and appropriate action to avoid causing harm must be taken in QI studies ( Dixon, 2017 ). A favourable risk-benefit balance must be achieved by limiting risks such as patient harm and breaches in confidentiality, as well as maximizing benefits to patients and patient care ( Dixon, 2017 ). The social and scientific value for the project, resources spent, and risks imposed on participants should be justified in QI activities ( Lynn, 2007 ). Furthermore, appropriate safeguards for security and confidentiality are critical in these projects ( Ezzat et al., 2010 ).

To aid researchers and clinicians, we propose a minimum set of considerations in the ethical oversight of QI activities: (1) purpose, (2) informed consent, (3) participant confidentiality, and (4) withdrawal from activity.

1. Review the purpose and design of the activity

When QI projects are poorly designed or not properly conducted, it would be unethical to proceed with the activity, as the project would be unlikely to lead to healthcare improvements. To ensure the goal of QI projects produces relevant knowledge that will be useful to the host organization, the Institute of Medicine (IOM) ( Wolfe, 2001 ) suggests that QI projects align with six aims:

• Safety: Care is intended to help patients; therefore, injuries are avoided.
• Effectiveness: Services are provided based on scientific knowledge to patients who are likely to benefit from them.
• Patient-centred: Care is respectful and responsive to individual preferences, needs, and values.
• Timely: Interventions should reduce wait-times for patients requiring care.
• Efficiency: Avoiding waste, such as equipment, supplies, energy, and funds.
• Equity: Care does not vary in quality, regardless of gender, ethnicity, geographic location, or socioeconomic status.

2. Consider the need for informed consent

The main rationale for informed consent is to respect the autonomy and protect participants from exposure to project risks that they have not agreed to accept ( Miller & Emanuel, 2008 ). However, QI initiatives are routinely adopted in hospital settings. For example, a hospital seeking to implement evidence-based interventions could establish a QI project to evaluate the implementation and, in this case, the consent to treatment would also imply consent to the intervention and inclusion in the QI project ( Miller & Emanuel, 2008 ). Moreover, it is often impractical to obtain informed consent from all participants enrolled in QI projects ( Miller & Emanuel, 2008 ). Wide-spread QI projects implemented across a large organization do not logistically allow for each participant to go through a consent process. Obtaining explicit signed consent from healthcare professionals may be less relevant when the QI project is conducted as part of activities that are expected in one’s job description. Quality improvement participants should be asked for informed consent if the QI initiative poses more than a minimal risk, and those risks should be compared with the relative risk of receiving standard healthcare ( Lynn, 2007 ).

3. Consider how participant confidentiality is protected

While QI activities often pose minimal physical, psychological, social, or financial risk to participants, the threat to privacy and the loss of confidentiality of health information are important considerations ( Baily, Bottrell, Lynn, & Jennings, 2006 ). Confidentiality extends to everything a member of the QI team can learn about a patient in the medical records or by observation in conducting the project. Participant information can be unintentionally transmitted if QI data is left unattended on desktops, computer screens, or discussed in corridors or elevators. To mitigate participant risk and maintain participant confidentiality, QI projects typically undergo some level of internal review. However, the quality of this review can vary, as there is no clear definition of requirements ( Fiscella et al., 2015 ; Taylor, Pronovost, & Sugarman, 2010 ).

4. Consider whether the right of participant withdrawal from project is necessary

When people participate in research, they have the reserved right to withdraw from a project at any time, and are entitled to the same ‘standard of care’ throughout their treatment, regardless of their actions ( Edwards, 2005 ). However, because informed consent is not always obtained in QI initiatives, participants may not have explicitly volunteered nor have been aware of their participation in a QI activity, so it may not be possible to allow participants to withdraw ( Miller & Emanuel, 2008 ). In this case, we recommend revisiting the concept of informed consent and providing strong, concise education on all options that are available for treatment. Participants require clear, concise information on all options that are available to them. In cases where the QI activities involve risks beyond standard of care, the concept of informed consent may become relevant.

REB Exemption

If a project is deemed to be QI, it is good practice to request an exemption letter from the institution’s REB, as most journals require this prior to publication ( Bauchner & Sharfstein, 2001 ; Eccles, Weijer, & Mittman, 2011 ). If the nature of risk in the QI study seems elevated beyond what is expected under routine care, a REB review may be requested to determine what sort of minimal criteria to apply to protect the participant (Nosowsky, n.d.).

Quality improvement projects can span a wide range of projects of differing complexity where potential benefits and risks to participants can vary ( Lo & Groman, 2003 ). Although the need for a REB review is presently deemed unnecessary for QI projects, it is not justification for less rigour or less attention to the protection of study participants. Project leaders are responsible to maintain ethical oversight and protect the safety and dignity of study participants ( Government of Canada, 2005 ). An important future directive for QI initiatives is ensuring practical, user-friendly ethical guidelines for QI projects that do not stifle the projects, and provide the adequate safeguards for QI participants.

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