Reporting Outcomes and Outcome Measures in Open Rhinoplasty: A Systematic Review.

BACKGROUND: Comparative studies have shown little statistical difference in outcomes following rhinoplasty, demonstrating near equivalent results across all surgical techniques. Cross-study comparisons of these trials are difficult because variation in outcome reporting prevents statistical pooling and analysis. OBJECTIVES: The authors sought to identify all outcomes and outcome measures used to evaluate postoperative results in rhinoplasty. METHODS: An extensive computerized database search of MEDLINE and EMBASE was performed; all trials involving n ≥ 20 patients, aged 18 years and older undergoing a primary, open rhinoplasty procedure, were included for review. RESULTS: Of the 3235 citations initially screened, 72 studies met the stated inclusion criteria. A total of 53 unique outcomes and 55 postoperative outcome measures were identified. Outcomes were divided into 6 unique domains: objective signs, subjective symptom severity, physical function related to activities of daily living, patient satisfaction, surgeon satisfaction, and quality of life. The identified outcome measures consisted of 5 nasal-specific, author-reported instruments; 5 nasal specific, patient-reported instruments; 5 patient-reported, generic instruments; and 40 author-generated instruments. Of the outcome measures identified, the Rhinoplasty Outcomes Evaluation, Sino-Nasal Outcome Test-22, and FACE-Q were the only instruments to demonstrate adequate validity, reliability, and responsiveness to change in patients who underwent a rhinoplasty procedure. CONCLUSIONS: There is heterogeneity in the outcomes and outcome measures employed to assess postsurgical outcomes following rhinoplasty. A standardized core outcome set is urgently needed to make it possible for future investigators to compare results of various techniques in rhinoplasty surgery.

Are We Measuring What Really Counts?

Most published clinical research is faulty because of many reasons, one being faulty design. A remedy to this problem is the correct utilization of the PICOT (population, intervention, comparative intervention, outcome and time horizon) format in the design of a clinical research question. One element of the PICOT format, "outcome," has not been assessed adequately in aesthetic surgery. In this review, we found that in the last decade of all randomized controlled trials and comparative studies published in Aesthetic Surgery Journal, only about half specified a primary outcome. Regrettably, only 40% reported both a primary outcome and justification for choosing this outcome. This poses a credibility issue with the conclusions of the majority of published studies. There is an urgent need to develop critical outcome sets for aesthetic procedures to be utilized by future investigators. With such a critical outcome set, we will be able to pool the results of multiple studies on the same subject and reach conclusive results.

A Retrospective Cohort and Systematic Review of Non-Operative Management of Exposed Calvaria Post-Radiotherapy.

Scalp defects with exposed calvaria that have previously been irradiated present a unique reconstructive challenge. Patients with previously radiated scalp defects often have few reconstructive options due to poor health or personal choice. The aim of this study was to evaluate the results of non-operative management for patients with prior radiotherapy to the scalp who developed exposed calvaria. The outcomes of interest were major and minor complications related to exposed calvaria with a time frame of follow-up of greater than one year or death from any cause. A retrospective chart review was performed to identify patients with prior radiotherapy and surgery for skin cancer to the scalp who subsequently developed exposed calvaria. Data from four surgeons from 2008 to 2019 was collected. Next, a systematic review of PubMed, EMBASE, Cochrane Library, and CINAHL was conducted to identify articles in which non-operative management was utilized for exposed calvaria post-radiotherapy. Nineteen patients were identified who received radiotherapy either before developing recurrent malignancy requiring operation or requiring radiation postoperatively because of close or involved margins and who subsequently developed exposed calvaria. Six of these patients had an additional attempt at local flap or skin grafting that failed. All patients had an American Society of Anesthesiologists score of three or four. All were managed with local wound care. Ten patients had near-complete healing with wound care alone. Eight patients are still alive from one to six years after the presentation. One patient, who remains alive, developed an intracranial abscess requiring long-term antibiotics but was medically compromised by concomitant myelodysplastic syndrome, mantle cell lymphoma on chemotherapy, atrial fibrillation on anticoagulation, and heart failure. Three patients developed new malignancies requiring re-operation with watchful waiting. Two of the three cases resulted in failure to control disease, but control of malignancy occurred in one case with resection of recurrent cancer and exposed bone.  The systematic review of the literature yielded three studies that met the inclusion criteria. None of the studies encountered cases of meningitis, encephalitis, or death due to the non-operative treatment of exposed calvaria post radiation. Coverage of the calvaria with well-vascularized tissue is the reconstructive goal in the majority of circumstances. This case series and systematic review found that non-operative management of exposed calvaria post-radiotherapy can be an option for patients who are either not candidates for aggressive surgical treatment or who refuse surgery.

Effectiveness of an Educational Nursing Intervention on Caring Ability and Burden in Family Caregivers of Patients with Chronic Non-Communicable Diseases. A Preventive Randomized Controlled Clinical Trial.

OBJECTIVES: To evaluate the effect of the "Caring for Caregivers" program in the caring ability and burden in family caregivers of patients with chronic diseases at health care institutions. METHODS: A randomized controlled clinical trial was conducted in 34 relatives of patients with chronic diseases that had cared for them for more than 3 months. Zarit scale was used to measure caregiver burden and the CAI (Caring Ability Inventory) was also used to measure caring ability. An educational intervention was applied based on the "Caring for Caregivers" strategy of the Universidad Nacional de Colombia. RESULTS: Although both groups improved their percentage of unburdened caregivers from the first to the second assessment, the difference between the two assessments was 41.2% in the intervention group whereas it was 11.8% in the control group, being only statistically significant the difference for the intervention group. Regarding the caring ability, no significant changes were identified in both groups. CONCLUSIONS: On family caregivers, it was observed that the "Caring for Caregivers" intervention had a positive impact on decreasing burden, but not on improving the caring ability.

Effectiveness of an Educational Nursing Intervention on Caring Ability and Burden in Family Caregivers of Patients with Chronic NonCommunicable Diseases. A Preventive Randomized Controlled Clinical Trial

Objective. To evaluate the effect of the "Caring for Caregivers" program in the caring ability and burden in family caregivers of patients with chronic diseases at health care institutions. Methods. A randomized controlled clinical trial was conducted in 34 relatives of patients with chronic diseases that had cared for them for more than 3 months. Zarit scale was used to measure caregiver burden and the CAI (Caring Ability Inventory) was also used to measure caring ability. An educational intervention was applied based on the "Caring for Caregivers" strategy of the Universidad Nacional de Colombia. Results. Although both groups improved their percentage of unburdened caregivers from the first to the second assessment, the difference between the two assessments was 41.2% in the intervention group whereas it was 11.8% in the control group, being only statistically significant the difference for the intervention group. Regarding the caring ability, no significant changes were identified in both groups. Conclusion. On family caregivers, it was observed that the "Caring for Caregivers" intervention had a positive impact on decreasing burden, but not on improving the caring ability.

Objetivo. Evaluar el efecto del programa "Cuidando a Cuidadores" en la habilidad del cuidado y la carga de los cuidadores familiares de personas con enfermedad crónica que asisten a una institución de salud. Métodos. Ensayo clínico controlado randomizado, realizado en 34 familiares de personas con enfermedad crónica que los hubieran cuidado por más de 3 meses. Se utilizaron las escalas de ZARIT para medir la sobrecarga del cuidador y el CAI (Caring Ability Inventory) para medir la habilidad del cuidado. Se aplicó una intervención educativa basada en la estrategia "cuidando a cuidadores" de la Universidad Nacional de Colombia. Resultados. Aunque ambos grupos mejoraron en el porcentaje de cuidadores sin sobrecarga de la primera a la segunda evaluación, en el grupo de intervención la diferencia entre los dos momentos de evaluación fue de 41.2%, mientras que en el grupo control fue de 11.8%, estadísticamente significante la diferencia para el grupo de intervención. En la habilidad del cuidado no se identificaron cambios significativos en los dos grupos. Conclusión. En los cuidadores familiares se apreció que la intervención "cuidando a los cuidadores" presentó impacto positivo en disminución de la sobrecarga, pero no en la mejora de la habilidad de cuidado.

Objetivo. Avaliar o efeito do programa "Cuidando a Cuidadores" na habilidade do cuidado e a carga dos cuidadores familiares de pessoas com doenças crônica que frequentam a uma instituição de saúde. Métodos. Ensaio controlado randomizado, realizado em 34 familiares de pessoas com doenças crônica que os tiveram cuidado por mais de 3 meses. Se utilizaram as escalas de ZARIT para medir a sobrecarga do cuidador e o CAI (Caring Ability Inventory) para medir a habilidade do cuidado. Se aplicou uma intervenção educativa baseada na estratégia "cuidando a cuidadores" da Universidade Nacional de Colômbia. Resultados. Embora ambos grupos melhoraram na porcentagem de cuidadores sem sobrecarga da primeira à segunda avaliação, no grupo de intervenção a diferença entre os dois momentos de avaliação é de 41.2%, enquanto que no grupo controle é de 11.8%, sendo unicamente estatisticamente significante esta diferença para o grupo de intervenção. Na habilidade do cuidado não se identificaram câmbios significativos nos dos grupos. Conclusão. Nos cuidadores familiares se apreciou que a intervenção "cuidando aos cuidadores" apresentou impacto positivo em diminuição da sobrecarga, mas não na melhora da habilidade de cuidado.

Evaluación de las aplicaciones locales de una solución limpiadora suave con Dinafitol de Bardana y pH8: estudio realizado en consulta privada / Evaluation of the local application of a mild cleansing solution: study carried out in private consultation

Estudio realizado en consulta privada de los 17 médicos participantes, en 150 pacientes con vulvovaginitis, de los que se reportan 148 casos provenientes de tres principales ciudades del Ecuador (Guayaquil, Quito y Cuenca).Tipo de estudio: Abierto, multicéntrico, no comparativo.Objetivo: Evaluar la eficacia y tolerancia de una solución limpiadora suave con contenido de Bardana, en el período previo al tratamiento específico, como ayuda en el control del prurito y eritema presentes en las vulvovaginitis.Material y método: Se utilizó una solución limpiadora suave con contenido de Dinafitoles de Bardana y nivel de pH 8. Fueron reclutadas 150 pacientes de acuerdo a los criterios de inclusión, no inclusión y exclusión. La sintomatología fue evaluada al inicio y al final del estudio. Se recomendó el uso del producto en higiene local dos veces al día por siete días mientras se esperaba el resultado del examen cito bacteriológico vaginal.Resultados:•98.0% de mejoría y desaparición del prurito.•96.5% de mejoría y desaparición del eritema.En cuanto a la tolerancia al producto utilizado, el 95.3% reportó la calificación de “buena”.Conclusión: Se logró demostrar la utilidad de la solución limpiadora suave con pH8 y contenido de Dinafitol de Bardana, concluyendo que su utilización está justificada en los casos de vulvovaginitis y que, gracias a la tolerancia y aceptación de las pacientes se puede recomendar también su uso cotidiano en la higiene íntima y corporal. Por los resultados obtenidos, podemos considerar el uso de esta solución limpiadora como de primera elección en el manejo de las patologías relacionadas con el prurito y eritema y como un excelente coadyuvante en el tratamiento etiológico de las vulvovaginitis en las que con frecuencia advertimos la presencia de esta sintomatología.

Study carried out in the private consultation of 17 doctors selected to participate in the study that included 150 patients with vulvovaginitis, of which 148 cases are reported from in the three main cities of the Ecuador, (Guayaquil, Quito and Cuenca). Type of study: Open, multicentral, not comparative. Objective: To evaluate the effectiveness and tolerance of a mild cleansing solution, containing Bardana, during the period prior to a specific treatment, in order to help the control of pruritus and erythema present in the vulvovaginitis. Material and method: A mild cleansing solution with a pH level 8 was used. 150 patients were recruited according to the inclusion and exclusion criteria of the study. The symptoms were evaluated at the beginning and at the end of the study. The use of the product was recommended twice a day for seven days while expecting the results of the bacteriological vaginal exam.Results:•98.0% of improvement and disappearance of pruritus.•96.5% of improvement and disappearance of erythema. As for the tolerance to the use of product, 95.3% of the patients reported it as “good”. Conclusion: It was possible to demonstrate the how important is the use of the mild cleansing solution with a pH 8. We conclude that its use is justified in the case of vulvovaginitis and that thanks to its tolerance and the patients' acceptance, it may also be recommended to be used daily in the intimate and corporal hygiene. With the reported results, one can consider the use of this mild cleansing solution as the first election in the handling of pathologies related with pruritus and erythema and as an excellent help for etiological treatment of the vulvovaginitis in those that frequently notice the presence of this symptoms.