Background Hay fever is typically poorly managed, particularly in adolescents, in whom it is responsible for considerable morbidity and impairment in educational performance. Evidence-based training of professionals has the potential to improve outcomes, but it can be expensive and so warrants formal evaluation. This trial sought to evaluate the effectiveness of a training intervention for primary care-based health care professionals on adolescent disease-specific quality of life. Methods A cluster randomised controlled trial was conducted in UK general practices. Practices were centrally randomised to a short, intensive training course on the evidence-based management of hay fever (intervention arm) or distribution of guidelines (control arm). The primary outcome measure was the change in the validated Rhinoconjunctivitis Quality of Life Questionnaire with Standardized Activities (RQLQ(S)) score in adolescents with hay fever between baseline and six weeks post-intervention (minimal clinically important difference = 0.5). Secondary outcome measures included health care professionals’ knowledge and confidence in managing hay fever, number of hay fever-related consultations, relevant treatments prescribed and symptom scores. Multi-level modelling using a random effects model was used to take account of between and within cluster variation, adjusting for strata, individual covariates and year of study. Results Thirty-eight general practices were randomised (20 in the intervention arm) and 246/341 patients (50.2% male, mean age 15 years) were included in the primary outcome analysis. Health care professionals’ self-assessed knowledge and confidence improved (prescribing/recommending treatment mean score 95% CI 1.4, 2.8), and the training was perceived to be of value. This did not however result in clinically or statistically significant improvements in RQLQ(S): -0.15, 95% CI -0.52 to +0.21. There were no differences in consultation frequency (95% CI -0.02, +0.63), treatments issued for hay fever (95% CI -0.24, +0.08) or symptom scores (95% CI - 1.03, +0.54). Conclusions Although attendance on this short, intensive hay fever training course was associated with professionals’ increased self-assessed confidence and understanding of the clinical management of hay fever, this did not translate into improvements in disease-specific quality of life or reduction in rhinitis symptoms in adolescents with hay fever.

Blood sampling causes significant blood loss in intensive care unit (ICU) patients (up to 41 mL per day). Only 10% of the blood collected is used for testing suggesting that volumes can be reduced without compromising patient care or laboratory processes. Blood loss contributes to anemia which is highly prevalent in the ICU (>90% after 3 days) and is associated with major adverse cardiovascular outcomes and death. Diagnostic blood loss increases the likelihood of red blood cell (RBC) transfusion which is administered to about 40% of ICU patients (half are given in absence of hemorrhage) and has significant health risks. Small-volume blood collection tubes, which collect about 50% less blood, are available, but rarely used in adults. They have the same cost as standard-volume tubes and are compatible with laboratory equipment. The rationale for the continued use of standard-volume tubes is a theoretical concern about inadequate volume for testing, and the absence of data showing the benefit of small-volume tube use on an important clinical outcome. A study is needed to show that small-volume tubes reduce blood loss, anemia and RBC transfusion without harms or negative consequences on patient care and hospital procedures compared to standard-volume tubes. If this could be shown, it may lead to practice change regarding blood collection for laboratory testing. A stepped-wedge cluster randomized trial is the ideal study design for this low-risk intervention. By incorporating the small-volume tubes into routine clinical practice and using administrative and hospital electronic medical record data, this study would be a pragmatic, cost-effective way to evaluate effectiveness and implementation. However, prior to conducting a full-scale trial powered on clinical outcomes, a pilot study is needed to determine whether a larger study will be feasible. The goals of this thesis are to (i) summarize the existing evidence regarding small-volume tubes; (ii) discuss cluster randomized trial methodology;(iii) discuss the use of health care administrative data for research; (iv) discuss the role of pilot studies; and (v) present the design of a pilot stepped wedge randomized trial of small-volume versus standard-volume blood collection tubes to evaluate the feasibility of a full-scale trial. / Thesis / Master of Science (MSc) / Blood testing is a preventable cause of blood loss. Patients in the intensive care unit (ICU) have about 41 mL of blood taken per day for testing (like donating 1 unit of blood every 8 days). This contributes to anemia (low red blood cells) and transfusion, which are harmful. About 40% of ICU patients get at least one red blood cell transfusion which is a limited resource with health risks. Most of the blood sent to the laboratory is discarded (up to 90%) suggesting that volumes can be reduced without compromising care. The goals of this thesis are to (i) summarize the evidence for reducing blood loss for laboratory testing; (ii) discuss cluster randomized trials; (iii) discuss use of health care administrative data for research; (iv) discuss the role of pilot studies; and (v) present a pilot stepped wedge cluster randomized trial of small-volume versus standard-volume blood collection tubes in ICU patients.