Benefits of Participation in Clinical Trials: An Umbrella Review

Bouzalmate-Hajjaj, Amira; Guijarro, Paloma; Khan, Khalid S.; Bueno‐Cavanillas, Aurora; Cano-Ibáñez, Naomi

doi:10.3390/ijerph192215368

Cited by 28 publications

(17 citation statements)

References 46 publications

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“…Efforts should be made to increase participation of women in RCTs because benefits are observed in women’s health versus nonparticipation. 51 The inadequate representation of women in RCTs impeded the investigation of disease presentation and treatment response by sex and gender. Consequently, this may limit the generalizability of medical evidence.…”

Section: Discussionmentioning

confidence: 99%

Systematic Review of Women Leading and Participating in Nephrology Randomized Clinical Trials

Lodhi,

Kibret,

Mangalgi

et al. 2024

Kidney International Reports

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Section: Discussionmentioning

confidence: 99%

Systematic Review of Women Leading and Participating in Nephrology Randomized Clinical Trials

Lodhi,

Kibret,

Mangalgi

et al. 2024

Kidney International Reports

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“…As in most clinical trials, our study may be affected by the “Hawthorne effect” or “trial effect” ( 54 , 55 ). This effect concerns the changing of behavior due to study participation and the feeling of being observed.…”

Section: Discussionmentioning

confidence: 99%

Effectiveness of coordinated care to reduce the risk of prolonged disability among patients suffering from subacute or recurrent acute low back pain in primary care: protocol of the CO.LOMB cluster-randomized, controlled study

Ramond-Roquin,

Bègue,

Vizzini

et al. 2023

Front. Med.

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BackgroundLow back pain (LBP) is a common musculoskeletal condition and, globally, a leading cause of years lived with disability. It leads to reduced social participation, impaired quality of life, and direct and indirect costs due to work incapacity. A coordinated approach focusing on psychosocial risk factors, active reeducation, and the early use of tools to maintain employment, may be effective for improving prognosis of patients with LBP. Primary care professionals and multidisciplinary teams, who see patients in the early stages of LBP may be in the best position to implement such a coordinated approach. We designed this study to assess a coordinated multi-faceted strategy in primary care for patients with subacute or recurrent acute LBP.MethodsThe CO.LOMB study was designed as a multicentric, cluster-randomized, controlled study. Patients aged 18–60 years, with subacute or recurrent acute LBP are eligible. Patients also need to be employed (but can be on sick leave) with access to occupational health services. The clusters of GPs will be randomized (1:1) to either the Coordinated-care group or the Usual-care group. Patients will be assigned the group allocated to their GP. The healthcare professionals (GPs and associated physiotherapists) allocated to the Coordinated-care group will perform a 2-session study training. The following interventions are planned in the Coordinated-care group: exploration and management of psychosocial factors, active reeducation with a physiotherapist, the implementing of tools to maintain employment, and a reinforced cooperation between primary healthcare professionals. The primary objective is to assess the benefit of coordinated primary care to reduce disability in LBP patients at 12 months after enrollment: measure using the validated French version of the Roland Morris Disability Questionnaire. Secondary objectives include the evaluation of pain, work status, and quality of life at various time points. The study plans to enroll 500 patients in 20 GP clusters. Patients will be followed up for 12months.DiscussionThis study will evaluate the benefit of a coordinated multi-faceted strategy in primary care for patients with LBP. Notably whether this approach will alleviate the associated disability, attenuate pain, and promote the maintenance or return to work.Clinical Trial RegistrationNCT04826757.

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“…10,11 More recently, patient portals have been used to invite patients to participate in clinical trials, giving these patients the potential advantage of better care that is associated with clinical trial participation. 12 Disadvantaged patient populations, including patients in racial and ethnic minority groups, patients who lack insurance, and patients whose preferred language is not English, are less likely to have their blood pressure under control. [13][14][15][16] It is unclear how engaged disadvantaged patients are with the patient portal.…”

Section: Introductionmentioning

confidence: 99%

“…Patient portals can be used to collect patient-reported data, such as home blood pressure readings, to enhance disease management, which has been linked to improved blood pressure control and has been recommended in clinical practice guidelines . More recently, patient portals have been used to invite patients to participate in clinical trials, giving these patients the potential advantage of better care that is associated with clinical trial participation …”

Section: Introductionmentioning

confidence: 99%

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Disparities in Patient Portal Engagement Among Patients With Hypertension Treated in Primary Care

Khatib,

Glowacki,

Chang

et al. 2024

JAMA Netw Open

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ImportancePatient portals are increasingly used for patient-clinician communication and to introduce interventions aimed at improving blood pressure control.ObjectiveTo characterize patient portal use among patients with hypertension managed in primary care.Design, Settings, and ParticipantsThis retrospective cohort study used electronic health records linked with patient portal log file data from a large, diverse Midwestern health care system. Patients with hypertension who had a primary care visit from January 1, 2021, to December 31, 2021, were included. The first visit in 2021 was considered the baseline visit; patient portal engagement was evaluated during the following year. Multivariate logistic regressions, presented as odds ratios (ORs) and 95% CIs, were used to evaluate associations between patient characteristics and patient portal engagement, adjusting for potential confounders.ExposuresPrimary exposures included 4 sociodemographic factors routinely collected in the electronic health record: race and ethnicity, insurance, preferred language, and smoking status.Main Outcomes and MeasuresIndicators of patient engagement with the patient portal included accessing the patient portal at least once, accessing the portal within 7 days of at least 50.0% of primary care physician (PCP) visits, frequent logins (&lt;28 vs ≥28), messaging (&lt;2 vs ≥2), and sharing home blood pressure readings.ResultsAmong 366 871 patients (mean [SD], 63.5 [12.6] years), 52.8% were female, 3.4% were Asian, 7.8% were Hispanic, 19.7% were non-Hispanic Black, 66.9% were non-Hispanic White, and 2.3% were of other race or ethnicity. During the 1-year study period starting in 2021, 70.5% accessed the patient portal at least once, 60.2% accessed around the time of their PCP visits, 35.7% accessed the portal frequently, 28.9% engaged in messaging, and 8.7% shared home blood pressure readings. Compared with White patients, non-Hispanic Black and Hispanic patients had lower odds of any access (Black: OR, 0.53; 95% CI, 0.52-0.54; Hispanic: OR, 0.66; 95% CI, 0.64-0.68), access around PCP visit time (Black: OR, 0.49; 95% CI, 0.48-0.50; Hispanic: OR, 0.62; 95% CI, 0.60-0.64), frequent access (Black: OR, 0.56; 95% CI, 0.55-0.57; Hispanic: OR, 0.71; 95% CI, 0.69-0.73), and messaging (Black: OR, 0.63; 95% CI, 0.61-0.64); Hispanic: OR, 0.71; 95% CI, 0.69-0.73).Conclusions and RelevanceThis cohort study of patients with hypertension found clear sociodemographic disparities in patient portal engagement among those treated in primary care. Without special efforts to engage patients with portals, interventions that use patient portals to target hypertension may exacerbate disparities.

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Benefits of Participation in Clinical Trials: An Umbrella Review

Cited by 28 publications

References 46 publications

Systematic Review of Women Leading and Participating in Nephrology Randomized Clinical Trials

Systematic Review of Women Leading and Participating in Nephrology Randomized Clinical Trials

Effectiveness of coordinated care to reduce the risk of prolonged disability among patients suffering from subacute or recurrent acute low back pain in primary care: protocol of the CO.LOMB cluster-randomized, controlled study

Disparities in Patient Portal Engagement Among Patients With Hypertension Treated in Primary Care

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