-
1.
A comparison of Gordon's functional health patterns model and standard nursing care in symptomatic heart failure patients: A randomized controlled trial.
Türen, S, Enç, N
Applied nursing research : ANR. 2020;:151247
Abstract
BACKGROUND Heart failure (HF) is associated with poor quality of life and increased morbidity and mortality. AIM: This study aimed to investigate effect of application of Gordon's functional health pattern (FHP) model in nursing care of symptomatic HF patients on quality of life, morbidity and mortality in the post-discharge 30-day. METHODS This is a prospective randomized controlled study conducted in a single center. Experimental group received nursing care planned in accordance with Gordon's FHP model. 60 control and 60 experimental HF patients were included in the study. In the control group nursing care was given according to the standard protocol of the hospital whereas in the experimental group nursing care was given in accordance with Gordon's FHP model. Patients in both groups were followed up after discharge at 30th day. RESULTS Mean Minnesota Living with Heart Failure Questionnaire score improved significantly in the experimental group compared to the control group at 30th day (40.2 ± 23.5 vs 62.3 ± 22.9 respectively, p = 0.001). Seven patients (11.7%) in the experimental group and 17 patients (28.3%) in the control group were readmitted in the post discharge 30-day (p = 0.02). Kaplan-Meier survival curve analysis revealed significant difference in 30-day event free survival rates between groups (log-rank p = 0.31). CONCLUSION Application of Gordon's FHP model in the nursing care of HF patients was associated with significantly improved quality of life, and reduced hospital readmission rates at 30th day. This was the only independent predictor of 30-day event free survival.
-
2.
Impact of Canagliflozin Treatment on Health-Related Quality of Life among People with Type 2 Diabetes Mellitus: A Pooled Analysis of Patient-Reported Outcomes from Randomized Controlled Trials.
Cai, J, Delahanty, LM, Akapame, S, Slee, A, Traina, S
The patient. 2018;(3):341-352
-
-
Free full text
-
Abstract
BACKGROUND Evidence from patient-reported outcomes in clinical trials may explain health-related behaviors observed in the real world. OBJECTIVE The purpose of this analysis was to evaluate the effect of treatment with canagliflozin, a sodium glucose co-transporter 2 inhibitor, compared with placebo or sitagliptin on health-related quality-of-life outcomes in participants with type 2 diabetes mellitus from the clinical development program. METHODS Patient-reported outcomes data from four randomized controlled trials of canagliflozin (n = 2536) were pooled and analyzed to evaluate participants' interest in continuing study medication; satisfaction with weight; and physical, mental, and emotional health after 26-52 weeks of treatment with canagliflozin vs. placebo or sitagliptin. RESULTS Upon trial completion, participants treated with canagliflozin were more likely to express interest in continuing study medication than participants treated with placebo or sitagliptin [odds ratio (95% confidence interval) of 1.54 (1.19-1.99); p = 0.001]. Those treated with canagliflozin were also more likely to be satisfied with their weight and report favorable outcomes (score improvement or maintenance of good scores) related to physical and emotional health. CONCLUSIONS The results of this pooled analysis suggest that people with type 2 diabetes mellitus treated with canagliflozin generally had positive experiences with treatment and improvements in health-related quality of life. Future research is needed to determine if these improvements result in improved type 2 diabetes mellitus management and treatment adherence. CLINICALTRIALS. GOV IDENTIFIERS NCT01106625, NCT01106677, NCT01137812, NCT02025907.
-
3.
Satisfaction, quality of life and perception of patients regarding burdens and benefits of vitamin K antagonists compared with direct oral anticoagulants in patients with nonvalvular atrial fibrillation.
Contreras Muruaga, MDM, Vivancos, J, Reig, G, González, A, Cardona, P, Ramírez-Moreno, JM, Martí, J, Suárez Fernández, C, ,
Journal of comparative effectiveness research. 2017;(4):303-312
Abstract
AIM: To compare the satisfaction of patients treated with vitamin K antagonists (VKA) with that of patients treated with direct oral anticoagulants (DOACs) and to determine the impact on quality of life of both treatments in patients with nonvalvular atrial fibrillation (NVAF). METHODS Cross-sectional multicenter study in which outpatients with NVAF completed the ACTS (Anti-Clot Treatment Scale), SAT-Q (Satisfaction Questionnaire) and EQ-5D-3L (EuroQol 5 dimensions questionnaire, 3 level version) questionnaires. RESULTS The study population comprised 1337 patients, of whom 587 were taking DOACs and 750 VKAs. Compared with VKAs, DOACs were more commonly prescribed in patients with a history of stroke and in patients with a higher thromboembolic risk. The study scores were as follows: SAT-Q: 63.8 ± 17.8; EQ-5D-3L total score: 75.6 ± 20.9; visual analog scale: 63.1 ± 20.6; ACTS Burdens: 51.8 ± 8.4 and ACTS Benefits: 11.9 ± 2.4. The ACTS Burdens score and ACTS Benefits score were higher with DOACs than with VKAs (54.83 ± 6.11 vs 49.50 ± 9.15; p < 0.001 and 12.36 ± 2.34 vs 11.48 ± 2.46; p < 0.001 respectively). CONCLUSION NVAF patients treated with oral anticoagulants had many comorbidities and a high thromboembolic risk. Satisfaction and quality of life with oral anticoagulants were high, although they were both better with DOACs than with VKAs.
-
4.
The complex interplay between clinical and person-centered diabetes outcomes in the two genders.
Rossi, MC, Lucisano, G, Pintaudi, B, Bulotta, A, Gentile, S, Scardapane, M, Skovlund, SE, Vespasiani, G, Nicolucci, A, ,
Health and quality of life outcomes. 2017;(1):41
Abstract
BACKGROUND New approaches to cope with clinical and psychosocial aspects of type 2 diabetes (T2DM) are needed; gender influences the complex interplay between clinical and non-clinical factors. We used data from the BENCH-D study to assess gender-differences in terms of clinical and person-centered measures in T2DM. METHODS Clinical quality of care indicators relative to control of HbA1c, lipid profile, blood pressure, and BMI were derived from electronic medical records. Ten self-administered validated questionnaires (SF-12 Health Survey; WHO-5 well-being index; Problem Areas in Diabetes (PAID) 5, Health Care Climate Questionnaire, Patients Assessment of Chronic Illness Care, Diabetes Empowerment Scale, Diabetes Self-care Activities, Global Satisfaction for Diabetes Treatment, Barriers to Taking Medications, Perceived Social Support) were adopted as person-centered outcomes indicators. RESULTS Overall, 26 diabetes clinics enrolled 2,335 people (men: 59.7%; women: 40.3%). Lower percentages of women reached HbA1c levels < =7.0% (23.2% vs. 27.8%; p = 0.03), LDL-cholesterol < 100 mg/dl (48.3 vs. 57.8%; p = 0.0005), and BMI <27 Kg/m2 (27.2 vs. 31.6%; p = 0.04) than men. Women had statistically significant poorer scores for physical functioning, psychological well-being, self-care activities dedicated to physical activities, empowerment, diabetes-related distress, satisfaction with treatment, barriers to medication taking, satisfaction with access to chronic care and healthcare communication, and perceived social support than men; 24.8% of women and 8.8% of men had WHO-5 < =28 (likely depression) (p < 0.0001); 67.7% of women and 55.1% of men had PAID-5 > 40 (high levels of diabetes-related distress) (p < 0.0001). At multivariate analysis, factors associated with an increased likelihood of having elevated HbA1c levels (≥8.0%) were different in men and women, e.g. having PAID-5 levels >40 was associated with a higher likelihood of HbA1c ≥8.0% in women (OR = 1.15; 95%CI 1.05-1.25) but not in men (OR = 1.00; 95%CI 0.93-1.08). CONCLUSIONS In T2DM, women show poorer clinical and person-centered outcomes indicators than men. Diabetes-related distress plays a role as a correlate of metabolic control in women but not in men. The study provides new information about the interplay between clinical and person-centered indicators in men and women which may guide further improvements in diabetes education and support programs.
-
5.
Comparing the effects of ketotifen fumarate eye drops and ketotifen oral pills on symptom severity and quality of life in patients with allergic rhinitis: a double-blind randomized clinical trial.
Akhavan, A, Karimi-Sari, H, Khosravi, MH, Arefzadeh, E, Yavarahmadi, M
International forum of allergy & rhinology. 2015;(5):386-91
-
-
Free full text
-
Abstract
BACKGROUND Allergic rhinitis is a chronic inflammatory disease of nasal mucosa. Previous studies have shown the therapeutic effects of ketotifen eye drops on allergic conjunctivitis and rhinitis patients. This study was designed to compare the effects of ketotifen drops and oral ketotifen pills on symptoms and quality of life in allergic rhinitis patients. METHODS In this double-blind randomized clinical trial, patients with mild allergic rhinitis who were referred to the allergy clinic of Baqiyatallah Hospital from March to April 2014 were randomly allocated to 2 groups; the first group received ketotifen drops (1 drop every 12 hours) with placebo pills (2 pills daily), and the second group received placebo eye drops with ketotifen pills for 4 weeks. Symptoms (sneezing, runny nose, itching, and nasal obstruction) severity were examined and Rhinitis Quality of Life Questionnaire (RQLQ) scores were evaluated in the second and fourth weeks. RESULTS A total of 140 patients were evaluated in 2 groups. The mean age was 30.33 years. There were no significant differences in demographic data between the groups (p > 0.05). Both groups showed a significant improvement in rhinorrhea, nasal congestion, nasal itching, coughing, sneezing, RQLQ, and nasal smear eosinophil percent compared to baseline amounts (p < 0.05). Improvements were significantly more in the drops group (p < 0.05). CONCLUSION Because of the absence of systemic complications in ketotifen eye drops in patients with allergic rhinitis and their easy availability in Iran, using this medication instead of systemic therapies is suggested. Nevertheless, more studies are required to evaluate the long-term effects of using this drug and the recurrence rate of symptoms.
-
6.
Comparison of quality of life and worry of cancer recurrence between endoscopic and surgical treatment for early gastric cancer.
Choi, JH, Kim, ES, Lee, YJ, Cho, KB, Park, KS, Jang, BK, Chung, WJ, Hwang, JS, Ryu, SW
Gastrointestinal endoscopy. 2015;(2):299-307
Abstract
BACKGROUND The quality of life (QOL) of patients who survive early gastric cancer (EGC) is an area of increasing interest. OBJECTIVE To compare the QOL and degree of worry of cancer recurrence in EGC patients who underwent endoscopic submucosal dissection (ESD) or surgery. DESIGN Cross-sectional study. SETTINGS A tertiary referral center. PATIENTS A total of 565 patients with EGC who received ESD or surgery. INTERVENTION Questionnaires. MAIN OUTCOME MEASUREMENTS QOL was evaluated using the Short-form Health Survey and the European Organization for Research and Treatment of Cancer QOL questionnaires (QLQ-C30 and EORTC-QLQ-STO22). Mood disorders and the worry of cancer recurrence were estimated using the Hospital Anxiety and Depression Scale (HADS) and Worry of Cancer Scale, respectively. RESULTS Questionnaires were completed by 55.7% of the ESD (137/246) and 58.9% of the surgery (188/319) patients. The surgery group had more QOL-related symptomatic and functional problems, including fatigue (P=.044), nausea/vomiting (P=.032), appetite loss (P=.023), diarrhea (P<.001), pain (P=.013), reflux symptoms (P=.005), eating restrictions (P<.001), anxiety (P=.015), taste impairment (P=.011), and poor body image (P<.001). The ESD group had significantly higher worry of cancer recurrence scores after adjusting for covariates, especially when visiting their physicians. The HADS results did not differ between the groups. LIMITATIONS Cross-sectional design. CONCLUSIONS Endoscopic treatment for EGC provides a better QOL, but stomach preservation might provoke cancer recurrence worries. Endoscopists should address this issue for relieving a patient's concern of cancer recurrence during follow-up period after ESD. ( CLINICAL TRIAL REGISTRATION NUMBER WHO ICTRP KCT0000791.).
-
7.
Vision-related quality of life before and after keratoplasty for Fuchs' endothelial dystrophy.
Trousdale, ER, Hodge, DO, Baratz, KH, Maguire, LJ, Bourne, WM, Patel, SV
Ophthalmology. 2014;(11):2147-52
Abstract
PURPOSE To assess vision-related quality of life in Fuchs' dystrophy and changes in vision-related quality of life after 3 types of keratoplasty (penetrating keratoplasty [PK], deep lamellar endothelial keratoplasty [DLEK], and Descemet stripping endothelial keratoplasty [DSEK]). DESIGN Prospective, observational case series. PARTICIPANTS Sixty-three subjects with Fuchs' endothelial dystrophy: 12 subjects (12 eyes) received PK, 11 subjects (11 eyes) received DLEK, and 40 subjects (40 eyes) received DSEK. METHODS Subjects were examined before keratoplasty and at regular intervals through 3 years after keratoplasty. At each examination, vision-related quality of life was assessed using the 25-item National Eye Institute Visual Functioning Questionnaire; best spectacle-corrected and uncorrected visual acuities were measured by using the electronic Early Treatment of Diabetic Retinopathy Study protocol; keratometric cylinder was measured by a manual keratometer. Disability glare was measured with a straylight meter. MAIN OUTCOME MEASURES Vision-related quality of life composite score. RESULTS Vision-related quality of life composite score for all eyes with Fuchs' dystrophy before keratoplasty was 72 ± 11 (n = 63) and did not differ between groups (P = 0.88). Vision-related quality of life improved by 6 months (PK, P = 0.008; DLEK, P = 0.03; DSEK, P < 0.001), with continued improvement between 6 months and 3 years after PK (P = 0.01) and DSEK (P = 0.004). At 6 months, the composite score was higher after DSEK than after PK (P = 0.006). At 3 years, there were no differences in composite scores between the 3 treatments (P = 0.33; mean minimum detectable difference, 8 [α = 0.05; β = 0.20]). After keratoplasty, quality of life was correlated with uncorrected visual acuity at 1 year (r = -0.38; P = 0.001) and at 3 years (r = -0.36; P = 0.02), with disability glare at 3 years (r = -0.41; P = 0.02), and with best-corrected visual acuity at 6 months (r = -0.34; P = 0.03), but not thereafter. CONCLUSIONS Vision-related quality of life in patients with Fuchs' endothelial dystrophy is significantly impaired but improves after keratoplasty, irrespective of the technique. The improvement is faster after DSEK than after PK, and this might be explained in part by rapid improvement in uncorrected visual acuity after DSEK. This study affirms an advantage of endothelial keratoplasty over PK with respect to patient-reported outcomes.
-
8.
Functional and psychosocial effects of either a traditional dancing or a formal exercising training program in patients with chronic heart failure: a comparative randomized controlled study.
Kaltsatou, AC, Kouidi, EI, Anifanti, MA, Douka, SI, Deligiannis, AP
Clinical rehabilitation. 2014;(2):128-38
Abstract
OBJECTIVE To compare the effects of traditional dancing with formal exercise training in terms of functional and cardiovascular benefits and motivation in patients with chronic heart failure. DESIGN Randomized controlled trial. SETTING Sports Medicine Laboratory. SUBJECTS Fifty-one Greek male patients aged 67.1±5.5 years with chronic heart failure of New York Heart Association (NYHA) class II-III, participated in an eight-month study. INTERVENTIONS They were randomly assigned to either training with Greek traditional dances (group A, n=18), formal exercise training (group B, n=16) or a sedentary control group (group C, n=17). MAIN MEASURES At entry and the end of the study all patients underwent cardiopulmonary exercise testing, functional ability assessment and quality of life evaluations. The Intrinsic Motivation Inventory was also used to assess participants' subjective experience. RESULTS After training group A showed increased peak oxygen consumption by 33.8% (19.5 vs. 26.1 ml/kg/min, p<0.05) and B by 32.3% (19.5 vs. 25.8 ml/kg/min, p<0.05), maximal treadmill tolerance by 48.5% (p<0.05) and by 46.4% (p<0.05), and a decreased Slope of expired minute ventilation for carbon dioxide output (VE/VCO2) slope by 18% (p<0.05) and 19.5% (p<0.05), respectively. Trained patients revealed significant improvement in the quality of life indices. Intrinsic Motivation Inventory was increased only in group A by 26.2% (3.08 vs. 3.87, p<0.05). CONCLUSIONS Exercise training in chronic heart failure patients with Greek traditional dances led to functional and cardiovascular benefits similar to formal exercise training and to a higher level of motivation.
-
9.
The influence of long-term awareness of hyperlipidemia and of 3 years of dietary counseling on depression, anxiety, and quality of life.
Einvik, G, Ekeberg, O, Lavik, JG, Ellingsen, I, Klemsdal, TO, Hjerkinn, EM
Journal of psychosomatic research. 2010;(6):567-72
Abstract
OBJECTIVE The purpose of this study is to investigate the long-term effects of participation in a cardiovascular screening program and of dietary counseling on self-reported psychosocial outcomes and health concerns. METHODS High-risk subjects (n=563) with hyperlipidemia from the Oslo Diet and Antismoking Study (1972-1977) were reexamined after 25 years and randomly assigned to a new 3-year prospective 2x2 factorial placebo-controlled study in 1997 of n-3 polyunsaturated fatty acids and/or dietary counseling. Hospital Anxiety and Depression Scale (HADS), Life Satisfaction Index (LSI), and a new questionnaire on health concerns and behavior in response to risk information were collected at the 25-year follow-up. Hospital Anxiety and Depression Scale and LSI were evaluated at the end of the 3-year Diet and Omega-3 Intervention Trial on atherosclerosis (DOIT) in 505 subjects. RESULTS Twenty-five years after the screening program, HADS-anxiety was similar to the Norwegian norms (3.3 vs. 3.5), while HADS-depression was significantly lower (3.6 vs. 4.1, P<.01). Patients reported that 25 years of awareness of hyperlipidemia had influenced health concerns through a moderate change in diet habits, some restriction in life conduct, but an improvement of the total life situation. After a novel 3-year intervention in DOIT, there was no difference between the dietary counseling and control group with regard to anxiety, depression, or life satisfaction, but HADS-anxiety increased significantly (4.0 vs. 3.3, P<.001) in both groups. CONCLUSION Compared to the general population, screening-positive subjects did not have increased mental distress 25 years after screening, and beneficial health behavior persisted. Dietary counseling did not affect psychosocial outcomes.
-
10.
Reduced body weight and adiposity with a high-protein diet improves functional status, lipid profiles, glycemic control, and quality of life in patients with heart failure: a feasibility study.
Evangelista, LS, Heber, D, Li, Z, Bowerman, S, Hamilton, MA, Fonarow, GC
The Journal of cardiovascular nursing. 2009;(3):207-15
-
-
Free full text
-
Abstract
BACKGROUND The effectiveness of high-protein (HP) diets in reducing body weight and adiposity and potentially improving clinical outcomes in heart failure (HF) is not known. OBJECTIVE This feasibility study was conducted to evaluate the impact of 3 dietary interventions on body weight and adiposity, functional status, lipid profiles, glycemic control, and quality of life (QOL) in overweight and obese patients with HF and type 2 diabetes mellitus. DESIGN Fourteen patients with HF with a body mass index greater than 27 kg/m2 were randomized to an HP diet, a standard protein diet, or a conventional diet. Data were obtained at baseline and 12 weeks. RESULTS There were no significant differences in age (59 +/- 10 years), sex (78% male), New York Heart Association class (43% class II, 57% class III), and HF etiology or left ventricular ejection fraction (26 +/- 7) between the groups at baseline. Patients on the HP diet demonstrated significantly greater reductions in weight (P = .005), percent body fat (P = .036), total cholesterol (P = .016), triglyceride concentrations (P = .034), and low-density lipoprotein cholesterol (P = .041) and greater improvements in functional status (6-minute walk [P = .010] and VO2 peak [P = .003]), high-density lipoprotein cholesterol (P = .006), and physical QOL scores (P = .022) compared with those on standard protein and conventional diets. CONCLUSION A 12-week HP diet resulted in moderate weight loss and reduced adiposity in a small sample of overweight and obese patients with HF that were associated with improvements in functional status, lipid profiles, glycemic control, and QOL. However, these preliminary findings must be confirmed in studies with more participants and long-term follow-up.