Second thoughts on the final rule: An analysis of baseline participant characteristics reports on ClinicalTrials.gov.

ClinicalTrials.gov is valuable for aggregate-level analysis of trials. The recently published final rule aims to improve reporting of trial results. We aimed to assess variability in ClinicalTirals.gov records reporting participants' baseline measures.The September 2015 edition of the database for Aggregate Analysis of ClinicalTrials.gov (AACT), was used in this study. To date, AACT contains 186,941 trials of which 16,660 trials reporting baseline (participant) measures were analyzed. We also analyzed a subset of 13,818 Highly Likely Applicable Clinical Trials (HLACT), for which reporting of results is likely mandatory and compared a random sample of 30 trial records to their journal articles. We report counts for each mandatory baseline measure and variability reporting in their formats. The AACT dataset contains 8,161 baseline measures with 1206 unique measurement units. However, of these 6,940 (85%) variables appear only once in the dataset. Age and Gender are reported using many different formats (178 and 49 respectively). "Age" as the variable name is reported in 60 different formats. HLACT subset reports measures using 3,931 variables. The most frequent Age format (i.e. mean (years) ± sd) is found in only 45% of trials. Overall only 4 baseline measures (Region of Enrollment, Age, Number of Participants, and Gender) are reported by > 10% of trials. Discrepancies are found in both the types and formats of ClinicalTrials.gov records and their corresponding journal articles. On average, journal articles include twice the number of baseline measures (13.6±7.1 (sd) vs. 6.6±7.6) when compared to the ClinicalTrials.gov records that report any results.We found marked variability in baseline measures reporting. This is not addressed by the final rule. To support secondary use of ClinicalTrials.gov, a uniform format for baseline measures reporting is warranted

The most frequently reported baseline measures of participants in studies with results listed in ClinicalTrials.gov (N = 16,660) by units and dispersion.

<p>The most frequently reported baseline measures of participants in studies with results listed in ClinicalTrials.gov (N = 16,660) by units and dispersion.</p

The most frequently reported baseline measures of participants in highly likely applicable clinical trials (HLACT)(N = 13,808) by units and dispersion.

<p>The most frequently reported baseline measures of participants in highly likely applicable clinical trials (HLACT)(N = 13,808) by units and dispersion.</p

Frequency of top aggregated baseline measures reported in >1 study on ClinicalTrials.gov (N = 16,660).

<p>Frequency of top aggregated baseline measures reported in >1 study on ClinicalTrials.gov (N = 16,660).</p

Frequency of reporting the top 100 unique baseline measures among trials with results listed on ClinicalTrials.gov.

<p>Frequency of reporting the top 100 unique baseline measures among trials with results listed on ClinicalTrials.gov.</p

Vaccination Coverage among Immunocompromised Patients in a Large Health Maintenance Organization: Findings from a Novel Computerized Registry

Immune-compromised patients (IPs) are at high risk for infections, some of which are preventable by vaccines. Specific vaccines are recommended for IP; however, the vaccination rate is suboptimal. The aim of this study is to describe the development of an IP registry and to assess vaccination rates in this population. A population-based registry of IPs was developed using an automated extraction of patient electronic health-record data in Maccabi Healthcare Services (MHS), an Israeli health maintenance organization serving over 2.4 million members. Included in the registry were patients receiving immunosuppressive therapy (IT); patients living with HIV (PLWH); solid organ and bone marrow transplant recipients (TR); patients with advanced kidney disease (AKD), and asplenic patients. We evaluated the full schedule for each vaccine&rsquo;s uptake rates for influenza, pneumococcal, meningococcal, and hepatitis B. On 1 October 2019, 32,637 adult immune-compromised patients were identified by the registry. Of them, 1647 were PLWH; 2354 were asplenic; 5317 had AKD; 23,216 were on IT; and 1824 were TR. Their mean age was 57 and 52.4% were females. The crude rate of immune compromise among adult MHS members was 2%. Vaccine coverage rate was overall low for PCV13, with only 11.9% of all IPs in the registry having received one dose. Influenza and PPV23 vaccination rates were higher (45% and 39.4%, respectively). Only 5.3% of all IPs received all three vaccines. Overall, low vaccination coverage was found among IPs. Our registry can serve to identify target-patient populations for interventions and monitor their effectiveness

A Nationwide Digital Multidisciplinary Intervention Aimed at Promoting Pneumococcal Vaccination in Immunocompromised Patients

Immunocompromised patients (IPs) are at high risk for infections, some of which are vaccine-preventable. The Israeli Ministry of Health recommends pneumococcal conjugate vaccine 13 (PCV13) and pneumococcal polysaccharide vaccine 23 (PPSV23) for IP, but vaccine coverage is suboptimal. We assessed the project’s effectiveness in improving the pneumococcal vaccination rate among IP. An automated population-based registry of IP was developed and validated at Maccabi Healthcare Services, an Israeli health maintenance organization serving over 2.6 million members. Included were transplant recipients, patients with asplenia, HIV or advanced kidney disease; or those receiving immunosuppressive therapy. A personalized electronic medical record alert was activated reminding clinicians to consider vaccination during IP encounters. Later, IP were invited to get vaccinated via their electronic patient health record. Pre- and post-intervention vaccination rates were compared. Between October 2019 and October 2021, overall PCV13 vaccination rates among 32,637 IP went up from 11.9% (n = 3882) to 52% (n = 16,955) (p p < 0.0001). In conclusion, implementation of targeted automated patient- and clinician-facing alerts, a remarkable increase in pneumococcal vaccine uptake was observed among IP. The outlined approach may be applied to increase vaccination uptake in large health organizations