Be Kind & the 21st Century Cures Act

I remember when I was first taught to dictate consultations. I was a resident doing a genetics rotation. My mentor, Peter Dignan, made several suggestions. One was to try to always include something nice about the patient. Many of my current colleagues are amused how many of my patients are ‘delightful.’ While there are a lot reasons for putting some kind information in the medical record, Dr. Dignan emphasized that patients and families can get hold of their records and undoubtedly they would appreciate a friendly word. Now with the 21st Century Cures Act Final Rule, access to records and notes will expand considerably and Dr. Dignan’s advice is probably even more important.

A good source of information on this new law, which is in effect Nov 2nd, 2020, is from the 33charts blogCures Act Final Rule – How It Will Change Medicine: “The ONC Cures Act Final Rule (Cures Rule) is the biggest health care law you’ve never heard of. But it’s a law that’s going to fundamentally shift the way we see patients and their information. It will change how physicians talk to patients about information. It will shift the way health professionals connect patients to their information.” This blog post details how this change is going to affect both healthcare providers and families. The two key changes are

  • Access to clinical notes (ie, ‘open notes’)
  • Immediate release of tests and studies.

The key point: “The Cures Rule will force health systems to be better stewards of information on behalf of our patients. I think this is going to force health professionals to help patients think about information and what they do with it. It will force patients to recognize the difference between information and knowledge and wisdom. I suspect that the most critical ultimate change will be transparent conversations and more timely physician follow-up on high stakes studies.”

Another take on the 21st Century Cures Act: C Blease et al. Annals of Internal Medicine; 2020: https://doi.org/10.7326/M20-5370. New U.S. Law Mandates Access to Clinical Notes: Implications for Patients and Clinicians

Some additional information (from EPIC training) — there are limited exceptions for note sharing:

Another reference:

My take: When this rolls out, a lot of physicians (myself included) will need to make some adjustments; since it is the law, don’t expect to avoid these changes. I expect early on this will generate a lot of additional questions and phone calls. In the long run, this is likely to improve communication, transparency, and availability of patient information. For example, it is more likely that needed lab results from referring physicians will be more available after this law is in effect.

PPD (TB Skin Test) or Interferon-Gamma Release Assay (TB Blood Test)?

A recent editorial (JG Hashash et al. Inflamm Bowel Dis 2020; 26: 1315-1318Approach to Latent Tuberculosis Infection Screening Before Biologic Therapy in IBD Patients: PPD or IGRA?) provides some guidance on screening for tuberculosis prior to biologic therapy as well as background on how these tests work.

Key points:

  • The authors state that both a PPD or TB Blood Test (aka Quantiferon-TB Gold) are reasonable for most individuals, though they have a preference for the TB Blood Test.
  • For those with history of BCG vaccination, the TB Blood Test is recommended
  • Steroids are associated with negative PPD and indeterminate TB Blood Test.
  • The authors advocate baseline testing prior to biologic therapy for everyone.
  • Annual testing: For  those in high TB endemic areas, “we propose yearly chest x-ray in addition to IGRA [TB Blood Test]…in low endemic areas…we do not perform yearly chest x-rays nor do we check yearly IGRA unless mandated by a patient’s insurance.”

My take: TB blood testing is more convenient but more costly.  The authors indicate that  for patients from low endemic areas, yearly TB testing is mainly to check boxes mandated by insurance companies rather than improving care.

Disclaimer: This blog, gutsandgrowth, assumes no responsibility for any use or operation of any method, product, instruction, concept or idea contained in the material herein or for any injury or damage to persons or property (whether products liability, negligence or otherwise) resulting from such use or operation. These blog posts are for educational purposes only. Specific dosing of medications (along with potential adverse effects) should be confirmed by prescribing physician.  Because of rapid advances in the medical sciences, the gutsandgrowth blog cautions that independent verification should be made of diagnosis and drug dosages. The reader is solely responsible for the conduct of any suggested test or procedure.  This content is not a substitute for medical advice, diagnosis or treatment provided by a qualified healthcare provider. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a condition

Use of Famotidine for COVID-19

A recent study (DE Freedberg et al. Gastroenterol 2020; DOI:https://doi.org/10.1053/j.gastro.2020.05.053Famotidine Use Is Associated With Improved Clinical Outcomes in Hospitalized COVID-19 Patients: A Propensity Score Matched Retrospective Cohort Study, highlighted on AGA blog, indicates that famotidine may improve outcomes in those with COVID-19.

Methods: Freedberg et al collected data from 1620 patients who tested positive for SARS-CoV-2 no more than 72 hours following admission; 84 of the patients (5.1%) had received famotidine (any dose, form of administration, or duration; median dose of 136 mg) within 24 hours of hospital admission.

Key finding: After the authors adjusted for baseline patient characteristics, use of famotidine was independently associated with risk for death or intubation (adjusted hazard ratio 0.42, 95% CI, 0.21–0.85). This did not change after propensity score matching to balance covariables (hazard ratio 0.43, 95% CI 0.21–0.88).

My take: While these results indicate that famotidine may improve outcomes with COVID-19, a randomized controlled trial is needed to confirm these findings (currently one is underway to determine whether famotidine can improve clinical outcomes in hospitalized patients with COVID-19 (NCT04370262)).

AGA Blog Summary: Use of Famotidine Associated With Improved Outcomes of Hospitalized COVID-19 Patients

Related blog posts:

Gluten-Free Diet Can Be Unhealthy

In some patients with celiac disease, institution of a gluten-free diet may be detrimental without good dietary counseling as a highly-processed diet can increase the risk of adverse cardiovascular events.

A recent study (J Runde et al. JPGN 2020; 71: 533-535. A Narrow Window: Booming Gluten-free Market and Fostering Healthy Dietary Habits in Children With Celiac Disease) assessed dietary patterns of children with celiac disease and indicates that early counseling is crucial.

In total dietary surveys were completed for 100 children with celiac disease. Key findings:

  • 77% consumed processed gluten-free (GF) foods multiple times per day
  • 20% ate exclusively processed GF foods
  • The main reasons for processed GF foods were convenience and taste
  • Patients and families interest in dietary counseling diminished with time. In children <1 year from diagnosis, 35% were interested in dietary feedback, compared to 18% 2-3 years after diagnosis, 15% 4-6 years after diagnosis, and 11% at 7+ years from diagnosis

The authors speculate that highly-processed foods are leading to obesity which is increasingly reported in pediatric celiac disease.

My take:

  • The greatest opportunity for dietary counseling is at the time of the diagnosis.
  • Children with celiac disease commonly consume an unhealthy diet and are at risk for the same types of outcomes as children without celiac disease who also frequently consume an unhealthy diet

Related blog posts:

 

It looks like the COVID-19 epidemic is going to get worse -while there is more testing, there is also a trend of more hospitalizations that is not likely explained by more testing.

How Much Infliximab Can You Give to Young Children?

A recent case series (A Assa et al. JPGN 2020; 71: 516-520. Therapeutic Drug Monitoring-guided High-dose Infliximab for Infantile-onset Inflammatory Bowel Disease: A Case Series) describes four infants (2 mo-12 mo) with infantile-onset IBD who received high doses of infliximab.

Treatments regimens utilized infliximab dosing of 10-22 mg/kg/dose with initial three doses over 2-4 weeks. Other prior treatments in these patients included antibiotics (eg. vancomycin/gentamicin) and corticosteroids. Sulfasalazine was administered in two of the patients.

Other Key Points:

  • The authors noted that patients gradually transitioned to every 4 week therapy whild seeking to maintain trough concentrations >10 mcg/mL.
  • Infants have several risk factors for inadequate serum infliximab levels. Infliximab clearance is not linearly weight-related and infants are “most susceptible for under-dosing.”
  • Infliximab distribution in infants & children differs from adults with more peripheral compartment distribution, leading to lower trough levels.
  • Severity of disease impacts infliximab levels and can cause a ‘sink’ effect

The authors note that higher doses may increase adverse events, including infections

My take: This study shows that highly-selected patients may need both accelerated and higher doses of infliximab to enable response. It adds to the literature that children, in general, are at high risk of under-dosing with ‘standard’ infliximab dosing.

Related blog posts:

NEJM: Competing Visions for U.S. Health Policy, Evolocumab for Pediatric Familial Hypercholesterolemia, and the Cervical Cancer Vaccine

A recent commentary (M Fiedler. NEJM 2020; 383: 1197-99. Competing Visions for the Future of Health Policy) describes two competing approaches to U.S. healthcare policy.

  • The current administration has supported legislation which would repeal or sharply curtail many of the Affordable Care Act’s (ACA’s) coverage provisions and is “asking the U.S. Supreme Court to strike down the entire ACA.”  Their approach views “existing federal coverage programs, particularly those serving lower-income people, [as] too expansive.”
  • The main alternative approach aims for expanded insurance coverage and deep subsidies to cover low- and moderate-income individuals.
  • Areas of potential agreement include encouraging competition to lower costs as well as making prices more transparent to encourage patients to seek out lower-priced alternatives.

My take: Overall, I favor more expansive health care coverage.


RD Santos et al. NEJM 2020; 383: 1317-1327. Evolocumab in Pediatric Heterozygous Familial Hypercholesterolemia

Methods: In this 24-week, randomized, double-blind, placebo-controlled trial with pediatric patients (n=157) with heterozygous familial hypercholesterolemia, patients 10 to 17 years of age were treated with evolocumab.  All had been receiving lipid-lowering treatment before screening and had LDL cholesterol level of 130 mg/dL.

Key finding: At week 24, the mean percent change from baseline in LDL cholesterol level was −44.5% in the evolocumab group and −6.2% in the placebo group.

My take: Long-term data are needed.  However, in high risk patients who have not responded to other intensive treatment, evolocumab may be worthwhile.


J Lei et al. NEJM 2020; 383: 1340-1348. HPV Vaccination and the Risk of Invasive Cervical Cancer

Methods: We used nationwide Swedish demographic and health registers to follow an open population of 1,672,983 girls and women who were 10 to 30 years of age from 2006 through 2017.

Key findings:

  • After adjustment for all covariates, the incidence rate ratio was 0.12 (95% CI, 0.00 to 0.34) among women who had been vaccinated before the age of 17 years and 0.47 (95% CI, 0.27 to 0.75) among women who had been vaccinated at the age of 17 to 30 years.

My take: HPV vaccine (aka ‘Cervical Cancer Vaccine’) may lower the risk of cancer by 88% in those vaccinated before the age of 17 years.

From The Onion

Should We Be Worried About Phthalates?

Short answer -you should always be worried about words that are so difficult to spell.

Two years ago, this blog highlighted recommendations from the AAP regarding food additives (Food Additives and Child Health).

More information of phthalates is available from the Cincinnati Children’s website: Phthalates and Your Health. The backdrop to this article is in relation to a recently published study Pubertal Growth, IGF-1, and Windows of Susceptibility: Puberty and Future Breast Cancer Risk (F Biro et al. Journal of Adolescent Health 2020).

Key points from Cincinnati Children’s website:

  • Phthalates have been used for many years to make plastics softer and more flexible. These plastics are so common that more than 95 percent of all people have detectible levels of phthalates in their urine. They can be found in everything from perfumes and shampoos to food packaging, detergents, vinyl flooring and shower-curtains.
  • These chemicals act like hormones, which in turn can disrupt the function of natural hormones, which can increase diabetes risk and interfere with male genital development.
  • These chemicals also are considered “obesogens,” which means they contribute to the risk of obesity. For these reasons, several types of phthalates have been banned from use in baby toys and teething rings since 2009, but they can still be found in many consumer products.
  • To avoid exposures, some tips include the following:
    • Minimize plastics used for food storage and avoid heating food in plastic. Use glass, ceramic and stainless steel containers when possible.
    • Minimize use of other plastic products with the recycling code numbers 3 and 7. Those coded 1, 2 or 5 are phthalate-free.
  • Increase consumption of fruits and vegetables, foods more frequently that are known to contain “phytoestrogens”.
  • The National Institute of Environmental Sciences offers this document: “Phthalates: the everywhere chemical.”

My take: Environmental research is quite difficult.  Yet, we know that changes in our environmental exposures are directly related to many adverse health outcomes since changes in disease frequencies related to genetics is a much slower process.

Outcomes Associated with Delayed Diagnosis in Pediatric Crohn’s Disease

A Ricciuto et al. Journal of Crohn’s and Colitis; 2020. jjaa197, https://doi.org/10.1093/ecco-jcc/jjaa197 Link: Diagnostic Delay Is Associated with Complicated Disease and Growth Impairment in Paediatric Crohn’s Disease

Methods: “We conducted a national, prospective multi-centre IBD inception cohort study, including 1399 children. Diagnostic delay was defined as time from symptom onset to diagnosis >75 th percentile.”

Key findings:

  • In CD, diagnostic delay was associated with a 2.5-times higher rate of strictures/internal fistulae (HR 2.53, 95% CI 1.41-4.56)
  • Every additional month of diagnostic delay was associated with a decrease in height-for-age z-score of 0.13 standard deviations
  • Diagnostic delay was more common in CD, particularly small bowel CD

My take: Delays in diagnosis in this study were associated with stricturing/internal fistulising complications and growth impairment in paediatric CD.  It is likely that inadequate treatment would increase the risk of these problems as well.

Related blog posts:

Insight Into Alpha-1 Antitrypsin Heterozygosity

CV Schneider, K Hamesch et al. Gastroenterol 2020; 159: 534-548Liver Phenotypes of European Adults Heterozygous or Homozygous for Pi∗Z Variant of AAT (Pi∗MZ vs Pi∗ZZ genotype) and Noncarriers)

Key findings:

  • Ten percent of subjects with the Pi∗MZ genotype vs 4% of noncarriers had LSMs (liver stiffness measurements) of 7.1 kPa or more (adjusted odds ratio, 4.8; 95% confidence interval, 2.0–11.8)
  • Obesity and diabetes were the most important factors associated with LSMs ≥7.1 kPa in subjects with the Pi∗MZ genotype.
  • AAT inclusions were detected in liver biopsies of 63% of subjects with the Pi∗MZ genotype, vs 97% of subjects with the Pi∗ZZ genotype, and increased with liver fibrosis stages.

The associated editorial (pg 433-34) noted that Pi∗MZ genotype is a disease modifier in cystic fibrosis, alcoholic liver disease, and nonalcoholic liver disease.

My take: This study indicates that Pi∗MZ genotype for alpha-one antitrypsin are more likely to develop liver fibrosis in the presence of other risk factors like obesity and diabetes mellitus.

Related blog posts:

IBD Briefs -October 2020

EV Loftus et al.  AP&T  2020; 52: 1343-1365. Full text: Long‐term safety of vedolizumab for inflammatory bowel disease

GEMINI long‐term safety (LTS) study results –initiated 2009:

  • Enrolled patients (UC, n = 894; CD, n = 1349) received vedolizumab 300 mg IV every 4 weeks. Total of 7999 patient years of vedolizumab exposure.
  • Vedolizumab discontinuation due to AEs occurred in 15% (UC) and 17% (CD) of patients.
  • There were no new trends for infections, malignancies, infusion‐related reactions, or hepatic events, and no cases of progressive multifocal leukoencephalopathy
  • Conclusion from authors: “The safety profile of vedolizumab remains favourable with no unexpected or new safety concerns.”

Related blog posts:

AS Faye et al. Inflamm Bowel Dis 2020; 26: 1368-1376. Fertility Impact of Initial Operation Type for Female Ulcerative Colitis Patients (link includes video abstract)

Surgical options include Ileal pouch–anal anastomosis (IPAA), rectal-sparing colectomy with end ileostomy (RCEI), and ileorectal anastomosis (IRA). Conclusions based on “a patient-level state transition microsimulation in TreeAge Pro:”… “Despite an increased risk of infertility, our model results suggest that IPAA may be the optimal surgical strategy for female UC patients aged 20–30 years who desire children. For patients aged 35 years, RCEI should additionally be considered, as QALYs for RCEI and IPAA were similar.”   In older age group, RCEI’s increase rate of childbirth (28%), decrease time to childbirth (14 months) and 77% reduction in IVF are important factors.

Related blog posts:

R Tariq et al. Inflamm Bowel Dis 2020; 26: 1415-1422. Efficacy of Fecal Microbiota Transplantation for Recurrent C. Difficile Infection in Inflammatory Bowel Disease

In this retrospective study with 145 patients,  the overall cure rate of CDI after FMT was 80.0%, without CDI recurrence at median follow-up of 9.3 (range, 0.1–51) months. The authors concluded that “fecal microbiota transplantation effectively treats recurrent CDI in IBD patients but has no apparent beneficial effect on the IBD course.”

Related blog posts:

Isle of Palms (July 2020)