Risk factors for acne scarring in Ecuador.

BACKGROUND: Acne is a common disease that is associated with scarring and substantial psychosocial burden. The Global Burden of Skin Disease reported that the burden from acne as measured by disability-adjusted life years (DALYs) from 188 countries and specifically that it is greatest in Western Europe, high-income North America and Southern Latin America. This paper aimed to identify risk factors for acne scarring specific to the Ecuadorian population in order to adapt the 4-ASRAT tool accordingly. METHODS: This was an observational prospective study. Participants were recruited to complete a survey that was developed based on the potential risk factors for acne scarring and had facial photographs taken. To determine risk factors and their respective weighting, a logistic regression was performed. RESULTS: The study included 404 participants. Results from univariate analyses indicated that being male (OR = 2.76 95%CI [1.72; 4.43]), having severe or very severe acne scarring (OR = 4.28 95%CI [1.24; 14.79]), acne duration over 1 year (OR = 1.71 95%CI [1.12; 2.60]), oily skin (OR = 2.02 95%CI [1.27; 3.22]) and the presence of acne on the neck (OR = 2.26 95%CI [1.30; 3.92]), were all significantly associated with the presence of acne scarring. Male sex (2.56 95%CI [1.58;4.17]), oily skin (1.96 95%CI [1.20;3.20]) and severe or very severe acne (3.75 95%CI [1.05;13.37]) remained significant risk factors for acne scarring in the multivariate analysis. CONCLUSION: By identifying acne scarring risk factors and applying the tool in everyday dermatology visits, we can reduce the physical and psychological burden that acne scarring causes in the adolescent and adult populations. Further research should be conducted to reassess potential risk factors and complete the adaptation of the tool for the Ecuadorian population, with a larger and more representative study population.

Serotonin and norepinephrine reuptake inhibitors antidepressant use is related to lower baroreflex sensitivity independently of the severity of depressive symptoms. A community-study of 9213 participants from the Paris Prospective Study III.

BACKGROUND AND AIMS: We assess the respective relationship of high depressive symptoms and antidepressant use (ATD) with baroreflex sensitivity (BRS) in subjects from the community who enrolled the Paris Prospective Study III. METHODS: Recruitment took place in a large health preventive centre in Paris (France), between May 2008 and June 2012. BRS was investigated by spectral analysis of the spontaneous carotid distension rate and RR intervals using non-invasive high-resolution ultrasound carotid-echotracking. A total score ≥7 on a 13-item standardized questionnaire defined the presence of high depressive symptoms. Information on ATD use was obtained on a face-to-face interview with a medical doctor who checked the most recent medical prescriptions and/or medical package. RESULTS: There were 9213 participants aged 50-75 years (38.6% of women), including 5.6% with high-depressive symptoms and 5.2% on ATD. High depressive symptoms were not associated with low BRS (below the median) even in unadjusted logistic regression analysis (OR = 1.09; 95%CI: 0.91-1.30). Instead, ATD use was related to low BRS in multivariate logistic regression analysis (OR = 1.27; 95% CI: 1.04-1.54). This association remains after adjusting for and matching on propensity score of receiving ATD. A specific association with serotonin and norepinephrine reuptake inhibitors was observed (OR = 1.94; 95% CI: 1.16-3.22). CONCLUSIONS: ATD use and serotonin and norepinephrine reuptake inhibitors in particular, but not high depressive symptoms, is associated with low BRS. If confirmed, these results may bring novel insights into the mechanisms linking depressive symptoms and/or ATD use with cardiovascular disease onset.

Comparison of central adjudication of outcomes and onsite outcome assessment on treatment effect estimates.

BACKGROUND: Assessment of events by adjudication committees (ACs) is recommended in multicentre randomised controlled trials (RCTs). However, its usefulness has been questioned. OBJECTIVES: The aim of this systematic review was to compare 1) treatment effect estimates of subjective clinical events assessed by onsite assessors versus by AC, and 2) treatment effect estimates according to the blinding status of the onsite assessor as well as the process used to select events to adjudicate. SEARCH METHODS: We searched Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, EMBASE, PsycINFO, CINAHL and Google Scholar (25 August 2015 as the last updated search date), using a combination of terms to retrieve RCTs with commonly used terms to describe ACs. SELECTION CRITERIA: We included all reports of RCTs and the published RCTs included in reviews and meta-analyses that reported the same subjective outcome event assessed by both an onsite assessor and an AC. DATA COLLECTION AND ANALYSIS: We extracted the odds ratio (OR) from onsite assessment and the corresponding OR from AC assessment and calculated the ratio of the odds ratios (ROR). A ratio of odds ratios < 1 indicated that onsite assessors generated larger effect estimates in favour of the experimental treatment than ACs. MAIN RESULTS: Data from 47 RCTs (275,078 patients) were used in the meta-analysis. We excluded 11 RCTs because of incomplete outcome data to calculate the OR for onsite and AC assessments. On average, there was no difference in treatment effect estimates from onsite assessors and AC (combined ROR: 1.00, 95% confidence interval (CI) 0.97 to 1.04; I(2) = 0%, 47 RCTs). The combined ROR was 1.00 (95% CI 0.96 to 1.04; I(2) = 0%, 35 RCTs) when onsite assessors were blinded; 0.76 (95% CI 0.48 to 1.12, I(2) = 0%, two RCTs) when AC assessed events identified independently from unblinded onsite assessors; and 1.11 (95% CI 0.96 to 1.27, I(2) = 0%, 10 RCTs) when AC assessed events identified by unblinded onsite assessors. However, there was a statistically significant interaction between these subgroups (P = 0.03) AUTHORS' CONCLUSIONS: On average, treatment effect estimates for subjective outcome events assessed by onsite assessors did not differ from those assessed by ACs. Results of subgroup analysis showed an interaction according to the blinded status of onsite assessors and the process used to submit data to AC. These results suggest that the use of ACs might be most important when onsite assessors are not blinded and the risk of misclassification is high. Furthermore, research is needed to explore the impact of the different procedures used to select events to adjudicate.

Potential workload in applying clinical practice guidelines for patients with chronic conditions and multimorbidity: a systematic analysis.

OBJECTIVES: To describe the potential workload for patients with multimorbidity when applying existing clinical practice guidelines. DESIGN: Systematic analysis of clinical practice guidelines for chronic conditions and simulation modelling approach. DATA SOURCES: National Guideline Clearinghouse index of US clinical practice guidelines. STUDY SELECTION: We identified the most recent guidelines for adults with 1 of 6 prevalent chronic conditions in primary care (ie hypertension, diabetes, coronary heart disease (CHD), chronic obstructive pulmonary disease (COPD), osteoarthritis and depression). DATA EXTRACTION: From the guidelines, we extracted all recommended health-related activities (HRAs) such as drug management, self-monitoring, visits to the doctor, laboratory tests and changes of lifestyle for a patient aged 45-64 years with moderate severity of conditions. SIMULATION MODELLING APPROACH: For each HRA identified, we performed a literature review to determine the potential workload in terms of time spent on this HRA. Then, we used a simulation modelling approach to estimate the potential workload needed to comply with these recommended HRAs for patients with several of these chronic conditions. RESULTS: Depending on the concomitant chronic condition, patients with 3 chronic conditions complying with all the guidelines would have to take a minimum of 6 to a maximum of 13 medications per day, visit a health caregiver a minimum of 1.2 to a maximum of 5.9 times per month and spend a mean (SD) of 49.6 (27.3) to 71.0 (34.5) h/month in HRAs. The potential workload increased greatly with increasing number of concomitant conditions, rising to 18 medications per day, 6.6 visits per month and 80.7 (35.8) h/month in HRAs for patients with 6 chronic conditions.

Impact of an online writing aid tool for writing a randomized trial report: the COBWEB (Consort-based WEB tool) randomized controlled trial.

BACKGROUND: Incomplete reporting is a frequent waste in research. Our aim was to evaluate the impact of a writing aid tool (WAT) based on the CONSORT statement and its extension for non-pharmacologic treatments on the completeness of reporting of randomized controlled trials (RCTs). METHODS: We performed a 'split-manuscript' RCT with blinded outcome assessment. Participants were masters and doctoral students in public health. They were asked to write, over a 4-hour period, the methods section of a manuscript based on a real RCT protocol, with a different protocol provided to each participant. Methods sections were divided into six different domains: 'trial design', 'randomization', 'blinding', 'participants', 'interventions', and 'outcomes'. Participants had to draft all six domains with access to the WAT for a random three of six domains. The random sequence was computer-generated and concealed. For each domain, the WAT comprised reminders of the corresponding CONSORT item(s), bullet points detailing all the key elements to be reported, and examples of good reporting. The control intervention consisted of no reminders. The primary outcome was the mean global score for completeness of reporting (scale 0-10) for all domains written with or without the WAT. RESULTS: Forty-one participants wrote 41 different manuscripts of RCT methods sections, corresponding to 246 domains (six for each of the 41 protocols). All domains were analyzed. For the primary outcome, the mean (SD) global score for completeness of reporting was higher with than without use of the WAT: 7.1 (1.2) versus 5.0 (1.6), with a mean (95 % CI) difference 2.1 (1.5-2.7; P <0.01). Completeness of reporting was significantly higher with the WAT for all domains except for blinding and outcomes. CONCLUSION: Use of the WAT could improve the completeness of manuscripts reporting the results of RCTs. TRIAL REGISTRATION: Clinicaltrials.gov ( http://clinicaltrials.gov NCT02127567 , registration date first received April 29, 2014).

The most important tasks for peer reviewers evaluating a randomized controlled trial are not congruent with the tasks most often requested by journal editors.

BACKGROUND: The peer review process is a cornerstone of biomedical research publications. However, it may fail to allow the publication of high-quality articles. We aimed to identify and sort, according to their importance, all tasks that are expected from peer reviewers when evaluating a manuscript reporting the results of a randomized controlled trial (RCT) and to determine which of these tasks are clearly requested by editors in their recommendations to peer reviewers. METHODS: We identified the tasks expected of peer reviewers from 1) a systematic review of the published literature and 2) recommendations to peer reviewers for 171 journals (i.e., 10 journals with the highest impact factor for 14 different medical areas and all journals indexed in PubMed that published more than 15 RCTs over 3 months regardless of the medical area). Participants who had peer-reviewed at least one report of an RCT had to classify the importance of each task relative to other tasks using a Q-sort technique. Finally, we evaluated editors' recommendations to authors to determine which tasks were clearly requested by editors in their recommendations to peer reviewers. RESULTS: The Q-sort survey was completed by 203 participants, 93 (46 %) with clinical expertise, 72 (36 %) with methodological/statistical expertise, 17 (8 %) with expertise in both areas, and 21 (10 %) with other expertise. The task rated most important by participants (evaluating the risk of bias) was clearly requested by only 5 % of editors. In contrast, the task most frequently requested by editors (provide recommendations for publication), was rated in the first tertile only by 21 % of all participants. CONCLUSIONS: The most important tasks for peer reviewers were not congruent with the tasks most often requested by journal editors in their guidelines to reviewers.

Taxonomy of the burden of treatment: a multi-country web-based qualitative study of patients with chronic conditions.

BACKGROUND: Management strategies for patients with chronic conditions are becoming increasingly complex, which may result in a burden of treatment for patients. To develop a Minimally Disruptive Medicine designed to reduce the burden of treatment, clinicians need to understand which healthcare tasks and aggravating factors may be responsible for this burden. The objective of the present study was to describe and classify the components of the burden of treatment for patients with chronic conditions from the patient's perspective. METHODS: We performed a multi-country qualitative study using an online survey and a purposive sampling strategy to select English-, French-, and Spanish-speaking participants with different chronic conditions. Participants were recruited by physicians, patients' associations, advertisement on social media, and 'snowballing'. The answers were analyzed by i) manual content analysis with a grounded theory approach, coded by two researchers, and ii) automatic textual analysis by Reinert's method. RESULTS: Between 2013 and 2014, 1,053 participants from 34 different countries completed the online survey using 408,625 words. Results from both analyses were synthesized in a taxonomy of the burden of treatment, which described i) the tasks imposed on patients by their diseases and by their healthcare system (e.g., medication management, lifestyle changes, follow-up, etc.); ii) the structural (e.g., access to healthcare resources, coordination between care providers), personal, situational, and financial factors that aggravated the burden of treatment; and iii) patient-reported consequences of the burden (e.g., poor adherence to treatments, financial burden, impact on professional, family, and social life, etc.). Our findings may not be applicable to patients with chronic conditions who differ from those who responded to our survey. CONCLUSIONS: Our taxonomy of the burden of treatment, provided by patients with chronic conditions from different countries and settings, supports the development of tools to ascertain the burden of treatment and highlights potential targets for interventions to minimize it.

Adaptation and validation of the Treatment Burden Questionnaire (TBQ) in English using an internet platform.

BACKGROUND: Treatment burden refers to the workload imposed by healthcare on patients, and the effect this has on quality of life. The Treatment Burden Questionnaire (TBQ) aims to assess treatment burden in different condition and treatment contexts. Here, we aimed to evaluate the validity and reliability of an English version of the TBQ, a scale that was originally developed in French. METHODS: The TBQ was translated into English by a forward-backward translation method. Wording and possible missing items were assessed during a pretest involving 200 patients with chronic conditions. Measurement properties of the instrument were assessed online with a patient network, using the PatientsLikeMe website. Dimensional structure of the questionnaire was assessed by factor analysis. Construct validity was assessed by associating TBQ global score with clinical variables, adherence to medication assessed by Morisky's Medication Adherence Scale (MMAS-8), quality of life (QOL) assessed by the PatientsLikeMe Quality of Life Scale (PLMQOL), and patients' confidence in their knowledge of their conditions and treatments. Reliability was determined by a test-retest method. RESULTS: In total, 610 patients with chronic conditions, mainly from the USA, UK, Canada, Australia, or New Zealand, completed the TBQ between September and October 2013. The English TBQ showed a unidimensional structure with Cronbach α of 0.90. The TBQ global score was negatively correlated with the PLMQOL score (rs = -0.50; p < 0.0001). Low rather than moderate or high adherence to medication was associated with high TBQ score (mean [SD] TBQ score 61.8 [30.5] vs. 37.7 [27.5]; P < 0.0001). The treatment burden was higher for patients who had insufficient knowledge compared with those who had sufficient knowledge about their treatments (mean ± SD TBQ score 62.3 ± 31.3 vs. 47.8 ± 30.4; P < 0.0001) and conditions (63.0 ± 31.6 vs. 49.3 ± 30.7; P < 0.0001). The intraclass correlation coefficient for the retest (n = 282) was 0.77 (95% CI 0.70 to 0.82). CONCLUSIONS: We found that the English TBQ is a reliable instrument in this population, and provide evidence supporting the construct validity for its use to assess treatment burden for patients with one or more chronic conditions in English-speaking countries.

Nurse-initiated, titrated intravenous opioid analgesia reduces time to analgesia for selected painful conditions.

OBJECTIVES: Traditionally, patients have to wait until assessed by a physician for opioid analgesia to be administered, which contributes to delays to analgesia. Western Hospital developed a protocol enabling nurses to initiate opioid analgesia prior to medical assessment for selected conditions. The aim of this study was to determine the impact of this protocol on time to first opioid dose in patients presenting to the emergency department (ED) with renal or biliary colic. METHODS: This was an explicit medical record review of all adult patients with an ED discharge diagnosis of renal or biliary colic presenting to a metropolitan teaching hospital ED. Patients were identified via the ED data management system. Data collected included demographics, condition, triage category, time of presentation, whether analgesia was nurse-initiated or not, and interval from arrival to first opioid analgesic dose. The narcotic drug register for the relevant period was also searched to cross-check whether opiates were doctor- or nurse-initiated. RESULTS: There were 58 presentations in the nurse-initiated opioid analgesia group and 99 in the non-nurse-initiated analgesia group. Groups were reasonably well matched for gender, triage category and time of presentation, but there was a higher proportion of biliary colic in the non-nurse-initiated analgesia group. Median time to first analgesic dose was 31 minutes in the nurse-initiated group and 57 minutes in the non-nurse-initiated analgesia group (effect size, 26 minutes; 95% confidence interval 16-36 min; p < 0.0001]. There were no major adverse events in either group. CONCLUSION: A nurse-initiated opioid analgesia protocol reduces delays to opioid analgesia for patients with renal and biliary colic.