Development and validation of the influenza intensity and impact questionnaire (FluiiQ™)

Clinical trials of new agents to reduce the severity and impact of influenza require accurate assessment of the effect of influenza infection. Because there are limited high-quality adult influenza Patient Reported Outcomes (PRO) measures, the aim was to develop and validate a simple but comprehensive questionnaire for epidemiological research and clinical trials.

Cognitive-reminiscence therapy and usual care for depression in young adults: study protocol for a randomized controlled trial

Background
Depression is a common affliction for young adults, and is associated with a range of adverse outcomes. Cognitive-reminiscence therapy is a brief, structured intervention that has been shown to be highly effective for reducing depressive symptoms, yet to date has not been evaluated in young adult populations. Given its basis in theory-guided reminiscence-based therapy, and incorporation of effective therapeutic techniques drawn from cognitive therapy and problem-solving frameworks, it is hypothesized to be effective in treating depression in this age group.

Methods and design
This article presents the design of a randomized controlled trial implemented in a community-based youth mental health service to compare cognitive-reminiscence therapy with usual care for the treatment of depressive symptoms in young adults. Participants in the cognitive-reminiscence group will receive six sessions of weekly, individual psychotherapy, whilst participants in the usual-care group will receive support from the youth mental health service according to usual procedures. A between-within repeated-measures design will be used to evaluate changes in self-reported outcome measures of depressive symptoms, psychological wellbeing and anxiety across baseline, three weeks into the intervention, post-intervention, one month post-intervention and three months post-intervention. Interviews will also be conducted with participants from the cognitive-reminiscence group to collect information about their experience receiving the intervention, and the process underlying any changes that occur.

Discussion
This study will determine whether a therapeutic approach to depression that has been shown to be effective in older adult populations is also effective for young adults. The expected outcome of this study is the validation of a brief, evidence-based, manualized treatment for young adults with depressive symptoms.

Development and validation of the influenza intensity and impact questionnaire (FluiiQ™)

Objective
Clinical trials of new agents to reduce the severity and impact of influenza require accurate assessment of the effect of influenza infection. Because there are limited high-quality adult influenza Patient Reported Outcomes (PRO) measures, the aim was to develop and validate a simple but comprehensive questionnaire for epidemiological research and clinical trials.

Methods
Construct and item generation was guided by the literature, concept mapping, focus groups, and interviews with individuals with laboratory-confirmed influenza and expert physicians. Items were administered to 311 people with influenza-like illness (ILI) across 25 US sites. Analyses included classic psychometrics, structural equation modeling (SEM), and Rasch analyses.

Results
Concept mapping generated 149 concepts covering the influenza experience and clustered into symptoms and impact on daily activities, emotions, and others. Items were drafted using simplicity and brevity criteria. Eleven symptoms from the literature underwent review by physicians and patients, and two were removed and one added. The symptoms domain factored into systemic and respiratory symptoms, whereas the impact domains were unidimensional. All domains displayed good internal consistency (Cronbach α ≥ 0.8) except the three-item respiratory domain (α = 0.48). A five-factor SEM indicated excellent fit where systemic, respiratory, and daily activities domains differentiated patients with ILI or confirmed influenza. All scales were responsive over time.

Conclusions
Patient and clinician consultations resulted in an influenza PRO measure with high validity and good overall evidence of reliability and responsiveness. The Influenza Intensity and Impact Questionnaire (FluiiQ™) will improve the evaluation of existing and future agents designed to prevent or control influenza infection by increasing the breadth and depth of measurement in this field.

Influenza symptoms and their impact on elderly adults: randomised trial of AS03-adjuvanted or non-adjuvanted inactivated trivalent seasonal influenza vaccines.

Patient-reported outcomes (PROs) are particularly relevant in influenza vaccine trials in the elderly where reduction in symptom severity could prevent illness-related functional impairment.

Feasibility of conducting a palliative care randomized controlled trial in children with advanced cancer: assessment of the PediQUEST study

Pediatric palliative care randomized controlled trials (PPC-RCTs) are uncommon.

Effects of study design and allocation on participant behaviour-ESDA: study protocol for a randomized controlled trial

BACKGROUND: What study participants think about the nature of a study has been hypothesised to affect subsequent behaviour and to potentially bias study findings. In this trial we examine the impact of awareness of study design and allocation on participant drinking behaviour. METHODS/DESIGN: A three-arm parallel group randomised controlled trial design will be used. All recruitment, screening, randomisation, and follow-up will be conducted on-line among university students. Participants who indicate a hazardous level of alcohol consumption will be randomly assigned to one of three groups. Group A will be informed their drinking will be assessed at baseline and again in one month (as in a cohort study design). Group B will be told the study is an intervention trial and they are in the control group. Group C will be told the study is an intervention trial and they are in the intervention group. All will receive exactly the same brief educational material to read. After one month, alcohol intake for the past 4 weeks will be assessed. DISCUSSION: The experimental manipulations address subtle and previously unexplored ways in which participant behaviour may be unwittingly influenced by standard practice in trials. Given the necessity of relying on self-reported outcome, it will not be possible to distinguish true behaviour change from reporting artefact. This does not matter in the present study, as any effects of awareness of study design or allocation involve bias that is not well understood. There has been little research on awareness effects, and our outcomes will provide an indication of the possible value of further studies of this type and inform hypothesis generation. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12610000846022.

Peripherally inserted central catheter cushioning: a pilot study comparing gauze with silicone foam

A pilot study was conducted to compare gauze with silicone foam that may be left in place for as long as seven days. Adult patients who were receiving treatment via peripherally inserted central catheters were recruited and alternately assigned to either the gauze or silicone foam group. Patient-reported itch and discomfort, nurse-reported ease of removal, and skin status were recorded for four weeks at each weekly dressing change.

Cancer 2015: a longitudinal whole-of-system study of genomic cancer medicine

Genomic cancer medicine promises revolutionary change in oncology. The impacts of 'personalized medicine', based upon a molecular classification of cancer and linked to targeted therapies, will extend from individual patient outcomes to the health economy at large. To address the 'whole-of-system' impact of genomic cancer medicine, we have established a prospective cohort of patients with newly diagnosed cancer in the state of Victoria, Australia, about whom we have collected a broad range of clinical, demographic, molecular, and patient-reported data, as well as data on health resource utilization. Our goal is to create a model for investigating public investment in genomic medicine that maximizes the cost:benefit ratio for the Australian community at large.

Geographic and Educational Factors and Risk of the First Peritonitis Episode in Brazilian Peritoneal Dialysis Study (BRAZPD) Patients

Background and objectives Peritonitis remains as the most frequent cause of peritoneal dialysis (PD) failure, impairing patient's outcome. No large multicenter study has addressed socioeconomic, educational, and geographic issues as peritonitis risk factors in countries with a large geographic area and diverse socioeconomic conditions, such as Brazil.Design, setting, participants, & measurements Incident PD patients recruited from 114 dialysis centers and reporting to BRAZPD, a multicenter observational study, from December 2004 through October 2007 were included. Clinical, dialysis-related, demographic, and socioeconomic variables were analyzed. Patients were followed up until their first peritonitis. Cox proportional model was used to determine independent factors associated with peritonitis.Results In a cumulative follow-up of 2032 patients during 22.026 patient-months, 474 (23.3%) presented a first peritonitis episode. In contrast to earlier findings, PD modality, previous hemodialysis, diabetes, gender, age, and family income were not risk predictors. Factors independently associated with increased hazard risk were lower educational level, non-white race, region where patients live, shorter distance from dialysis center, and lower number of patients per center.Conclusions Educational level and geographic factors as well as race and center size are associated with risk for the first peritonitis, independent of socioeconomic status, PD modality, and comorbidities. Clin J Am Soc Nephrol 6: 1944-1951, 2011. doi: 10.2215/CJN.11431210

Pigmentação exógena em pododáctilos simulando isquemia de extremidades: um desafio diagnóstico provocado por artrópodos da classe Diplopoda (piolhos-de-cobra)

Um paciente de 24 anos relatou ter pisado em um piolho de cobra. Ao ser examinado, este apresentava máculas eritêmato-cianóticas, nos três primeiros pododáctilos do pé direito, com queixas de dor local e parestesias, com fluxos arteriais palpáveis. Os diplopodas são artrópodos cilíndricos segmentados que assumem posição enrodilhada - quando ameaçados - liberam quinonas e outros agentes irritativos e pigmentantes. A coloração de aspecto cianótico lembra sofrimento tissular isquêmico, o que pode confundir profissionais em atendimentos de Emergência, quando a história não apresenta clareza e coerência.

Gengivite Plasmocitária induzida por uso de pimenta

The aim of this case report is present a case in which the patient had plasma cell gingivitis induced by consumption of pepper. Patient A.M.S., male, 23 years, presented himself at the Clinic of Periodontology, complaining of severe pain, bleeding gums and tooth mobility. Interview was conducted not observing anything relevant. In oral evaluation, we observed in the anterior swollen gums, bleeding, suppuration and great touch, and tooth mobility. Being an aggressive framework in relation to patient age, we performed the following laboratory tests: complete blood count, blood sugar, and coagulation, and biopsy in the anterior inferior, because a diagnosis of lymphoma. At the end of antibiotic therapy, a significant improvement of clinical symptoms, pain relief, less swollen gums and reduce the suppuration and mobility. Laboratory tests showed no change. Fifteen days later, the patient returned with worsening of clinical status. The pathological diagnosis was plasma cell gingivitis and then performed a new history by placing greater emphasis on dietary habits, and the patient reported consumption of pepper in their meals, and relate this to clinical presentation. After elimination of pepper diet the patient showed remission of clinical data.

Lesão endoperio: apicectomia com abordagem palatina: Relato de caso clínico com 30 meses de acompanhamento

Traditionally, the apicoectomies are carried out with the vestibular approach for visibility and easiness of access. The aim of this study was to present a case report of a patient with extensive injury endo-periodontal opted for the surgical access through a palatal incision. The patient presented with abscess drainage via periodontal ligament. The periodontal probing coincident with the radiographic apex in mesial tooth on dental element 22. Radiographically it was noted that the periapical lesion extended from the distal of the tooth 11 to the mesial of tooth 23. The tooth 22 had undergone endodontic treatment and showed signs of shutter material extravasation. It was decide to carry out an approach by the Palatine of the tooth to prevent gingival. After the flap elevation, the injury was debrided and apicoectomy was performed. The patient reported no pain or discomfort after surgery. Furthermore, as follow-up of 30 months there was total remission of signs and symptoms presented initially and absence of gingival recession. Therefore, according to the results showed in this case report, it is suggested that the Palatine access is an alternative approach that can be successfully employed in cases of apicoectomies in order to avoid the occurrence of gingival recessions.

Aplicação do enxerto conjuntivo subepitelial para recobrimento de recessões em dentes inferiores

Some regions of the oral cavity present anatomical conditions that seem to hinder the result of gingival recessions coverage. Thus, the aim of this case report was to present two surgeries for gingival recessions coverage in the mandibular teeth performed on the same patient with the follow-up of 24 months. Patient RP, 35 years old, male, Caucasian, nonsmoker, systemically healthy, sought care at the clinic of specialization course in Periodontics from the Araraquara Dental School (Foar-Unesp). His main complaint was the gingival recessions within the lower teeth 33, 34, 35, 43, 44 and 45. Besides the aesthetic nuisance, the patient reported occasional dentin sensitivity. For resolution of the case was referred to the technique of subepithelial connective tissue graft associated with a coronally advanced flap. After 2 years of surgery, it was observed an excellent root guards with significant aesthetic improvement of the case. It can be concluded that the subepithelial connective tissue graft technique was effective in covering of type class I gingival recessions of Miller, even in a region that provides a difficult procedure.

Replantation as treatment for extrusive luxation

In the treatment of extrusive luxation cases, it is important that the repositioning of extruded tooth in the socket is done as soon as possible. If this does not occur, periapical clot becomes organized and makes replantation difficult reposition. In this article the patient referred to the Clinics for dental trauma sustaining extrusive luxation of the maxillary right central incisor. The patient reported having suffered a bicycle accident 12 days before, which caused traumatic tooth injuries. The repositioning was attempted without success and an alternative form of treatment was necessary to solve the case. Intentional tooth replantation, which is the deliberate extraction of the tooth and its replantation, was indicated. This technique allows clot removal and correct repositioning of the extruded tooth. Care should be taken as endodontic treatment is required for the prevention of subsequent infection-related resorption. Intracanal dressing with calcium hydroxide was used for 30 days before final root filling. Splint, systemic antibiotics and avoidance of further damage to the root surface is also important. After 49 months, showed clinical and radiographic characteristics of normality and demonstrates the availability of this technique to adversity in trauma.