Ten (not so) simple rules for clinical trial data-sharing.

Clinical trial data-sharing is seen as an imperative for research integrity and is becoming increasingly encouraged or even required by funders, journals, and other stakeholders. However, early experiences with data-sharing have been disappointing because they are not always conducted properly. Health data is indeed sensitive and not always easy to share in a responsible way. We propose 10 rules for researchers wishing to share their data. These rules cover the majority of elements to be considered in order to start the commendable process of clinical trial data-sharing: Rule 1: Abide by local legal and regulatory data protection requirementsRule 2: Anticipate the possibility of clinical trial data-sharing before obtaining fundingRule 3: Declare your intent to share data in the registration stepRule 4: Involve research participantsRule 5: Determine the method of data accessRule 6: Remember there are several other elements to shareRule 7: Do not proceed aloneRule 8: Deploy optimal data management to ensure that the data shared is usefulRule 9: Minimize risksRule 10: Strive for excellence.

CPAP telemonitoring can track Cheyne-Stokes respiration and detect serious cardiac events: The AlertApnée Study.

BACKGROUND AND OBJECTIVE: Case reports have suggested that continuous positive airway pressure (CPAP) telemonitoring can detect the onset of acute cardiac events such as decompensated heart failure (HF) or atrial fibrillation through an increase in the apnoea-hypopnoea index (AHI) and onset of Cheyne-Stokes Respiration (CSR). This study addressed whether long-term remote CPAP treatment telemonitoring revealing CSR can help detect serious cardiac events (SCEs) in obstructive sleep apnoea (OSA) patients. METHODS: This monocentric prospective cohort study included adults receiving CPAP therapy for OSA with daily telemonitoring. Any sudden increase in AHI generated an alert for the home healthcare provider to download CPAP data to identify CSR. A medical consultation was scheduled if CSR was detected. RESULTS: We included 555 adults (412 men; 57% with known cardiovascular comorbidities). During the 1-year follow-up, 78 CSR episodes were detected in 74 patients (CSR+). The main conditions associated with incident CSR were HF (24 patients [30.8%]), ventilatory instability (21, 26.9%), leaks (13, 16.7%), medications inducing central apnoeas (baclofen, ticagrelor, opioids) (7, 9.0%), arrhythmias (6, 7.7%) and renal failure (2, 2.6%). Fifteen (20.3%) CSR+ patients had a confirmed SCE. In univariable analysis, a CSR episode increased the risk of an SCE by 13.8-fold (5.7-35.6) (p < 0.0001), with an adjusted OR of 5.7 (2.0-16.8) in multivariable analysis. CONCLUSION: Long-term telemonitoring of patients on CPAP treatment can alert CSR episodes and allows early detection of SCEs in patients with or without known cardiac comorbidities.

Medical journal requirements for clinical trial data sharing: Ripe for improvement.

Florian Naudet and co-authors discuss strengthening requirements for sharing clinical trial data.

Persistence of uncontrolled hypertension post-cardiac rehabilitation in stable coronary patients.

In stable coronary heart disease, uncontrolled risk factors are strongly associated with incident myocardial infarction. We analysed the management of hypertension in 746 stable coronary patients recruited between 2005 and 2015 in a single-centre prospective study. Risk factors and pharmacological treatments were documented prior to and immediately after cardiac rehabilitation, and 1 year later. One year post-cardiac rehabilitation, all cardiovascular risk factors were significantly better controlled with the notable exception of hypertension: blood pressure (BP) <140/90 mmHg in 60% of the total population vs 49% (N = 450) of hypertensive patients (20% or 10%, according to the ACC/AHA 2017 or ESH/ESC guidelines, respectively). Of those who had achieved normotension by the end of cardiac rehabilitation, 42% had uncontrolled hypertension again 1 year later; in addition, body weight had increased, while physical activity and antihypertensive drug use had dropped (differences between controlled or uncontrolled hypertension at 1 year post-cardiac rehabilitation, NS). Three factors were correlated with BP elevations: discontinuation of betablockade: +7.9 mmHg; age >65 years: +6.2 mmHg; diabetes mellitus: +7.6 mmHg. Only 48% hypertensive patients were on guideline-recommended antihypertensive polytherapy. Although 28% were still hypertensive post-cardiac rehabilitation, and hypertension remained uncontrolled in 70% 1 year later, 61% antihypertensive prescriptions were not adjusted post-cardiac rehabilitation. One year post-cardiac rehabilitation, hypertension was the only cardiovascular risk factor that had not improved. This can be attributed to three main reasons, all associated with BP elevations: precipitous reduction in betablockade, physicians' inertia when faced with uncontrolled hypertension and lack of adherence to international guidelines.

Intent to share Annals of Internal Medicine's trial data was not associated with data re-use.

OBJECTIVE: To explore the impact of the Annals of Internal Medicine (AIM) data-sharing policy for randomized controlled trials (RCTs) in terms of output from data-sharing (i.e. publications re-using the data). STUDY DESIGN AND SETTING: Retrospective study. RCTs published in the AIM between 2007 and 2017 were retrieved on PubMed. Publications where the data had been re-used were identified on Web of Science. Searches were performed by two independent reviewers. The primary outcome was any published re-use of the data (re-analysis, secondary analysis, or meta-analysis of individual participant data [MIPD]), where the first, last and corresponding authors were not among the authors of the RCT. Analyses used Cox (primary analysis) models adjusting for RCTs characteristics (registration: https://osf.io/8pj5e/). RESULTS: 185 RCTs were identified. 106 (57%) mentioned willingness to share data and 79 (43%) did not. 208 secondary analyses, 67 MIPD and no re-analyses were identified. No significant association was found between intent to share and re-use where the first, last and corresponding authors were not among the authors of the primary RCT (adjusted hazard ratio = 1.04 [0.47-2.30]). CONCLUSION: Over ten years, RCTs published in AIM expressing an intention to share data were not associated with more extensive re-use of the data.