An alternative approach to deal with the absence of clinical trials: a proportional meta-analysis of case series studies

PURPOSE: Systematic reviews are criticized for frequently offering inconsistent evidences and absence of straightforward recommendations. Their value seems to be depreciated when the conclusions are uncertain. To describe an alternative approach of evaluating case series studies in health care when there is absence of clinical trials. METHODS: We provide illustrations from recent experiences. Proportional meta-analysis was performed on surgical outcomes: (a) case series studies, (b) use of cryoablation or radiofrequency ablation, and (c) patients with small renal cell carcinoma. The statistically significant difference between both interventions studied was defined if their combined 95% confidential interval (CI) did not overlap. RESULTS: As demonstrated by the example, this analysis is an alternative approach to provide some evidence of the intervention´s effects under evaluation and plotting all available case series in the absence of clinical trials for the health field. CONCLUSIONS: Although we are leading to a low level of evidence to determine efficacy, effectiveness and safety of interventions this alternative approach can help surgeons, physicians and health professionals for a provisionally decision in health care along with their clinical expertise and the patient´s wishes and circumstances in the absence of high-quality primary studies. It´s not a replacement for the gold standard randomized clinical trial, but an alternative analysis for clinical research.

Enhanced Recovery after Elective Open Surgical Repair of Abdominal Aortic Aneurysm: A Complementary Overview through a Pooled Analysis of Proportions from Case Series Studies

Objectives: To evaluate the efficacy and safety of enhanced recovery after surgery (ERAS) programs in elective open surgical repair (OSR) of abdominal aortic aneurysm (AAA).Background: Open surgical repair of AAA is associated with high morbidity and mortality, prolonged hospital stay and high costs. ERAS programs contribute to the optimization of treatment by reducing hospital stay and improving clinical outcomes.Methods: A review of PubMed, EMBASE and LILACS databases was conducted. As only one randomized controlled trial was found, a pooled analysis of proportions from case series was conducted, considering it a complementary overview of the topic. Inclusion criteria were case series with more than five cases reported, adult patients who underwent an elective OSR of AAA and use of an ERAS program. ERAS was compared to conventional perioperative care. The pooled proportion and the confidence interval (CI) are shown for each outcome. The overlap of the CI suggests similar effect of the interventions studied.Results: Thirteen case series studies with ERAS involving 1,250 patients were compared to six case series with conventional care with a total of 1,429 patients. The pooled, respective proportions for ERAS and conventional care were: mortality, 1.51% [95% CI: 0.0091, 0.0226] and 3.0% [95% CI 0.0183, 0.0445]; and incidence of complications, 3.82% [95% CI 0.0259, 0.0528] and 4.0% [95% CI 0.03, 0.05].Conclusion: This review shows that ERAS and conventional care therapies have similar mortality and complication rates in OSR of AAA.

Chronic reparative changes in medium-sized vessels in a case of primary cutaneous anaplastic large-cell lymphoma with angioinvasive features and cytotoxic phenotype: new histopathological findings in line with indolent clinical behavior

Angioinvasion/angiodestruction has been reported in a small subset of primary cutaneous anaplastic large-cell lymphomas (PCALCL). Recently, PCALCL with angioinvasive features and cytotoxic phenotype has been characterized as a variant associated with good clinical outcomes despite worrisome histopathologic features. We report a case of PCALCL with angioinvasive features and cytotoxic phenotype associated with reparative changes on the wall of medium-sized vessels involved by the neoplasm, including intimal fibroblastic proliferation and luminal obliteration. This vascular pattern, although previously unreported in PCALCL, is in accordance with the indolent behavior observed in this entity and provides a further link with lymphomatoid papulosis type E.

Color masking of developmental enamel defects: a case series

Developmental defects involving color alteration of enamel frequently compromise the esthetic appearance of the tooth. The resin infiltration technique represents an alternative treatment for color masking of these lesions and uniformization of tooth color. This technique is considered relatively simple and microinvasive, since only a minimal portion of enamel is removed. This article illustrates the color-masking effect with resin infiltration of fluorosis and traumatic hypomineralization lesions with a case series. The final esthetic outcomes demonstrated the ability of the resin infiltrant to mask the color of white developmental defect lesions, resulting in satisfactory clinical esthetic improvements. However, in more severe cases, the color-masking effect was not complete.

Enamel matrix protein derivative plus synthetic bone substitute for the treatment of mandibular Class II furcation defects: a case series

Objectives: The aim of this study is to report on the treatment of mandibular Class II furcation defects with enamel matrix protein derivative (EMD) combined with a beta TCP/HA (beta-tricalcium phosphate/hydroxyapatite) alloplastic material. Method and Materials: Thirteen patients were selected. All patients were nonsmokers, systemically healthy, and diagnosed with chronic periodontitis; had not taken medications known to interfere with periodontal tissue health and healing; presented one Class II mandibular furcation defect with horizontal probing equal to or greater than 4 mm at buccal site. The clinical parameters evaluated were probing depth (PD), relative gingival margin position (RGMP), relative vertical clinical attachment level (RVCAL), and relative horizontal clinical attachment level (RHCAL). A paired Student t test was used to detect differences between the baseline and 6-month measurements, with the level of significance of .05. Results: After 6 months, the treatment produced a statistically significant reduction in PD and a significant gain in RVCAL and RHCAL, but no observable change in RGMP. RVCAL ranged from 13.77 (+/- 1.31) at baseline to 12.15 (+/- 1.29) after 6 months, with a mean change of -1.62 +/- 1.00 mm (P<.05). RHCAL ranged from 5.54 (+/- 0.75) to 2.92 (+/- 0.92), with a mean change of -2.62 +/- 0.63 mm (P<.05). After 6 months, 76.92% of the patients improved their diagnosis to Class I furcation defects while 23.08% remained as Class II. Conclusion: The present study has shown that positive clinical results may be expected from the combined treatment of Class II furcation defects with EMD and beta TCP/HA, especially considering the gain of horizontal attachment level. Despite this result, controlled clinical studies are needed to confirm our outcomes.

Reconstruction of maxillary ridge atrophy caused by dentoalveolar trauma, using autogenous block bone graft harvested from chin: a case report

Background Dentoalveolar trauma, especially when involving front teeth, negatively affect the patient’s life; in particular, tooth avulsion is a complex injury that affects multiple tissues, and no treatment option offers stable long-term outcomes. The aim of this study was to report a case of reconstruction of atrophic anterior alveolar ridge after tooth loss, performed with autograft harvested from the chin, and subsequent prosthetic rehabilitation with the use of an osseointegrated implant. Case report A 23-years-old Caucasian girl, presented an atrophic alveolar bone in the area of tooth 11, as a result of tooth resorption 10 years after a tooth reimplantation procedure. Reconstruction was performed with autogenous bone harvested from the chin. After 6-months healing period to allow autograft incorporation, a dental implant was inserted. After further 6- months, a screw-retained implant supported metal-ceramic prosthesis was fabricated. Results The prosthetic rehabilitation was successful, and after a follow-up period of 5 years, the achieved result was stable.Conclusion It can be concluded that the autogenous bone graft harvested from the chin, is a safe and effective option for alveolar ridge defects reconstruction, allowing a subsequent placement of a dental implant supporting a prosthetic restoration.

Visual outcomes and pacient satisfaction follwing implantation of a supplementary multifocal IOL in patients undergoing cataract surgery

Purpose: To assess visual outcomes and patient satisfaction following implantation of the Sulcoflex® multifocal intraocular lens (IOL; Rayner Intraocular Lenses Ltd., Hove, UK) in a procedure combining capsular bag lens implantation with sulcus placement of the Sulcoflex® IOL. Setting: Instituto de Oftalmologia de Assis, Assis, SP, Brazil. Methods: Cataract patients > 45 years, with hyperopia ≥ 1.50 D and potential acuity measurement ≥ 20/30 undergoing Sulcoflex® multifocal IOL implantation were included. Monocular and binocular uncorrected near and distance visual acuity (VA) were evaluated at five days, one month, and three months postoperatively. Contrast sensitivity and refraction were measured in a subset of patients three months postoperatively. Patient satisfaction was assessed one month postoperative. Results: This non-consecutive case series comprised 25 eyes of 13 patients. Eleven eyes (52%) had pre-existing retinal pathologies. Monocular distance VA improved significantly at all follow-up visits. At final follow-up, 88% of eyes had monocular uncorrected distance VA (UDVA) of at least 20/25 and 24% had monocular UDVA of 20/20. All eyes had binocular UDVA of at least 20/25, and 58% had binocular UDVA of 20/20. Monocular uncorrected near vision (UNVA) was J1 in 68% of eyes and all patients had binocular UNVA of J1. Of all eyes studied, 92% and 58% achieved a spherical equivalent within 1 D and −0.5 D, respectively. The majority of patients reported satisfaction with visual outcomes. Complications included a postoperative intraocular pressure spike in four eyes. Conclusion: The Sulcoflex® multifocal IOL improves near and distance VA in cataract patients with retinal abnormalities and good VA potential.

United Way and University partnerships in community-wide human services planning and plan implementation: The case of Lincoln/Lancaster County, Nebraska.

Given the similar interests of United Way organizations and universities in planning, implementation, and evaluation of human services, the two social institutions could be extensively and effectively partnering with one another. However, there is little documentation that such cooperative efforts are taking place. This article describes one such collaboration in Lincoln, Nebraska. The purpose of the article is to show the potential of such collaboration to improve community-wide coordination and outcomes by following the principles of a community-engagement model, to generate more effective use of evaluative tools that can assist in developing evidence-based practices in community planning, and to connect areas of study within the university to United Way efforts.

Lean diesel technology and human health: a case study in six Brazilian metropolitan regions

OBJECTIVE: Due to their toxicity, diesel emissions have been submitted to progressively more restrictive regulations in developed countries. However, in Brazil, the implementation of the Cleaner Diesel Technologies policy (Euro IV standards for vehicles produced in 2009 and low-sulfur diesel with 50 ppm of sulfur) was postponed until 2012 without a comprehensive analysis of the effect of this delay on public health parameters. We aimed to evaluate the impact of the delay in implementing the Cleaner Diesel Technologies policy on health indicators and monetary health costs in Brazil. METHODS: The primary estimator of exposure to air pollution was the concentration of ambient fine particulate matter (particles with aerodynamic diameters, <2.5 mu m, [PM2.5]). This parameter was measured daily in six Brazilian metropolitan areas during 2007-2008. We calculated 1) the projected reduction in the PM2.5 that would have been achieved if the Euro IV standards had been implemented in 2009 and 2) the expected reduction after implementation in 2012. The difference between these two time curves was transformed into health outcomes using previous dose-response curves. The economic valuation was performed based on the DALY (disability-adjusted life years) method. RESULTS: The delay in implementing the Cleaner Diesel Technologies policy will result in an estimated excess of 13,984 deaths up to 2040. Health expenditures are projected to be increased by nearly US$ 11.5 billion for the same period. CONCLUSIONS: The present results indicate that a significant health burden will occur because of the postponement in implementing the Cleaner Diesel Technologies policy. These results also reinforce the concept that health effects must be considered when revising fuel and emission policies.

Intraoperative ultrasonography for presumed brain metastases: a case series study

Brain metastases (BM) are one of the most common intracranial tumors and surgical treatment can improve both the functional outcomes and patient survival, particularly when systemic disease is controlled. Image-guided BM resection using intraoperative exams, such as intraoperative ultrasound (IOUS), can lead to better surgical results. Methods: To evaluate the use of IOUS for BM resection, 20 consecutives patients were operated using IOUS to locate tumors, identify their anatomical relationships and surgical cavity after resection. Technical difficulties, complications, recurrence and survival rates were noted. Results: IOUS proved effective for locating, determining borders and defining the anatomical relationships of BM, as well as to identify incomplete tumor resection. No complications related to IOUS were seen. Conclusion: IOUS is a practical supporting method for the resection of BM, but further studies comparing this method with other intraoperative exams are needed to evaluate its actual contribution and reliability.

Orbital Abscess during Endodontic Treatment: A Case Report

Introduction: Orbital infections may result in permanent morbidity because of the severity of infection. Furthermore, delayed diagnosis or treatment of orbital infections can lead to intracranial complications and even death. The majority of orbital infections develop from paranasal sinus infections, cutaneous infections, and periorbital trauma. Dacryocystitis and odontogenic infection are also accounted as potential etiologies but are scarcely reported in scientific literature. Methods: The patient revealed a history of having endodontic treatment on left maxillary second molar performed 2 weeks previously. Moreover, she exhibited signs of facial pain accompanied by sinusitis symptoms, fever, and nasal obstruction the week after this endodontic procedure. The patient presented proptosis, impairment of ocular motility to the right side, facial tenderness, palpebral erythema, and referred decreased visual acuity. Intraoral exam revealed root fragments of left maxillary first molar and an extensive carious lesion on left maxillary second molar. Computed tomography enabled the observation of frontal sinus, left-sided maxillary, opacity of sphenoidal and ethmoidal sinuses, and apical lesion of left maxillary first and second molars, all suggesting the presence of their apex in the maxillary sinus. In addition, images revealed ocular proptosis and presence of high-density areas suggestive of pus in the medial orbital wall region. Results: The patient was submitted to surgical drainage under general anesthesia approximately 8 hours after the clinical evaluation. Conclusions: Early detection of orbital infection, proper diagnostic tests, and treatment may provide successful outcomes of this rarely occurring disease. (J Endod 2012;38:1541-1543)

Laparoscopic Adrenalectomy in Children for Neuroblastoma: Report of Case Series

Background: Neuroblastoma is one of the most common solid tumors in the pediatric population and the adrenal gland is the main abdominal site of this tumor. The laparoscopic approach has become the standard of care for most benign adrenal tumors in adults, but the role of laparoscopic adrenalectomy in children for malignant tumor is still a point of controversy. However, there is a growing experience with laparoscopic neuroblastoma resection of small lesions and the use of minimally invasive techniques for the initial management of infiltrative neuroblastoma in the last years. The aim of this study is to describe our initial experience with laparoscopic adrenalectomy for neuroblastoma in children, based on surgical outcomes. Methods: A retrospective review of 7 laparoscopic adrenalectomies performed in a single institution between October 2008 and October 2009. We focused our analysis on early surgical outcomes. Results: The mean tumoral size was 2.8 +/- 0.9 cm, the average surgical time was 38.6 +/- 65.5 minutes, and the mean hospital stay was 2.9 +/- 1.6 days. One stage IV patient was submitted to conversion due to bleeding and needed blood transfusion. There were no late complications or deaths and the mean follow-up time was 18.8 +/- 6.1 months. Conclusions: The laparoscopic approach for adrenal neuroblastoma resection is feasible in children with good outcomes, but should be reserved to patients with small, well-circumscribed adrenal lesions, without invasive or infiltrative disease.

Factors associated with maternal intrapartum transfers from a freestanding birth centre in Sao Paulo, Brazil: A case control study

Objectives: to identify factors associated with maternal intrapartum transfer from a freestanding birth centre to hospital. Design: case-control study with retrospective data collection. Participants and settings: cases included all 111 women transferred from a freestanding birth centre in Sao Paulo to the referral hospital, from March 2002 to December 2009. The controls were 456 women who gave birth in the birth centre during the same period who were not transferred, randomly selected with four controls for each case. Methods: data were obtained from maternal records. Factors associated with maternal intrapartum transfers were initially analysed using a chi(2) test of association. Variables with p < 0.20 were then included in multivariate analyses. A multiple logistic regression model was built using stepwise forward selection; variables which reached statistical significance at p < 0.05 were considered to be independently associated with maternal transfer. Findings: during the study data collection period, 111(4%) of 2,736 women admitted to the centre were transferred intrapartum. Variables identified as independently associated factors for intrapartum transfer included nulliparity (OR 5.1, 95% CI 2.7-9.8), maternal age >= 35 years (OR 5.4, 95% CI 2.1-13.4), not having a partner (OR 2.8, 95% CI 1.5-5.3), cervical dilation <= 3 cm on admission to the birth centre (OR 1.9, 95% CI 1.1-3.2) and between 5 and 12 antenatal appointments at the birth centre (OR 3.8, 95% CI 1.9-7.5). In contrast, a low correlation between fundal height and pregnancy gestation (OR 0.3, 95% CI 0.2-0.6) appeared to be protective against transfer. Conclusions and implications for practice: identifying factors associated with maternal intrapartum transfer could support decision making by women considering options for place of birth, and support the content of appropriate information about criteria for admission to a birth centre. Findings add to the evidence base to support identification of women in early labour who may experience later complications and could support timely implementation of appropriate interventions associated with reducing transfer rates. (C) 2012 Elsevier Ltd. All rights reserved.

Evaluating sport projects which promote social inclusion for young people: a case study

[EN] This work presents the findings of a participatory research program evaluating the outcomes of an Italian sports program for minors at risk. Using a participatory evaluation approach enabled an evaluation-research close to the real objectives and useful for monitoring and e-planning actions, starting from an initial exploration of the different stakeholders’ views of the project itself. The research design is presented in the form of a case study, emphasizing the continuous involvement of the project’s stakeholders in the evaluation process. The outcomes here presented make evident how the participatory evaluation project allowed a targeted and ongoing monitoring at group level as well as at individual level with the minors involved in the project.

Outcomes feto-neonatali dell'infezione non primaria da Cytomegalovirus

OBIETTIVI: Valutazione del rischio di trasmissione verticale e delle conseguenze dell’infezione congenita da cytomegalovirus (CMV) in caso di infezione non primaria versus l’outcome delle gravidanze complicate da infezione primaria. MATERIALI E METODI: Studio retrospettivo di coorte di gravide con infezione recente da CMV diagnosticata c/o il nostro centro negli anni 2000-2013. Le pazienti sono state suddivise in 2 gruppi in base al risultato delle indagini sierologiche (avidità IgG e immunoblot): il primo con profilo sierologico compatibile con infezione non primaria e l'altro compatibile con infezione primaria da CMV. Sono stati confrontati il rischio di trasmissione e di infezione congenita sintomatica nei due gruppi. RISULTATI: Il follow-up è risultato disponibile in 1122 casi di cui 182 con infezione materna non-primaria e 940 con infezione primaria materna. L’infezione congenita è stata diagnosticata in 7 (3.86%) feti/neonati nei casi di infezione non primaria e in 217 (23%) feti/neonati nei casi di infezione primaria (p<0.001). Tra gli infetti, erano sintomatici 43 (19,8%) e 3 (42,8%) rispettivamente nell’infezione primaria e non primaria. COMMENTO: La preesistente immunità materna offre una protezione contro la trasmissione intrauterina nell’infezione da CMV ma non protegge dalla malattia congenita sintomatica.