About
261
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Introduction
Paul Wicks, Ph.D., is an independent consultant who helps digital health companies generate evidence, revenue, and awareness. Prior to consulting, for 13 years he led innovation at PatientsLikeMe, an online community for over 850,000 people living with medical conditions. Paul has over 185 peer-reviewed publications including multiple decentralized clinical trials, patient-reported outcomes, applications of medical AI, and a dose-response curve for friendship.
Additional affiliations
Education
October 2002 - September 2005
September 1999 - June 2002
Publications
Publications (261)
ALSUntangled reviews alternate and off-label treatments prompted by patient interest. Here, we review psilocybin, a chemical derived from mushrooms and belonging in the category of drugs known as psychedelics. Psilocybin has plausible mechanisms for slowing ALS progression because of its ability to cross the blood brain barrier and effect neurogene...
The Wahls diet is a modified Paleolithic diet that emphasizes dark green leafy vegetables, colorful fruits, high-quality animal proteins, and omega-3 polyunsaturated fatty acids, while limiting grains, legumes, dairy products, sugar, and processed foods containing proinflammatory omega-6 fatty acids. The Wahls diet may reduce inflammation, oxidativ...
Smartphone applications are one of the main delivery modalities in digital health. Many of these mHealth apps use gamification to engage users, improve user experience, and achieve better health outcomes. Yet, it remains unclear whether gamified approaches help to deliver effective, safe, and clinically beneficial products to users. This study exam...
UNSTRUCTURED
Healthcare technologies have the ability to bridge or hinder equitable care. Advocates of digital mental health interventions (DMHIs) report that such technologies are poised to reduce the documented gross health care inequities that have plagued generations of people seeking care. This is due to a multitude of factors such as their po...
Health care technologies have the ability to bridge or hinder equitable care. Advocates of digital mental health interventions (DMHIs) report that such technologies are poised to reduce the documented gross health care inequities that have plagued generations of people seeking care in the United States. This is due to a multitude of factors such as...
Spurred by patient interest, ALSUntangled herein examines the potential of the Portable Neuromodulation Stimulator (PoNS™) in treating amyotrophic lateral sclerosis (ALS). The PoNS™ device, FDA-approved for the treatment of gait deficits in adult patients with multiple sclerosis, utilizes translingual neurostimulation to stimulate trigeminal and fa...
Background
Novel therapeutics should always be tested in a sample representative of the population in need of treatment. Initial efforts of drug development take place in early phase trials (phase-I and -II), setting the direction for late-stage studies (phase-III and -IV). However, study samples in early phase trials typically fail to recruit Blac...
ALSUntangled reviews alternative and off-label treatments on behalf of people with ALS (PALS) who ask about them. Here, we review withania somnifera (WS) commonly known as ashwagandha or winter cherry. WS has plausible mechanisms for slowing ALS progression because of its effects on inflammation, oxidative stress, autophagy, mitochondrial function,...
Background
The ability of digital mental health interventions (DMHIs) to reduce mental health disparities relies on the recruitment of research participants with diverse sociodemographic and self-identity characteristics. Despite its importance, sociodemographic reporting in research is often limited, and the state of reporting practices in DMHI re...
Smartphone applications are one of the main delivery modalities in digital health. Many of these mHealth apps use gamification to engage users, improve user experience, and achieve better health outcomes. Yet it remains unclear whether gamified or game approaches help to deliver effective, safe, and clinically beneficial products to users. This stu...
Lion's Mane (Hericium erinaceus) has historically been used as traditional medicine in Asia and Europe for its potential benefits in fighting infection and cancer. It has gained interest in the neurodegenerative disease field because of its mechanisms of action; these include anti-inflammation, neuroprotection, and promoting neurite growth demonstr...
ALSUntangled reviews alternative and off-label treatments for people living with amyotrophic lateral sclerosis (PALS). Here we review insulin, which has at least one plausible mechanism for slowing ALS progression. However, pre-clinical studies are limited and there have been no trials in PALS yet. Insulin use in patients without a metabolic need m...
Introduction:
Postpartum depression (PPD) is common, persistent, and stigmatized. There are insufficient trained professionals to deliver appropriate screening, diagnosis, and treatment.
Areas covered:
WB001 is a Software as a Medical Device (SaMD) based Agent-Guided Cognitive-Behavioral Therapy (AGCBT) program for the treatment of PPD, for whic...
Background: The ability for digital mental health interventions (DMHI) to reduce mental health disparities relies on recruitment of research participants with diverse sociodemographic and self-identity characteristics. Despite its importance, sociodemographic reporting in research is often limited, and the state of reporting practices in DMHI resea...
Nuedexta is a combination of dextromethorphan hydrobromide and quinidine sulfate and was approved by the Food and Drug Administration (FDA) in 2010 to treat pseudobulbar affect (PBA). There have since been anecdotal case reports of bulbar function improvements after Nuedexta treatment. Here, we review the off-label use of Nuedexta for improving bul...
This poster describes a genetic education, counseling, and testing program titled "Light the Way" for people at risk of genetic ALS in the UK and US.
ALSUntangled reviews alternative and off-label treatments for people living with amyotrophic lateral sclerosis (PALS). Here, we review caffeine which has plausible mechanisms for slowing ALS progression. However, pre-clinical studies are contradictory, and a large case series showed no relationship between caffeine intake and ALS progression rate....
Dozens of frameworks have been proposed to assess evidence for digital health interventions (DHIs), but existing frameworks may not facilitate DHI evidence reviews that meet the needs of stakeholder organizations including payers, health systems, trade organizations, and others. These organizations may benefit from a DHI assessment framework that i...
Background
Paediatric trials must contend with many challenges that adult trials face but often bring additional obstacles. Decentralised trials, where some or all trial methods occur away from a centralised location, are a promising strategy to help meet these challenges. This scoping review aims to (a) identify what methods and tools have been us...
We read with great interest Dr Benatar and colleagues’ detailed description of pre-diagnosis periods in amyotrophic lateral sclerosis (ALS).¹ We are a group of people living with (or affected by) genetic forms of ALS/FTD (frontotemporal dementia). Many of us have cared for family members as they moved from the ‘susceptible’ period into the ‘prodrom...
Patient registries fulfill a number of key roles for clinicians, researchers, non-profit organizations, payers, and policy makers. They can help the field understand the natural history of a condition, determine the effectiveness of interventions, measure safety, and audit the quality of care provided. Successful registries in cystic fibrosis, Duch...
ALSUntangled reviews alternative and off-label treatments for people living with amyotrophic lateral sclerosis (PALS). Here we review astaxanthin which has plausible mechanisms for slowing ALS progression including antioxidant, anti-inflammatory, and anti-apoptotic effects. While there are no ALS-specific pre-clinical studies, one verified “ALS rev...
Background: Paediatric trials must contend with many challenges that adult trials face but often bring additional obstacles. Decentralised trials, where some or all trial methods occur away from a centralised location, are a promising strategy to help meet these challenges. This scoping review aims to (a) identify what methods and tools have been u...
Background
The role of thromboprophylaxis in the post-acute phase of COVID-19 is uncertain due to conflicting results from randomised controlled trials and observational studies. We aimed to determine the effectiveness of post-hospital apixaban in reducing the rate of death and hospital readmission of hospitalised adults with COVID-19.
Methods
HEAL...
People affected by rare diseases want to be involved in research and the search for new treatments. Randomized controlled trials remain the best way of finding new interventions, but many elements of traditional study design are not best suited for rare diseases. Barriers to patients and families include the use of specialist hospital sites for rec...
It is increasingly recognized that involving patients and the public in the design of clinical trials can lead to better recruitment, retention, and satisfaction. A recent scoping review determined that between 1985 and 2018, just 23 articles meeting quality criteria obtained feedback from clinical trial participants after a trial had been complete...
ALSUntangled reviews alternative and off-label treatments for people living with amyotrophic lateral sclerosis (PALS). Here we review ozone therapy. Ozone therapy has possible mechanisms for slowing ALS progression based on its antioxidant, anti-inflammatory, and mitochondrial effects. A non-peer-reviewed report suggests that ozone treatment may sl...
ALSUntangled reviews alternative and off-label treatments on behalf of people with ALS who ask about them. Here we review rituximab, a drug which specifically depletes B lymphocytes. We show a current lack of evidence for a role of these cells in ALS progression. The one patient we found who described using Rituximab for their ALS found no benefit....
ALSUntangled reviews alternative and off-label treatments for people with amyotrophic lateral sclerosis (PALS). Here we review glucocorticoids. Neuroinflammation plays a prominent role in amyotrophic lateral sclerosis (ALS) pathogenesis, so some hypothesize that glucocorticoids might be an effective ALS therapy through their immunosuppressive effec...
Several infections have been associated with motor neuron diseases resembling ALS, including species of viruses, bacteria, and parasites. Mycobacterium avium subspecies paratuberculosis (MAP), most known for its probable etiologic association with Crohn's disease, has been suggested as another possible infectious cause of motor neuron disease. Two...
Background: Amyotrophic lateral sclerosis (ALS) shows considerable clinical heterogeneity, which affects clinical trials. A clinical staging system has been proposed for ALS with potential applications in patient care, research, trial design and health economic analyses. The King's system consists of five stages. We have previously shown that progr...
Introduction: This scoping review will determine how online, randomised trials with children are conducted. The objectives of the review are: (a) to determine what methods and tools have been used to create and conduct online trials with children and (b) to identify the gaps in the knowledge in this field.
Over the last decade, randomised trials em...
Traditional clinical trials have often failed to recruit representative participant populations. Just 5% of eligible patients participate in clinical research. Participants, particularly those from minority groups, cite geographical constraints, mistrust, miscommunication, and discrimination as barriers. Here, an intersectional view of inclusion in...
Introduction
This scoping review will determine how online, randomised trials with children are conducted. The objectives of the review are: (a) to determine what methods and tools have been used to create and conduct online trials with children and (b) to identify the gaps in the knowledge in this field.
Over the last decade, randomised trials emp...
Introduction:
Postpartum Depression (PPD) is common, persistent, and stigmatized. There are insufficient trained professionals to deliver appropriate screening, diagnosis, and treatment.
Areas covered:
WB001 is a Software as a Medical Device (SaMD) based Agent-Guided Cognitive Behavioral Therapy (AGCBT) program for the treatment of PPD, for whic...
Objective:
Most assessments of suicidal ideation and behavior (SIB) are limited by reliance on a single assessor, typically a clinician or patient, with scant detail on patient-related drivers of SIB and inability to detect rapid change in SIB. Furthermore, many techniques do not include a semistructured interview, increasing rater variability. Th...
Background
Increasing use of emergency departments (EDs) by patients with low urgency, combined with limited availability of medical staff, results in extended waiting times and delayed care. Technological approaches could possibly increase efficiency by providing urgency advice and symptom assessments.
Objective
The purpose of this study is to ev...
Background
Randomised trials are considered the gold standard in providing robust evidence on the effectiveness of interventions. However, there are relatively few initiatives to help increase public understanding of what randomised trials are and why they are important. This limits the overall acceptance of and public participation in clinical tri...
ALSUntangled reviews alternative and off-label treatments for people living with amyotrophic lateral sclerosis (PALS). Here we review butyrate and its different chemical forms (butyrates). Butyrates have plausible mechanisms for slowing ALS progression and positive pre-clinical studies. One trial suggests that sodium phenylbutyrate (NaPB) in combin...
Cardiovascular diseases (CVDs) are the primary cause of all death globally. Timely and accurate identification of people at risk of developing an atherosclerotic CVD and its sequelae is a central pillar of preventive cardiology. One widely used approach is risk prediction models; however, currently available models consider only a limited set of ri...
Conducting a successful clinical trial is arduous at the best of times. Protocol development, site selection, contracting, and regulatory compliance all take significant time and attention from multidisciplinary teams before a single participant is enrolled [1]. Once active, many trials face challenges recruiting sufficient participants in a timely...
Background
The best way of comparing healthcare treatments is through a randomised trial. In a randomised trial, we compare something (a treatment or intervention) to something else, often another treatment. Who gets what is decided at random, meaning everyone has an equal chance of getting any of the treatments. This means any differences found ca...
Cardiovascular diseases (CVDs) are the primary cause of all global death. Timely and accurate identification of people at risk of developing an atherosclerotic CVD and its sequelae, via risk prediction model, is a central pillar of preventive cardiology. However, currently available models only consider a limited set of risk factors and outcomes, d...
ALSUntangled reviews alternative and off label treatments with a goal of helping patients make more informed decisions about them. Here we review ketogenic diets. We shows that these have plausible mechanisms, including augmenting cellular energy balance and reducing excitotoxicity, neuroinflammation and oxidative stress. We review a mouse model st...
When people face a health problem, they often first ask, ‘Is there an app for that?’. We investigated the quality of advice provided by the Ada symptom assessment application to address the question, ‘How do I know the app on my phone is safe and provides good advice?’. The app was tested with 48 independently created vignettes developed for a prev...
This viewpoint focuses on the ways in which digital medicine and measurement-based care can be utilized in tandem to promote better assessment, patient engagement, and an improved quality of psychiatric care. To date, there has been an underutilization of digital measurement in psychiatry, and there is little discussion of the feedback and patient...
BACKGROUND
Increasing use of emergency departments (EDs) by patients with low urgency, combined with limited availability of medical staff, results in extended waiting times and delayed care. Technological approaches could possibly increase efficiency by providing urgency advice and symptom assessments.
OBJECTIVE
The purpose of this study is to ev...
Vitamin C is one of the most common supplements taken by people with ALS. As an antioxidant, it has a plausible mechanism for slowing disease progression and there are some flawed pre-clinical studies and case reports suggesting benefit. However, a small human trial showed no benefit. Given this negative trial, we do not currently advise vitamin C...
Background
There are far more patients in mental distress than there is time available for mental health professionals to support them. Although digital tools may help mitigate this issue, critics have suggested that technological solutions that lack human empathy will prevent a bond or therapeutic alliance from being formed, thereby narrowing thes...
ALSUntangled reviews alternative and off-label treatments for people with ALS. Here we review light therapy. We show that it has theoretically plausible mechanisms, three flawed pre-clinical data, studies, and one incompletely documented case report supporting its use. We explain why further studies are needed to determine whether any specific ligh...
Background
Establishing rapport and empathy between patients and their health care provider is important but challenging in the context of a busy and crowded emergency department (ED).
Objective
We explore the hypotheses that rapport building, documentation, and time efficiency might be improved in the ED by providing patients a digital tool that u...
BACKGROUND
Establishing rapport and empathy between patients and their health care provider is important but challenging in the context of a busy and crowded emergency department (ED).
OBJECTIVE
We explore the hypotheses that rapport building, documentation, and time efficiency might be improved in the ED by providing patients a digital tool that...
Background
Randomised trials are considered the gold standard in providing robust evidence on the effectiveness of interventions. However, there are relatively few initiatives to help increase public understanding of what randomised trials are and why they are important. This limits the overall acceptance of and public participation in clinical tri...
Background
The best way of comparing healthcare treatments is through a randomised trial. In a randomised trial, we compare something (a treatment or intervention) to something else, often another treatment. Who gets what is decided at random, meaning everyone has an equal chance of getting any of the treatments. This means any differences found ca...
BACKGROUND
There are far more patients in mental distress than there is time available for mental health professionals to support them. Although digital tools may help mitigate this issue, critics have suggested that technological solutions that lack human empathy will prevent a bond or therapeutic alliance from being formed, thereby narrowing thes...
Here we use the ALSUntangled methodology to review Tamoxifen as an ALS treatment. We show that it has plausible mechanisms, a positive preclinical study, a case report and 2 small trials suggesting benefits. We show that it appears reasonably safe, though there is a small risk of developing cancer with long term use. While we cannot yet endorse thi...
Individuals who are diagnosed with amyotrophic lateral sclerosis (ALS) today face the same historically intransigent problem that has existed since the initial description of the disease in the 1860s — a lack of effective therapies. In part, the development of new treatments has been hampered by an imperfect understanding of the biological processe...
To the Editor The Viewpoint by Dr McGreevey and colleagues¹ drew attention to the increasing use of conversational agents (CAs) in health care. However, they suggested a less mature field than we find in practice, and their call for CA-specific regulations risks creating confusion.
BACKGROUND
Overcrowding can negatively affect the performance of the health care facilities not only for patients in terms of delayed care delivery and increased health risk, but also for health care workers in terms of increased burden and stress. Sometimes overcrowding is a result duplicate activity such as history taking and recording of patient...
Background
Crowding can negatively affect patient and staff experience, and consequently the performance of health care facilities. Crowding can potentially be eased through streamlining and the reduction of duplication in patient history-taking through the use of a digital symptom-taking app.
Objective
We simulated the introduction of a digital s...
Objectives
To compare breadth of condition coverage, accuracy of suggested conditions and appropriateness of urgency advice of eight popular symptom assessment apps.
Design
Vignettes study.
Setting
200 primary care vignettes.
Intervention/comparator
For eight apps and seven general practitioners (GPs): breadth of coverage and condition-suggestio...
IMPORTANCE
Communication between patients and healthcare professionals is frequently challenging in the crowded emergency department (ED), with few opportunities to develop rapport or empathy. Digital tools for patients and physicians have been proposed as helpful but their utility is not established.
OBJECTIVE
To evaluate a patient-facing digital...
Objectives: To investigate the quality of condition suggestion and urgency advice provided by the Ada symptom assessment application and to compare it to published literature evaluation of free website and mobile symptom assessment applications accessible in Australia.
Design: The application was tested with 48 independently created medical conditi...
Objectives: This study explores the effect of patient clinical history taking, using a digital symptom assessment app, on patient flow.
Design, methods and participants: We used a discrete event approach to simulate patient flow in an urgent care center.
Setting: The base case: a small center with 2 triage nurses, 2 doctors, 1 treatment/examination...
Objectives To compare breadth of condition coverage, accuracy of suggested conditions and appropriateness of urgency advice of 8 popular symptom assessment apps with each other and with 7 General Practitioners.
Design Clinical vignettes study.
Setting 200 clinical vignettes representing real-world scenarios in primary care.
Intervention/comparator...
BACKGROUND
When someone needs to know whether and when to seek medical attention, there are a range of options to consider. Each will have consequences for the individual (primarily considering trust, convenience, usefulness, and opportunity costs) and for the wider health system (affecting clinical throughput, cost, and system efficiency). Digital...
Background:
When someone needs to know whether and when to seek medical attention, there are a range of options to consider. Each will have consequences for the individual (primarily considering trust, convenience, usefulness, and opportunity costs) and for the wider health system (affecting clinical throughput, cost, and system efficiency). Digit...
https://www.tandfonline.com/doi/full/10.1080/21678421.2020.1726565
Big data, coupled with the use of advanced analytical approaches, such as artificial intelligence (AI), have the potential to improve medical outcomes and population health. Data that are routinely generated from, for example, electronic medical records and smart devices have become progressively easier and cheaper to collect, process, and analyze....
Date Presented 04/04/19
This survey of patient members of an online health community who use power wheelchairs suggests that OTs may better meet patient functional and social needs during power wheelchair assessment by discussing power wheelchair features that are available but may not be covered by insurance, as well as recommendations for avoidin...