Podcast

Gregory J, Huynh B, Tayler B, et al. High-dose vs standard-dose amoxicillin plus clavulanate for adults with acute sinusitis. A randomized clinical trial. JAMA Network Open 2021;4(3):e212713

Study design: Randomized controlled trial (double-blinded)

 primary care offices with sinus symptoms consistent with currently accepted clinical criteria for acute bacterial sinusitis. 

andomly received (concealed allocation assignment) either a standard-dose regimen of amoxicillin 875 mg plus clavulanate 125 mg plus placebo twice daily for 7 days or a high-dose regimen of amoxicillin 875 mg plus clavulanate 125 mg plus amoxicillin 875 mg twice daily for 7 days. 

They planned to have 240 patients enrolled in the trial but then COVID happened and the authors say “  At an unplanned interim analysis prompted by COVID-19 restrictions” made us look at the data and then stop the trial. 

They found that there was NO difference between the high dose and the standard dose

a global rating of "a lot better" or "no symptoms" occurred in 44.3% of patients in the standard-dose group compared with 36.4% of patients in the high-dose group 

 79 randomized to the standard dose and 78 to the high dose; 9 and 12, respectively, withdrew or were lost to follow-up 

 Because of the high drop-out rate, the investigators assigned a negative outcome to everyone in the standard-dose group and a positive outcome to everyone in the high-dose group; the group difference in the primary outcome was still not significant.

DONT DO SOEMTHING STAND THERE

China L, Freemantle N, Forrest E, et al, for the ATTIRE Trial Investigators. A randomized trial of albumin infusions in hospitalized patients with cirrhosis. N Engl J Med 2021;384(9):808-817.

Study design: Randomized controlled trial (nonblinded)

in hospitalized patients with decompensated cirrhosis dose Routine daily albumin infusions to target an albumin level of 30 g/L or more prevent infection, kidney dysfunction, or death? 

 The intervention group (n = 380) received a daily 20% albumin infusion at 100 mL per hour to target an albumin level of at least 30 g/L for a maximum of 14 days or until discharge. The control group (n = 397) received standard care. 

The primary outcome was a composite of new infection from any cause, kidney dysfunction, or in-hospital death between trial day 3 and trial day 15 or day of discharge (whichever occurred earlier).

 There was no significant difference detected in the composite endpoint with an approximately 30% event rate in both groups.

And whats worse

The intervention group had more severe and life-threatening adverse events, including pulmonary edema or fluid overload (6.1% vs 2.0%) and lung infections (3.9% vs 2.0%). 

We all want to do something but do nothing, just stand there

Or dont just do something let your patients do something

Scarinci IC, Li Y, Tucker L, et al. Given a choice between self-sampling at home for HPV testing and standard of care screening at the clinic, what do African American women choose? Findings from a group randomized controlled trial. Prev Med 2021;142:106358. 

Clinical question

Does giving women the option of doing home self-sampling for human papillomavirus increase the rates of cervical cancer screening?

 study identified 12 rural, underserved towns

 and randomized the towns to either 

 (1) a visit from a Black female community health worker with information about cervical cancer screening and encouragement to have a free Pap test at the local health department (standard care), or 

(2) a visit in which they were given the choice of a free Pap test at the health department or the option to do free home self-sampling for HPV (choice). 

 Among women in the standard care group, only 16 of 170 (9.4%) were ultimately screened, compared with 63 of 165 (38.2%) in the choice group.

We all want to do something but do nothing, just stand there

Clinical question

What is the effect of a delayed prescription approach for children with respiratory tract infection?

Mas-Dalmau G, Villanueva López C, Gorrotxategi Gorrotxategi P, et al, for the DAP PEDIATRICS GROUP. Delayed antibiotic prescription for children with respiratory infections: a randomized trial. Pediatrics 2021;147(3):e20201323. 

Study design: Randomized controlled trial (nonblinded)