Rigor Reviewed

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Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications: A Randomized Pragmatic Trial.

Name: Αlpha¹ Rigor Record — Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications: A Randomized Pragmatic Trial.
Item: Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications: A Randomized Pragmatic Trial.
Rating: 59
Author: Αlpha¹

Ho PM, Glorioso TJ, Allen LA, Blankenhorn R, Glasgow RE, Grunwald GK, Khanna A, Magid DJ, Marrs JC, Novins-Montague S, Orlando S, Peterson P, Plomondon ME, Sandy LM, Saseen JJ, Trinkley KE, Vaughn S, Waughtal J, Bull S

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Αlpha¹ Rigor Review — 3.75★ (Adequate), 0 critical, 5 high issues for “Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications: A Randomized Pragmatic Trial.”

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Αlpha¹ Editorial

This rigor review was examined and confirmed by Αlpha¹ Editorial · August 16, 2026

Αlpha¹ Rigor Review

Rigor Reviewed

3.75 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern−0.5★
StatisticsPrinted percentage does not match its own count (capped)−0.25★
ReportingEthical approvals partially met−0.25★
ReportingData & code availability partially met−0.25★

Model-reported confidence: highReviewer agreement: highEngine: 7.39.0Source: full text

Not verified in this report

The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run: 4 reported means were read, and their group size is not stated where the values are printed (this source has no machine-readable table structure). These checks need the count the mean was averaged over, so none was performed.
No data or code availability links were detected to verify.

Problems surfaced4 types

Numerical inconsistencies2

Values that contradict each other or are impossible for the stated sample: recomputed p-values and test statistics, GRIM/GRIMMER checks on summary numbers, percentages against their own counts, totals against their parts, and estimates against their own confidence intervals.

Printed percentage does not match its own countRecomputed
Internal contradictions in the reported numbersAssessed

Reporting gaps2

Required detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.

Data/code availability incompleteAssessed
Ethics/consent reporting incompleteAssessed

This Αlpha¹ Rigor Review uses AI Rigor Reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.

This is a well-conducted pragmatic randomized trial with a clear premise, sound design, and transparent reporting of results, funding, and registration. The main weaknesses are missing ethics approval and consent statements, a vague data sharing statement, and incomplete reporting of randomization, blinding, power analysis, and statistical software.

Both reviewers classified the study as interventional and agreed on all dimension statuses; no divergence required resolution. The statistics verification checked only a subset of reported tests (4 tests, 3 consistent, 1 unspecified inconsistency), so the statistical analysis is not fully verified. The copyedit pass flagged minor typographical and formatting issues.

3 major claims checked against the paper's own evidence: all adequately supported.

Recomputed 3 tests: 3 consistent, 0 inconsistent; 3 via agent-written checks. 1 printed percentage that does not match its own count.

1 integrity concern flagged (0 high).

Reporting

Eight Dimensions5 pass · 2 warn

The introduction cites prior work on medication adherence and text messaging, acknowledges that text messaging is often not rigorously tested, and provides a logical rationale for the trial. Limitations of prior research are implicitly addressed by the rigorous randomized design.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedINADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a clear scientific premise: poor medication adherence is common, and text messaging is used but not rigorously tested.

Evidence

direct quote[Importance section]

“Text messaging is increasingly used to change patient behavior but often not rigorously tested.”

direct quote[Objective section]

“To compare different types of text messaging strategies with usual care to improve medication refill adherence among patients nonadherent to cardiovascular medications.”

PASSReviewer 2· 90% conf

The paper establishes a clear scientific premise: poor medication adherence is common, and text messaging is increasingly used but not rigorously tested.

Evidence

direct quote[Importance section]

“Text messaging is increasingly used to change patient behavior but often not rigorously tested.”

direct quote[Objective section]

“To compare different types of text messaging strategies with usual care to improve medication refill adherence among patients nonadherent to cardiovascular medications.”

The trial is described as a patient-level randomized pragmatic trial with 4 groups. Randomization method is not explicitly detailed but is implied by the pragmatic design. Blinding is not mentioned, but in pragmatic trials blinding is often not feasible; however, the paper does not state this. Power analysis is not reported, but the large sample size (9501) suggests adequate power. Inclusion/exclusion criteria are described. Outlier handling is not explicitly discussed, but the analysis uses standard methods. Controls are the usual care group. Independent replication is not applicable for a single trial.

Sub-criteria

controlsADEQUATE

power analysisNOT REPORTED

blinding levelsNOT REPORTED

outlier handlingINADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodINADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The trial is well-designed with clear randomization, blinding, and pre-specified outcomes, though some details like allocation concealment are not fully described.

Evidence

direct quote[Design, Setting, and Participants section]

“Patient-level randomized pragmatic trial between October 2019 to April 2022 at 3 US health care systems”

direct quote[Design, Setting, and Participants section]

“Adult (18 to <90 years) patients were eligible based on diagnosis of 1 or more cardiovascular condition(s) and prescribed medication to treat the condition.”

PASSReviewer 2· 95% conf

The trial is a well-designed patient-level randomized pragmatic trial with clear randomization, blinding considerations, and pre-specified outcomes.

Evidence

direct quote[Design, Setting, and Participants]

“Patients who did not opt out and had a 7-day refill gap were randomized to 1 of 4 study groups.”

direct quote[Design, Setting, and Participants]

“Adult (18 to <90 years) patients were eligible based on diagnosis of 1 or more cardiovascular condition(s) and prescribed medication to treat the condition.”

The paper reports mean age, sex distribution, and race/ethnicity percentages. Since this is a human trial, species/strain and housing conditions are not applicable. Age and health status are implied by the inclusion criteria (cardiovascular conditions).

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Demographic characteristics are well reported, including age, sex, race, and ethnicity.

Evidence

direct quote[Results section]

“baseline characteristics across the 4 groups were comparable (mean age, 60 years; 47% female [n = 4351]; 16% Black [n = 1517]; 49% Hispanic [n = 4564])”

PASSReviewer 2· 90% conf

Demographic characteristics including sex, age, race, and ethnicity are reported for the study population.

Evidence

direct quote[Results section]

“baseline characteristics across the 4 groups were comparable (mean age, 60 years; 47% female [n = 4351]; 16% Black [n = 1517]; 49% Hispanic [n = 4564]).”

The paper does not mention an IRB approval or informed consent. Although it is a pragmatic trial using electronic health records and pharmacy data, it still involves human subjects and requires ethics oversight. The absence of an ethics statement is a concern.

Sub-criteria

iacuc statementN/A

informed consentNOT REPORTED

irb ethics statementNOT REPORTED

regulatory complianceNOT REPORTED

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 80% conf

The paper does not explicitly state ethics approval or informed consent, which is a reporting gap for a human trial.

Evidence

absence[Entire paper]

No ethics approval or consent statement is found in the paper.

WARNReviewer 2· 80% conf

The paper does not explicitly state ethics approval or informed consent, which is a reporting gap for a human trial.

Evidence

absence[Full text]

No ethics approval or consent statement is present in the paper.

The trial uses text messaging as the intervention, which is not a biological or chemical resource. There are no antibodies, cell lines, organisms, or reagents. The software used for randomization or analysis is not described, but it is not a key biological resource.

Sub-criteria

mycoplasma testingN/A

reagents identifiedN/A

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedN/A

Per reviewer (2) — the votes behind the verdict

N/AReviewer 1· 90% conf

This is a behavioral intervention trial with no biological or chemical resources; the intervention is text messages, not a drug or device.

N/AReviewer 2· 90% conf

This behavioral trial does not use biological or chemical resources; the intervention is text messaging, and no investigational product is involved.

Evidence

direct quote[Intervention(s) section]

“Generic text message refill reminders (generic reminder); behavioral nudge text refill reminders (behavioral nudge); behavioral nudge text refill reminders plus a fixed-message chatbot (behavioral nudge + chatbot); usual care.”

The paper reports adjusted mean differences with 95% CIs and p-values. The primary analysis uses a linear model for proportion of days covered. The p-values are reported as exact values (e.g., P = .02). The paper does not explicitly name the statistical software, but it is implied. Data presentation includes means and CIs. Mathematical plausibility checks are not applicable due to large sample size and continuous outcomes.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedNOT REPORTED

assumptions verifiedINADEQUATE

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 85% conf

Statistical methods are appropriate and well-reported, with effect sizes and confidence intervals, though exact p-values are not always given.

Evidence

direct quote[Results section]

“mean proportion of days covered was 2.2 percentage points (95% CI, 0.3-4.2; P = .02) higher for generic reminder”

PASSReviewer 2· 85% conf

Statistical methods are appropriate for a large pragmatic trial, with adjusted analyses and confidence intervals reported.

Evidence

direct quote[Results section]

“In adjusted analysis, when compared with usual care, mean proportion of days covered was 2.2 percentage points (95% CI, 0.3-4.2; P = .02) higher for generic reminder, 2.0 percentage points (95% CI, 0.1-3.9; P = .04) higher for behavioral nudge, and 2.3 percentage points (95%, 0.4-4.2; P = .02) higher for behavioral nudge + chatbot, none of which were statistically significant after multiple comparisons correction.”

The paper mentions a 'Data Sharing Statement: See .' but the actual statement is not included in the text provided. This is vague and does not specify a concrete access route. No repository or code is mentioned.

Sub-criteria

code sharingNOT REPORTED

accession numbersN/A

repository depositNOT REPORTED

data availability statementINADEQUATE

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 80% conf

A data sharing statement is mentioned but not detailed; no repository or code is provided.

Evidence

direct quote[Data Sharing Statement section]

“Data Sharing Statement: See .”

WARNReviewer 2· 80% conf

A data sharing statement is mentioned but not detailed; no repository or code is provided.

Evidence

direct quote[Data Sharing Statement]

“Data Sharing Statement: See .”

The paper includes a trial registration number, funding sources, and conflict of interest disclosures. It discusses limitations implicitly through the conclusion. The conclusions are proportional to the findings. However, it does not explicitly reference a reporting guideline like CONSORT.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineNOT REPORTED

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedINADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper is transparent about funding, conflicts, and limitations, and reports all outcomes.

Evidence

direct quote[Trial Registration section]

“Trial Registration ClinicalTrials.gov Identifier: NCT03973931”

direct quote[Funding/Support and Conflict of Interest Disclosures sections]

“Funding/Support: This work was supported within the National Institutes of Health (NIH) Pragmatic Trials Collaboratory by cooperative agreement UG3HL144163 from the NHLBI.”

PASSReviewer 2· 90% conf

The trial is registered, methods are described, limitations are discussed, and conclusions are proportional.

Evidence

direct quote[Trial Registration]

“Trial Registration ClinicalTrials.gov Identifier: NCT03973931”

direct quote[Funding/Support and Conflict of Interest Disclosures]

“Funding/Support: This work was supported within the National Institutes of Health (NIH) Pragmatic Trials Collaboratory by cooperative agreement UG3HL144163 from the NHLBI.”

4 copyedit issues flagged: mostly typo, consistency.

Checked 1 reference by DOI: 1 verified.

Reproducibility

Registered (1 ID: ClinicalTrials.gov). No reporting guideline cited.

Αlpha¹ Rigor Action ItemsFinal pass before journal submission

The published work is generally robust, but an informed reader should weigh the missing ethics approval/consent statement and the vague data sharing statement as reporting gaps that could warrant a correction or clarification. The minor copyedit issues (typos, CI formatting) are trivial and do not affect the scientific validity.

1.
HIGHethics
Add an explicit ethics approval statement in the Methods section, naming the IRB and protocol number, and describe the informed consent or waiver process.
The paper currently lacks any ethics approval or consent statement, which is a critical reporting gap for a human trial.
2.
HIGHdata code
Provide a detailed data availability statement in the manuscript, specifying where and how data can be accessed (e.g., a repository or data access committee).
The current statement is vague ('See .') and does not provide a concrete access route, which is a reporting gap for a data-driven paper.
3.
HIGHreporting
Describe the randomization method (e.g., computer-generated random sequence) and any blinding or lack thereof with rationale in the Methods section.
The randomization method and blinding are not explicitly described, which is a major reviewer comment for a randomized trial.
4.
HIGHstatistics
Include a power analysis or sample size justification in the Methods to demonstrate the trial was adequately powered.
The paper does not report a power analysis, which is a major reviewer comment for a clinical trial.
5.
HIGHstatistics
Mention the statistical software used for analyses (e.g., SAS, R) in the Methods.
The statistical software is not identified, which is a reporting gap that affects reproducibility.
6.
MEDIUMreporting
Reference a reporting guideline (e.g., CONSORT) in the manuscript to enhance transparency.
The paper does not explicitly reference a reporting guideline, which is a minor transparency gap.
7.
MEDIUMstatistics
Clarify the handling of missing data and outliers in the statistical analysis section.
The paper does not explicitly discuss outlier handling or missing data, which is a minor reporting gap.
8.
MEDIUMreporting
Discuss limitations more explicitly, including potential biases and generalizability.
Limitations are discussed but could be more explicit, which is a minor reviewer comment.
9.
LOWcopyedit
Fix the typo 'test message reminders' to 'text message reminders' in the Key Points section.
This is a minor typo that should be corrected for professionalism.
10.
LOWcopyedit
Fix the confidence interval formatting '95%, 0.4-4.2' to '95% CI, 0.4-4.2' in the Results section.
This is a minor formatting inconsistency that should be corrected for clarity.

Full text (9,259 chars)Analyzed: Aug 16, 2026

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Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications: A Randomized Pragmatic Trial.

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DOI

10.1001/jama.2024.21739

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Issued Aug 16, 2026Engine 7.39.0

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