Characteristics of persistent postural perceptual dizziness patients in a multidisciplinary dizziness clinic.

BACKGROUND: Persistent Postural Perceptual Dizziness (PPPD) is a newly defined condition which was added to the International Classification of Vestibular Disorders in 2017. Little is known about its impact on patients. OBJECTIVE: The goal of this study was to analyze the symptomology, epidemiology and impact of PPPD on patients. METHODS: A retrospective chart review was done to identify patients who attended the Multidisciplinary Dizziness Clinic (MDC) and were diagnosed with PPPD. Responses to demographic questions, health-related quality of life surveys and several well-validated questionnaires commonly used to assess dizziness severity were analyzed. RESULTS: One hundred patients were diagnosed with PPPD between March 2017 and January 2019, of which 80%(80/100) were females. The average Dizziness Handicap Index score was 60.3±19.0. Responses to the Patient Health Questionnaire classified 53 patients (53/99;53.5%) as moderately to severely depressed. Sixty-four patients (64/100;64.0%) were minimally or mildly anxious according to the Generalized Anxiety Disorder scale. The average Vertigo Symptom Scale score was 24.1/60. The average Situational Vertigo Questionnaire score was 2.00. Forty-nine (49/100;49.0%) patients had migraine symptoms according to the Migraine Screen Questionnaire. CONCLUSIONS: In conclusion, patients with PPPD display important handicap and an elevated risk of depression, anxiety and migraines.

Coconut Oil as a Novel Approach to Managing Radiation-Induced Xerostomia: A Primary Feasibility Study.

BACKGROUND: Xerostomia is a common complication following radiation therapy for head and neck cancer (HNC), for which there is no single, universally accepted therapy. Coconut oil has been anecdotally suggested to provide relief for this complication. This study sought to examine the feasibility and effectiveness of coconut oil as a therapy for radiation-induced xerostomia. METHODS: A feasibility study was performed among 30 patients with xerostomia subsequent to radiation for HNC. Coconut oil samples were provided along with a protocol for use over a 2-week period and the option to continue if they found it beneficial. Patients were also instructed to keep diaries to document their patterns of use. The Xerostomia-related Quality of Life Scale (XeQOLS) was administered at baseline and 3-month follow-up. Descriptive methods were used to summarize patterns of coconut oil use and paired t-tests were used to assess changes in XeQOLS scores over time. RESULTS: The mean total duration of coconut oil use during the study period was 16 days (1-71). The average number of uses per day was 3 (1-5), with an average amount per use of 5 mL (1.2-8.5). Twelve patients (41.4%) continued coconut oil use beyond the advised period. There was no statistically significant difference in XeQOLS scores pre- and post-treatment. There were no adverse events during the study period. CONCLUSIONS: The use of coconut oil as a treatment strategy for xerostomia post-HNC radiation is feasible, inexpensive, and safe. This study demonstrates that there may be a group of HNC patients that benefit from its use.

Dizziness at a Canadian tertiary care hospital: a cost-of-illness study.

BACKGROUND: In the Canadian health care system, determining overall costs associated with a particular diagnostic subgroup of patients, in this case dizzy patients, is the first step in the process of determining where costs could be saved without compromising patient care. This study is the first Canadian study that evaluates these costs at a tertiary care hospital and will allow for the extrapolation of cost data for other similar academic health science centers, regional health initiatives, and provincial healthcare planning structures. METHODS: We conducted a retrospective cohort study of patients of any age presenting to The Ottawa Hospital (TOH), a tertiary care hospital, between January 1st, 2009 and December 31st, 2014 with a main diagnosis of dizziness or dizziness-related disease. De-identified patient information was acquired through TOH Data Warehouse and included a patient's sex, age, arrival and departure dates, Elixhauser co-morbidity score, location of presentation (emergency department or admitted inpatient) presenting complaint, final diagnosis code, any procedure codes linked to their care, and the direct and indirect hospital costs linked with any admission. We derived the mean hospital costs and 95% confidence interval for each diagnosis. We obtained the number of patients who were diagnosed with dizziness within Ontario in year 2015-16 from Canadian Institute for Health Information (CIHI). A simple frequency multiplication was performed to estimate the total cost burden for Ontario based on the cost estimate for the same year obtained from TOH. Cost data were presented in 2017 Canadian dollars. RESULTS: The average total hospital cost per patient with dizziness for the entire cohort is $450 (SD = $1334), with ED only patients costing $359 (SD = $214). The total estimated hospital cost burden of dizziness in Ontario is $31,202,000 (95% CI $29,559,000 - 32,844,000). CONCLUSIONS: The estimated annual costs of emergency department ambulatory and inpatient dizziness in Ontario was calculated to be approximately 31 million dollars per year. This is the first step in identifying potential areas for cost savings to aid local and provincial policy-makers in allocation of health care spending.

Ramipril versus placebo in kidney transplant patients with proteinuria: a multicentre, double-blind, randomised controlled trial.

BACKGROUND: Angiotensin-converting enzyme inhibitors have been shown to reduce the risk of end-stage renal disease and death in non-transplant patients with proteinuria. We examined whether ramipril would have a similar beneficial effect on important clinical outcomes in kidney transplant recipients with proteinuria. METHODS: In this double-blind, placebo-controlled, randomised trial, conducted at 14 centres in Canada and New Zealand, we enrolled adult renal transplant recipients at least 3-months post-transplant with an estimated glomerular filtration rate (GFR) of 20 mL/min/1·73m(2) or greater and proteinuria 0·2 g per day or greater and randomly assigned them to receive either ramipril (5 mg orally twice daily) or placebo for up to 4 years. Patients completing the final 4-year study visit were invited to participate in a trial extension phase. Treatment was assigned by centrally generated randomisation with permuted variable blocks of 2 and 4, stratified by centre and estimated GFR (above or below 40 mL/min/1·73 m(2)). The primary outcome was a composite consisting of doubling of serum creatinine, end-stage renal disease, or death in the intention-to-treat population. The principal secondary outcome was the change in measured GFR. We ascertained whether any component of the primary outcome had occurred at each study visit (1 month and 6 months post-randomisation, then every 6 months thereafter). This trial is registered with ISRCTN, number 78129473. FINDINGS: Between Aug 23, 2006, and March 28, 2012, 213 patients were randomised. 109 were allocated to placebo and 104 were allocated to ramipril, of whom 109 patients in the placebo group and 103 patients in the ramipril group were analysed and the trial is now complete. The intention to treat population (placebo n=109, ramipril n=103) was used for the primary analysis and the trial extension phase analysis. The primary outcome occurred in 19 (17%) of 109 patients in the placebo group and 14 (14%) of 103 patients in the ramipril group (hazard ratio [HR] 0·76 [95% CI 0·38-1·51]; absolute risk difference -3·8% [95% CI -13·6 to 6·1]). With extended follow-up (mean 48 months), the primary outcome occurred in 27 patients (25%) in the placebo group and 25 (24%) patients in the ramipril group (HR 0·96 [95% CI 0·55-1·65]); absolute risk difference: -0·5% (95% CI -12·0 to 11·1). There was no significant difference in the rate of measured GFR decline between the two groups (mean difference per 6-month interval: -0·16 mL/min/1·73m(2) (SE 0·24); p=0·49). 14 (14%) of patients died in the ramipril group and 11 (10%) in the placebo group, but the difference between groups was not statistically significant (HR 1·45 [95% CI 0·66 to 3·21]). Adverse events were more common in the ramipril group (39 [38%]) than in the placebo group (24 [22%]; p=0·02). INTERPRETATION: Treatment with ramipril compared with placebo did not lead to a significant reduction in doubling of serum creatinine, end-stage renal disease, or death in kidney transplant recipients with proteinuria. These results do not support the use of angiotensin-converting enzyme inhibitors with the goal of improving clinical outcomes in this population. FUNDING: Canadian Institutes of Health Research.

Effect of fresh red blood cell transfusions on clinical outcomes in premature, very low-birth-weight infants: the ARIPI randomized trial.

CONTEXT: Even though red blood cells (RBCs) are lifesaving in neonatal intensive care, transfusing older RBCs may result in higher rates of organ dysfunction, nosocomial infection, and length of hospital stay. OBJECTIVE: To determine if RBCs stored for 7 days or less compared with usual standards decreased rates of major nosocomial infection and organ dysfunction in neonatal intensive care unit patients requiring at least 1 RBC transfusion. DESIGN, SETTING, AND PARTICIPANTS: Double-blind, randomized controlled trial in 377 premature infants with birth weights less than 1250 g admitted to 6 Canadian tertiary neonatal intensive care units between May 2006 and June 2011. INTERVENTION: Patients were randomly assigned to receive transfusion of RBCs stored 7 days or less (n = 188) vs standard-issue RBCs in accordance with standard blood bank practice (n = 189). MAIN OUTCOME MEASURES: The primary outcome was a composite measure of major neonatal morbidities, including necrotizing enterocolitis, retinopathy of prematurity, bronchopulmonary dysplasia, and intraventricular hemorrhage, as well as death. The primary outcome was measured within the entire period of neonatal intensive care unit stay up to 90 days after randomization. The rate of nosocomial infection was a secondary outcome. RESULTS: The mean age of transfused blood was 5.1 (SD, 2.0) days in the fresh RBC group and 14.6 (SD, 8.3) days in the standard group. Among neonates in the fresh RBC group, 99 (52.7%) had the primary outcome compared with 100 (52.9%) in the standard RBC group (relative risk, 1.00; 95% CI, 0.82-1.21). The rate of clinically suspected infection in the fresh RBC group was 77.7% (n = 146) compared with 77.2% (n = 146) in the standard RBC group (relative risk, 1.01; 95% CI, 0.90-1.12), and the rate of positive cultures was 67.5% (n = 127) in the fresh RBC group compared with 64.0% (n = 121) in the standard RBC group (relative risk, 1.06; 95% CI, 0.91-1.22). CONCLUSION: In this trial, the use of fresh RBCs compared with standard blood bank practice did not improve outcomes in premature, very low-birth-weight infants requiring a transfusion. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00326924; Current Controlled Trials Identifier: ISRCTN65939658.

The age of red blood cells in premature infants (ARIPI) randomized controlled trial: study design.

Despite recent trends in decreasing transfusion thresholds and the development of technologies designed to avoid allogeneic exposure, allogeneic red blood cell (RBC) transfusions remain an important supportive and life-saving measure for neonatal intensive care patients experiencing illness and anemia. Reluctantly, a number of laboratory and observational studies have indicated that the amount of time RBCs are stored can affect oxygen delivery to tissues. Consequently, older RBCs may result in higher rates of organ dysfunction, nosocomial infection, and lengths of stay. Because of such harmful effects, an evaluation of the association between age of blood and nosocomial infection and organ dysfunction is warranted. The aim of the study was to determine if RBCs stored for 7 days or less (fresh RBCs) compared to current standard transfusion practice decreases major nosocomial infection and organ dysfunction in neonates admitted to the neonatal intensive care unit and requiring at least one RBC transfusion. This study is a double-blind, multicenter, randomized controlled trial design. The trial will be an effectiveness study evaluating the effectiveness of stored vs fresh RBCs in neonates requiring transfusion. Neonatal patients requiring at least one unit of RBCs will be randomized to receive either (1) RBCs stored no longer than 7 days or (2) standard practice. The study was conducted in Canadian university-affiliated level III (tertiary) neonatal intensive care units. The primary outcome for this study will be a composite measure of major neonatal morbidities (necrotizing enterocolitis, retinopathy of prematurity, bronchopulmonary dysplasia, intraventricular hemorrhage, and mortality). Secondary outcomes include individual items of the composite measure and nosocomial infection (bacteremia, septic shock, and pneumonia). The sample size calculations have been estimated based on the formula for 2 independent proportions using an alpha of .05, a (1-beta) of .80, and a 10% noncompliance factor. The baseline rate for our composite measure is estimated to be 65% as indicated by the literature. Assuming a 15% absolute risk reduction with the use of RBCs stored 7 days or less, our estimated total sample size required will be 450 (225 patients per treatment arm). The Age of Red Blood Cells in Premature Infants (ARIPI) trial is registered at the US National Institutes of Health (ClinicalTrials.gov) no. NCT00326924 and current controlled trials ISRCTN65939658.

How effective is tetracaine 4% gel, before a venipuncture, in reducing procedural pain in infants: a randomized double-blind placebo controlled trial.

BACKGROUND: Procedural pain relief is sub-optimal in neonates. Topical tetracaine provides pain relief in children. Evidence of its efficacy and safety in neonates is limited. The objective of this study was to assess the efficacy and safety of topical tetracaine on the pain response of neonates during a venipuncture. METHODS: Medically stable infants greater than or equal to 24 weeks gestation, requiring a venipuncture, were included. Following randomization and double blinding, 1.1 g of tetracaine or placebo was applied to the skin for 30 minutes. Participants received oral sucrose if they met local eligibility criteria. The venipuncture was performed according to a standard protocol. A medium effect size in the pain score (corresponding to about 2 point difference in the PIPP score) was considered clinically significant, leading to a sample size of 142 infants, with 80% statistical power. Local skin reactions and immediate adverse cardiorespiratory events were noted. The primary outcome, PIPP score at 1 minute, was analysed using an independent Student's t-test. RESULTS: One hundred and forty two infants were included, 33 +/- 4 weeks gestation, 2100 +/- 900 grams and 6 +/- 3 days of age. There was almost no difference in PIPP scores at 1 minute between groups (mean difference -0.09; 95% confidence interval [CI]: -1.68 to 1.50; P = . 91). Similarly, there were no differences in PIPP scores during the 2nd, 3rd and 4th minute. Duration of cry did not differ between the groups (median difference, 0; 95% CI, -3 to 0; P = . 84). The majority of infants in both groups received sucrose 24%. Sucrose had a significant effect on the PIPP score, as assessed by an ANOVA model (p = 0.0026). Local skin erythema was observed transiently in 11 infants (7 in the tetracaine and 4 in the placebo group). No serious side effect was observed. CONCLUSION: Tetracaine did not significantly decrease procedural pain in infants undergoing a venipuncture, when used in combination with routine sucrose administration.

How effective is tetracaine 4% gel, before a peripherally inserted central catheter, in reducing procedural pain in infants: a randomized double-blind placebo controlled trial [ISRCTN75884221].

BACKGROUND: Procedural pain relief is sub-optimal in infants, especially small and vulnerable ones. Tetracaine gel 4% (Ametop, Smith-Nephew) provides pain relief in children and larger infants, but its efficacy in smaller infants and for peripherally inserted central catheters (PICC) remains uncertain. The objective of this trial was to assess the safety and efficacy of tetracaine gel on the pain response of very low birth weight (VLBW) infants during insertion of a PICC. METHODS: Medically stable infants greater than or equal to 24 weeks gestation, requiring a non-urgent PICC, were included. Following randomization and double blinding, 1.1 g of tetracaine or placebo was applied to the skin for 30 minutes. The PICC was inserted according to a standard protocol. Pain was assessed using the Premature Infant Pain Profile (PIPP). A 3-point change in the pain score was considered clinically significant, leading to a sample size of 54 infants, with 90% statistical power. Local skin reactions and immediate adverse cardiorespiratory events were noted. The primary outcome, PIPP score at 1 minute, was analysed using an independent Student's t-test. RESULTS: Fifty-four infants were included, 27 +/- 2 weeks gestation, 916 +/- 292 grams and 6.5 +/- 3.2 days of age. Baseline characteristics were similar between groups. The mean PIPP score in the first minute was 10.88 in the treatment group as compared to 11.74 in the placebo group (difference 0.86, 95% CI -1.86, 3.58). Median duration of crying in non-intubated infants was 181 seconds in the tetracaine group compared to 68 seconds in the placebo group (difference -78, 95% CI -539, 117). Local skin erythema was observed transiently in 4 infants (3 in the treatment and 1 in the placebo group). No serious harms were observed. CONCLUSION: Tetracaine 4% when applied for 30 minutes was not beneficial in decreasing procedural pain associated with a PICC in very small infants.

The Ottawa Model of Research Use: a guide to clinical innovation in the NICU.

PURPOSE/OBJECTIVES: To improve performance of a neonatal transport team by implementing a research-based family assessment instrument. Objectives included providing a structure for evaluating families and fostering the healthcare relationship. BACKGROUND/RATIONALE: Neonatal transports are associated with family crises. Transport teams require a comprehensive framework to accurately assess family responses to adversity and tools to guide their practice toward parental mastery of the event. Currently, there are no assessment tools that merge family nursing expertise with neonatal transport. DESCRIPTION OF THE PROJECT: A family assessment tool grounded in contemporary family nursing theory and research was developed by a clinical nurse specialist. The Ottawa Model of Research Use guided the process of piloting the innovation with members of a transport team. Focus groups, interviews, and surveys were conducted to create profiles of barriers and facilitators to research use by team members. Tailored research transfer strategies were enacted based on the profile results. OUTCOME: Formative evaluations demonstrated improvements in team members' perceptions of their knowledge, family centeredness, and ability to assess and intervene with families. The family assessment tool is currently being incorporated into Clinical Practice Guidelines for Transport and thus will be considered standard care. CONCLUSION: Use of a family assessment tool is an effective way of appraising families and addressing suffering. The Ottawa Model of Research Use provided a framework for implementing the clinical innovation. IMPLICATIONS FOR NURSING PRACTICE: A key role of the clinical nurse specialist is to influence nursing practice by fostering research use by practitioners. When developing and implementing a clinical innovation, input from end users and consumers is pivotal. Incorporating the innovation into a practice guideline provides a structure to imbed research evidence into practice.