Data-Driven Cutoff Selection for the Patient Health Questionnaire-9 Depression Screening Tool.

Importance: Test accuracy studies often use small datasets to simultaneously select an optimal cutoff score that maximizes test accuracy and generate accuracy estimates.

Objective: To evaluate the degree to which using data-driven methods to simultaneously select an optimal Patient Health Questionnaire-9 (PHQ-9) cutoff score and estimate accuracy yields (1) optimal cutoff scores that differ from the population-level optimal cutoff score and (2) biased accuracy estimates.

Design, Setting, And Participants: This study used cross-sectional data from an existing individual participant data meta-analysis (IPDMA) database on PHQ-9 screening accuracy to represent a hypothetical population.

Relative effectiveness of adjuvanted versus non-adjuvanted influenza vaccines in older adults with risk factors for influenza complications during the 2019-2020 U.S. influenza season.

This study estimated the relative vaccine effectiveness (rVE) of the MF59®-adjuvanted trivalent influenza vaccine (aTIV) versus standard-dose nonadjuvanted egg-based quadrivalent influenza vaccines (QIVe) for the prevention of influenza-related medical encounters (IRMEs), outpatient IRMEs, and influenza- and pneumonia-related hospitalizations during the 2019-2020 US influenza season among adults ≥65 years of age who had ≥1 high-risk condition. A secondary objective evaluated the rVE of aTIV versus QIVe in preventing these outcomes among older adults with specific high-risk conditions. This retrospective cohort study included US adults ≥65 years of age vaccinated with aTIV or QIVe between August 1, 2019, and January 31, 2020.

Relative Effectiveness of the MF59-Adjuvanted Influenza Vaccine Versus High-Dose Influenza Vaccine in Older Adults With Influenza Risk Factors During the 2019-2020 US Influenza Season.

Background: This study estimated the relative vaccine effectiveness (rVE) of the MF59-adjuvanted trivalent influenza vaccine (aTIV) versus high-dose trivalent inactivated influenza vaccine (HD-TIV) for prevention of influenza-related medical encounters (IRMEs) during the 2019-2020 United States (US) influenza season stratified by the cumulative number of influenza risk factors. A secondary objective evaluated outpatient IRMEs and influenza- and pneumonia-related hospitalizations.

Methods: This retrospective cohort study included US adults ≥65 years old vaccinated with aTIV or HD-TIV between 1 August 2019 and 31 January 2020.

Relative vaccine effectiveness of MF59-adjuvanted vs high-dose trivalent inactivated influenza vaccines for prevention of test-confirmed influenza hospitalizations during the 2017-2020 influenza seasons.

Objectives: This study evaluated relative vaccine effectiveness (rVE) of MF59-adjuvanted trivalent inactivated influenza vaccine (aTIV) vs high-dose trivalent inactivated influenza vaccine (HD-TIV) for prevention of test-confirmed influenza emergency department visits and/or inpatient admissions ("ED/IP") and for IP admissions alone pooled across the 2017-2020 influenza seasons. Exploratory individual season analyses were also performed.

Methods: This retrospective test-negative design study included United States (US) adults age ≥65 years vaccinated with aTIV or HD-TIV who presented to an ED or IP setting with acute respiratory or febrile illness during the 2017-2020 influenza seasons.

Relative Effectiveness of the MF59®-Adjuvanted Influenza Vaccine Versus High-Dose and Non-Adjuvanted Influenza Vaccines in Preventing Cardiorespiratory Hospitalizations During the 2019-2020 US Influenza Season.

Background: Adults ≥ 65 years of age have suboptimal influenza vaccination responses compared to younger adults due to age-related immunosenescence. Two vaccines were specifically developed to enhance protection: MF59-adjuvanted trivalent influenza vaccine (aIIV3) and high-dose egg-based trivalent influenza vaccine (HD-IIV3e).

Methods: In a retrospective cohort study conducted using US electronic medical records linked to claims data during the 2019-2020 influenza season, we compared the relative vaccine effectiveness (rVE) of aIIV3 with HD-IIV3e and a standard-dose non-adjuvanted egg-based quadrivalent inactivated influenza vaccine (IIV4e) for the prevention of cardiorespiratory hospitalizations, including influenza hospitalizations.

Relative Effectiveness of the Cell-Based Quadrivalent Influenza Vaccine in Preventing Cardiorespiratory Hospitalizations in Adults Aged 18-64 Years During the 2019-2020 US Influenza Season.

Background: The mammalian cell-based quadrivalent inactivated influenza vaccine (IIV4c) has advantages over egg-based quadrivalent inactivated influenza vaccine (IIV4e), as production using cell-derived candidate viruses eliminates the opportunity for egg adaptation. This study estimated the relative vaccine effectiveness (rVE) of IIV4c versus IIV4e in preventing cardiorespiratory hospitalizations during the 2019-2020 US influenza season.

Methods: We conducted a retrospective cohort study using electronic medical records linked to claims data of US individuals aged 18-64 years.

Relative Effectiveness of Cell-Based Versus Egg-Based Quadrivalent Influenza Vaccines in Adults During the 2019-2020 Influenza Season in the United States.

Background: Mutations occurring during egg-based influenza vaccine production may affect vaccine effectiveness. The mammalian cell-based quadrivalent inactivated influenza vaccine (IIV4c) demonstrated improved protection relative to egg-based vaccines in prior seasons. This study estimated the relative vaccine effectiveness (rVE) of IIV4c versus standard-dose egg-based quadrivalent inactivated influenza vaccine (IIV4e) in preventing influenza-related medical encounters (IRMEs) in the 2019-2020 US influenza season.

Relative Effectiveness of Cell-based Versus Egg-based Quadrivalent Influenza Vaccines in Children and Adolescents in the United States During the 2019-2020 Influenza Season.

Background: Egg-based influenza vaccine production can lead to the accumulation of mutations that affect antigenicity. The mammalian cell-based inactivated quadrivalent influenza vaccine (IIV4c) may improve effectiveness compared with egg-based vaccines. This study estimated the relative vaccine effectiveness (rVE) of IIV4c versus egg-based inactivated quadrivalent influenza vaccine (IIV4e) in preventing influenza-related medical encounters (IRME) among children and adolescents during the 2019-2020 US influenza season.

Integrating Electronic Medical Records and Claims Data for Influenza Vaccine Research.

Real-world evidence (RWE) increasingly informs public health and healthcare decisions worldwide. A large database has been created (“Integrated Dataset”) that integrates primary care electronic medical records with pharmacy and medical claims data on >123 million US patients since 2014. This article describes the components of the Integrated Dataset and evaluates its representativeness to the US population and its potential use in evaluating influenza vaccine effectiveness.

Relative Effectiveness of MF59 Adjuvanted Trivalent Influenza Vaccine vs Nonadjuvanted Vaccines During the 2019-2020 Influenza Season.

Background: Age-related immunosenescence may impair the immune response to vaccination in older adults. Adjuvanted influenza vaccines are designed to overcome immune senescence in older adults. This study estimated the relative vaccine effectiveness (rVE) of MF59-adjuvanted trivalent inactivated influenza vaccine (aIIV3) vs egg-derived quadrivalent inactivated influenza vaccine (IIV4e) and high-dose trivalent inactivated influenza vaccine (HD-IIV3) in preventing influenza-related medical encounters in the 2019-2020 US season.

Reporting transparency and completeness in trials: Paper 4 - reporting of randomised controlled trials conducted using routinely collected electronic records - room for improvement.

Objective: To describe characteristics of randomized controlled trials (RCTs) conducted using electronic health records (EHRs), including completeness and transparency of reporting assessed against the 2021 CONSORT Extension for RCTs Conducted Using Cohorts and Routinely Collected Data (CONSORT-ROUTINE) criteria.

Study Design: MEDLINE and Cochrane Methodology Register were searched for a sample of RCTs published from 2011-2018. Completeness of reporting was assessed in a random sample using a pre-defined coding form.

Reporting transparency and completeness in Trials: Paper 2 - reporting of randomised trials using registries was often inadequate and hindered the interpretation of results.

Objective: Registries are important data sources for randomized controlled trials (RCTs), but reporting of how they are used may be inadequate. The objective was to describe the current adequacy of reporting of RCTs using registries.

Study Design And Setting: We used a database of trials using registries from a scoping review supporting the development of the 2021 CONSORT extension for Trials Conducted Using Cohorts and Routinely Collected Data (CONSORT-ROUTINE).

Reporting transparency and completeness in trials: Paper 3 - trials conducted using administrative databases do not adequately report elements related to use of databases.

Objective: We evaluated reporting completeness and transparency in randomized controlled trials (RCTs) conducted using administrative data based on 2021 CONSORT Extension for Trials Conducted Using Cohorts and Routinely Collected Data (CONSORT-ROUTINE) criteria.

Study Design And Setting: MEDLINE and the Cochrane Methodology Register were searched (2011 and 2018). Eligible RCTs used administrative databases for identifying eligible participants or collecting outcomes.

Intensity of care and perceived burden among informal caregivers to persons with chronic medical conditions: a systematic review and meta-analysis.

Purpose: Informal caregivers provide ongoing assistance to a loved one with a health condition. No studies have compared caregiving intensity and perception of burden across chronic medical conditions.

Materials And Methods: Databases were searched from inception through 11 September 2020 to identify studies that included the Level of Care Index or the Zarit Burden Inventory (ZBI) among caregivers for people with chronic diseases.

Effectiveness of the Adjuvanted Influenza Vaccine in Older Adults at High Risk of Influenza Complications.

MF59-adjuvanted trivalent inactivated influenza vaccine (aIIV3) and high-dose trivalent inactivated influenza vaccine (HD-IIV3) elicit an enhanced immune response in older adults compared to standard, quadrivalent inactivated influenza vaccines (IIV4). We sought to determine the relative vaccine effectiveness (rVE) of aIIV3 versus IIV4 and HD-IIV3 in preventing influenza-related medical encounters in this retrospective cohort study involving adults ≥65 years with ≥1 health condition during the 2017-2018 and 2018-2019 influenza seasons. Data were obtained from primary and specialty care electronic medical records linked with pharmacy and medical claims.

Effectiveness of the Cell-Derived Inactivated Quadrivalent Influenza Vaccine in Individuals at High Risk of Influenza Complications in the 2018-2019 United States Influenza Season.

Background: Higher rates of influenza-related morbidity and mortality occur in individuals with underlying medical conditions. To improve vaccine effectiveness, cell-based technology for influenza vaccine manufacturing has been developed. Cell-derived inactivated quadrivalent influenza vaccines (cIIV4) may improve protection in seasons in which egg-propagated influenza viruses undergo mutations that affect antigenicity.

Methods and results used in the development of a consensus-driven extension to the Consolidated Standards of Reporting Trials (CONSORT) statement for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE).

Objectives: Randomised controlled trials conducted using cohorts and routinely collected data, including registries, electronic health records and administrative databases, are increasingly used in healthcare intervention research. A Consolidated Standards of Reporting Trials (CONSORT) statement extension for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE) has been developed with the goal of improving reporting quality. This article describes the processes and methods used to develop the extension and decisions made to arrive at the final checklist.

CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE): checklist with explanation and elaboration.

Randomised controlled trials are increasingly conducted as embedded, nested, or using cohorts or routinely collected data, including registries, electronic health records, and administrative databases, to assess if participants are eligible for the trial and to facilitate recruitment, to deliver an embedded intervention, to collect trial outcome data, or a combination of these purposes. This report presents the Consolidated Standards of Reporting Trials (CONSORT) extension for randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE). The extension was developed to look at the unique characteristics of trials conducted with these types of data with the goal of improving reporting quality in the long term by setting standards early in the process of uptake of these trial designs.

Overestimation of Postpartum Depression Prevalence Based on a 5-item Version of the EPDS: Systematic Review and Individual Participant Data Meta-analysis.

Objective: The Maternal Mental Health in Canada, 2018/2019, survey reported that 18% of 7,085 mothers who recently gave birth reported "feelings consistent with postpartum depression" based on scores ≥7 on a 5-item version of the Edinburgh Postpartum Depression Scale (EPDS-5). The EPDS-5 was designed as a screening questionnaire, not to classify disorders or estimate prevalence; the extent to which EPDS-5 results reflect depression prevalence is unknown. We investigated EPDS-5 ≥7 performance relative to major depression prevalence based on a validated diagnostic interview, the Structured Clinical Interview for DSM (SCID).

Depression prevalence based on the Edinburgh Postnatal Depression Scale compared to Structured Clinical Interview for DSM DIsorders classification: Systematic review and individual participant data meta-analysis.

Objectives: Estimates of depression prevalence in pregnancy and postpartum are based on the Edinburgh Postnatal Depression Scale (EPDS) more than on any other method. We aimed to determine if any EPDS cutoff can accurately and consistently estimate depression prevalence in individual studies.

Methods: We analyzed datasets that compared EPDS scores to Structured Clinical Interview for DSM (SCID) major depression status.

Depression prevalence using the HADS-D compared to SCID major depression classification: An individual participant data meta-analysis.

Objectives: Validated diagnostic interviews are required to classify depression status and estimate prevalence of disorder, but screening tools are often used instead. We used individual participant data meta-analysis to compare prevalence based on standard Hospital Anxiety and Depression Scale - depression subscale (HADS-D) cutoffs of ≥8 and ≥11 versus Structured Clinical Interview for DSM (SCID) major depression and determined if an alternative HADS-D cutoff could more accurately estimate prevalence.

Methods: We searched Medline, Medline In-Process & Other Non-Indexed Citations via Ovid, PsycINFO, and Web of Science (inception-July 11, 2016) for studies comparing HADS-D scores to SCID major depression status.

Individual participant data meta-analyses (IPDMA): data contribution was associated with trial corresponding author country, publication year, and journal impact factor.

Objectives: The objectives were to determine the proportion of eligible randomized controlled trials (RCTs) that contributed data to individual participant data meta-analyses (IPDMAs) and explore associated factors.

Study Design And Setting: IPDMAs with ≥10 eligible RCTs were identified by searching MEDLINE, EMBASE, CINAHL, and Cochrane May 1, 2015 to February 13, 2017. Mixed-effect logistic regression was used to identify factors associated with data contribution.

Patient Health Questionnaire-9 scores do not accurately estimate depression prevalence: individual participant data meta-analysis.

Objectives: Depression symptom questionnaires are not for diagnostic classification. Patient Health Questionnaire-9 (PHQ-9) scores ≥10 are nonetheless often used to estimate depression prevalence. We compared PHQ-9 ≥10 prevalence to Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (SCID) major depression prevalence and assessed whether an alternative PHQ-9 cutoff could more accurately estimate prevalence.