SF-36 Quality Of Life Questionnaire Research Articles

Effect of targeted physiotherapy on the quality of life of patients with epilepsy of unknown etiology – a pilot study

Introduction: Epilepsy is one of the most common diseases of the central nervous system. According to the World Health Organization, it accounts for 1% of the global burden of disease worldwide. Pharmacotherapy remains the primary therapeutic tool in this disease. However, more and more emphasis is placed on approaching this group of patients in an interdisciplinary manner, taking their various needs into account: social, professional, economic or psychological. Attention is also paid to the positive impact of physical activity on the quality of life of patients with epilepsy. The patients with diagnosed epilepsy often complain of a feeling of instability not reflected in standard neurological examination. Early detection of postural control disorders is possible using an objective research tool which is the modified CTSIB test (Clinical Test of Sensory Interaction and Balance). Aim of the study: The aim of the study was to assess the influence of targeted physical therapy on the quality of life among patients with diagnosed epilepsy of unknown etiology using the SF-36 quality of life questionnaire. Materials and methods: The study included 11 professionally active adults with diagnosed generalized epilepsy of unknown etiology, treated at the Department or Outpatient Clinic of Neurology at John Paul II Specialist Hospital in Kraków. Finally, out of the 11 recruited patients (5 women and 6 men), 1 patient was excluded from the study due to a history of craniocerebral trauma. Patients were examined 3 times every month using EEG and the SF-36 quality of life questionnaire. Additionally, between the 2nd and the 3rd month of the pilot study, the study group underwent physical therapy focused on balance disorders using the Biodex SD stabilometric platform. Results: Overall, the quality of life index measured using the SF-36 quality of life questionnaire in the study group improved after the completion of targeted physical therapy. Conclusions: 1. Generalized epilepsy of unknown etiology results in a significant deterioration in the quality of life of patients, which may also be accompanied by disorders of postural control. 2 A targeted program of physiotherapy in the treatment of patients with generalized epilepsy of unknown etiology may has a positive effect on their quality of life. null

Factors that Influence Soft-tissue Injury in Fractures of the Distal Tibia.

Soft tissue injury associated with fractures of the distal tibia is a predictive factor for a poor prognosis. The purpose of this study was to investigate factors associated with the need for a flap coverage after distal tibial fracture, and whether there was a difference in functional outcomes between patients with flap coverage or no flap coverage for a distal tibial fracture. All fractures of the distal tibia treated in our department between 2010 and 2017 were reviewed. The functional result was assessed using the SF-36 Quality of Life Questionnaire, the Visual Analog Scale (VAS) when walking and the AOFAS scale (American Orthopedic Foot and Ankle Society). 132 distal tibia fractures were reviewed, of which 51 required soft tissue flap reconstruction, which was associated with open fractures (P<0.001, OR 5.25), high energy trauma (P<0.001, OR 1.7)), the use of external fixation (p <0.001, OR 12.5) and the presence of vascular alterations on the Angio-CT scan (P<0.001). No significant differences were found in any of the scales that assessed the functional results between the group of patients who required soft tissue flap reconstruction and the group of patients who did not. We found that the need for a soft tissue flap was associated with the following parameters: open fracture, high energy of trauma, presence of skin necrosis, the use of external fixation and the existence of vascular injury. In relation to functional results, differences were not found between the group that needed coverage with a flap and the one that did not.

Acute patient-reported outcomes in B-cell malignancies treated with axicabtagene ciloleucel.

Chimeric antigen receptor T‐cell therapy with axicabtagene ciloleucel (axi‐cel) has considerably improved survival in adults with relapsed/refractory large B‐cell lymphoma. This study reports patient‐reported outcomes (PROs) such as quality of life (QOL) and toxicity in the first 90 days after treatment. Hematologic cancer patients treated with axi‐cel (N = 103, mean age = 61, 39% female) completed SF‐36 or PROMIS‐29 QOL questionnaires prior to treatment and 90 days after. PRO‐Common Terminology Criteria for Adverse Events toxicity items were completed by patients at baseline and 14, 30, 60, and 90 days after treatment. Mixed models examined change in PROs over time. From preinfusion to 90 days later, patients reported improvements in physical functioning, pain, and fatigue (ps < 0.01), but worsening of anxiety (p = 0.02). Patient‐reported toxicities worsened by day 14 with improvement thereafter. The five most severe symptoms at day 14 included fatigue, decreased appetite, dry mouth, diarrhea frequency, and problems with concentration. Results indicate improvement in some domains of QOL over time with transient patient‐reported toxicities.

Quality of Life After Open Abdominal Treatment With Vacuum-Assisted Wound Closure and Mesh-Mediated Fascial Traction

Little is known about the long-term outcome of open abdomen treatment with vacuum-assisted wound closure and mesh-3. Therefore, this study's purpose is to evaluate this with a particular focus on incisional hernia development and quality of life (QoL). Fifty-five patients who underwent vacuum-assisted wound closure and mesh-mediated fascial traction at our institution from 2006 to 2013 were prospectively enrolled in this study. After a median follow-up period of 3.8 years, 34 patients attended a follow-up examination, including the SF-36 QoL questionnaire. The fascial closure rate was 74% (intention-to-treat) and 89% (per-protocol). Enteroatmospheric fistulae occurred in 1.8%. In-hospital mortality was 16.4%, and during the follow-up period, it was 27.4%. Incisional hernias developed in 35% of the cases.The SF-36 physical role (54.6 ± 41.0 (0-100), P < 0.01), physical functioning (68.4 ± 29.5 (0-100), P = 0.01), and physical component summary (41.6 ± 13.0 (19-62), P = 0.01) scores for the patient population were significantly lower than normative scores. The mental dimensions of QoL showed no differences.A subgroup analysis revealed that the lower scores for physical role, physical functioning, and physical component summary only existed in the subgroup of incisional hernia patients. In contrast, physical and mental SF-36 scores of patients without incisional hernias did not differ from the normative scores. Vacuum-assisted wound closure and mesh-mediated fascial traction seems to result in low complication rates. However, incisional hernias occur in 35%, which are the leading cause of reduced QoL. Measures to further improve this rate, such as prophylactic meshes, have to be evaluated.

Evaluation of SF-36 Questionnaire Dimensions in Quality of Life of Postmenopausal Women Referring to Yazd City Health Centers in 2019

Introduction: Menopause can have negative effects on the quality of life of postmenopausal women. The main purpose of this study was to evaluate the quality of life of post-menopausal women in Yazd City, Iran. Methods: This descriptive cross-sectional study was conducted among 250 postmenopausal women over 50 years of age in Yazd. The standard SF-36 quality of life questionnaire was used to collect the data. The mean score of quality of life was calculated for the postmenopausal women in different domains based on their age, education, menopausal age, and number of children. Furthermore, the effect of participants’ age, education, menopausal age, and number of children was studied on the questionnaire domains and the mean menopausal age. Results: The participants’ mean age was 62±5/198 years and the mean age of menopause was 54±4/419years. Life expectancy had a significant relationship with education variables, BMI, and number of children, but it had no significant relationship with occupation and age at menopause. The variables of education, employment, and BMI had a direct and significant relationship with the mean age of menopause, but the number of children did not show a significant relationship with the mean age of menopause. Conclusion: Based on the findings, postmenopausal women were at an undesirable level in terms of physical health and social vitality. The information collected through this study can help the authorities to plan appropriate programs and take measures to improve the quality of life in these women.

THE EFFECT OF DIABETES SYMPTOMS ON QUALITY OF LIFE IN INDIVIDUALS WITH TYPE 2 DIABETES.

This study aimed to investigate the effect of symptoms of diabetes on the quality of life of individuals with Type 2 diabetes. The study used a cross-sectional design. No sampling procedure was employed in the study; instead, 410 individuals presenting to the Balikesir Atatürk City Hospital Endocrinology and Internal Medicine Polyclinics between December 2016 and July 2017, diagnosed with Type 2 diabetes, and meeting the inclusion criteria were enrolled in the study sample. The study data were collected with a "Socio-demographic Characteristics Questionnaire", the "Diabetes Symptom Checklist", and the "SF-36 Quality of Life Questionnaire". The participants obtained the highest mean scores from the hyperglycemia subscale of the Diabetes Symptoms Checklist (3.35±0.60) and the mental health subscale of the SF-36 Quality of Life Questionnaire (50.65±8.10). The hypoglycemia, cardiology, psychology, and neurology variables included in the model were statistically significant and predicted 35% of the mental subscale score of the SF 36 questionnaire. SF 36 physical subscale score increased as the hypoglycemia, cardiology, psychology, and neurology scores decreased (p<0.05). The participants obtained high scores from the hyperglycemia subscale of the diabetes symptom checklist and mental health subscale of the quality of life questionnaire. Diabetes symptoms were found to affect the quality of life of individuals with diabetes.

Опыт применения фиксированной комбинации рамиприла и индапамида в клинической практике

Relevance. Arterial hypertension is one of the most common cardiovascular diseases in the adult population, but much has already been achieved in its treatment. The advantages of combination therapy, according to the clinical recommendations "Arterial Hypertension in Adults" in 2020, are as follows: an increase in the degree of blood pressure reduction is much stronger than an increase in the dose of a single drug; the possibility of physiological and pharmacological synergy between drugs of different classes, which may underlie a more pronounced reduction in blood pressure and better tolerability of treatment; suppression of the opposite mechanisms of increasing blood pressure. Aim. Aim of the study was to study the effect of the antihypertensive drug – Konsilar-D24 on the clinical picture, HRV data, and hemodynamic parameters in patients with stage II hypertension of the 2nd degree. Materials and methods. 40 patients with stage II AH and grade 2 AH were examined. During the outpatient examination, all patients were evaluated for HRV, SCAD, SMAD, ECHO-KG, ECG, GFR, laboratory and biochemical examination (UAC, OAM, blood bch-creatinine, urea, glucose, ASAT, ALAT), and the SF-36 quality of life questionnaire. Results. An increase in SVVR, a decrease in blood pressure, and an increase in the quality of life of the patient. Discussion: Konsilar-D24 is an effective antihypertensive agent for grade 2 hypertension in the complex treatment of stage II hypertension. Against the background of therapy, there is a persistent achievement of target figures, an increase in vagal tone. There is a metabolic neutrality of the drug, as well as nephro and cardioprotective effects. Keywords: arterial hypertension, ramipril, indapamide For citation: Kochetkovа I.V. Experience of using a fixed combination of ramipril and indapamide in clinical practice. Consilium Medicum. 2021; 23 (1): 103–108. DOI: 10.26442/20751753.2021.1.200759

Quality of life of patients undergoing specific allergen immunotherapy in allergic rhinitis

Although allergic diseases have been known since antiquity, both their understanding and systematics came later. The World Allergy Organization (WAO) defines the phenomenon of atopy as a predisposition of a person or family to the uncontrolled synthesis and release of IgE antibodies. Allergic rhinitis (AR) is one of the most important clinical diseases of rhinitis (NN, rhinitis). AR significantly reduces the quality of life, tends to increase, and its consequences may be life-threatening diseases. The aim of the study is to determine the quality of life of patients who underwent specific allergen immunotherapy in allergic rhinitis. The study was conducted at the Center for Specialist Allergology in Lublin between October 2018 - February 2019. The study covered a group of 157 patients. The diagnostic method used was a questionnaire. The first research tool was own questionnaire consisting of 31 questions. The second tool was the standardized questionnaire, the Polish version of the SF-36 Quality of Life Questionnaire. Studies have shown statistically significant changes in the symptoms of before and after immunotherapy, which means improving the quality of life and reducing the severity of symptoms and problems of respondents after therapy. The respondents were not in the best of health (50%). Over 50% of respondents said that the immunotherapy process significantly reduced personal / family expenses for treatment associated with allergic rhinitis. The conducted process of specific allergen immunotherapy improved the quality of life of respondents by increasing awareness of the quality of life through the prism of health change in relation to the general indicator in the area of mental problems by reducing their nuisance value more than in the area of somatic symptoms.

Management of Advanced Stages of Chronic Kidney Disease Patients with the Administration of Renadyl Capsule: A Single Center Pilot Study in Bangladesh

Background: Chronic kidney diseases become a public health concern as the rate of this diseases is increasing. Thus, the aim of the study was to evaluate the changes in key biomarkers in Bangladeshi CKD stages IV and V patients by using Renadyl capsule.&#x0D; Study Design: Open label randomized placebo controlled clinical trial.&#x0D; Methods: Data were collected from patients with CKD stage IV and V in 2017, in an out-patient setting in Kidney Foundation Hospital and Research Institute, Bangladesh. Patient’s information, medical history and clinical data were also collected. Health condition of the patients was collected by using SF-36 QOL questionnaire. Data were analyzed using SPSS software version 23.0.&#x0D; Results: Administration of Renadyl capsule improved the clinical and biochemical data of the patients. Renadyl administration improved the filtration rate, kidney size, creatinine level, heart rate and liver function. Patient’s physical and mental health was also improved.&#x0D; Conclusion: Renadyl administration appeared to be safe among chronic kidney patients with improved kidney function. However, more clinical trials are suggested to determine the efficacy and effects of Renadyl.

Enhanched External Counterpulsation Therapy Improves Clinical Outcomes, Quality of Life and Functional Effort Capacity in Patients with Symptomatic Heart Failure

ABSTRACT Introduction: Symptomatic chronic heart failure is an important health problem that limits the daily life, quality of life, effort capacity and physiological condition of the patients. In subset of these patients symptoms persist despite optimal medical management. Enhanced External Counterpulsation (EECP) is a non-invasive Food and Drug Administration (FDA) approved therapy which improves symptoms and clinical outcomes in patients with heart failure. However, there is limited data in Turkish cohort. In this study, we investigated the clinical effects of EECP on multiple parameters in Turkish patients with symptomatic chronic heart failure. Material and Methods: Twenty-one individuals who were diagnosed with symptomatic chronic heart failure (left ventricular ejection fraction ≤40%) with New York Heart Association Class (NYHA) II-III were enrolled in the study. Patients were assigned to 35-session EECP treatment. NYHA classification, SF-36 quality of life questionnaire, Minnesota living heart failure questionnaire, quality of life index cardiac version-IV and Beck depression scale were assessed, and 6-minute walk tests were performed before and after EECP treatment. Results: The mean age of the patients was 57.4±12.5 years. EECP therapy resulted in significant improvement in NYHA functional class, quality of life index, effort capacity and pyhsiological condition in all patients without any adverse event (p=0.001). Conclusion: Enchanced external counterpulsation treatment significantly improved clinical parameters and effort capacity in patients with symptomatic heart failure. These results suggest that EECP is an effective and a safe therapy in Class II-III heart failure patients whose symptoms persist despite optimal medical management. Keywords: heart failure, symptom, quality of life, depression, EECP

Efficiency of Skhidnytsia’ Drinking Mineral Waters Using to Improve the Quality of Life of the Patients with Chronic Pancreatitis in Combination with Diabetes mellitus

Chronic pancreatitis (CP) and diabetes mellitus (DM) with their consequences cause significant economic losses to patients and their families, as well as to health systems and national economies. Quality of life (QOL) of patients with a combined course of CP and diabetes is an extremely important problem of medical science and practice.The objective: to investigate the effectiveness of comprehensive rehabilitation of patients with chronic pancreatitis with concomitant diabetes mellitus with the inclusion of ademethionine and a course of treatment with drinking mineral waters of Skhidnytsia deposit on the impact on quality of life parameters according to SF-36 and GSRS questionnaires.Materials and methods. We examined 60 outpatients with CP and concomitant diabetes in remission, who were divided into two groups according to treatment programs: 1 group received protocol treatment (pancreatin, proton pump inhibitor, antispasmodic and/or prokinetic, metformin 1000 mg twice a day, ademethionine (400 mg) one tablet 2 times a day for one month, group 2 – in addition to the program of group 1, received a course of drinking mineral water (DMV) according to the proposed scheme. QL was determined by the general international questionnaire MOS SF-36 and special questionnaire GSRS (Gastrointestinal Symptom Rating Scale) in the dynamics of treatment.Results. The decrease in the intensity of abdominal pain in group 1 was 1.6 times, and in group 2 – 2.2 times. The frequency of dyspeptic syndrome probably decreased (p &lt;0.001) in both groups: by 46.66 % – in group 1 and by 70.00 % – in group 2; a 1.7 – fold decrease in the intensity of dyspepsia was observed in patients of group 1 and in group 2 – dyspeptic disorders bothered patients 2 times less. Thus, the rehabilitation complex with the inclusion ohf et DMV course was more effective. In general, one month after the start of medical rehabilitation on the QOL scale of gastroenterological patient GSRS, the total intensity of gastrointestinal symptoms and syndromes on QOL of patients with CP in comorbidity with diabetes mellitus decreased 1.7 times and 2.1 times in groups 1 and 2, respectively, which proved significantly (p&lt;0,001) higher efficiency of the rehabilitation program with the inclusion of the course of DMV according to the proposed method.Conclusion. The use of oral form of ademethionine per 1 month and a 2-week course of drinking mineral waters of the Skhidnytsia deposit according to the proposed scheme significantly increased the effectiveness of the monthly protocol rehabilitation program on the dynamics of physical and mental parameters of quality of life questionnaire SF-36: role physical functioning – by 23,6 % and 16,8 % respectively; pain intensity – by 44,8 % and 33.4 %; general health indicators – by 36.7 % and 36.7 %; vital activity – by 33.4 % and 18.9 % (p&lt;0.001), which allows us to recommend this program for implementation in clinical practice.

Randomized controlled clinical trial evaluating the efficacy of hyperbaric oxygen therapy in facilitating the healing of chronic foot ulcers in diabetic patients: the study protocol

BackgroundDiabetic limb ulcers are highly prevalent and contribute to a significant increase in cost for the treatment of these patients in health services. However, healing of these wounds is a major health problem and may even lead to amputation. The primary aim of the current study is to evaluate the efficacy of hyperbaric oxygen therapy (HBOT) in facilitating the healing of diabetic foot ulcers, in addition to secondarily evaluating whether it reduces the number of amputations and improves the quality of life in these patients.MethodsA non-blind randomized clinical study will be conducted in the city of Imperatriz, Maranhão state, Brazil, from 2019 to 2020, in diabetic patients with chronic foot ulcers (classified as Wagner grades 2, 3 and 4, persisting for more than 1 month). The outpatient follow-up for diabetic foot patients will be done at the Unified Health System, with a sample size of 120 patients (the randomization allocation will be 1:1, being 60 patients for each arm). Half of the patients will receive standard treatment, i.e. dressings, debridement, antibiotics and load relief, along with HBOT (HBOT group), and the other half will receive only standard treatment (control group). The patients of the HBOT group will be evaluated upon admission, after 10, 20, 30 and 35 HBOT sessions, and after 6 months and 1 year. The patients of the control group will also be evaluated at equivalent periods (upon admission, after 2, 4, 6 and 7 weeks, 6 months and 1 year). The SF-36 quality of life questionnaire will be filled upon admission and after 3 months of follow-up in both groups. The primary and secondary endpoints will be assessed with 1 year of follow-up.DiscussionDiabetic foot ulcers are a highly prevalent complication of diabetes with serious consequences. A study to assess the efficacy of HBOT in healing the ulcers and reducing the rate of amputations in diabetic patients is justified, which will eventually aid in the development of guidelines for treating these ulcers.Trial registrationRegistration number RBR-7bd3xy. Registered on 17 July 2019—Retrospectively registered.

Efficacy of Manual Therapy on Pain, Impact of Disease, and Quality of Life in the Treatment of Fibromyalgia: A Systematic Review

Background: Myofascial mobilization has been used as an intervention for patients with fibromyalgia (FM) for acting on ascending nociceptive pathways possibly involved in the central sensitization process, modulating the pain experience. However, there is still a gap in its efficacy compared with another hands-on approach because manual therapy has nonspecific effects, such as placebo. Objectives: This systematic review aims to review the scientific literature for an overview of the efficacy of manual therapy in pain, disease impact, and quality of life in patients with FM compared with control or other treatments through randomized clinical trials. Study Design: This study involved systematic review of published randomized controlled trials (RCTs). Setting: This study examined all RCTs evaluating the effect of manual therapy on pain, impact of disease, and quality of life for patients with FM. Methods: Systematic review. The research was performed in 9 databases: MEDLINE/PubMed, CINAHL, Web of Science, Scopus, ScienceDirect, Lilacs, SciELO, PEDro, and Cochrane. Searches were carried out from the end of the project until September 2019, with no language and year restrictions. Randomized controlled clinical trials that used the following outcome measures were included: Visual Analog Scale, Fibromyalgia Impact Questionnaire, and SF-36 Quality of Life Questionnaire. The risk of bias and quality of studies was assessed using the PEDro scale; the Cochrane risk-of-bias tool; and Grading of Recommendations Assessment, Development, and Evaluation System. Results: Seven studies were included (368 patients). The quantitative analysis was performed on 4 studies because of the lack of data in the others. Myofascial release was the most used modality. The level of evidence ranged from very low to moderate, mainly because of the inconsistency and inaccuracy of results. Limitations: The present systematic review presented limitations because of the heterogeneity of the included studies and only a short-term analysis of the intervention results. It was observed that other information, such as pressure, repetition, and/or sustaining manual therapy techniques, could be better described in future protocols, aiming at a better comparison between the techniques and their subsequent reproducibility. Conclusions: Current evidence of manual therapy in patients with FM, based on a very low to moderate quality of evidence, was inconclusive and insufficient to support and recommend the use of manual therapy in this population. To date, only general osteopathic treatment has achieved clinically relevant pain improvement when compared with control. Key words: Fibromyalgia, manual therapy, pain, quality of life, impact of disease, physiotherapy, manipulation techniques, mobilization

The Effect of Positive Thinking Training on Different Dimensions of Quality of Life of Hemodialysis Patients: A Randomized Controlled Clinical Trial

Background: Nowadays, the quality of life of hemodialysis patients has decreased, which doubled the need for educational interventions. Objectives: The current study investigated the effect of positive thinking training on different dimensions of quality of life of hemodialysis patients. Methods: This is a controlled clinical trial study conducted on 70 hemodialysis patients in Fasa, Fars province, in 2019. The patients were selected using the simple sampling method. Then, they were divided into two groups of intervention (n = 35) and control (n = 35). After obtaining informed consent, the researchers asked the participants to complete the SF-36 Quality of Life Questionnaire. The intervention group was trained positive thinking skills in 8 workshop sessions; each lasted for 90 minutes. Data were analyzed using SPSS version 20. To analyze the data, statistical tests such as chi-square, Kolmogorov-Smirnov, independent, and t-test were used. Results: The mean and standard deviation of the patients’ quality of life in the intervention group increased from 35.95 ± 10.07 to 55.98 ± 11.71 (P &lt; 0.001). The changes in patients’ quality of life before and after the intervention were also assessed in 8 dimensions, which showed that the quality of life of the patients did not change significantly in terms of physical function (P = 0.42) and physical pain (P = 0.62), but for other dimensions, it was significantly increased (P &lt; 0.001). Conclusions: Positive thinking training improved the quality of life of hemodialysis patients, particularly in the dimensions of the emotional role, emotional health, energy and vitality, social performance, and general health is recommended.

Effect of self-care counselling on depression and anxiety in women with endometriosis: a randomized controlled trial

BackgroundConsidering the prevalence of endometriosis and consequent depression and anxiety as well as the resultant effects on the body, mind, and quality of life of patients, this study aimed to determine the effects of self-care counselling on depression and anxiety (primary outcome) and on quality of life (secondary outcome) among women with endometriosis.MethodThis randomized controlled clinical trial was conducted on 76 women with endometriosis who were treated at Al-Zahra Teaching and Treatment Center of Tabriz within the 2015–2019 period. The random blocking method was employed to divide the patients into intervention (counselling) and control groups. In the intervention group, seven self-care group counselling sessions were held on a weekly basis. The control group received routine care. A sociodemographic questionnaire, Beck Depression Inventory, Spielberger State-Trait Anxiety Inventory (STAI) and the SF-36 Quality of Life Questionnaire were completed by the researcher through an interview before and 4 weeks after the intervention.ResultsThere was no significant difference between the intervention and control groups in terms of sociodemographic characteristics (p > 0.05). After the intervention, the mean scores of state anxiety (mean difference: − 0.12, 95% confidence interval: − 9.6 to − 14.4, p < 0.001) and trait anxiety (mean difference: − 10.9: 95% confidence interval: − 9.1 to − 12.7, p = 0.001) were significantly lower in the counselling group than those of the control group. The mean score of depression was lower in the counselling group than in the control group; however, it was not significant (p = 0/565). The mean score of quality of life for physical health (mean difference = 17.2, 95% confidence interval: 13.8 to 20.5, p < 0.001) and for mental health (mean difference = 12.0, 95% confidence interval: 9.0 to 14.9, p < 0.001) were significantly higher in the counselling group than in the control group.ConclusionSelf-care counselling affects the anxiety and quality of life of women with endometriosis. Therefore, in addition to other therapies, this method is proposed to improve quality of life and mental health of patients with endometriosis.Trial registrationIRCT Registration Number: IRCT 20111219008459 N13, registered on February 10, 2019 (https://irct.ir/user/trial/35915).

Six and eight weeks injection frequencies of bevacizumab are non-inferior to the current four weeks injection frequency for quality of life in neovascular age-related macular degeneration: a randomized controlled trial

PurposePatients with neovascular age-related macular degeneration (nARMD) will not deteriorate on visual acuity and retinal thickness when treated with bevacizumab injection frequencies of 6 or 8 weeks compared to 4 weeks. This study aimed to investigate this non-inferiority in quality of life (QoL). We hypothesized that less frequent bevacizumab injections are not inferior regarding patients reported QoL.MethodsPatients were randomized to bevacizumab every 4 (n = 64), 6 (n = 63), and 8 weeks (n = 64). Patients were at least 65 years old, have a best-corrected visual acuity of 20/200 to 20/20, no previous ARMD treatment and active leakage. Vision-related QoL questionnaire NEI VFQ-39 was used to assess QoL at baseline and after 1 year. General QoL questionnaire SF-36 was included for secondary analysis. Multilevel analyses were performed, correcting for age, gender and baseline.ResultsThe 6 (3.68; 95% CI − 0.63 to 8.00) and 8 (2.15; 95% CI − 2.26 to 6.56) weeks bevacizumab regimens resulted in non-inferior QoL differences compared to 4 weeks on the NEI VFQ-39. Also on the SF-36 the differences were well within the non-inferiority limits.ConclusionNon-inferiority of the 6 and 8 weeks frequencies was demonstrated compared to 4 weeks on vision-related and general QoL in patients with nARMD. These results are in line with previously published results of lower frequency injections regarding visual acuity and central retinal thickness. Lower injection frequency may reduce burden, side effects, and treatment costs. In consideration of these results, 8 weeks frequency injections of intravitreal bevacizumab could be considered in patients with nARMD.

The use of elastic bandage and kinesiotherapy in lombar pain treatment: case report

Background: Nowadays, lumbar pain may be one of the most frequent causes of medical leave, regardless of age and gender, and may have a known or unknown cause. Objective: To evaluate the existence of a decrease in pain and improvement in the lumbar functionalities using therapeutic elastic bandaging by the Therapy Taping method and kinesiotherapy. Method: 23 years old subject, 80 pounds, 1.73 high, single, assists in the school transportation of children. The patient answered the questionnaires SF-36 Quality of Life Questionnaire, Oswetry 2.0 Disability Index, McGill pain questionnaire, Visual Analogue Scale and was submitted to Schöber’s flexibility test, as well as an exercise protocol and elastic bandaging application in Region of pain for 6 weeks. Results: The results showed improvement in the tests, decrease of pain, gain of functionality and improvement in quality of life. Conclusion: The use of kinesiotherapy and elastic bandaging was effective for the treatment of chronic low back pain.

Gastrointestinal symptoms in acromegaly: A case control study.

BACKGROUNDAcromegaly is a chronic disease caused by a pituitary somatotroph adenoma resulting in excess secretion of growth hormone, which leads to excess secretion of Insulin like growth factor 1 from the liver, causing abnormal soft tissue growth. There is increasing awareness that diseases affecting connective tissue are associated with an increase in functional gastrointestinal symptoms. Data was collected from patients with a confirmed diagnosis of acromegaly to evaluate the intensity, variety and impact of abdominal symptoms in comparison with a control group who were healthy participants recruited from the local fracture clinic.AIMTo evaluate the frequency type and burden of abdominal symptoms in acromegaly in comparison with a control group.METHODSMedical documentation of patients with a diagnosis of acromegaly treated in one tertiary medical centre between 2010 and 2017 has been analysed. Data was collected from patients with confirmed acromegaly, using the Short Form Health Survey (SF36) and Rome IV Diagnostic questionnaire for Functional Gastrointestinal Disorders in Adults (R4DQ) and compared to a sex- and age-matched control group, to assess the burden of abdominal symptoms. Microsoft Excel and IBM SPSS v 25 were used for data analysis.RESULTSFifty patients with acromegaly (24 male and 26 females; age range 23-64 years, mean 43) and 200 controls (96 male and 104 females; age range 18-84, mean 42.4) were recruited. 92% (46 out of 50) of patients with acromegaly reported abdominal symptoms and 78% (39 out of 50) had at least one functional gastrointestinal disorder according to the Rome IV diagnostic criteria, compared to 16% of controls (OR > 1, P < 0.0001). The most commonly reported symptom was constipation (69% acromegaly vs 21% of controls OR > 1, P < 0.0001, 95%CI: 4.4–15.8). 34 out of 50 (68%) respondents met the criteria for functional constipation according to Rome IV. Upper gastrointestinal disorders were also more prevalent in the acromegaly group. There was no statistically significant difference in the prevalence of biliary and anorectal symptoms between the two groups. Patients in acromegaly group scored lower on the mean scores of the eight parameters of SF36 Quality of Life questionnaire (mean scores 60.04 vs 71.23, 95%CI: -13.6829 to -8.6971, OR > 1, P < 0.001) as compared to the control group.CONCLUSIONUpper and lower functional gastrointestinal tract disorders (defined by Rome IV diagnostic criteria) are significantly more prevalent in patients with acromegaly compared with healthy age and sex matched controls in our study. Functional constipation is the most commonly reported problem. Poorer quality of life may in part be attributable to the increased prevalence of abdominal symptoms.

MON-506 Assessment of Quality of Life in Persons with Thyroid Cancer and Thyroid Nodules: A Single Center Experience

INTRODUCTION: Despite an excellent prognosis and survival rate, quality of life (QOL) in thyroid cancer is lower than expected. QOL in thyroid cancer survivors is similar to persons with colon and gynecologic cancers, but worse than breast cancer.1 The SF-36 QOL questionnaire has shown to be a valid tool for assessing QOL in thyroid cancer subjects.2 We evaluated QOL in both thyroid nodule and thyroid cancer patients in an institutional cancer registry. METHODS: The Short Form-36 data version 2 (SF-36) QOL data was obtained from single institution prospective bioinformatics thyroid cancer and benign nodule registry. Physical and mental health scores from the SF-36 questionnaire were obtained from both thyroid cancer and nodule patients. Physical and mental QOL responses were scored on a scale from 20-80 and categorized as either “the same or better than the average population,”; “below average,”; or “well below average.” A two sample Wilcoxon rank sum test and a chi-squared test were used to compare QOL between thyroid cancer and nodule subjects, using QOL as a continuous or categorical variable. Univariate descriptive statistics and bivariate analyses were performed using a Wilcoxon Rank Sum and Chi-squared test for categorical QOL data and Kruskal-Wallis for continuous QOL data. RESULTS: We analyzed 321 thyroid cancer and 32 nodule subjects who completed the SF-36 at a single point in time after diagnosis. There was no difference between the groups with regard to sex, age or QOL scores overall. Average age was 43 and 48 years in cancer and nodule groups respectively. Average Physical QOL score was 50.8 (standard deviation SD + 8.8) and 29.6 (SD+ 12.1), respectively (p=0.42). Average Mental QOL score was 48.9 (SD + 9.9) and 48.3 (SD + 8.1) respectively, p=0.16. Physical QOL score was significantly decreased as cancer stage increased when evaluating results as a continuous variable: Stage 1: 51.8 + 8.7; Stage 2: 50.6 +9.5; Stage 3: 48.7 + 7.2; Stage 4: 47.4 + 9.2. Results for mental QOL as a continuous variable by cancer stage showed improvement in reported QOL with increasing cancer stage: Stage 1: 48 (SD+ 9.9); Stage 2: 50.6 (SD + 11.1); Stage 3: 51.1 (SD + 9.13); Stage 4: 53 (SD+ 6.4), p=0.03. CONCLUSIONS: We found no overall difference in physical nor mental QOL between patients with thyroid cancer or benign thyroid nodules. Overall, QOL was in the “same or better than average” for all respondents, but low cancer stage was associated with higher physical and lower mental QOL scores.REFERENCES:1. Barbus, Elena & Peştean, Claudiu & Iulia Larg, Maria & Piciu, Doina. (2016). Quality of life in thyroid cancer patients: A literature review. Clujul Medical. 90. 10.15386/cjmed-7032. Lubitz CC, De Gregorio L, Fingeret AL, et al. Measurement and Variation in Estimation of Quality of Life Effects of Patients Undergoing Treatment for Papillary Thyroid Carcinoma. Thyroid. 2017;27(2):197-206. doi:10.1089/thy.2016.0260

Mesenchymal Stem Cells Transplantation in newly diagnosed type-1 diabetes patients:a phase I/II Randomized Controlled trial

Background & Aim Background Insulin injection is a routine treatment for type-1 diabetes which couldn't result in physiologic reaction to blood glucose changes and patients are encountered with diabetes complications. Therefore, a treatment option that leads to modulate the immune system and mitigate the procedure of insulitis could be a hopeful clinical choice. Mesenchymal Stem Cells (MSC) have been shown to have immunomodulatory and regenerative effects. Aim In this clinical trial, autologous bone marrow-derived MSCs (BM-MSCs) were used for immune response modulation and to assess the safety and efficacy of transplantation in newly diagnosed type-1 diabetes patients. Methods, Results & Conclusion Methods A Crossover triple blinded randomized controlled trial in two 12-months periods conducted between 2015 and 2020, at “Royan Institute” with the collaboration of “Growth and Development Research Center of Tehran University of Medical Sciences” in Tehran, Iran. Patients of 8 to 40 years old who have been diagnosed with type-1 diabetes in no more than 6weeks, and met other inclusion criteria, were randomly assigned to receive either two doses of 1 million per kg of patient's body weight MSCs or placebo. Safety was assessed based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. Efficacy was defined as a reduction in the number of hypoglycemic episodes and changes in metabolic indices compared to baseline. Patients’ Quality of life (QOL) was assessed by SF36 and Diabetes Specific QOL (DSQOL) Questionnaires. Percent of regulatory T cells population were assessed in patients’ blood before and 48 hours after MSCs transplantation by flow cytometry. Statistical analysis was done by SPSS v.13. Results The primary outcome was safety concluding there were not any major adverse events in this trial. The total number of hypoglycemic episodes was significantly reduced in patients who received MSCs compared to the placebo group. There were not any significant differences in metabolic indices between intervention and placebo groups. DSQOL showed a significant increase in QOL of patients received MSCs after 12 months compared to baseline. SF36 showed a considerable increase in QOL in patients received MSC. The population of regulatory T cells in patients’ blood was significantly increased 48 hours after MSC transplantation compared to baseline. Conclusion Autologous transplantation of BM- MSCs in newly diagnosed type-1 diabetes patients is safe, feasible, and could improve some of the clinical parameters.