Promoting REproductive Planning And REadiness in Diabetes (PREPARED) Study protocol: a clinic-randomised controlled trial testing a technology-based strategy to promote preconception care for women with type 2 diabetes

Abstract

Introduction

Women with type 2 diabetes (T2DM) are more likely to experience adverse reproductive outcomes, yet preconception care can significantly reduce these risks. For women with T2DM, preconception care includes reproductive planning and patient education on: (1) the importance of achieving glycaemic control before pregnancy, (2) using effective contraception until pregnancy is desired, (3) discontinuing teratogenic medications if pregnancy could occur, (4) taking folic acid, and (5) managing cardiovascular and other risks. Despite its importance, few women with T2DM receive recommended preconception care.

Methods and analysis

We are conducting a two-arm, clinic-randomised trial at 51 primary care practices in Chicago, Illinois to evaluate a technology-based strategy to ‘hardwire’ preconception care for women of reproductive age with T2DM (the PREPARED (Promoting REproductive Planning And REadiness in Diabetes) strategy) versus usual care. PREPARED leverages electronic health record (EHR) technology before and during primary care visits to: (1) promote medication safety, (2) prompt preconception counselling and reproductive planning, and (3) deliver patient-friendly educational tools to reinforce counselling. Post-visit, text messaging is used to: (4) encourage healthy lifestyle behaviours. English and Spanish-speaking women, aged 18–44 years, with T2DM will be enrolled (N=840; n=420 per arm) and will receive either PREPARED or usual care based on their clinic’s assignment. Data will be collected from patient interviews and the EHR. Outcomes include haemoglobin A1c (primary), reproductive knowledge and self-management behaviours. We will use generalised linear mixed-effects models (GLMMs) to evaluate the impact of PREPARED on these outcomes. GLMMs will include a fixed effect for treatment assignment (PREPARED vs usual care) and random clinic effects.

Ethics and dissemination

This study was approved by the Northwestern University Institutional Review Board (STU00214604). Study results will be published in journals with summaries shared online and with participants upon request.

Trial registration number

ClinicalTrials.gov Registry (NCT04976881).

Correspondence to Dr Stacy C Bailey; [email protected]

STRENGTHS AND LIMITATIONS OF THIS STUDY

• Performance sites for our trial include both academic and community health centres with sociodemographically diverse patient populations. We will specifically evaluate whether the effectiveness of PREPARED (Promoting REproductive Planning And REadiness in Diabetes) differs among individuals of different backgrounds.

• The PREPARED strategy is purposely designed to be flexible, with adaptations made for each performance site and electronic health record system. While this promotes sustainability, it does introduce variation in terms of how the intervention is implemented and deployed. We will record all variations and consider these in our effectiveness and fidelity analyses.

• The PREPARED trial is being conducted only in primary care practices within the Chicago metropolitan area. This limits the generalisability of our results.

Introduction

More than 37 million people in the USA have diabetes and one in three adults are projected to have diabetes by 2050.^{1 2} While diabetes has historically affected older individuals, its incidence is increasing rapidly among younger adults, many of whom are women of reproductive age. Women with early-onset type 2 diabetes mellitus (T2DM) have a unique risk profile: they are less likely to achieve glycaemic control and are at higher risk of cardiovascular-related morbidity and mortality than their male counterparts.^{3 4} Also, compared with pregnant individuals without diabetes, they are more likely to experience adverse reproductive outcomes, such as miscarriage, congenital malformation, premature birth and perinatal mortality, among others.^5–9

Achieving glycaemic control improves women’s own health outcomes and promotes a reproductive risk profile similar to those of women without T2DM,^10–12 yet more than 50% of this population has suboptimal haemoglobin A1c (HbA1c).¹³ As half of all pregnancies are unintended, clinical guidelines recommend providers routinely engage women of reproductive age in preconceptional and interconceptional care.^{14 15} For women with T2DM, this includes reproductive planning and patient education on the importance of: (1) achieving glycaemic control, (2) using effective contraception until glycaemic control is achieved and pregnancy is desired, (3) discontinuing use of teratogenic medications if pregnancy could occur, (4) taking folic acid daily to reduce the risk of neural tube defects, and (5) managing cardiovascular and other T2DM-related risks.¹⁶

Despite these guidelines, up to 80% of women with T2DM do not receive preconceptional counselling.¹⁷ Provider time limitations and lack of available educational resources are often cited as a barriers to care.¹⁷ As a result, women with T2DM are often unaware of the particular risks associated with pregnancy and T2DM. This disconnect presents a major public health concern and health disparity. Women from minoritised communities are up to three times more likely than non-Hispanic white women to have T2DM during their reproductive years.^{18 19}

In response, we developed and are currently implementing and evaluating the Promoting REproductive Planning And REadiness in Diabetes (PREPARED) strategy. This intervention uses health information and consumer technologies to ‘hardwire’ preconception care and promote diabetes self-management among women aged 18–44 years with T2DM in primary care. Here, we provide an overview of the PREPARED strategy and describe the methods and rationale for testing this approach in a clinic-centred randomised controlled trial (RCT) funded by the National Institute of Diabetes and Digestive and Kidney Diseases.

Methods

The PREPARED strategy

PREPARED is a multifaceted strategy that includes components delivered before, during and after a clinic visit. PREPARED was purposely designed to be flexible so that it could be adapted to health centres delivering the intervention (referred to here as performance sites) to minimise workflow disruption and promote sustainability. PREPARED leverages electronic health record (EHR) technology before and during clinic visits to: (1) promote medication reconciliation and safety, (2) prompt patient–provider preconception counselling and reproductive planning, and (3) deliver patient-friendly educational tools to reinforce counselling and promote diabetes self-management. Post-visit, text messaging is used to: (4) encourage healthy lifestyle behaviours through promotional messaging. Each component is detailed below.

• Medication Reconciliation (MedRec) tool: As patients check in for their visit (either online or in person) or are roomed during the clinic visit, they are asked to review medications that they are currently prescribed from a list generated from the EHR. Patients are asked to report which medications they are taking to reflect actual use; this is done electronically or on a hard copy tool. Following the medication reconciliation process, patients are asked a modified version of One Key Question or ‘Would you like to become pregnant in the next year?’ (responses: yes, no, unsure, ok either way)²⁰ with a follow-up question on current contraceptive practices. Patient responses are shared with providers during the visit to reconcile medication lists in the EHR, assess any teratogenicity concerns and inform preconception counselling.

• Provider alert and/or clinical decision support: During the clinic visit, providers are notified that the patient is a woman of reproductive age with T2DM and should have medications reviewed for possible teratogenicity. At most performance sites, this is done through an interruptive ‘best practices alert’ while at some community health centres (CHCs) clinical decision support tools are provided upon opening the electronic patient chart. Alerts and support tools prompt providers to counsel patients on the importance of glycaemic control, contraceptive use, and/or the benefits of folic acid depending on patients’ current reproductive intentions and contraceptive practices. At most sites, an order set is available to facilitate contraceptive prescribing for providers.

• PREPSheet: When patients leave an encounter, they receive a two-page, patient-friendly educational material (aka the PREPSheet) that reviews potential risks of pregnancy in the context of T2DM and highlights the importance of: (1) achieving glycaemic control through diabetes self-care, (2) using effective contraception until glycaemic control is achieved and pregnancy is desired, (3) discussing medication use with a provider if planning or becoming pregnant, and (4) taking folic acid daily. The tool is provided to patients in English or Spanish either in hard copy and/or electronically.^{21 22}

• Text messaging: Within ~3–15 days of their index clinic visit, patients in the intervention group begin to receive unidirectional text messages to reinforce diabetes self-care behaviours.^{21 23 24} Messages use health literacy ‘best practices’ and are brief and action-oriented to promote comprehension. Each message is focused on a different behaviour (eg, stress, diet, exercise); topics rotate to avoid participant fatigue. Texts are sent ~3 times per week for 6 weeks; patients may opt out of receiving texts at any time. After 6 weeks, texts are discontinued, unless patients opt to continue receiving them.

Study design and aims

We are conducting a two-arm, clinic-RCT at primary care practices affiliated with academic and CHCs in metropolitan Chicago, Illinois to evaluate PREPARED versus usual care among women of reproductive age with T2DM.

The specific aims of this study are to: (1) test the effectiveness of PREPARED, compared with usual care, to improve patient: (a) knowledge of reproductive risks associated with T2DM and recommended self-care behaviours, (b) engagement in recommended self-care behaviours including diet, physical activity, adherence to antidiabetic medications, use of folic acid, and, when indicated, desired contraception, and (c) clinical measures, including HbA1c, blood pressure and cholesterol; (2) assess whether PREPARED reduces disparities in above outcomes versus usual care; and (3) evaluate the fidelity of PREPARED to prompt medication reconciliation and counselling and to deliver patient education and post-visit support of diabetes self-management.

Those in the usual care arm receive standard care, including: (1) no routine, specific educational materials to promote preconception care; (2) ad hoc provider preconception counselling without additional EHR tools; and (3) no text message-based prompts to encourage healthy behaviours.

Performance sites

Primary care clinics (N=38) affiliated with Northwestern Memorial Medical Group and Regional Medical Group serve as performance sites. All sites are located in the greater Chicago metropolitan area and use a common EHR (Epic) which is centrally managed by Northwestern Medicine. Together, these clinics have 265 providers who, in 2022, cared for more than 2500 women of reproductive age with T2DM.

Three large CHCs affiliated with AllianceChicago, a health centre-controlled network composed of safety net organisations, are also serving as performance sites. Practices from each CHC (N=13) elected to participate. These CHCs share a data warehouse hosted by AllianceChicago, to provide data infrastructure, and promote quality improvement and research initiatives. Together these CHCs serve approximately 148 000 patients in the Chicagoland area. In 2022, approximately 150 providers at these CHCs cared for more than 1700 women of reproductive age with T2DM.

Implementation of PREPARED occurred on a rolling basis. The first group of academic performance sites were on-boarded in late Spring 2022; the final group of sites will implement the intervention in Fall 2023.

Study participants

To participate in this trial, patients must: (1) be biologically female, (2) be aged 18–44 years, (3) be English or Spanish speaking, (4) have a chart diagnosis of T2DM, (5) not be currently pregnant, (6) not be infecund, have had a hysterectomy, tubal ligation or tubal removal, or in a monogamous relationship with a sterilised partner, and (7) have a private cell phone with text messaging capability. Patients are excluded if they have severe, uncorrectable vision, hearing or cognitive impairments (measured by the six-item screener)²⁵ that would preclude study participation. Women who become pregnant will be censored as pregnancy may independently affect certain outcomes.²⁶ Eligibility is determined via EHR data and a phone screener conducted prior to enrolment.

Randomisation

As PREPARED includes changes to healthcare delivery, the intervention itself is diffuse; thus, randomisation at the patient level is not feasible. Therefore, randomisation was performed at the clinic level for all academic practices and those from two of our CHCs (N=44 clinics). Clinics from the remaining health centre (N=7) were randomised at the clinic region level (N=2 regions) to reduce the potential for contamination as patients of this health centre may use multiple practices in their region. To optimise the likelihood of obtaining similar populations in each arm, randomisation was stratified by health centre. The study biostatistician, blinded to clinic identity, assigned clinics within strata using a random number generator via the R programming language (V.4.2.1).

All patients who visit an intervention clinic and meet specified eligibility criteria automatically receive PREPARED EHR components before and during their index visit (components 1–3 above). However, post-visit intervention and evaluation activities occur only for eligible patients who later provide consent and are enrolled in the trial. This process ensures that enrolled patients receive all EHR-based PREPARED components on the day they have their index clinic visit. It also results in some of the PREPARED materials being given to patients seen in an intervention clinic, but not enrolled in the study or included in analyses. As the EHR components are low risk, a waiver of patient consent was granted for these activities.

Recruitment

Potential participants are identified via electronic data warehouse queries at study sites. At all sites, a list of patient names and characteristics is compiled in a report that can be securely accessed and reviewed by study staff. Reports are run twice weekly to identify eligible patients with a recent visit. Trained research assistants (RAs) contact identified patients by phone, verify eligibility and obtain electronic informed consent. Only those who complete the enrolment process are considered participants and included in subsequent analyses.

Data collection

Data collection occurs at T₁ (3–15 days post-index visit), T₂ (3–8 weeks) and T₃ (3–4 months); all interviews occur via phone and are administered by a trained, bilingual coordinator. Data are collected and managed using REDCap, hosted by the Northwestern University Clinical and Translational Sciences Institute.^{27 28} Patient incentives are $40, $20 and $25 per interview, respectively. Clinical outcomes are abstracted from the EHR.

Effectiveness measures

Patient outcomes include: (1) clinical measures, including HbA1c, blood pressure and cholesterol; (2) knowledge of reproductive risks associated with T2DM; (3) engagement in T2DM self-care activities; (4) folic acid use and (5) use of more effective contraception, when desired. We also collect data on demographic characteristics, health literacy, psychosocial characteristics (eg, depression, self-efficacy, diabetes distress, patient engagement) and clinical history (eg, comorbidities, body mass index, reproductive history, medications prescribed). Outcome measures are described below.

Clinical measures

All HbA1c, blood pressure and cholesterol values are abstracted from patient records recorded from 6 months prior to the index visit through 12 months post-visit. These data can be abstracted for all enrolled participants, regardless of any attrition that may occur.

Knowledge of T2DM reproductive risks

We used a 15-item questionnaire developed by our team based on prior literature^{11 29} to evaluate patient knowledge of reproductive risks and recommended health behaviours for women with T2DM. It assesses knowledge of pregnancy planning, reproductive risks and desired diabetes self-care behaviours; the number of correct answers is summed and expressed as percentage correct.

Engagement in diabetes self-care

We are using the validated Summary of Diabetes Self-Care Activities (SDSCA) to measure patient engagement in a range of self-care activities, including diet, physical activity, smoking and medication adherence, measured over the prior week.¹² The SDSCA asks participants to indicate the numbers of days (0–7) on which they performed the referenced behaviour in the past week. Subscales for each activity will be scored and analysed separately, all scale scores range from 0 to 7 with higher scores suggesting better self-care. The SDSCA is one of the most widely used self-report measures for assessing diabetes self-management.¹² It is supplemented by objective measures of medication adherence, including the Adherence to Medications and Refills Scale-Diabetes¹⁰ and pill count.

Use of folic acid

Patients are asked if they have taken folic acid supplements or a vitamin containing folic acid over the past month (yes/no). If yes, patients are asked to report frequency of use using a Likert scale.

Use of ‘most or moderately effective’ contraception

Using items from the Center for Disease Control and Prevention (CDC) National Survey of Family Growth Subscale (NSFG),³⁰ we assess patient contraceptive use, which is categorised into use of a ‘most or moderately effective’ form of contraception or ‘less effective/no contraception’ according to published criteria.³¹

Fidelity measures and investigations of post-trial implementation outcomes

For aim 3, we will assess key implementation outcomes: fidelity, appropriateness, acceptability, feasibility and sustainability.³² Mixed methods will be employed to obtain data from three sources: (1) patients, (2) electronic platforms (EHR, text messaging) and (3) clinic providers and staff.

Receipt of PREPARED materials

We will determine whether materials were delivered as intended via EHR review and patient self-report. At T₁, patients are asked whether they received and completed the MedRec tool prior to their clinic visit (y/n) and whether they received the PREPSheet at a clinic visit (y/n). We assess their acceptability of both tools separately (scale 1–10). At T₂ and T₃, patients are asked about receipt of texts (y/n), acceptability of the outreach (scale 1–10) and current use of PREPSheets (Likert scale).

Medication discrepancies

Medication discrepancies are measured ~3–15 days post-index clinic visit using a protocol used in prior studies by our team.^{33 34} Specifically, on the day of the T₁ interview, the RA reviews the most current patient medication list from the EHR. The RA asks the patient to provide the names of all medications they are currently taking, noting whether these are listed in the chart. If a medication is listed in the chart but not named by the patient, the RA will inquire about its use and record the patient response. Patients may refer to their prescription bottles during this interview. Discrepancies are analysed and the total number of discrepancies calculated. Data are also categorised as discrepancies present (yes/no).

Provider preconception counselling and visit acceptability

Receipt of provider counselling and visit acceptability is assessed at T₁ via the NSFG.³⁰ Additionally, we ask participants about receipt of preconception counselling and experiences during the clinic visit through items from the CDC Pregnancy Risk Assessment Monitoring Systems.³⁵

Post-trial interviews

To further assess implementation outcomes of PREPARED, RAs who have been trained in qualitative research will conduct interviews with a subsample of 45 intervention patients and 30 clinic providers (n=15 by site type; academic vs CHC) after they have completed all intervention activities. This number should be sufficient for achieving data saturation.^{36 37} Purposive sampling will be used to ensure adequate representation by participant characteristics.

Proctor’s implementation outcomes will inform the development of semistructured interview guides.³² Both patients and providers will give informed consent before participation. Interviews, lasting ~1 hour, will be audio-recorded and transcribed. Patient interviews will explore their: (1) challenges with reproductive planning, preconception care and T2DM care; (2) perception of the usefulness of PREPARED (appropriateness); (3) satisfaction with patient-facing intervention components (acceptability) and (4) unmet needs. Provider interviews will explore their opinions of PREPARED, including their: (1) perception of the usefulness of PREPARED (appropriateness), (2) satisfaction with the provider-facing intervention components (acceptability), (3) determinants of actual use (feasibility) and (4) perceived determinants of routinisation within the CHC setting (sustainability). Demographic information and work history (eg, race/ethnicity, years since residency, sex, age) will be collected at the conclusion of provider interviews.

Data analysis plans

We will apply a modified intent-to-treat approach to analyses. Only patients enrolled in the study will be included in analyses; data from all enrolled participants will be analysed based on the randomisation assignment of the clinic where they receive care and regardless of degree of engagement in intervention activities.

HbA1c is the primary outcome of interest and patient knowledge of T2DM reproductive risks is considered a key secondary outcome; both outcomes will be analysed as continuous variables. Our overall analytical strategy will use generalised linear mixed-effects models (GLMMs) to evaluate the effects of PREPARED on outcomes specifying the proper link functions for outcome variable distribution (ie, identity link for continuous outcomes, logit link for binary outcomes). Analyses will proceed using normal theory methods, though we will use residual diagnostics to evaluate model assumptions and appropriate data transformations, model specifications and/or semiparametric methods may be used. Analyses will be performed using PROC MIXED or PROC GLIMMIX in SAS (V.9.4) and we will report all parameter estimates, SEs and 95% CIs, unless otherwise specified tests for the effect of PREPARED on outcomes will be two sided at the α=5% level. GLMMs will include a fixed effect for treatment assignment (PREPARED vs usual care) and outcome measures at baseline if available and random effects for clinic to account for cluster randomisation. To test the impact of PREPARED on HbA1c and knowledge of T2DM reproductive risks, we will use two-sided Wald tests and define statistical significance as p<0.025 to control the family-wise error rate. Similarly, for diabetes self-care activities (diet, physical activity and adherence to antidiabetic medications—subscales on the SDSCA—as well as use of folic acid and more effective contraception, when indicated) at the 1-month post-index visit, we will test the effect of PREPARED on engagement in each activity and define statistical significance as p<0.01.

For aim 2, we will repeat all GLMM analyses from aim 1, but with the inclusion of a fixed effect for participants’ health literacy, which will be defined as limited (inadequate or marginal literacy) versus adequate.³⁸ We will examine potential differences in intervention effects according to health literacy by including a health literacy–intervention interaction term. We will estimate and graph the changes in the least square means from the GLMMs and 95% CIs to explore whether there are clinically relevant differences in HbA1c or other outcomes over time. We will use similar GLMMs to assess differences in intervention effects by race, ethnicity and clinic type (academic vs CHC).

Though we will work diligently to minimise the frequency of missing data, we expect some data to be missing. Should greater than 5% of a variable be missing at analysis, we will inspect missing data patterns and frequencies, as well as correlates of missingness. Should we determine that data are missing at random, we will employ multiple imputation as appropriate. If data appear to be missing not at random, we will use pattern mixture models or selection models as sensitivity analyses.

For aim 3, quantitative implementation data (N=420) will be compiled and synthesised with qualitative findings from patients (N=45) and providers (N=30) to understand what participants thought of PREPARED, whether it was implemented as planned and how it might be modified. Analyses will be conducted separately and integrated for side-by-side comparison.³⁹

Quantitative data will be analysed using simple descriptive statistics, including the means and variances of continuous measures and proportions for categorical measures. We will also compute summary statistics (correlation, Cohen’s κ) to measure associations between fidelity measures (eg, between receipt of materials and preconception counselling) and to examine which elements of PREPARED were likely to be implemented together with high fidelity.

Power and sample size

We will conduct statistical tests of the impact of PREPARED on HbA1c (primary outcome) and knowledge of T2DM reproductive risks (α=2.5%) as well as engagement in diabetes self-care activities (α=1%). Prior data from the participating sites suggest the average HbA1c value of this population is 7.8 (SD=1.8).^{40 41} As this is a cluster randomised trial, we expect some modest correlation between outcomes for patients in the same clinic, and thus assume an intraclass correlation coefficient of 0.015. We further anticipate ≤3% pregnancy rate among participants and at least 85% retention at 6 months.

Given these assumptions, a total sample size of 840 patients will need to be enrolled to obtain 695 across N=51 sites (N>13 per site). This would provide 80% power to detect effects of Cohen’s d=0.26 (ie, 0.43–0.47% decrease in HbA1c, 2.4–2.6% increase in knowledge of T2DM reproductive risks) for primary outcomes tested at the α=2.5% level.⁴² Analyses of secondary outcomes would have 80% power to detect increases in rates of patients engaging in diabetes self-care activities of 8–15% (ORs of 1.7–2.8) in PREPARED versus usual care, depending on how frequently usual care patients engage in these activities (α=1%). Note that even if attrition is as large as 25%, this sample size would ensure 80% power to detect changes in HbA1c of 0.5%.

Data storage and security

Data will be stored on Northwestern University secure network drives with access limited to study personnel. Study data will be de-identified and a password-protected, encrypted master linking log with identifiers will be kept and stored separately from the data.

Study monitoring

A Data Safety Monitoring Board (DSMB) consisting of senior, independent investigators was convened at the beginning of this study. DSMB members reviewed and approved a DSMB charter, which included a list of responsibilities for the board, including: (1) approving the study protocol so that intervention activities could begin, (2) ensuring the protection and well-being of study participants, (3) approving of any major changes to the approved protocol, and (4) monitoring study progress and informing the investigator team of any external factors that could impact study effectiveness, feasibility or safety. The DSMB convenes virtually at least twice per year to review the study; ad hoc meetings can be scheduled if needed. The investigator team is responsible for notifying the DSMB of any safety concerns within 24–48 hours of their knowledge of the occurrence. No interim analyses or audits are planned for this trial but may be requested by the DSMB if deemed necessary.

Ethics and dissemination

All research activities were reviewed and approved by the Northwestern University Institutional Review Board (IRB) as the single IRB of record. The trial is registered at ClinicalTrials.gov (NCT04976881). Study results will be published in peer-reviewed journals and shared at international conferences; authorship will follow International Committee of Medical Journal Editors guidelines and no ghostwriters will be used.⁴³ Study final reports will be provided to the National Institutes of Health. Data will be available to other investigators upon request, with minimal requirements to ensure the confidentiality of study participants. Study summaries will be published online and provided to study participants and the general public upon request.

Patient and public involvement

To develop PREPARED patient-facing materials (eg, text messages, patient education), we sought input from Stakeholder-Academic Resource Panels (or ShARPs) comprised of patients, health professionals and others. Panels were organised by the Northwestern University Center for Community Health (CCH). ShARPs (in English and Spanish) were conducted virtually and recorded; they were hosted and led by a trained, bilingual facilitator identified by CCH. Input from these panels was used to finalise all materials. We additionally conducted cognitive interviews, in English and Spanish, with patients meeting eligibility criteria to determine whether study interviews and procedures were appropriate and easy to understand from the participant perspective.

Ethics statements

Patient consent for publication

Not required.

Footnote

Contributors SCB was responsible for funding acquisition, manuscript conception, design of the work, editing of manuscript drafts and finalising the manuscript. AP, AEk, AEg, AW, MW, JMS, ST, DL and WG were responsible for substantial contributions to the design of the work, reviewing the draft critically and providing edits based on subject matter expertise. GW, NC, EV and SB contributed to text related to the acquisition, analysis and interpretation of data, reviewed drafts of the manuscript and provided editing as required. All authors have approved the submitted version.

Funding This work was supported by the National Institute of Diabetes and Digestive and Kidney Diseases (grant number 5R01DK127184). REDCap software is supported by the National Institutes of Health's National Center for Advancing Translational Sciences (grant number UL1TR001422). Effort for study co-investigators was also supported, in part, by the National Institutes of Health's National Institute on Aging (grant number P30AG059988).

Disclaimer The opinions expressed in this paper are those of the authors and do not necessarily represent those of National Institutes of Health. Study funders have no role in study design, data collection, data interpretation or publishing study findings.

Competing interests SCB reports grants from the NIH, Gilead, Merck, Pfizer, Gordon and Betty Moore Foundation, RRF Foundation for Aging, Lundbeck and Eli Lilly via her institution; and personal fees from Gilead, Sanofi, Pfizer, University of Westminster, Lundbeck and Luto UK outside the submitted work. AP reports grants from Merck, Pfizer, Lundbeck, Eli Lilly, Gordon and Betty Moore Foundation, RRF Foundation for Aging and Gilead and through her institution, and personal fees from Gilead. MW reports grants from the NIH, Gordon and Betty Moore Foundation and Eli Lilly; and personal fees from Pfizer, Sanofi, Luto UK, University of Westminster and Lundbeck outside the submitted work.

Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.

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