Kushal T. Kadakia's research while affiliated with Harvard Medical School and other places
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Publications (21)
The US Food and Drug Administration should address health misinformation through existing and new regulatory approaches, including modernizing product labeling, investing in infodemic surveillance and addressing the roles of the internet and social media.
Importance:
In the US, nearly all medical devices progress to market under the 510(k) pathway, which uses previously authorized devices (predicates) to support new authorizations. Current regulations permit manufacturers to use devices subject to a Class I recall-the FDA's most serious designation indicating a high probability of adverse health co...
This study compares graduate medical education (GME) payments between nonprofit and for-profit hospitals between 2011 and 2020 to assess how hospitals value GME.
Importance
Labor unionization efforts have resurged in the US, and union membership has been shown to improve worker conditions in some industries. However, little is known about labor unionization membership and its economic effects across the health care workforce.
Objectives
To examine the prevalence of labor unionization among health care work...
Policy Points
• Hospital-at-Home (HaH) is a home-based alternative for acute care that has expanded significantly under COVID-19 regulatory flexibilities.
• The post-pandemic policy agenda for HaH will require consideration of multistakeholder perspectives, including patient, caregiver, provider, clinical operations, technology, equity, legal, qua...
The financial impact of the COVID-19 pandemic has been particularly significant in surgical specialties, with an estimated loss of $22 billion due to deferrals and cancelations of procedures. Evidence suggests that alternative payment models may have reduced the financial impact of COVID-19 for some providers; however, representation of plastic sur...
Importance
Strengthening premarket and postmarket surveillance of medical devices has long been an area of focus for health policy makers. The recent class I recall (the most serious of the US Food and Drug Administration [FDA] recalls) of reperfusion catheters manufactured by Penumbra, a US-based medical device company, illustrates issues of devic...
Barriers to timely data collection and exchange hindered health departments throughout COVID-19, from fax machines creating bottlenecks for disease monitoring to inconsistent reporting of race and ethnicity. Modernizing public health data systems has become a bipartisan postpandemic imperative, with President Trump engaging the US Digital Service t...
Digital health products have played an important role in the COVID-19 response, from supporting the remote monitoring of patients to enabling continuity in data collection for clinical trials. The U.S. Food and Drug Administration (FDA) has issued a number of temporary policies to support digital health innovation during the pandemic, such as guida...
Citations
... Moreover, if the predicate device poses risk or is ineffective, then the new device may perpetuate these flaws. It is not uncommon for a device to cite a recalled predicate [9][10][11], with one estimate being about 4.3% [11]. There is disagreement, however, as to whether this aspect of the process is invalid entirely or only for specific types of high risk or technologically complex devices [3,9,12]. ...
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... 4,5 Even though the 510(k) pathway facilitates expedient iterative device development, 4 hundreds of 510(k) devices are recalled annually due to potential patient harm, 6 with more than 300 recalls occurring in 2020 alone. Recalls of 510(k) devices, including transvaginal surgical meshes 7,8 and reperfusion catheters, 9 have raised concerns that substantial equivalence may be a poor marker of safety and efficacy. ...
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... Although some clinical practice organizations oppose this approach citing safety concerns, 17 other groups argue that patient risk can be mitigated by careful drug selection. 18 Recent pilot studies of at-home infusion of cytotoxic therapies provide early insight into potential feasibility of this approach. [18][19][20][21][22][23] For example, Penn Medicine's Cancer Care at Home has administered and monitored 13 common cancer treatments at patients' homes. ...
... A total of 6 lessons, derived from 27 studies [7,10,12,16,22,34,39,43,44,49,59,60,68,70,73,75,77,81,85,107,[114][115][116][117][118][119][120] and quoted on 53 single occasions, were referred to this pillar: among them, 10 citations were referred to AFRO region, 5 to EMRO region, 3 to EURO region, 24 to AMRO region, 7 to SEARO, and 4 to WPRO region (see Figure S5). ...
... 32 This fully decentralized individually randomized, parallel-group multicenter trial enrolled participants without any in-person contact. 33,34 Some collaborating breast oncologists were asked to hand out study leaflets to their patients, but this did not involve any in-person intervention. Participants were randomly assigned to a smartphone-based intervention plus treatment as a usual group or a waitlist control group receiving treatment as usual. ...
... In addition to advancing the scientific enterprise, publicly sharing data and code can benefit society at large [10][11][12]. For example, open science practices led to rapid advancements in our understanding of, and thus ability to combat, the emergence of SARS-CoV-2 [13][14][15][16]. ...
... The FDA issued a digital health innovation action plan in 2017 to address the regulation of software as a medical device and most recently launched the Digital Health Center of Excellence as a resource for digital health policy. [83] To date, only a small percentage of wearable devices have obtained FDA clearance. ...
... There is growing impetus for surgeon-anesthesiologist to collaboratively participate in the "hospital-at-home" paradigm. 13,14 Improving effectiveness and efficiency through clinical pathways will also reduce hospitalacquired infections and other complications, thereby reducing length-of-stay-all of which are paramount as we define the "new normal" in perioperative care. Therefore, current successful experience with remotely triaging and managing asymptomatic COVID-19 patients can pave the way to widespread future RPM implementation in the postoperative discharge setting. ...
