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1.
Clin Oral Investig ; 28(10): 518, 2024 Sep 07.
Article in English | MEDLINE | ID: mdl-39243303

ABSTRACT

OBJECTIVES: Little is known about oral hygiene habits of patients suffering from chronic diseases. This study aims to describe oral hygiene behavior (OHB) in terms of tooth brushing and professional scaling frequency among patients with chronic diseases. Secondarily, it aims to assess the association between OHB and periodontitis, tooth loss, and oral health-related quality of life (OHRQoL). MATERIALS AND METHODS: This is a cross-sectional analysis of data of adult participants in the ComPaRe e-cohort. Participants were classified into having good, moderate, and poor OHB according to self-reported frequency of toothbrushing and professional tooth scaling. Periodontitis was assessed using the PEriodontal Screening Score (PESS). Weighted binary regression models were used to estimate the association between OHB and the following outcomes: (i) periodontitis; (ii) number of missing teeth; and (iii) OHRQoL based on the Oral Health Impact Profile-14. RESULTS: Overall, 8553 patients were included in the analyses (52.9% females, mean age of 56.3 ± 17 years). Of these, 2907 (34%), 3953 (46%) and 1693 (20%) were considered as having good, moderate, and poor OHB, respectively. Over half (54.1%) of the patients had a PESS ≥ 5 suggestive for severe periodontitis. Moderate OHB was associated with lower odds of PESS ≥ 5 compared to poor OHB (Adjusted Odds Ratio, OR = 0.81 [95%CI: 0.70-0.92]). Good and moderate OHB were significantly associated with lower odds of ≥ 10 missing teeth (OR = 0.26 [95%CI: 0.21-0.33] and OR = 0.47 [95%CI: 0.4-0.56], respectively) and better OHRQoL than poor OHB. CONCLUSIONS: Although, most of patients with chronic diseases reported to have good or moderate OHB, severe periodontitis is highly prevalent among this patient population in France. CLINICAL RELEVANCE: This study describes OHB in a representative sample of patients suffering from one or more chronic diseases and provides an estimate of the prevalence of self-reported severe periodontitis, missing teeth, and OHRQoL.


Subject(s)
Oral Hygiene , Periodontitis , Quality of Life , Tooth Loss , Humans , Cross-Sectional Studies , Female , Male , Middle Aged , Periodontitis/epidemiology , Tooth Loss/epidemiology , Chronic Disease , Oral Health , Surveys and Questionnaires
2.
BMC Med ; 22(1): 415, 2024 Sep 27.
Article in English | MEDLINE | ID: mdl-39334281

ABSTRACT

BACKGROUND: The objective of the study was to identify the psychosocial and contextual markers considered by physicians to personalize care. METHODS: An online questionnaire with one open-ended question, asking physicians to describe clinical situations in which they personalized care, was used. Physicians were recruited from March 31, 2023, to August 10, 2023, from three hospitals, five university departments of general practice and six physician organizations in France. Recruitment was conducted through email invitations, with participants encouraged to invite their colleagues via a snowball sampling method. The participants were a diverse sample of French general practitioners and other medical specialists who see patients in consultations or in hospital wards. We extracted the psychosocial and contextual markers considered by physicians to personalize care in each clinical situation. The analysis involved both manual and AI-assisted content analysis using GPT3.5-Turbo (OpenAI). Mathematical models to assess data saturation were used to ensure that a comprehensive list of markers was identified. RESULTS: In total, 1340 people connected to the survey platform and 1004 (75.0%) physicians were eligible for the study (median age 39 years old, IQR 34 to 50; 60.5% women; 67.0% working in outpatient settings), among whom 290 answered the open-ended question. The participants reported 317 clinical situations during which they personalized care. Personalization was based on the consideration of 40 markers: 27 were related to patients' psychosocial characteristics (e.g., patient capacity, psychological state, beliefs), and 13 were related to circumstances (e.g., competing activities, support network, living environment). The data saturation models showed that at least 97.0% of the potential markers were identified. Manual and AI-assisted content analysis using GPT3.5-Turbo were concordant for 89.9% of clinical situations. CONCLUSIONS: Physicians personalize care to patients' contexts and lives using a broad range of psychosocial and contextual markers. The effect of these markers on treatment engagement and effectiveness needs to be evaluated in clinical studies and integrated as tailoring variables in personalized interventions to build evidence-based personalization.


Subject(s)
Physicians , Precision Medicine , Humans , Female , Male , Precision Medicine/methods , Adult , Surveys and Questionnaires , Middle Aged , Physicians/psychology , France , Attitude of Health Personnel
3.
JAMA Intern Med ; 2024 Sep 30.
Article in English | MEDLINE | ID: mdl-39348113

ABSTRACT

This systematic review assesses the availability and temporality of evidence from effectiveness and efficacy studies for digital therapeutics.

4.
Fam Pract ; 2024 Aug 02.
Article in English | MEDLINE | ID: mdl-39093609

ABSTRACT

BACKGROUND: Smoking cessation interventions requires attending to the circumstances and needs of individual patients. We aimed at highlighting the discordances between patients' and physicians' perspectives on contextual factors that should be considered during smoking cessation. METHODS: We identified 36 contextual factors identified that should be considered during smoking cessation using PubMed and interviewing general practitioners. Physicians recruited through social networks campaigns and smoker or former smoker patients from the ComPaRe cohort selected the factors they considered most relevant in two online paired comparison experiment. Bradley Terry Luce models estimated the ability of each factor (i.e. the probability to be preferred). We calculated the Pearson's correlation and the intraclass correlation coefficients for the contextual factor from each perspective and compared the ranking of the 10 contextual factors with the highest abilities. RESULTS: Seven hundred and ninety-three patients' and 795 physicians' perspectives estimated the ability (i.e., importance) of the contextual factors in 11 963 paired comparisons. We found a high correlation between physicians' and patients' perspectives of the contextual factors to be considered for smoking cessation (r = 0.76, P < 0.0001). However, the agreement between the abilities of contextual factors was poor (ICC = 0.42 [-0.10; 0.75]; P = 0.09). Fine-grain analysis of participants' answers revealed many discrepancies. For example, 40% factors ranked in the top 10 most important for physicians were not in patients' top 10 ranking. CONCLUSION: Our results highlight the importance of patient-centered care, the need to engage discussions about patients' values, beyond what is thought to be important, to avoid overlooking their real context.

5.
J Clin Epidemiol ; 174: 111482, 2024 Jul 26.
Article in English | MEDLINE | ID: mdl-39067541

ABSTRACT

OBJECTIVES: Some therapeutic strategy questions in oncology could be answered with studies using observational data. Target trial emulation is the application of design principles from randomized controlled trials (RCTs) to the analysis of observational data, to reduce design-induced biases. Our objective was to determine which type of study physicians would preferably plan to answer a comparative effectiveness question lacking evidence in oncology. METHODS: We launched an online survey among physicians specialized in oncology. We constructed a vignette-based inquiry where vignettes described study scenarios which could be conducted to answer the predefined question. We designed six vignettes described by study design (RCT or observational study with a trial emulation framework), main study characteristics, probability of the study succeeding and anticipated delay before results availability. Participants randomly assessed five pair-wise comparisons of the vignettes and were asked which study they would preferably plan by using a Likert scale ranging from -5 to 5. The main outcome was the evaluation of clinicians' preferences for each pairwise comparison. Mean and median preference scores were calculated. RESULTS: Two hundred thirteen participants, specialized in many tumor types, assessed at least one comparison with 82% reporting France as their country of affiliation. The interquartile range was -4 to 4 across pairwise comparisons. The median preference score was in disfavor of the monocentric RCT for the five comparisons where it appeared. The median preference score was strongly in favor of the multicentric national emulated trial when compared to the monocentric emulated trial 4 [IQR 2.5-4]. The mean preference score was the highest for the large European observational study 1.14 (SD 3.33), while the mean preference score was the lowest for the monocentric RCT -1.86 (SD 2.93). CONCLUSION: No study design was strongly preferred, but the monocentric RCT was the least favored study in pair-wise comparisons. The planification of the new research is a compromise between scientific soundness, feasibility, cost, and time before obtaining results. We need to have the right answers to the right questions at the right time.

7.
Ann Intern Med ; 177(6): 791-799, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38768452

ABSTRACT

BACKGROUND: Systematic reviews are performed manually despite the exponential growth of scientific literature. OBJECTIVE: To investigate the sensitivity and specificity of GPT-3.5 Turbo, from OpenAI, as a single reviewer, for title and abstract screening in systematic reviews. DESIGN: Diagnostic test accuracy study. SETTING: Unannotated bibliographic databases from 5 systematic reviews representing 22 665 citations. PARTICIPANTS: None. MEASUREMENTS: A generic prompt framework to instruct GPT to perform title and abstract screening was designed. The output of the model was compared with decisions from authors under 2 rules. The first rule balanced sensitivity and specificity, for example, to act as a second reviewer. The second rule optimized sensitivity, for example, to reduce the number of citations to be manually screened. RESULTS: Under the balanced rule, sensitivities ranged from 81.1% to 96.5% and specificities ranged from 25.8% to 80.4%. Across all reviews, GPT identified 7 of 708 citations (1%) missed by humans that should have been included after full-text screening at the cost of 10 279 of 22 665 false-positive recommendations (45.3%) that would require reconciliation during the screening process. Under the sensitive rule, sensitivities ranged from 94.6% to 99.8% and specificities ranged from 2.2% to 46.6%. Limiting manual screening to citations not ruled out by GPT could reduce the number of citations to screen from 127 of 6334 (2%) to 1851 of 4077 (45.4%), at the cost of missing from 0 to 1 of 26 citations (3.8%) at the full-text level. LIMITATIONS: Time needed to fine-tune prompt. Retrospective nature of the study, convenient sample of 5 systematic reviews, and GPT performance sensitive to prompt development and time. CONCLUSION: The GPT-3.5 Turbo model may be used as a second reviewer for title and abstract screening, at the cost of additional work to reconcile added false positives. It also showed potential to reduce the number of citations before screening by humans, at the cost of missing some citations at the full-text level. PRIMARY FUNDING SOURCE: None.


Subject(s)
Meta-Analysis as Topic , Sensitivity and Specificity , Humans , Abstracting and Indexing , Review Literature as Topic , Systematic Reviews as Topic
8.
Clin Res Hepatol Gastroenterol ; 48(6): 102371, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38719146

ABSTRACT

INTRODUCTION: The prevalence of Barrett's esophagus (BE) in France is unknown. However, the management of dysplastic BE in expert centers is recommended and reduces the risk of developing invasive adenocarcinoma. Our aim was to determine the burden of BE patients in the Paris Region. METHODS: We performed a retrospective study using the data from electronic medical records from the data warehouse of the 39 Greater Paris public hospitals (Entrepôt de données de santé de l' Assistance Publique- Hôpitaux de Paris) for the year 2018, and used natural language processing to search for occurrences of Barrett's esophagus in endoscopy and pathology reports. RESULTS: we observed a 2.2 % prevalence of Barrett's esophagus. Patients with Barrett's esophagus were older, more frequently males, with a hiatal hernia, proton pump inhibitor users, and less frequently infected by H. Pylori. Gastro-esophageal reflux symptoms were not more frequently encountered in Barrett's patients. Eleven percent of patients with Barrett's esophagus had dysplasia or adenocarcinoma. DISCUSSION: Over 200 000 patients with Barrett's esophagus are expected in the Paris Region, of which 11 % harbor dysplasia or adenocarcinoma. This data should be taken into account to tailor healthcare offer in France.


Subject(s)
Barrett Esophagus , Barrett Esophagus/epidemiology , Humans , Retrospective Studies , Male , Paris/epidemiology , Female , Middle Aged , Aged , Prevalence , Hernia, Hiatal/epidemiology , Hernia, Hiatal/complications , Adenocarcinoma/epidemiology , Cost of Illness , Esophageal Neoplasms/epidemiology , Adult
9.
J Clin Epidemiol ; 170: 111362, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38615827

ABSTRACT

OBJECTIVES: To identify the patient-reported outcome measures (PROMs) used in clinical trials assessing interventions for chronic pain, describe their psychometric properties, and the clinical domains they cover. STUDY DESIGN AND SETTING: We identified phase 3 or 4 interventional trials: on adult participants (aged >18 years), registered in clinicaltrials.gov between January 1, 2021 and December 31, 2022, and which provided "chronic pain" as a keyword condition. We excluded diagnostic studies and phase 1 or 2 trials. In each trial, one reviewer extracted all outcomes registered and identified those captured using PROMs. For each PROM used in more than 1% of identified trials, two reviewers assessed whether it covered the six important clinical domains from the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT): pain, emotional functioning, physical functioning, participant ratings of global improvement and satisfaction with treatment, symptoms and adverse events, and participant disposition (eg, adherence to medication). Second, reviewers searched PubMed for both the initial publication and latest review reporting the psychometric properties of each PROM and assessed their content validity, structural validity, internal consistency, reliability, measurement error, hypotheses testing, criterion validity, and responsiveness using published criteria from the literature. RESULTS: In total, 596 trials assessing 4843 outcomes were included in the study (median sample size 60, interquartile range 40-100). Trials evaluated behavioral (22%), device-based (21%), and drug-based (10%) interventions. Of 495 unique PROMs, 55 were used in more than 1% trials (16 were generic pain measures; 8 were pain measures for specific diseases; and 30 were measures of other symptoms or consequences of pain). About 50% PROMs had more than 50% of psychometric properties rated as sufficient. Scales often focused on a single clinical domain. Only 25% trials measured at least three clinical domains from IMMPACT. CONCLUSION: Half of PROMs used in trials assessing interventions for chronic pain had sufficient psychometric properties for more than 50% of criteria assessed. Few PROMs assessed more than one important clinical domain. Only 25% of trials measured more than 3/6 clinical domains considered important by IMMPACT.


Subject(s)
Chronic Pain , Patient Reported Outcome Measures , Psychometrics , Humans , Chronic Pain/therapy , Psychometrics/methods , Adult , Pain Measurement/methods , Male , Female , Middle Aged , Reproducibility of Results , Clinical Trials as Topic
10.
J Am Med Inform Assoc ; 31(5): 1074-1083, 2024 Apr 19.
Article in English | MEDLINE | ID: mdl-38452293

ABSTRACT

OBJECTIVE: The timely initiation of renal replacement therapy (RRT) for acute kidney injury (AKI) requires sequential decision-making tailored to individuals' evolving characteristics. To learn and validate optimal strategies for RRT initiation, we used reinforcement learning on clinical data from routine care and randomized controlled trials. MATERIALS AND METHODS: We used the MIMIC-III database for development and AKIKI trials for validation. Participants were adult ICU patients with severe AKI receiving mechanical ventilation or catecholamine infusion. We used a doubly robust estimator to learn when to start RRT after the occurrence of severe AKI for three days in a row. We developed a "crude strategy" maximizing the population-level hospital-free days at day 60 (HFD60) and a "stringent strategy" recommending RRT when there is significant evidence of benefit for an individual. For validation, we evaluated the causal effects of implementing our learned strategies versus following current best practices on HFD60. RESULTS: We included 3748 patients in the development set and 1068 in the validation set. Through external validation, the crude and stringent strategies yielded an average difference of 13.7 [95% CI -5.3 to 35.7] and 14.9 [95% CI -3.2 to 39.2] HFD60, respectively, compared to current best practices. The stringent strategy led to initiating RRT within 3 days in 14% of patients versus 38% under best practices. DISCUSSION: Implementing our strategies could improve the average number of days that ICU patients spend alive and outside the hospital while sparing RRT for many. CONCLUSION: We developed and validated a practical and interpretable dynamic decision support system for RRT initiation in the ICU.


Subject(s)
Acute Kidney Injury , Renal Replacement Therapy , Adult , Humans , Randomized Controlled Trials as Topic , Renal Replacement Therapy/adverse effects , Acute Kidney Injury/therapy , Acute Kidney Injury/etiology , Intensive Care Units , Critical Illness/therapy
11.
Sci Rep ; 14(1): 6850, 2024 03 21.
Article in English | MEDLINE | ID: mdl-38514722

ABSTRACT

During the early phase of outbreaks, awareness of the presence of the disease plays an important role in transmission dynamics. To investigate the processes of how people become aware of a disease, we conducted two complementary investigations. First, we surveyed 868 academic researchers in France, on the time and circumstances when they became aware of COVID-19 as an important event. We found that 25% did so before February 18th (first death in France), 50% did so before March 10th (first presidential allocution) and 75% did so before March 16th (announcement of the lockdown). Awareness came from nine categories of circumstances: (1) decisions taken by the government (elicited by 35.7% participants); (2) information from media or social media (24.7%); (3) conversation with friends (22.4%); (4) observed changes in their personal lives (14.0%); (5) decisions taken by the employer (9.2%); (6) observed changes at work (9.9%); (7) suspected case of COVID-19 in their entourage (3.1%); (8) fear for oneself or their entourage (2.8%) and (9) self-appraisal of scientific reports (2.8%). Second, we appraised three general media in France (a television news show, a radio news show, and a newspaper) and showed that COVID-19 became a preeminent topic only after March 1st 2020 when the epidemic is present on national soil. Our results show that multiple intricated factors prompt the awareness of an emerging infectious disease. Awareness is not solely driven by general media as they begin to focus on the topic late.


Subject(s)
COVID-19 , Epidemics , Humans , COVID-19/epidemiology , SARS-CoV-2 , Communicable Disease Control , France/epidemiology
12.
Lancet Psychiatry ; 11(4): 285-294, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38490761

ABSTRACT

Research waste occurs when randomised controlled trial (RCT) outcomes are heterogeneous or overlook domains that matter to patients (eg, relating to symptoms or functions). In this systematic review, we reviewed the outcome measures used in 450 RCTs of adult unipolar and bipolar depression registered between 2018 and 2022 and identified 388 different measures. 40% of the RCTs used the same measure (Hamilton Depression Rating Scale [HAMD]). Patients and clinicians matched each item within the 25 most frequently used measures with 80 previously identified domains of depression that matter to patients. Seven (9%) domains were not covered by the 25 most frequently used outcome measures (eg, mental pain and irritability). The HAMD covered a maximum of 47 (59%) of the 80 domains that matter to patients. An interim solution to facilitate evidence synthesis before a core outcome set is developed would be to use the most common measures and choose complementary scales to optimise domain coverage. TRANSLATIONS: For the French and Dutch translations of the abstract see Supplementary Materials section.


Subject(s)
Outcome Assessment, Health Care , Randomized Controlled Trials as Topic , Humans , Psychiatric Status Rating Scales , Bipolar Disorder/therapy , Bipolar Disorder/psychology , Depressive Disorder/therapy
13.
Br J Dermatol ; 190(5): 712-717, 2024 Apr 17.
Article in English | MEDLINE | ID: mdl-38234050

ABSTRACT

BACKGROUND: Vitiligo is the most common cause of skin depigmentation worldwide. Patients with vitiligo may experience stigma and this needs to be addressed. OBJECTIVES: To evaluate stigma in patients with vitiligo, search for associated factors and establish severity strata for the Patient Unique Stigmatization Holistic tool in Dermatology (PUSH-D) for patients with vitiligo. METHODS: We conducted a cross-sectional study in ComPaRe Vitiligo, an e-cohort of adult patients with vitiligo. Stigmatization was assessed using the PUSH-D, a recently validated dermatology-specific stigmatization assessment tool. We conducted univariate and multivariable linear regression to identify patient and disease factors associated with the stigmatization. We used an anchor-based approach to define severity strata for the PUSH-D. RESULTS: In total, 318 patients participated (mean age 49.7 years; 73.9% women). Fitzpatrick skin phototype IV-VI, severe facial involvement (high Self-Assessment Vitiligo Extent Score of the face) and depression (high Patient Health Questionnaire-9 score) were positively -associated with a higher stigmatization score, although this association was weak [r = 0.24 (P < 0.001) and r = 0.30 (P < 0.001), respectively]. PUSH-D cutoff values that best discriminated patients with high and low stigma, as defined by the anchor question, were 13 and 23 (κ = 0.622, 95% confidence interval 0.53-0.71). CONCLUSIONS: Our study is the first to use a skin-specific stigmatization tool to assess stigma in patients with vitiligo. Creating strata helps to better interpret the PUSH-D in daily practice and may facilitate its use in clinical trials.


Vitiligo is an acquired autoimmune condition characterized by well-defined depigmented patches of skin on the body. The condition affects approximately 1% of the world's population and those living with vitiligo have long experienced stigmatization. Despite the fact that previous research has investigated the correlation between stigma and vitiligo using non-specific stigma tools, to our knowledge, no study has specifically assessed stigma in people with vitiligo. This study was carried out among French patients with vitiligo to evaluate both felt and actual stigma using the Patient Unique Stigmatization Holistic tool in Dermatology (PUSH-D), a new skin-specific stigma score. We also looked for correlations between PUSH-D scores and other questionnaires measuring levels of anxiety (GAD-7) and depression (PHQ-9). We found that PHQ-9 scores for depression were significantly positively correlated with PUSH-D scores, although these correlations were weak. When examining which factors were associated with higher stigma, we found that darker skin phototypes and severe facial involvement predicted higher stigma. However, we found that hand involvement did not. Overall, vitiligo is associated with a lot of stigma and it has been shown to be a barrier to employment. Therefore, an objective evaluation of vitiligo is required in order to facilitate access and reimbursement of treatment (including those existing and under development). The findings from this study highlight how further research is needed with more diverse groups of people, to better objectify stigma associated with vitiligo.


Subject(s)
Dermatology , Vitiligo , Adult , Humans , Female , Middle Aged , Male , Stereotyping , Cross-Sectional Studies , Quality of Life
14.
Gastrointest Endosc ; 99(3): 408-416.e2, 2024 Mar.
Article in English | MEDLINE | ID: mdl-37793506

ABSTRACT

BACKGROUND AND AIMS: We aimed to compare the long-term outcomes of patients with high-risk T1 colorectal cancer (CRC) resected endoscopically who received either additional surgery or surveillance. METHODS: We used data from routine care to emulate a target trial aimed at comparing 2 strategies after endoscopic resection of high-risk T1 CRC: surgery with lymph node dissection (treatment group) versus surveillance alone (control group). All patients from 14 tertiary centers who underwent an endoscopic resection for high-risk T1 CRC between March 2012 and August 2019 were included. The primary outcome was a composite outcome of cancer recurrence or death at 48 months. RESULTS: Of 197 patients included in the analysis, 107 were categorized in the treatment group and 90 were categorized in the control group. From baseline to 48 months, 4 of 107 patients (3.7%) died in the treatment group and 6 of 90 patients (6.7%) died in the control group. Four of 107 patients (3.7%) in the treatment group experienced a cancer recurrence and 4 of 90 patients (4.4%) in the control group experienced a cancer recurrence. After balancing the baseline covariates by inverse probability of treatment weighting, we found no significant difference in the rate of death and cancer recurrence between patients in the 2 groups (weighted hazard ratio, .95; 95% confidence interval, .52-1.75). CONCLUSIONS: Our study suggests that patients with high-risk T1 CRC initially treated with endoscopic resection may not benefit from additional surgery.


Subject(s)
Colorectal Neoplasms , Neoplasm Recurrence, Local , Humans , Retrospective Studies , Neoplasm Recurrence, Local/pathology , Colorectal Neoplasms/surgery , Colorectal Neoplasms/pathology , Endoscopy/methods , Lymph Node Excision , Risk Factors , Treatment Outcome
15.
Br J Dermatol ; 190(2): 216-225, 2024 Jan 23.
Article in English | MEDLINE | ID: mdl-37877514

ABSTRACT

BACKGROUND: Cutaneous neurofibromas (cNF) are considered one of the highest burdens of neurofibromatosis type 1 (NF1). To date, no medical treatment can cure cNF or prevent their development. In that context, there is an urgent need to prepare and standardize the methodology of future trials targeting cNF. OBJECTIVES: The objective was to develop a core outcome domain set suitable for all clinical trials targeting NF1-associated cNF. METHODS: The validated approach of this work consisted of a three-phase methodology: (i) generating the domains [systematic literature review (SLR) and qualitative studies]; (ii) agreeing (three-round international e-Delphi consensus process and working groups); and (iii) voting. RESULTS: (i) The SLR and the qualitative studies (three types of focus groups and a French e-survey with 234 participants) resulted in a preliminary list of 31 candidate items and their corresponding definitions. (ii) A total of 229 individuals from 29 countries participated in the first round of the e-Delphi process: 71 patients, relatives or representatives (31.0%), 130 healthcare professionals (HCPs, 56.8%) and 28 researchers, representatives of a drug regulatory authority, industry or pharmaceutical company representatives or journal editors (12.2%). The overall participation rate was 74%. After round 2, five candidate items were excluded. Between rounds 2 and 3, international workshops were held to better understand the disagreements among stakeholders. This phase led to the identification of 19 items as outcome subdomains. (iii) The items were fused to create four outcome domains ('clinical assessment', 'daily life impact', 'patient satisfaction' and 'perception of health') and prioritized. The seven items that did not reach consensus were marked for the research agenda. The final core outcome domain set reached 100% of the votes of the steering committee members. CONCLUSIONS: Although numerous outcomes can be explored in studies related to cNF in NF1, the present study offers four outcome domains that should be reported in all trial studies, agreed on by international patients, relatives and representatives of patients; HCPs; researchers, representatives of drug regulatory authorities or pharmaceutical companies and journal editors. The next step will include the development of a set of core outcome measurement instruments to further standardize how these outcomes should be assessed.


Subject(s)
Neurofibroma , Neurofibromatosis 1 , Skin Neoplasms , Humans , Delphi Technique , Research Design
17.
JAMA Intern Med ; 183(8): 858-869, 2023 08 01.
Article in English | MEDLINE | ID: mdl-37459057

ABSTRACT

Importance: Just-in-time interventions (JITIs) are a type of digital therapeutic intervention that combines remote monitoring tools and algorithms to personalize the delivery of specific interventions at the right time. The US Food and Drug Administration (FDA) regulatory approval documents are often the only available source of information on the effectiveness of therapeutic interventions based on these devices. Objective: To systematically review the publicly available information from the FDA on all recently approved medical devices used in JITIs to (1) assess how they operate to deliver JITIs and (2) appraise the evidence supporting their performance and clinical effectiveness. Evidence Review: Two reviewers systematically searched the Premarket Notifications (510(k)), Premarket Approvals, De Novo, and Humanitarian Device Exemption databases from January 2019 to December 2021 for all entries associated with devices that monitored patients' data over time to personalize the delivery of interventions to treat, prevent, or mitigate health conditions or events. They assessed whether the product summaries (1) enabled an understanding of how the device operated to deliver a JITI (eg, the nature, type, and frequency of the monitoring, the nature of the decision algorithm, and the nature and intended receiver of the intervention); (2) informed about the performance and effectiveness of the JITI; and (3) included information on data security and ownership. Findings: In total, 38 devices were included in this review. These were mainly intended for cardiac conditions (12 [31.6%]), diabetes (10 [26.3%]), and neurological diseases (4 [10.5%]). Monitoring devices ranged from wearable (18 of 28 [64.4%]; eg, smartwatches) to implanted sensors (6 of 28 [21.4%]; eg, inserted electrocardiographic sensors). Only 10 of 38 product summaries (26.3%) allowed a full understanding of how the device operated to deliver a JITI. Similarly, only 12 of 28 (42.9%), 12 of 36 (33.3%), and 5 of 38 (13.2%) reported the assessment of the performance of the monitoring device, assessment of the decision algorithm, and results of clinical studies assessing the effectiveness of the JITI, respectively. Finally, 14 of 36 product summaries (38.9%) included some information on data security, but none included information on data ownership. Conclusion and Relevance: The results of this systematic review suggest that the information publicly available in the FDA databases on the performance and effectiveness of digital medical devices used in JITIs is heterogeneous.


Subject(s)
Device Approval , Product Surveillance, Postmarketing , Humans , Compassionate Use Trials , Databases, Factual , United States , United States Food and Drug Administration
18.
J Clin Epidemiol ; 159: 235-245, 2023 07.
Article in English | MEDLINE | ID: mdl-37311514

ABSTRACT

OBJECTIVES: To develop a methodological framework to identify and prioritize personomic markers (e.g., psychosocial situation, beliefs…) to consider for personalizing interventions and to test in smoking cessation interventions. STUDY DESIGN AND SETTING: (1) We identified potential personomic markers considered in protocols of personalized interventions, in reviews of predictors of smoking cessation, and in interviews with general practitioners. (2) Physicians, and patient smokers or former smokers selected the markers they considered most relevant during online paired comparison experiments. Data were analyzed with Bradley Terry Luce models. RESULTS: Thirty-six personomic markers were identified from research evidence. They were evaluated by 795 physicians (median age: 34, IQR [30-38]; 95% general practitioners) and 793 patients (median age: 54, IQR [42-64], 71.4% former smokers) during 11,963 paired comparisons. Physicians identified patients' motivation for quitting (e.g., Prochaska stages), patients' preferences, and patients' fears and beliefs (e.g., concerns about weight gain) as the most relevant elements to personalize smoking cessation. Patients considered their motivation for quitting, smoking behavior (e.g., smoking at home/at work), and tobacco dependence (e.g., Fagerström Test) as the most relevant elements to consider. CONCLUSION: We provide a methodological framework to prioritize which personomic markers should be considered when developing smoking cessation interventions.


Subject(s)
Smoking Cessation , Tobacco Use Disorder , Humans , Adult , Middle Aged , Smoking Cessation/methods , Smoking , Tobacco Use Disorder/psychology , Delivery of Health Care , Motivation
19.
Int J Infect Dis ; 133: 67-74, 2023 Aug.
Article in English | MEDLINE | ID: mdl-37182548

ABSTRACT

OBJECTIVES: We aimed to identify trajectories of the evolution of post-COVID-19 condition, up to 2 years after symptom onset. METHODS: The ComPaRe long COVID e-cohort is a prospective cohort of patients with symptoms lasting at least 2 months after SARS-CoV2 infection. We used trajectory modeling to identify different trajectories in the evolution of post-COVID-19 condition, based on symptoms collected every 60 days using the long COVID Symptom Tool. RESULTS: A total of 2197 patients were enrolled in the cohort between December 2020 and July 2022 when the Omicron variant was not dominant. Three trajectories of the evolution of post-COVID-19 condition were identified: "high persistent symptoms" (4%), "rapidly decreasing symptoms" (5%), and "slowly decreasing symptoms" (91%). Participants with highly persistent symptoms were older and more likely to report a history of systemic diseases. They often reported tachycardia, bradycardia, palpitations, and arrhythmia. Participants with rapidly decreasing symptoms were younger and more likely to report a confirmed infection. They often reported diarrhea and back pain. Participants with slowly decreasing symptoms were more likely to have a history of functional diseases. CONCLUSION: Most patients with post-COVID-19 condition improve slowly over time, while 5% have rapid improvement in the 2 years after symptom onset and 4% have a persistent condition.


Subject(s)
COVID-19 , Humans , Post-Acute COVID-19 Syndrome , Prospective Studies , RNA, Viral , SARS-CoV-2
20.
J Invest Dermatol ; 143(11): 2226-2232.e1, 2023 Nov.
Article in English | MEDLINE | ID: mdl-37149083

ABSTRACT

Cutaneous neurofibromas (cNF) contribute to the impairment of QOL in individuals with neurofibromatosis 1. The cNF-Skindex, validated in a French population, specifically assesses the cNF-related QOL. In this study, we first defined severity strata using an anchoring approach on the basis of patient's burden. In total, 209 patients answered the anchor question and the cNF-Skindex. We tested the agreement among the three strata, generated by all potential couples of cut-off values of the cNF-Skindex and the three strata defined in the anchor question. The cut-off values 12 and 49 provided the highest Kappa value (κ = 0.685, 95% confidence interval = 0.604-0.765). Second, we validated the score and the strata in a United States population using the answers provided by 220 French and 148 United States adults. In the multivariable linear regression analysis, the country of origin was not a factor associated with the score (P = 0.297). The number of cNF along the different severity strata was similar between the French and the United States populations. In conclusion, stratification constitutes a powerful tool to better interpret the cNF-Skindex in daily practice and in clinical trials. This study validates its use in two populations that together constitute a large cohort of patients willing to participate in clinical research.

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