Pragmatic Prospective Study Research Articles

Immunonutrition with Omega-3 Fatty Acid Supplementation in Severe TBI: Retrospective Analysis of Patient Characteristics and Outcomes.

Early evidence-based medical interventions to improve patient outcomes after traumatic brain injury (TBI) are lacking. In patients admitted to the ICU after TBI, optimization of nutrition is an emerging field of interest. Specialized enteral nutrition (EN) formulas that include immunonutrition containing omega-3 polyunsaturated fatty acids (n-3 PUFAs) have been developed and are used for their proposed anti-inflammatory and proimmune properties; however, their use has not been rigorously studied in human TBI populations. A single-center, retrospective, descriptive observational study was conducted at the LAC + USC Medical Center. Patients with severe TBI (sTBI, Glasgow Coma Scale score ≤ 8) who remained in the ICU for ≥2 weeks and received EN were identified between 2017 and 2022 using the institutional trauma registry. Those who received immunonutrition formulas containing n-3 PUFAs were compared with those who received standard, polymeric EN with regard to baseline characteristics, clinical markers of inflammation and immune function, and short-term clinical outcomes. A total of 151 patients with sTBI were analyzed. Those who received immunonutrition with n-3 PUFA supplementation were more likely to be male, younger, Hispanic/Latinx, and have polytrauma needing non-central nervous system surgery. No differences in clinical markers of inflammation or infection rate were found. In multivariate regression analysis, immunonutrition was associated with reduced hospital length of stay (LOS). ICU LOS was also reduced in the subgroup of patients with polytrauma and TBI. This study identifies important differences in patient characteristics and outcomes associated with the EN formula prescribed. Study results can directly inform a prospective pragmatic study of immunonutrition with n-3 PUFA supplementation aimed to confirm the biomechanistic and clinical benefits of the intervention.

A179 UNDERSTANDING THE NEED FOR A ZINC DIET TO TREAT ZINC DEFICIENCY IN PATIENTS WITH CELIAC DISEASE

Abstract Background Nutritional deficiencies in celiac disease (CeD) are caused by delayed intestinal healing and a nutrient-lacking gluten-free diet (GFD). At our specialized adult celiac clinic, zinc (Zn) was the most common deficiency present in patients and is clinically treated through Zn supplementation. However, Zn supplements in excess may cause inhibition of other minerals, and gastrointestinal side effects. Alternatively, a Zn diet may be a sustainable option to treat zinc deficiency, however patient preference regarding this treatment method is unknown. Aims To understand patient preference of zinc supplementation compared to a zinc diet to treat Zn deficiency in CeD. We also aim to determine the tolerability and effectiveness of Zn supplements to reduce gastrointestinal and extraintestinal symptoms in the CeD population. Methods This observational prospective pragmatic study was conducted from March 2022-September 2023. Eligible participants had bloodwork indicating plasma Zn levels ampersand:003C 9.4 μ/mol . All participants were prescribed 25 mg per day of Zn gluconate supplements throughout the study. Patients were provided a RedCap link where they completed questionnaires at Visit 1 and at their next clinic appointment in 3-6 months (Visit 2). These surveys included; Celiac Symptom Index (CSI) Questionnaire 2) Extraintestinal Symptoms Visual Analogue Scale (ES-VAS) and 3) Patient Perception Survey (PPS). Continuous data are expressed as Mean (SD), and categorical data is reported as frequencies (%). The Wilcoxon test was used to assess changes in symptoms. Results A total of 42 participants completed the Visit 1 survey, of which 17 participants had their follow up clinic appointment (Visit 2). Out of these 17 participants, 15 were female (88.2%) and the mean age was 33.7 years (+/- 10.6). The mean CSI score at Visit 1 was 35.3 (+/- 10.3) and 33.7 (+/- 13.0) at Visit 2, indicating moderate disease symptoms (p=0.552). The most common extraintestinal symptoms was anxiety (ES-VAS: 5.7), foggy mind (ES-VAS: 4.1), fatigue (ES-VAS: 4.1) and depression (ES-VAS: 3.5). There were no significant changes in extraintestinal symptoms between clinic visits. Out of 42 participants, 15 (35.7%) prefer to treat their Zn deficiency through diet, 26 (59.5%) through supplement, and 1 (2.4%) of participants had no preference. Additionally, 35 (85.4%) participants indicated that they were “likely” to comply to a Zn-diet treatment. Conclusions CeD patients did not experience improvement in gastrointestinal or extraintestinal symptoms on Zn supplementation. However, a portion of CeD patients prefer to treat and are likely to comply with a Zn diet to treat their deficiency. Based on this knowledge, further studies should investigate the efficacy of a Zn diet compared to supplements CeD patients. Funding Agencies CIHR

Identifying the Characteristics of Responders and Nonresponders in a Behavioral Intervention to Increase Physical Activity Among Patients With Moderate to Severe Asthma: Protocol for a Prospective Pragmatic Study.

Previous research has suggested that most adults improve their asthma control after a short-term behavioral intervention program to increase physical activity in daily life (PADL). However, the characteristics of individuals who respond and do not respond to this intervention and the medium-term response remain unknown. This study aims to (1) identify the characteristics of adult responders and nonresponders with asthma to a behavioral intervention to increase physical activity and (2) evaluate the functional and clinical benefits in the medium term. This prospective pragmatic study will include adults with moderate to severe asthma who enroll in a behavioral intervention. All individuals will receive an educational program and an 8-week intervention to increase PADL (1 time/wk; up to 90 min/session). The educational program will be conducted in a class setting through group discussions and video presentations. Behavioral interventions will be based on the transtheoretical model using counseling, incentives, and individual feedback aiming to increase participation in physical activity. Motivational interviewing and guidelines for overcoming barriers will be used to stimulate individuals to reach their goals. Pre- and postintervention assessments will include the following: PADL (triaxial accelerometry), body composition (octopolar bioimpedance), barriers to PADL (questionnaire), clinical asthma control (Asthma Control Questionnaire), quality of life (Asthma Quality of Life Questionnaire), anxiety and depression levels (Hospital Anxiety and Depression Scale), and exacerbations. "Responders" to the intervention will be defined as those who demonstrate an increase in the number of daily steps (≥2500). In December 2021, the clinical trial registration was approved. Recruitment and data collection for the trial is ongoing, and the results of this study are likely to be published in late 2024. The intervention will likely promote different effects according to the clinical characteristics of the individuals, including asthma control, age, anxiety and depression levels, obesity, and several comorbidities. Identifying individuals who respond or do not respond to behavioral interventions to increase PADL will help clinicians prescribe specific interventions to adults with asthma. ClinicalTrials.gov NCT05159076; https://clinicaltrials.gov/ct2/show/NCT05159076. DERR1-10.2196/49032.

Impact of Electronic Chronic Pain Questions on patient-reported outcomes and healthcare utilization, and attitudes toward eCPQ use among patients and physicians: prospective pragmatic study in a US general practice setting.

The Electronic Chronic Pain Questions (eCPQ) has been developed to help healthcare providers systematically capture chronic pain data. This study evaluated the impact of using the eCPQ on patient-reported outcomes (PROs) and healthcare resource utilization (HCRU) in a primary care setting, and patient and physician perceptions regarding use of, and satisfaction with, the eCPQ. This was a prospective pragmatic study conducted at the Internal Medicine clinic within the Henry Ford Health (HFH) Detroit campus between June 2017 and April 2020. Patients (aged ≥18 years) attending the clinic for chronic pain were allocated to an Intervention Group to complete the eCPQ in addition to regular care, or a control group to receive regular care only. The Patient Health Questionnaire-2 and a Patient Global Assessment were assessed at baseline, 6-months, and 12-months study visits. HCRU data were extracted from the HFH database. Telephone qualitative interviews were conducted with randomly selected patients and physicians who used the eCPQ. Two hundred patients were enrolled, 79 in each treatment group completed all 3 study visits. No significant differences (p > 0.05) were found in PROs and HCRU between the 2 groups. In qualitative interviews, physicians and patients reported the eCPQ as useful, and using the eCPQ improved patient-clinician interactions. Adding the eCPQ to regular care for patients with chronic pain did not significantly impact the PROs assessed in this study. However, qualitative interviews suggested that the eCPQ was a well-accepted and potentially useful tool from a patient and physician perspective. By using the eCPQ, patients were better prepared when they attended a primary care visit for their chronic pain and the quality of patient-physician communication was increased.

Evaluation of Five Host Inflammatory Biomarkers in Early Diagnosis of Ventilator-Associated Pneumonia in Critically Ill Children: A Prospective Single Center Cohort Study.

Background: Early diagnosis of ventilator-associated pneumonia (VAP) remains a challenge due to subjective clinical criteria and the low discriminative power of diagnostic tests. We assessed whether rapid molecular diagnostics in combination with Clinically Pulmonary Index Score (CPIS) scoring, microbiological surveillance and biomarker measurements of PTX-3, SP-D, s-TREM, PTX-3, IL-1β and IL-8 in the blood or lung could improve the accuracy of VAP diagnosis and follow-up in critically ill children. Methods: A prospective pragmatic study in a Pediatric Intensive Care Unit (PICU) was conducted on ventilated critically ill children divided into two groups: high and low suspicion of VAP according to modified Clinically Pulmonary Index Score (mCPIS). Blood and bronchial samples were collected on days 1, 3, 6 and 12 after event onset. Rapid diagnostics were used for pathogen identification and ELISA for PTX-3, SP-D, s-TREM, IL-1β and IL-8 measurements. Results: Among 20 enrolled patients, 12 had a high suspicion (mCPIS > 6), and 8 had a low suspicion of VAP (mCPIS < 6); 65% were male; and 35% had chronic disease. IL-1β levels at day 1 correlated significantly with the number of mechanical ventilation days (rs = 0.67, p < 0.001) and the PICU stay (r = 0.66; p < 0.002). No significant differences were found in the levels of the other biomarkers between the two groups. Mortality was recorded in two patients with high VAP suspicion. Conclusions: PTX-3, SP-D, s-TREM, IL-1β and IL-8 biomarkers could not discriminate patients with a high or low suspicion of VAP diagnosis.

Exploring a multi-disciplinary model of supportive cancer care for monoclonal antibody treatment-related dermatological symptoms.

The present study examined the perspectives of healthcare providers (HCPs) in designing a multi-disciplinary model of supportive cancer care for the relief of dermatology-related symptoms caused by monoclonal antibody therapies. The study employed a mixed research methodology, with qualitative research embedded within a pragmatic prospective study of a registry protocol study. Patients undergoing oncology therapy with MoAB, anti-HER2, and anti-PD-L1 monoclonal antibodies were identified among a cohort of patients referred to an integrative oncology (IO) consultation for symptom relief and improved quality of life (QoL). Case studies with significant dermatology-related concerns were selected and presented to a panel of 6 HCPs trained in medical oncology, oncology nursing, family medicine, supportive cancer care, and IO. HCP narratives were qualitatively analyzed and assessed using ATLAS.Ti software for systematic coding. Of the 924 patients referred to the IO consultation, 208 were treated with monoclonal antibodies, from which 50 were selected for further evaluation. Of these, 7 cases were presented to the HCP team who were asked to identify treatment gaps requiring a multi-disciplinary approach. Qualitative analysis identified 3 major themes: a biophysical perspective; a psycho-social-spiritual perspective; and the implementation of integrated care. There is a need for a multi-disciplinary approach when treating patients suffering from monoclonal antibody treatment-related skin toxicities. HCP-reported themes highlight the need to identify patients for whom such an approach is warranted; conditions in which a psycho-social-spiritual perspective should be considered, in addition to a bio-physical approach; and considerations of who should be designated as the patient's primary case manager.

The MODIFY Study Protocol: An Open-Label, Single-Arm, Multicenter, Prospective Pragmatic Study of Ixazomib-Based Triple-Drug Therapy in Chinese Patients with Multiple Myeloma.

Although the bortezomib-based triple-drug therapy is considered as a front-line therapy for multiple myeloma (MM) in Chinese patients, increased level of toxicity leads to treatment dissatisfaction. Treatment with ixazomib, an oral proteasome inhibitor, has demonstrated better efficacy and safety profile without increasing the toxicity. In this study, we investigate the safety and clinical outcomes of Chinese patients with newly diagnosed MM (NDMM) who transitioned from a bortezomib-based triple-drug therapy to an ixazomib-based triple-drug therapy in a real-world clinical setting. This will be an open-label, single-arm, multicenter, prospective, observational study will recruit Chinese patients (aged ≥ 18years) diagnosed with NDMM using International Myeloma Working Group (IMWG) criteria and who have received a bortezomib-based triple-drug therapy for more than two cycles as initial therapy. The previous bortezomib-based triple-drug therapy may include bortezomib, cyclophosphamide, and dexamethasone or lenalidomide, bortezomib, and dexamethasone or bortezomib, doxorubicin, and dexamethasone or bortezomib, thalidomide, and dexamethasone. At the time of enrollment, patients must have achieved at least partial response as defined by IMWG criteria. Approximately 320 eligible patients at 15 top MM hospitals in China will be treated with ixazomib triple-drug therapy and followed up once every 3months for 24months, unless specified. The primary endpoint is to assess progression-free survival at 2years for Chinese patients with NDMM who have transitioned from a bortezomib-based triple-drug therapy to ixazomib-based triple-drug therapy. The clinical effectiveness, safety and tolerability, patient-reported outcomes, and health economic/resource utilization will be evaluated as secondary endpoints. The results from this study may provide evidence to verify the benefits of transitioning from bortezomib-based triple-drug therapy to ixazomib-based triple-drug therapy in Chinese patients with NDMM in a real-world clinical setting. The study has been registered at clinicalTrials.gov (NCT05013190).

Abstract 10856: Artificial Intelligence-Guided Screening for Atrial Fibrillation Using the Electrocardiogram in Sinus Rhythm

Introduction: Prior AF screening trials demonstrated low yield, highlighting the need for more targeted approaches. An AI algorithm was developed to identify ECG signatures of AF risk during normal sinus rhythm, which has been validated in diverse external populations. Hypothesis: An AI-guided, targeted screening approach could improve the diagnosis of AF. Methods We conducted a pragmatic decentralized trial to prospectively recruit patients with stroke risk factors but no prior AF. The AI algorithm was applied to the ECGs performed in routine practice and divided patients into high- or low-risk groups. The primary endpoint was AF lasting ≥ 30 seconds on a subsequent 30-day continuous cardiac rhythm monitor. In a secondary analysis, trial participants were 1:1 propensity score-matched to real-world controls derived from the eligible but unenrolled population. Results A total of 1,003 patients from 40 U.S. states completed the study, with a mean age of 74 [SD 8.8] years. Over a mean of 22.3 days of continuous monitoring, AF was detected in 6 (1.6%) of low-risk patients and 48 (7.6%) of high-risk patients (OR 4.98 [2.11-11.75], p&lt;0.001). Compared to usual care, AI-guided AF screening was associated with increased detection of AF (high-risk group: 4.2% vs. 11.1%, p&lt;0.001; low-risk group: 0.9% vs. 2.4%, p=0.12) over a median follow-up of 10 months. Conclusions A prospective pragmatic study found that the AI a can risk-stratify a relatively uniform population (i.e., older adults at risk for stroke) to detect AF during short-term cardiac monitoring. Furthermore, when compared with usual care, AI-guided cardiac monitoring was associated with increased AF detection. As such, an AI-guided AF screening approach, leveraging existing EHR data and infrastructure, could be effective, patient-centered, and massively scalable, thereby reducing unnecessary health utilization and diagnosis-related anxiety (Clinicaltrials.gov: NCT04208971).

Patient reported outcomes in women with type I and type II uterine cancer: a pragmatic prospective study

Objectives: The objective of this pragmatic study was to describe patient reported outcomes (PROs) in a routine clinic population with Type I and Type II uterine cancers over the course of their disease management. Methods: PROs were collected prospectively at a tertiary care gynecologic oncology center beginning in 2018 using validated tools (PROMIS, EORTC EN-24, and EORTC QLQ-C30). Responses were compared using Chi-square, independent T-tests, and binary logistic regressions (controlling for Type I vs. II cancer, insurance, stage, age, time since diagnosis, recurrence, and race). Download : Download high-res image (124KB) Download : Download full-size image Results: There were 247 women with uterine cancer included, 216 of whom responded to the PROs (87.4% response rate). Responders were not significantly different from non-responders apart from being slightly younger (mean age 64.9 vs. 68.9; p=0.049). Baseline characteristics differed for women with Type II uterine cancer compared to Type I in expected ways (higher stage, older age, higher recurrence rate, higher rates of adjuvant therapy). Women with Type II cancers were significantly burdened by their disease, reporting higher rates of social (22.4% vs. 8.2%; p=0.002) and family life (12.1% vs. 3.2%; p=0.008) interference and higher rates of adverse outcomes on the QLQ-C30 instrument (Figure). On adjusted analyses, women with Type II uterine cancer reported higher rates of suffering, specifically citing trouble taking short walks outside the house (aOR 27.43, 95% CI 3.16-237.90; p=0.003), feeling limited in their work/daily activities (aOR 4.04, 95% CI 1.48-11.02; p=0.006), being limited in pursuing their hobbies (aOR 3.79, 95% CI 1.31-10.99; p=0.014), and feeling irritable (aOR 4.37, 95% CI 1.11-17.30; p=0.036) after controlling for recurrence, stage, and other confounders. Publicly insured women were less likely to have someone to help if they were bedbound (aOR 2.48, 95% CI 1.05-5.85; p=0.038) and reported overall poorer quality of life (aOR 8.74, 95% CI 2.81-27.18; p Conclusions: Uterine cancer patients with Type II cancers and public insurance suffer more during their treatment and survivorship. These data are important because by understanding what types of adverse outcomes different women experience, gynecologic oncologists can more effectively alleviate suffering for the patients they care for.

Online Acceptance and Commitment Therapy and Nutrition Workshop for Parents of Children with Inflammatory Bowel Disease: Feasibility, Acceptability, and Initial Effectiveness.

Parents of children with inflammatory bowel disease (IBD) are important members of their healthcare team and influence their child’s adaptation to disease. The primary aim of this research was to test the feasibility and acceptability of a three-session online parent workshop based on acceptance and commitment therapy (ACT) and address concerns about eating well and nutrition in IBD. The secondary aim was to explore the initial effectiveness of this workshop in parent reported psychological flexibility, mindfulness, experiential avoidance, cognitive fusion, valued living, and symptoms of depression, anxiety, and stress. We used a single arm pragmatic prospective study design with parents of children attending the IBD program at a tertiary pediatric healthcare centre in Canada. Mixed methods patient reported outcomes were measured at baseline, immediate post participation, and 3 months post participation in the workshop. Thirty-seven parents enrolled in the study and feasibility and acceptability goals were largely met. Parents qualitatively described changes to their parenting, what aspects of the workshop were most helpful, and targeted feedback on how to improve workshop. Findings suggest that providing parents of children with IBD a brief online ACT workshop including nutrition guidance is feasible and leads to changes in parenting behaviours.

High intensity focused ultrasound for glaucoma: 1-year results from a prospective pragmatic study.

Ciclo plasty usinghigh-intensity focused ultrasound (HIFU) technology acts through the selective coagulation of the ciliary body. Our aim was to evaluate the safety and efficacy profiles of 8-s probe HIFU cyclocoagulation using the EyeOP1 device. Prospective pragmatic trial. adult glaucoma patients with uncontrolled IOP despite optimised medical therapy, and/or intolerant to medical therapy required to achieve target IOP. surgical success defined as IOP reduction from baseline >20% with final IOP ≤21 mmHg, without adding any IOP-lowering drugs, and without loss of light perception; or decreased use of IOP-lowering drugs with stable/decreased IOP, without loss of light perception. mean IOP, intra and postoperative complications, best-corrected visual acuity (BCVA) and number of IOP-lowering drugs at each visit. Outcome data were collected preoperatively and at postoperative day 1, and months 1, 3, 6 and 12. Forty-nine eyes of forty-nine patients (28 male) with a mean age of 70 ± 14 years were enroled. Pre-operative IOP was 26.9 ± 7.4 mmHg under 2.8 ± 0.9 topical medications, decreasing to 17.8 ± 6.4 mmHg under 2.3 ± 1 drugs at 12 months (p < 0.01). One-year surgical success was achieved in 71.4% of patients (IOP-reduction criteria: 59.2%; decreased use of IOP-lowering drugs: 38.8%). Eight patients were ultimately submitted to other glaucoma surgical interventions. Five patients experienced serious adverse events (loss of light perception n = 5; hypotony n = 1). This innovative non-invasive technology seems to be effective in decreasing IOP and/or the number of administered drops in patients with refractory glaucoma. It seems a valuable tool to delay or preclude the need for filtering procedures in the majority of the patients.

What Child Oral Health-Related Behaviors Can First-time Mothers Actualize? A Pragmatic Prospective Study.

First-time pregnant women are considered to be receptive to health information, rendering the prenatal period an opportune time to provide helpful information on the importance of child-related oral health. However, little is known about pregnant women's knowledge of child oral health-related behaviors (COHBs) during pregnancy and their implementation after birth. We sought to address this knowledge gap by a prospective investigation of intended and actualized oral health behaviors among first-time pregnant women. We examined relationships between intended and actualized COHBs and their correlations with changes in oral health knowledge, health literacy, general self-efficacy, and dental neglect in a cohort of first-time pregnant clients at Women, Infants, and Children sites in North Carolina-participants of a large community-based study. The COHBs were related to diet (i.e., frequency of fruit juice and sweet snacks consumption and nighttime bottle-feeding) and oral hygiene practices (e.g., performance of daily oral hygiene and use of fluoridated toothpaste). Analyses relied on descriptive statistics and bivariate tests (Student's t and McNemar's). Data were collected from 48 participants (White, 44%; African American, 40%; Native American, 17%) at baseline and again at least 12 months after the birth of their first child. On average, most mothers actualized 3 of 5 COHBs (range, 1 to 4). Significant differences between before and after birth were noted for frequency of sweet snacks consumption and putting the baby in bed with a bottle. No correlation was found between knowledge, literacy, self-efficacy, neglect, and sociodemographic characteristics and COHB actualization. Our findings suggest that first-time mothers in the studied population are likely to implement some but not all positive intended COHBs during pregnancy. Interventions are needed to assist women in implementing these practices. We support that, for prenatal interventional efforts to reap positive benefits, messaging should be personalized and include specific guidance on how to implement these recommendations. A knowledge gap exists in our understanding of the relationship between first-time mothers' intended and actualized child oral health behaviors, with implications in the optimal timing of infant and early childhood oral health messaging. Our findings suggest that first-time mothers are likely to implement some but not all positive behaviors that they intended to adopt during pregnancy. Interventions are needed to assist women in implementing these practices.

Self-assessed neurological disturbances after surgical removal of impacted lower third molar: a pragmatic prospective study on 423 surgical extractions in 247 consecutive patients.

The aim of this study was to assess the combined role of current radiographic risk indicators and patient age in predicting lower lip sensitivity disturbances after surgical removal of impacted lower third molars. The question was which combinations indicate low or high risk. A prospective study was implemented involving 247 consecutive outpatients who underwent 423 surgical extractions. The predictor variables were patient age and risk indicators observed on panoramic radiographs. The outcome variable was the incidence of self-assessed lip sensitivity alterations. The extractions were subdivided into four groups according to the predictors. Two hundred forty-five teeth were extracted in patients younger than 25years and 178 in patients 25years old or older; radiographic risk indicators were associated with 226 out of 423 teeth (53.43%). No permanent neurological damage was observed. Transient lip sensitivity alterations were observed in five cases (1.18%; 95% confidence interval = 0.4 to 2.7%), all in the older group with radiographic risk indicators. The data indicate a low overall incidence of transient lip sensitivity impairment that occurred only in the presence of radiographic risk indicators in patients aged ≥ 25years. Informed consent should include the possibility of inferior alveolar nerve injury in mature patients with radiographic risk indicators. Prophylactic removal of impacted teeth with radiographic signs of risk may be indicated when the patient is not yet aged 25years.

Reduction in hospital-associated methicillin-resistant Staphylococcus aureus and vancomycin-resistant Enterococcus with daily chlorhexidine gluconate bathing for medical inpatients.

Daily bathing with chlorhexidine gluconate (CHG) is increasingly used in intensive care units to prevent hospital-associated infections, but limited evidence exists for noncritical care settings. A prospective crossover study was conducted on 4 medical inpatient units in an urban, academic Canadian hospital from May 1, 2014-August 10, 2015. Intervention units used CHG over a 7-month period, including a 1-month wash-in phase, while control units used nonmedicated soap and water bathing. Rates of hospital-associated methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococcus (VRE) colonization or infection were the primary end point. Hospital-associated S. aureus were investigated for CHG resistance with a qacA/B and smr polymerase chain reaction (PCR) and agar dilution. Compliance with daily CHG bathing was 58%. Hospital-associated MRSA and VRE was decreased by 55% (5.1 vs 11.4 cases per 10,000 inpatient days, P = .04) and 36% (23.2 vs 36.0 cases per 10,000 inpatient days, P = .03), respectively, compared with control cohorts. There was no significant difference in rates of hospital-associated Clostridium difficile. Chlorhexidine resistance testing identified 1 isolate with an elevated minimum inhibitory concentration (8 µg/mL), but it was PCR negative. This prospective pragmatic study to assess daily bathing for CHG on inpatient medical units was effective in reducing hospital-associated MRSA and VRE. A critical component of CHG bathing on medical units is sustained and appropriate application, which can be a challenge to accurately assess and needs to be considered before systematic implementation.

AD8 Informant Questionnaire for Cognitive Impairment: Pragmatic Diagnostic Test Accuracy Study.

The diagnostic accuracy of the AD8 informant questionnaire for cognitive impairment was assessed in patients referred to a dedicated memory clinic. This pragmatic prospective study of consecutive referrals attending with an informant who completed AD8 (n = 212) lasted 12 months. Diagnosis used standard clinical diagnostic criteria for dementia and mild cognitive impairment as reference standard (prevalence of cognitive impairment = 0.62). The AD8 proved acceptable to informants, was quick, and easy to use. Using the cutoff of ≥2/8, AD8 was highly sensitive (0.97) for diagnosis of cognitive impairment but specificity was poor (0.17). Combining AD8 with either the Mini-Mental State Examination or the Six-Item Cognitive Impairment Test showed little additional diagnostic benefit. In conclusion, AD8 is very sensitive for cognitive impairment in a memory clinic but specificity may be inadequate.

Vitamin D supplementation for diffuse musculoskeletal pain: Results of a before-and-after study

Background: Several studies have shown that vitamin D supplementation could be useful for treating diffuse musculoskeletal (DMS) pain in adults.Objectives: The aim of this study was to evaluate the effects of correcting a vitamin D deficiency (≤ 50 nmol/l) on DMS pain and quality of life in adults.Methods: A pragmatic prospective study was conducted in a general practice setting in the Rhone-Alps area between 1 February and 30 April 2009. Patients between the ages of 18 and 50 years old who consulted their general practitioner (GP) for DMS pain or chronic unexplained asthenia and had a deficient serum 25 (OH) D level with no signs of any other disease were enrolled in this study. The patients received high doses of vitamin D supplements (400 000 to 600 000 units). Mean pain evaluation scores were evaluated before and after vitamin D supplementation using mixed models and accounting for repeated measures.Results: Before vitamin D supplementation, the adult study cohort (n = 49) had an adjusted mean serum 25 (OH) D level of 23.7 nmol/l, a mean pain evaluation score of 5.07 and a mean quality of life score of 3.55. After vitamin D supplementation, the adjusted mean serum 25 (OH) D level increased to 118.8 nmol/l (P < 0.001), the mean quality of life score increased to 2.8 nmol/l (P < 0.001) and the mean pain evaluation score decreased to 2.8 (P < 0.001).Conclusion: In this small before-and-after study, vitamin D supplementation decreased pain scores in adult patients with diffuse musculoskeletal pain and vitamin D deficiency. These results must be confirmed by further studies.

Front-loading allied health intervention in the emergency department does not reduce length of stay for admitted older patients

Allied health intervention may play an important role in the timely discharge of older people admitted to hospital. The impact of early allied health intervention on length of stay has not been quantified. We sought to determine whether early allied health intervention conducted in the emergency department (ED) reduces hospital length of stay in older patients admitted with common diagnoses. A non-randomised prospective pragmatic study in ED patients aged 65 and over diagnosed with one or more of six conditions (cerebrovascular insufficiency; fractured neck of femur; cardiac failure; myocardial ischaemia; exacerbation of chronic airways disease; respiratory tract infection). Intervention patients receiving comprehensive allied health assessment/intervention by at least one professional working in a care coordination team were compared with patients who underwent no assessment. The primary outcome measure was hospital length of stay measured in hours from commencement of inpatient bed occupancy to discharge or death. A zero truncated negative binomial regression model was used to analyse length of stay while adjusting for covariates. In 2121 patients and 1451 comparators, there was no difference in length of stay (median 88 vs 87 h) on unadjusted (log-rank p 0.28) or adjusted (IRR 0.97, p 0.32) analysis. Front loading allied health assessment in ED has no effect on hospital length of stay.

Douleurs musculo-squelettiques non systématisées diffuses et déficit sévère en vitamine D. Étude avant-après en médecine générale

The objective of this study was to evaluate the effect of the correction of vitamin D deficiency (defined by a rate≤50 nmol/l) on the pain, fatigue and quality of life. A pragmatic prospective study was conducted in Rhone-Alpes area, in general practices between February 1 and April 30, 2009. All patients aged 18 to 50 years consulting for diffuse musculoskeletal pain and/or chronic unexplained fatigue, with the only abnormality deficient serum vitamin D were enrolled in this study. They might agree to complete questionnaires on quality of life, pain assessment and control their vitamin D levels after treatment. Forty-nine complete records were analyzed. The deficiency was severe (mean 26 nmol/l). High doses of vitamin were necessary to correct deficiency, between 400,000 to 600,000 units. The correction of vitamin D deficiency resulted in a significant decrease in the level of pain intensity according to verbal rating scale (P=0.034) and the Digital Scale (P<0.001), consumption of analgesics (P=0.002) and discomfort in carrying out activities of daily living following: the shopping, cleaning, walking for more than a kilometer (P<0.001) and dressing (P=0.012). The correction has had a positive impact both physical, mental and social activities. Non-specific musculoskeletal pain or unexplained asthenia are common in primary care. Make a dosage of vitamin D and correct deficits is a necessity before performing complex and expensive examinations.

Clinical outcome after total knee replacement: forgotten knee. a single-centre prospective pragmatic study

Purpose: Total knee replacement is the radical surgical treatment of knee osteoarthritis and usually produces good or very good results in terms of pain and function. However the patient may report that the knee, although free of pain, does not feel normal. As a result, the patient's assessment may be less favourable than the surgeon's assessment of the outcome. A “forgotten” knee is a joint that feels completely normal to the patient and is therefore the best possible outcome from the patient's viewpoint. To evaluate the prevalence of “forgotten knee” in a single-centre pragmatic prospective study of a uniform patient population, from January 2001 to December 2008. Methods: The study patients were selected for TKR by a specialized surgeon based on tibiofemoral and/or patellofemoral knee osteoarthritis stage IV in the Alback radiological classification, with a >70-mm visual-analogue-scale (VAS) pain score and non response to appropriate medical management. All procedures were done by the same surgeon (MB). A mobile-bearing posterior cruciate ligament-substituting prosthesis was used. The following were recorded at baseline and during regular post-surgery visits: VAS pain score, Knee Society knee and function scores, and four functional scores (KOOS, Oxford, WOMAC, and Lequesne). Forgotten knee was assessed at last follow-up based on the patient's answer to the following question: “Do you feel your knee is completely normal all the time?” Knee radiograph findings before and after TKR were recorded. The chi-square test was used for qualitative parameters and the t test and analysis of variance for quantitative parameters. Results: We included 498 knees in 406 patients (63% of women). Mean age was 70±8.6 years, mean body mass index was 29 Kg/m2, and mean follow-up was 6.4 (3-10) years. Varus deformity was noted in 63% and valgus deformity in 36% of patients. At last follow-up, 375 patients were still active. All functional scores improved significantly (p<0.001) from baseline to last follow-up: KOSS, 40±14 to 95±9; Oxford, 38±9 to 14±4; global WOMAC, 51±18 to 12±7; and Lequesne, 14±9 to 1±3. Among the patients, 80% felt satisfied with the procedure and 87% felt the results were consistent with their expectations, but only 44% met our criterion for “forgotten” knee. There were 17 complications (3.4%) including 5 cases of sepsis with favourable outcomes after reoperation. Conclusions: Only 44% of patients had a forgotten knee after TKR, although 80% were satisfied and free of pain. A forgotten knee may be a criterion for complete recovery that might be of use in future studies of TKR outcomes.

Screening utility of the Montreal Cognitive Assessment (MoCA): in place of – or as well as – the MMSE?

This aim of this study was to assess the clinical utility of the Montreal Cognitive Assessment (MoCA) as a screening instrument for cognitive impairment in patients referred to a memory clinic, alone and in combination with the Mini-Mental State Examination (MMSE). This was a pragmatic prospective study of consecutive referrals attending a memory clinic (n = 150) over an 18-month period. Patients were diagnosed using standard clinical diagnostic criteria for dementia (DSM-IV) and mild cognitive impairment (MCI; cognitive impairment prevalence = 43%) independent of MoCA test scores. MoCA proved acceptable to patients and was quick and easy to use. Using the cut-offs for MoCA and MMSE specified in the index paper (≥26/30), MoCA was more sensitive than MMSE (0.97 vs 0.65) but less specific (0.60 vs 0.89), with better diagnostic accuracy (area under Receiver Operating Characteristic curve 0.91 vs 0.83). Downward adjustment of the MoCA cut-off to ≥20/30 maximized test accuracy and improved specificity (0.95) for some loss of sensitivity (0.63). Combining MoCA with the MMSE - either in series or in parallel - did not improve diagnostic utility above that with either test alone. In a memory clinic population, MoCA proved sensitive for the diagnosis of cognitive impairment. Use of a cut-off lower than that specified in the index study may be required to improve overall test accuracy and specificity for some loss of sensitivity in populations with a high prior probability of cognitive impairment. Combining the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) with the MMSE did not improve diagnostic utility.