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The objectives of this study were to evaluate efficacy of a 2-dose regimen of ceftiofur crystalline free acid sterile suspension (CCFA-SS) for treatment of acute metritis in lactating dairy cows under field conditions and to provide additional safety and injection site tolerance data for injections at the base of the ear. Cows at 15 dairies with rectal temperature ≥ 39.5°C and fetid uterine discharge ≤ 10 d postcalving were randomly assigned by blocks of 2, based on order of entry and without regard to parity, to treatment with saline (1.5 mL/45.5 kg of body weight, n=509) or CCFA-SS (6.6 mg of ceftiofur equivalents/kg of body weight, n=514). Treatments were administered by subcutaneous injection in the posterior aspect of the ear where it attaches to the head; the first dose was administered on study d 0 and the second dose was administered in the contra lateral ear on study d 3. Rectal temperatures were recorded on study d 1 to 4 and 5 or 6 and cows were clinically evaluated daily from study d 1 to 13. Cows that exhibited increased adverse clinical signs of poor health or complications associated with metritis were categorized as a treatment failure and administered escape therapy. Each cow received a veterinary physical examination on study d 5 or 6 to determine if she should be removed from the study and on study d 14 to determine clinical cure or failure to cure. Clinical cure was defined as rectal temperature <39.5°C and non-fetid and purulent or mucopurulent discharge on study d 14 and no escape therapy administered. The injection procedure was scored after each injection (study d 0 and 3) and injection sites and ear carriage were scored on study d 5 or 6, 14, and 57±3. Of the 1,023 cows enrolled, 7 were completely censored due to protocol deviations and 34 were removed for protocol deviations or medical conditions not related to metritis. Clinical cure rate was higher for CCFA-SS than for saline (74.3 vs. 55.3%) and rectal temperatures for each of study d 1 to 5 or 6 were lower for CCFA-SS than saline. Injection procedure indices showed that CCFA-SS could be practically and safely administered using commercial dairy facilities. Although injection site scores were higher for CCFA-SS than saline at study d 5 or 6 and 14, ≥98.6% of ears were normal on d 57±3. Thus, a 2-dose treatment with CCFA-SS given 72h apart increased metritis clinical cure rate and was well tolerated in dairy cows.

BackgroundHealth services face the challenges created by complex problems, and so need complex intervention solutions. However they also experience ongoing difficulties in translating findings from research in this area in to quality improvement changes on the ground. BounceBack was a service development innovation project which sought to examine this issue through the implementation and evaluation in a primary care setting of a novel complex intervention.MethodsThe project was a collaboration between a local mental health charity, an academic unit, and GP practices. The aim was to translate the charity’s model of care into practice-based evidence describing delivery and impact. Normalisation Process Theory (NPT) was used to support the implementation of the new model of primary mental health care into six GP practices. An integrated process evaluation evaluated the process and impact of care.ResultsImplementation quickly stalled as we identified problems with the described model of care when applied in a changing and variable primary care context. The team therefore switched to using the NPT framework to support the systematic identification and modification of the components of the complex intervention: including the core components that made it distinct (the consultation approach) and the variable components (organisational issues) that made it work in practice. The extra work significantly reduced the time available for outcome evaluation. However findings demonstrated moderately successful implementation of the model and a suggestion of hypothesised changes in outcomes.ConclusionsThe BounceBack project demonstrates the development of a complex intervention from practice. It highlights the use of Normalisation Process Theory to support development, and not just implementation, of a complex intervention; and describes the use of the research process in the generation of practice-based evidence. Implications for future translational complex intervention research supporting practice change through scholarship are discussed.Electronic supplementary materialThe online version of this article (doi:10.1186/s12913-016-1726-6) contains supplementary material, which is available to authorized users.

Maropitant (Cerenia), a selective neurokinin(1) receptor antagonist, was evaluated for safety and efficacy in treatment and prevention of acute vomiting due to various etiologies in dogs in a randomized clinical trial. Two-hundred seventy-eight dogs were enrolled from 29 veterinary hospitals. Two-hundred fifty-two were evaluable for efficacy, while 275 were evaluable for safety. A randomized block design was utilized (three maropitant- and one placebo-treated dog per block). Initial treatment was maropitant at 1 mg/kg body weight (0.45 mg/lb) or an equivalent volume of saline (placebo) administered subcutaneously. On the subsequent 1 to 4 days, maropitant or placebo (dependent on allocation) was administered subcutaneously or orally at approximate 24-h intervals as needed. Oral doses were administered as maropitant tablets using unit dosing to deliver a minimum dose of 2 mg/kg body weight (0.9 mg/lb) or equivalent numbers of similar placebo tablets. Dogs and housing were observed twice daily for evidence of vomiting. Emesis was significantly (P

Summary Objective:  To assess the safety and efficacy of botulinum toxin‐A (botn‐A) in the management of patients with bladder oversensitivity (BO). Patients and methods:  Twenty‐three consecutive patients with a diagnosis of BO refractory to anticholinergics were enrolled in this randomised, double blind, placebo‐controlled trial. Patients were randomly allocated to receive intradetrusor injections of either botn‐A (100 U Botox®) or saline (placebo) via a flexible cystoscopic approach. The study was designed to have 90% power to detect a change in the maximum cystometric capacity (MCC) of 30%. It was calculated that a total cohort of 58 patients would be required. Urodynamic assessment (UDS), voiding diaries (VD) and quality of life (QoL) were assessed at baseline and at 4 and 12 weeks following intervention. Results:  An interim analysis was performed and the trial halted after recruitment of 23 patients as a result of poorly perceived patient benefit. Data were analysed for 21 patients (10 botn‐A; 11 placebo). In the treatment arm, there was a significant increase in MCC (mean rise 105 ml; p = 0.009). However, storage symptoms remained statistically unchanged following botn‐A. Three patients in the treatment arm were required to perform clean intermittent self‐catheterisation with no clinical improvement. The limitations of this trial include the small sample size and the unplanned interim analysis. Conclusions:  This is the first randomised, double blind, placebo‐controlled trial examining the effects of botn‐A exclusively in patients with BO. A significant increase in MCC was observed but this did not translate to clinical benefit with no change observed in the symptoms and quality of life for the majority of patients.

Objective• To validate the Bladder Control Self-Assessment Questionnaire (B-SAQ), a short screener to assess lower urinary tract symptoms (LUTS) and overactive bladder (OAB) in men. Patients and Methods• This was a prospective, single-centre study including 211 patients in a urology outpatient setting.• All patients completed the B-SAQ and Kings Health Questionnaire (KHQ) before consultation, and the consulting urologist made an independent assessment of LUTS and the need for treatment.• The psychometric properties of the B-SAQ were analysed. Results• A total of 98% of respondents completed all items correctly in <5 min.• The mean B-SAQ scores were 12 and 3.3, respectively for cases (n = 101) and controls (n = 108) (P < 0.001).• Good correlation was evident between the B-SAQ and the KHQ.• The agreement percentages between the individual B-SAQ items and the KHQ symptom severity scale were 86, 85, 84 and 79% for frequency, urgency, nocturia and urinary incontinence, respectively.• Using a B-SAQ symptom score threshold of ≥4 alone had sensitivity, specificity and positive predictive values for detecting LUTS of 75, 86 and 84%, respectively, with an area under the curve of 0.88; however, in combination with a bother score threshold of ≥1 these values changed to 92, 46 and 86%, respectively. Conclusions• The B-SAQ is an easy and quick valid case-finding tool for LUTS/OAB in men, but appears to be less specific in men than in women.• The B-SAQ has the potential to raise awareness of LUTS.• Further validation in a community setting is required.

Objective To evaluate the patient experience of our dedicated botulinum toxin A (BTX‐A) service using a validated patient‐reported experience measure (PREM) and assess patient‐reported satisfaction with treatment. Materials and Methods The first 100 patients who underwent BTX‐A treatment for refractory idiopathic detrusor overactivity (IDO) in our institution were contacted for telephone interview. They had all been assessed, injected and followed up in a dedicated BTX‐A clinic. Patients were asked to complete a validated PREM – the Client Satisfaction Questionnaire (CSQ‐8) – as well as a questionnaire developed in our department to assess satisfaction with the results of the treatment. Most patients received 200 U OnabotulinumtoxinA (Botox®) via an outpatient local anaesthetic flexible cystoscopy technique. Results Complete data was available for 72 patients. In all, 49 patients were continuing to receive BTX‐A treatment while 23 had opted for no further injections. The overall mean (sd) CSQ‐8 satisfaction score was 38.3 (3.3), indicating a high level of patient satisfaction with the service offered in our institution. There was a significant difference in total satisfaction scores between those still receiving BTX‐A (mean score 29.8) and those who have discontinued treatment (mean score 25.1) (P < 0.01). Overall patient satisfaction with the result of the treatment was high with an overall mean (sd) score of 8.6 (2.0) on a visual analogue scale. Of those who had discontinued BTX‐A, most were either using conservative measures only (44%) or had recommenced anticholinergic medications. Conclusion Overall patient satisfaction with the dedicated BTX‐A service offered in our institution is high and can result in a positive patient experience. The use of PREMs are advocated in order to fully capture the patient's views of the quality of services and treatments they receive.