Impact of Information Leaflets on Behavior of Patients with Gastroenteritis or Tonsillitis: A Cluster Randomized Trial in French Primary Care

Sustersic, Mélanie; Jeannet, E; Cozon-Rein, Lucile; Marechaux, F; Genty, C.; Foote, Alison; David-Tchouda, Sandra; Martínez, L.; Bosson, Jean‐Luc

doi:10.1007/s11606-012-2164-8

Cited by 20 publications

(27 citation statements)

References 17 publications

(22 reference statements)

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“…1,p.8 Therefore, the number of clusters in the two arms (control, experiment) was set to (6,6), (12,6), and (12,12) with an average of 50, 100, and 200 observations per cluster. These parameter values were consistent with existing community randomized trials and trials randomizing physician practices, [24][25][26][27] and with the simulation study performed by Flynn and Peters 12 for normal and lognormal data from a cluster randomization trial.…”

Section: Data Generation and Parameters Of Interestsupporting

confidence: 85%

Confidence intervals for a difference between lognormal means in cluster randomization trials

Poirier

Zou

Koval

2014

Stat Methods Med Res

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Cluster randomization trials, in which intact social units are randomized to different interventions, have become popular in the last 25 years. Outcomes from these trials in many cases are positively skewed, following approximately lognormal distributions. When inference is focused on the difference between treatment arm arithmetic means, existent confidence interval procedures either make restricting assumptions or are complex to implement. We approach this problem by assuming log-transformed outcomes from each treatment arm follow a one-way random effects model. The treatment arm means are functions of multiple parameters for which separate confidence intervals are readily available, suggesting that the method of variance estimates recovery may be applied to obtain closed-form confidence intervals. A simulation study showed that this simple approach performs well in small sample sizes in terms of empirical coverage, relatively balanced tail errors, and interval widths as compared to existing methods. The methods are illustrated using data arising from a cluster randomization trial investigating a critical pathway for the treatment of community acquired pneumonia.

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Section: Data Generation and Parameters Of Interestsupporting

confidence: 85%

Confidence intervals for a difference between lognormal means in cluster randomization trials

Poirier

Zou

Koval

2014

Stat Methods Med Res

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“…Yet PILs are heterogeneous both in terms of format and content. They can go from a single page up to 3, 4, 6, 28 or even 45 pages, although several studies emphasize the superiority of a short format. Although many guidelines are available, few authors cite any of those used nor justify their choices (e.g.…”

Section: Discussionmentioning

confidence: 99%

“…Also, few studies compare the effectiveness of different styles of writing . The impact of different contents, styles and formats for the same clinical situation or close clinical situations is rarely studied, which makes difficult a comparison of PILs' effectiveness. The results of an evaluation of PILs also depend on the target clinical situation, the method of distribution and the design of the RCTs evaluating it.…”

Section: Discussionmentioning

confidence: 99%

“…Since the 1970s, various authors have investigated the use of Patient Information Leaflets (PILs) and have suggested that they are helpful for patients, particularly as they improve recall of what was said during the consultation . Although more and more information is available through the Internet, patients continue to ask for more written information .…”

Section: Introductionmentioning

confidence: 99%

“…Since then, many groups have used RCTs to assess the impact of PILs in specific clinical situations, such as in chronic illness, contraception screening, chest pain in the emergency room, preparing for surgical interventions or in consultations with a primary care physician . However, problems of heterogeneous research protocols remain, both in the choice of primary outcome and in the main measurement technique, resulting in conclusions that are sometimes contradictory .…”

Section: Introductionmentioning

confidence: 99%

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How best to use and evaluate Patient Information Leaflets given during a consultation: a systematic review of literature reviews

Sustersic

Gauchet

Foote

et al. 2016

Health Expectations

Self Cite

117

121

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BackgroundIn the past, several authors have attempted to review randomized clinical trials (RCT) evaluating the impact of Patient Information Leaflets (PILs) used during a consultation and draw some general conclusions. However, this proved difficult because the clinical situations, size and quality of RCTs were too heterogeneous to pool relevant data.ObjectiveTo overcome this 30‐year stalemate, we performed a review of reviews and propose general recommendations and suggestions for improving the quality of PILs, how to use them and methods for evaluating them.MethodologyWe searched five databases for reviews, systematic reviews and meta‐analyses describing PILs. We drew general and condition‐linked conclusions concerning the impact of PILs. Checklists summarize criteria for quality PILs, and ways of using and evaluating them.ResultsOf 986 articles found, 24 reviews were pertinent; the five oldest considered the impact of PILs irrespective of the condition the patient consulted for; the 19 more recent ones mostly addressed precise clinical situations.DiscussionWhatever the clinical situation, PILs improve patients' knowledge and satisfaction. For acute conditions, in the short‐term PILs also improve adherence to treatment. For chronic diseases, invasive procedures or screening situations, their impact on adherence varies depending on the context, how the PILs are given and the invasiveness of the intervention.Conclusion PILs are considered to be very useful, especially for acute conditions where the patient is the first to suffer from lack of information. We propose checklists for writing, designing, using and evaluating PILs in RCTs to enable comparisons between different studies.

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Readability of Patient Education Materials in Head and Neck Cancer

Armache,

Assi,

et al. 2024

JAMA Otolaryngol Head Neck Surg

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ImportancePatient education materials (PEMs) can promote patient engagement, satisfaction, and treatment adherence. The American Medical Association recommends that PEMs be developed for a sixth-grade or lower reading level. Health literacy (HL) refers to an individual’s ability to seek, understand, and use health information to make appropriate decisions regarding their health. Patients with suboptimal HL may not be able to understand or act on health information and are at risk for adverse health outcomes.ObjectiveTo assess the readability of PEMs on head and neck cancer (HNC) and to evaluate HL among patients with HNC.Evidence ReviewA systematic review of the literature was performed by searching Cochrane, PubMed, and Scopus for peer-reviewed studies published from 1995 to 2024 using the keywords head and neck cancer, readability, health literacy, and related synonyms. Full-text studies in English that evaluated readability and/or HL measures were included. Readability assessments included the Flesch-Kincaid Grade Level (FKGL grade, 0-20, with higher grades indicating greater reading difficulty) and Flesch Reading Ease (FRE score, 1-100, with higher scores indicating easier readability), among others. Reviews, conference materials, opinion letters, and guidelines were excluded. Study quality was assessed using the Appraisal Tool for Cross-Sectional Studies.FindingsOf the 3235 studies identified, 17 studies assessing the readability of 1124 HNC PEMs produced by professional societies, hospitals, and others were included. The mean FKGL grade ranged from 8.8 to 14.8; none of the studies reported a mean FKGL of grade 6 or lower. Eight studies assessed HL and found inadequate HL prevalence ranging from 11.9% to 47.0%.Conclusions and RelevanceThese findings indicate that more than one-third of patients with HNC demonstrate inadequate HL, yet none of the PEMs assessed were developed for a sixth grade or lower reading level, as recommended by the American Medical Association. This incongruence highlights the need to address the readability of HNC PEMs to improve patient understanding of the disease and to mitigate potential barriers to shared decision-making for patients with HNC. It is crucial to acknowledge the responsibility of health care professionals to produce and promote more effective PEMs to dismantle the potentially preventable literacy barriers.

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Impact of Information Leaflets on Behavior of Patients with Gastroenteritis or Tonsillitis: A Cluster Randomized Trial in French Primary Care

Abstract: Patient information leaflets given by the physician during the consultation significantly modify the patient's behavior and knowledge of the disease, compared with patients not receiving the leaflets, for the conditions studied.

Cited by 20 publications

References 17 publications

Confidence intervals for a difference between lognormal means in cluster randomization trials

Confidence intervals for a difference between lognormal means in cluster randomization trials

How best to use and evaluate Patient Information Leaflets given during a consultation: a systematic review of literature reviews

Readability of Patient Education Materials in Head and Neck Cancer

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