scholarly journals Long-Term Patient Satisfaction and Quality of Life After Breast-Conserving Therapy: A Prospective Study Using the BREAST-Q

2021 ◽  
Author(s):  
Ilona Stolpner ◽  
Jörg Heil ◽  
Fabian Riedel ◽  
Markus Wallwiener ◽  
Benedikt Schäfgen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Risk Factors ◽  
Patient Satisfaction ◽  
Repeated Measures ◽  
Aesthetic Surgery ◽  
Well Being ◽  
Breast Conserving Therapy ◽  
Patient Reported

Abstract Background Poor patient-reported satisfaction after breast-conserving therapy (BCT) has been associated with impaired health-related quality of life (HRQOL) and subsequent depression in retrospective analysis. This prospective cohort study aimed to assess the HRQOL of patients who have undergone BCT using the BREAST-Q, and to identify clinical risk factors for lower patient satisfaction. Methods Patients with primary breast cancer undergoing BCT were asked to complete the BREAST-Q preoperatively (T1) for baseline evaluation, then 3 to 4 weeks postoperatively (T2), and finally 1 year after surgery (T3). Clinicopathologic data were extracted from the patients’ charts. Repeated measures analysis of variance (ANOVA) was used to determine significant differences in mean satisfaction and well-being levels among the test intervals. Multiple linear regression was used to evaluate risk factors for lower satisfaction. Results The study enrolled 250 patients. The lowest baseline BREAST-Q score was reported for “satisfaction with breast” (mean, 61 ± 19), but this increased postoperatively (mean, 66 ± 18) and was maintained at the 1 year follow-up evaluation (mean, 67 ± 21). “Physical well-being” decreased from T1 (mean, 82 ± 17) to T2 (mean, 28 ± 13) and did not recover much by T3 (mean, 33 ± 13), being the lowest BREAST-Q score postoperatively and in the 1-year follow-up evaluation. In multiple regression, baseline psychosocial well-being, body mass index (BMI), and type of incision were risk factors for lower “satisfaction with breasts.” Conclusion Both the aesthetic/surgery-related and psychological aspects are equally important with regard to “satisfaction with breasts” after BCT. The data could serve as the benchmark for future studies.

Significance of patient-reported outcomes for occupational resumption and quality of life after cardiac rehabilitation

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Salzwedel ◽  
I Koran ◽  
E Langheim ◽  
A Schlitt ◽  
J Nothroff ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Performance ◽  
Well Being ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Funding Source ◽  
Patient Reported ◽  
Returning To Work

Abstract Introduction Comprehensive cardiac rehabilitation (CR) programs based on the bio-psycho-social approach of the international classification of functioning and disease are carried out to achieve improved prognosis, superior health-related quality of life (HRQL) and social integration. We aimed to identify predictors of returning to work (RTW) and HRQL among cardiovascular risk factors and physical performance as well as patient-reported outcome measures (PROMs) modifiable during CR. Methods We designed a prospective observational multi-center study and enrolled 1,586 patients (2017/18) in 12 German rehabilitation centers regardless of their primary allocation diagnoses (e.g. acute myocardial infarction (AMI), coronary artery bypass grafting (CABG), coronary artery disease (CAD), valvular disease). Besides general data (e.g. age, gender, diagnoses), parameters of risk factor management (e.g. smoking, lipid profile, hypertension, lifestyle change motivation), physical performance (e.g. maximum exercise capacity, endurance training load, 6-min walking distance), and PROMs (e.g. depression, heart-focused anxiety, HRQL, subjective well-being, somatic and mental health, pain, general self-efficacy, pension desire as well as self-assessment of occupational prognosis using several questionnaires) were documented at CR admission and discharge. 6 months after discharge, status of RTW and HRQL (SF-12) were captured by a follow-up (FU) survey and analyzed in multivariable regression models with multiple imputation of missing values. Results Out of the study participants, 1,262 patients (54±7 years, 77% men) responded to the follow-up survey and could be analyzed regarding the outcome parameters. Most of them were assigned to CR primarily due to AMI (40%) or CAD without myocardial infarction (18%), followed by heart valve diseases in 12% of patients and CABG (8%). 864 patients (69%) returned to work within the follow-up period. Pension desire, negative self-assessed occupational prognosis, heart-focussed anxiety, major life events, smoking and heart failure were negatively associated with RTW, while higher endurance training load, HRQL and work stress were positively associated (Figure 1). HRQL after 6 months was determined more by PROMs (e.g. pension desire, heart-focused anxiety, physical/mental HRQL in SF-12, physical/mental health in indicators of rehab-status questionnaire (IRES-24), stress, well-being in the World Health Organization well-being index and self-efficacy expectations) than by clinical parameters or physical performance. Conclusions Patient-reported outcome measures predominantly influenced RTW and HRQL in heart-disease patients, whereas patients' pension desire and heart-focussed anxiety had a dominant impact on all investigated endpoints. Therefore, the multi-component CR approach focussing on psychosocial support is crucial for subjective health prognosis and occupational resumption. Figure 1. Predictors of returning to work Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): German pension insurance

scholarly journals Hydroxycarbamide Plus Aspirin Versus Aspirin Alone in Patients With Essential Thrombocythemia Age 40 to 59 Years Without High-Risk Features

2018 ◽  
Vol 36 (34) ◽  
pp. 3361-3369 ◽  
Author(s):  
Anna L. Godfrey ◽  
Peter J. Campbell ◽  
Cathy MacLean ◽  
Georgina Buck ◽  
Julia Cook ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Risk Factors ◽  
Platelet Count ◽  
High Risk ◽  
Vascular Events ◽  
End Point ◽  
High Risk Factors ◽  
Patient Reported

Purpose Cytoreductive therapy is beneficial in patients with essential thrombocythemia (ET) at high risk of thrombosis. However, its value in those lacking high-risk features remains unknown. This open-label, randomized trial compared hydroxycarbamide plus aspirin with aspirin alone in patients with ET age 40 to 59 years and without high-risk factors or extreme thrombocytosis. Patients and Methods Patients were age 40 to 59 years and lacked a history of ischemia, thrombosis, embolism, hemorrhage, extreme thrombocytosis (platelet count ≥ 1,500 × 109/L), hypertension, or diabetes requiring therapy. In all, 382 patients were randomly assigned 1:1 to hydroxycarbamide plus aspirin or aspirin alone. The composite primary end point was time to arterial or venous thrombosis, serious hemorrhage, or death from vascular causes. Secondary end points were time to first arterial or venous thrombosis, first serious hemorrhage, death, incidence of transformation, and patient-reported quality of life. Results After a median follow-up of 73 months and a total follow-up of 2,373 patient-years, there was no significant difference between the arms in the likelihood of patients reaching the primary end point (hazard ratio, 0.98; 95% CI, 0.42 to 2.25; P = 1.0). The incidence of significant vascular events was low, at 0.93 per 100 patient-years (95% CI, 0.61 to 1.41). There were also no differences in overall survival; in the composite end point of transformation to myelofibrosis, acute myeloid leukemia, or myelodysplasia; in adverse events; or in patient-reported quality of life. Conclusion In patients with ET age 40 to 59 years and lacking high-risk factors for thrombosis or extreme thrombocytosis, preemptive addition of hydroxycarbamide to aspirin did not reduce vascular events, myelofibrotic transformation, or leukemic transformation. Patients age 40 to 59 years without other clinical indications for treatment (such as previous thrombosis or hemorrhage) who have a platelet count < 1,500 × 109/L should not receive cytoreductive therapy.

Patient-reported outcomes in congenital cardiac disease: are they as good as you think they are?

2010 ◽  
Vol 20 (S3) ◽  
pp. 143-148 ◽  
Author(s):  
Philip Moons
Keyword(s):  
Quality Of Life ◽  
Cardiac Disease ◽  
Patient Reported Outcomes ◽  
Well Being ◽  
Main Question ◽  
Congenital Cardiac Disease ◽  
Patient Reported ◽  
Satisfaction With Treatment

AbstractPatient-reported outcomes are “any outcome based on data provided by patients or patient proxy as opposed to data provided from other sources”. Examples of patient-reported outcomes are quality of life, well-being, functional status, symptoms, adherence to treatment, satisfaction with treatment, and utility or preference-based measures. The main question of this manuscript is whether patient-reported outcomes in patients with congenital cardiac disease are as good as we think they are. In general, we could say yes, because numerous studies show that patients with congenital cardiac disease have an excellent quality of life. By contrast, we could say no, because patients generally overestimate their functioning, and up to two out of three patients are not compliant with the prescribed therapy or recommendations for follow-up. However, most importantly, we have to say that we do not know whether the patient-reported outcomes are good, because research with patient-reported outcomes in congenital cardiac disease is limited. Hence, patient-reported outcomes should be a priority on the agenda for research in the domain of congenital cardiac disease.

scholarly journals A randomised trial of the effect and cost-effectiveness of early intensive multifactorial therapy on 5-year cardiovascular outcomes in individuals with screen-detected type 2 diabetes: the Anglo–Danish–Dutch Study of Intensive Treatment in People with Screen-Detected Diabetes in Primary Care (ADDITION-Europe) study

2016 ◽  
Vol 20 (64) ◽  
pp. 1-86 ◽  
Author(s):  
Rebecca K Simmons ◽  
Knut Borch-Johnsen ◽  
Torsten Lauritzen ◽  
Guy EHM Rutten ◽  
Annelli Sandbæk ◽  
...  
Keyword(s):  
Risk Factors ◽  
Patient Reported Outcomes ◽  
Cost Effective ◽  
Well Being ◽  
Health Technology ◽  
Patient Reported ◽  
All Cause Mortality

BackgroundIntensive treatment (IT) of cardiovascular risk factors can halve mortality among people with established type 2 diabetes but the effects of treatment earlier in the disease trajectory are uncertain.ObjectiveTo quantify the cost-effectiveness of intensive multifactorial treatment of screen-detected diabetes.DesignPragmatic, multicentre, cluster-randomised, parallel-group trial.SettingThree hundred and forty-three general practices in Denmark, the Netherlands, and Cambridge and Leicester, UK.ParticipantsIndividuals aged 40–69 years with screen-detected diabetes.InterventionsScreening plus routine care (RC) according to national guidelines or IT comprising screening and promotion of target-driven intensive management (medication and promotion of healthy lifestyles) of hyperglycaemia, blood pressure and cholesterol.Main outcome measuresThe primary end point was a composite of first cardiovascular event (cardiovascular mortality/morbidity, revascularisation and non-traumatic amputation) during a mean [standard deviation (SD)] follow-up of 5.3 (1.6) years. Secondary end points were (1) all-cause mortality; (2) microvascular outcomes (kidney function, retinopathy and peripheral neuropathy); and (3) patient-reported outcomes (health status, well-being, quality of life, treatment satisfaction). Economic analyses estimated mean costs (UK 2009/10 prices) and quality-adjusted life-years from an NHS perspective. We extrapolated data to 30 years using the UK Prospective Diabetes Study outcomes model [version 1.3;©Isis Innovation Ltd 2010; seewww.dtu.ox.ac.uk/outcomesmodel(accessed 27 January 2016)].ResultsWe included 3055 (RC,n = 1377; IT,n = 1678) of the 3057 recruited patients [mean (SD) age 60.3 (6.9) years] in intention-to-treat analyses. Prescription of glucose-lowering, antihypertensive and lipid-lowering medication increased in both groups, more so in the IT group than in the RC group. There were clinically important improvements in cardiovascular risk factors in both study groups. Modest but statistically significant differences between groups in reduction in glycated haemoglobin (HbA1c) levels, blood pressure and cholesterol favoured the IT group. The incidence of first cardiovascular event [IT 7.2%, 13.5 per 1000 person-years; RC 8.5%, 15.9 per 1000 person-years; hazard ratio 0.83, 95% confidence interval (CI) 0.65 to 1.05] and all-cause mortality (IT 6.2%, 11.6 per 1000 person-years; RC 6.7%, 12.5 per 1000 person-years; hazard ratio 0.91, 95% CI 0.69 to 1.21) did not differ between groups. At 5 years, albuminuria was present in 22.7% and 24.4% of participants in the IT and RC groups, respectively [odds ratio (OR) 0.87, 95% CI 0.72 to 1.07), retinopathy in 10.2% and 12.1%, respectively (OR 0.84, 95% CI 0.64 to 1.10), and neuropathy in 4.9% and 5.9% (OR 0.95, 95% CI 0.68 to 1.34), respectively. The estimated glomerular filtration rate increased between baseline and follow-up in both groups (IT 4.31 ml/minute; RC 6.44 ml/minute). Health status, well-being, diabetes-specific quality of life and treatment satisfaction did not differ between the groups. The intervention cost £981 per patient and was not cost-effective at costs ≥ £631 per patient.ConclusionsCompared with RC, IT was associated with modest increases in prescribed treatment, reduced levels of risk factors and non-significant reductions in cardiovascular events, microvascular complications and death over 5 years. IT did not adversely affect patient-reported outcomes. IT was not cost-effective but might be if delivered at a reduced cost. The lower than expected event rate, heterogeneity of intervention delivery between centres and improvements in general practice diabetes care limited the achievable differences in treatment between groups. Further follow-up to assess the legacy effects of early IT is warranted.Trial registrationClinicalTrials.gov NCT00237549.Funding detailsThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 64. See the NIHR Journals Library website for further project information.

scholarly journals Effect of a telemedicine intervention for diabetes-related foot ulcers on health, well-being and quality of life: secondary outcomes from a cluster randomized controlled trial (DiaFOTo)

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Marjolein M. Iversen ◽  
Jannicke Igland ◽  
Hilde Smith-Strøm ◽  
Truls Østbye ◽  
Grethe S. Tell ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Foot Ulcer ◽  
Well Being ◽  
Foot Ulcers ◽  
Control Group ◽  
Patient Reported ◽  
Reported Health

Abstract Background Follow-up care provided via telemedicine (TM) is intended to be a more integrated care pathway to manage diabetes-related foot ulcers (DFU) than traditionally-delivered healthcare. However, knowledge of the effect of TM follow-up on PROMs including self-reported health, well-being and QOL in patients with DFUs is lacking and often neglected in RCT reports in general. Therefore, in this study of secondary outcomes from the DiaFOTo trial, the aim was to compare changes in self-reported health, well-being and QOL between patients with DFUs receiving telemedicine follow-up care in primary healthcare in collaboration with specialist healthcare, and patients receiving standard outpatient care. Methods The current study reports secondary endpoints from a cluster randomized controlled trial whose primary endpoint was ulcer healing time. The trial included 182 adults with diabetes-related foot ulcers (94/88 in the telemedicine/standard care groups) in 42 municipalities/districts, recruited from three clinical sites in Western Norway. Mean (SD) diabetes duration for the study population was 20.8 (15.0). The intervention group received care in the community in collaboration with specialist healthcare using an asynchronous telemedicine intervention. The intervention included an interactive web-based ulcer record and a mobile phone enabling counseling and communication between the community nurses and specialist healthcare; the control group received standard outpatient care. In total 156 participants (78/78) reported on secondary endpoints: self-reported health, well-being and quality of life evaluated by generic and disease-specific patient-reported outcome measures (e.g. Euro-QOL, the Hospital Anxiety and Depression Scale (HADS), Problem Areas in Diabetes (PAID), Neuropathy and Foot Ulcer–Specific Quality of Life Instrument (NeuroQOL)). Linear mixed-effects regression was used to investigate possible differences in changes in the scores between the intervention and control group at the end of follow-up. Results In intention to treat analyses, differences between treatment groups were small and non-significant for the health and well-being scale scores, as well as for diabetes-related distress and foot ulcer-specific quality of life. Conclusions There were no significant differences in changes in scores for the patient reported outcomes between the intervention and control group, indicating that the intervention did not affect the participants’ health, well-being and quality of life. Trial registration Clinicaltrials.gov, NCT01710774. Registered October 19th, 2012.

scholarly journals Satisfaction with the Aesthetic Effect and Quality of Life for Women after Breast Conserving Therapy (BCT)—Preliminary Research

2019 ◽  
Vol 16 (23) ◽  
pp. 4682 ◽  
Author(s):  
Agata Krzos ◽  
Andrzej Stanisławek ◽  
Marian Jędrych ◽  
Marta Łuczyk ◽  
Barbara Ślusarska
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Patient Satisfaction ◽  
Psychosocial Functioning ◽  
Well Being ◽  
Breast Conserving Therapy ◽  
Aesthetic Outcome ◽  
The Mean ◽  
The Aesthetic

All methods of breast cancer treatment may potentially lead to breast deformities, which are often associated with the reduced mental well-being of patients. Breast conserving therapy (BCT) is commonly used, and its core element is breast conserving surgery (BCS).The aim of this study was to determine the level of satisfaction with the aesthetic outcome of surgery and quality of life (QoL) of breast cancer patients undergoing BCT in a longitudinal study performed three months, six months and 12 months after surgery. This longitudinal observational study was carried out on a group of 91 women. The Breast-QTM BCT 1.0 questionnaire was used in this study. Before surgery, patients assessed their satisfaction with the appearance of their breasts (SwB) at an average level of M = 56.0. Satisfaction with the aesthetic outcome (SwO) of BCS was highest among all patients three months after surgery (M = 63.0). The mean score in the sub-scale of psychosocial well-being (Psycho-soc W-B) before surgery was M = 62.0, while in the subsequent periods of the study, it was higher. The mean score for physical well-being (Physical W-B) before surgery was M = 69.92; and in the subsequent study periods, it was lower. The level of patient satisfaction with the outcome of the surgery and the QoL related to health do not differ significantly in post-operative observation. QoL in terms of psychosocial functioning in patients undergoing BCT is significantly higher 12 months after surgery compared to the pre-operative period. Patient satisfaction with the BCS aesthetic outcome is positively related to the evaluation of QoL in terms of psychosocial functioning.

scholarly journals Long-term patient satisfaction and durability of laparoscopic anti-reflux surgery in a large Danish cohort: study protocol for a retrospective cohort study with development of a novel scoring system for patient selection

BMJ Open ◽  
2020 ◽  
Vol 10 (3) ◽  
pp. e034257
Author(s):  
Jonas Sanberg Ljungdalh ◽  
Katrine Hass Rubin ◽  
Jesper Durup ◽  
Kim Christian Houlind
Keyword(s):  
Quality Of Life ◽  
Cohort Study ◽  
Patient Satisfaction ◽  
Retrospective Cohort Study ◽  
Reflux Disease ◽  
Retrospective Cohort ◽  
Patient Reported

IntroductionLaparoscopic anti-reflux surgery is standard of care in surgical treatment of gastro-oesophageal reflux disease and is not without risks of adverse effects, including disruption of the fundoplication and postfundoplication dysphagia, in some cases leading to reoperation. Non-surgical factors such as pre-existing anxiety or depression influence postoperative satisfaction and symptom relief. Previous studies have focused on a short-term follow-up or only certain aspects of disease, such as reoperation or postoperative quality of life. The aim of this study is to evaluate long-term patient-satisfaction and durability of laparoscopic anti-reflux surgery in a large Danish cohort using a comprehensive multimodal follow-up, and to develop a clinically applicable scoring system usable in selecting patients for anti-reflux surgery.Methods and analysisThe study is a retrospective cohort study utilising data from patient records and follow-up with patient-reported quality of life as well as registry-based data. The study population consists of all adult patients having undergone laparoscopic anti-reflux surgery at The Department of Surgery, Kolding Hospital, a part of Lillebaelt Hospital Denmark in an 11-year period. From electronic records; patient characteristics, preoperative endoscopic findings, reflux disease characteristics and details on type of surgery, will be identified. Disease-specific quality of life and dysphagia will be collected from a patient-reported follow-up. From Danish national registries, data on comorbidity, reoperative surgery, use of pharmacological anti-reflux treatment, mortality and socioeconomic factors will be included. Primary outcome of this study is treatment success at follow-up.Ethics and disseminationStudy approval has been obtained from The Danish Patient Safety Agency, The Danish Health Data Authority and Statistics Denmark, complying to Danish and EU legislation. Inclusion in the study will require informed consent from participating subjects. The results of the study will be published in peer-reviewed medical journals regardless of whether these are positive, negative or inconclusive.Trial registration numberClinicaltrials.gov (NCT03959020).

scholarly journals Affect and Mindfulness as Predictors of Change in Mood Disturbance, Stress Symptoms, and Quality of Life in a Community-Based Yoga Program for Cancer Survivors

2013 ◽  
Vol 2013 ◽  
pp. 1-13 ◽  
Author(s):  
Michael J. Mackenzie ◽  
Linda E. Carlson ◽  
Panteleimon Ekkekakis ◽  
David M. Paskevich ◽  
S. Nicole Culos-Reed
Keyword(s):  
Quality Of Life ◽  
Cancer Survivors ◽  
Well Being ◽  
Mood Disturbance ◽  
Yoga Practice ◽  
Psychological Determinants ◽  
Stress Symptoms ◽  
Patient Reported

Little attention has been paid to the psychological determinants by which benefits are accrued via yoga practice in cancer-related clinical settings. Using a longitudinal multilevel modeling approach, associations between affect, mindfulness, and patient-reported mental health outcomes, including mood disturbance, stress symptoms, and health-related quality of life (HRQL), were examined in an existing seven-week yoga program for cancer survivors. Participants(N=66)were assessed before and after the yoga program and at three- and six-month follow-ups. Decreases in mood disturbance and stress symptoms and improvements in HRQL were observed upon program completion. Improvements in mood disturbance and stress symptoms were maintained at the three- and six-month follow-ups. HRQL exhibited further improvement at the three-month follow-up, which was maintained at the six-month follow-up. Improvements in measures of well-being were predicted by initial positive yoga beliefs and concurrently assessed affective and mindfulness predictor variables. Previous yoga experience, affect, mindfulness, and HRQL were related to yoga practice maintenance over the course of the study.

scholarly journals QOLP-20. A FEASIBILITY STUDY UTILIZING MINDFULNESS MEDITATION DURING CONCOMITANT CHEMORADIATION IN MALIGNANT GLIOMA PATIENTS: HEALTH-REPORTED QUALITY OF LIFE (HRQOL) RESULTS

2020 ◽  
Vol 22 (Supplement_2) ◽  
pp. ii179-ii179
Author(s):  
Dina Randazzo ◽  
Evan Buckley ◽  
James Herndon ◽  
Nicole Cort ◽  
Mary Affronti ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Malignant Glioma ◽  
Mindfulness Meditation ◽  
Malignant Gliomas ◽  
Well Being ◽  
Small Sample ◽  
Coping Skill ◽  
Patient Reported

Abstract BACKGROUND Primary brain tumor patients experience high levels of distress due to their diagnosis and treatment leading to changes in their health-related quality of life (HRQoL). Even with the standard treatment of 6 weeks of radiation with concurrent temozolomide for malignant gliomas, the prognosis remains poor. We sought to provide a new intervention and coping skill for our patients during chemoradiation to alleviate some of their stress and anxiety. Mindfulness meditation is a mind-body therapy used in many other cancer groups which can alleviate stress and improve fatigue, cognition, and sleep. METHODS 15 newly diagnosed malignant glioma subjects started 1-hour weekly phone mindfulness sessions during the 6 weeks of chemoradiation. They completed an in-person mindfulness session and interview upon return to the clinic with a final follow up survey 2 months later. Patient reported outcomes questionnaires were collected at each time point. RESULTS 0/15 subjects completed their post-chemo/in-person visit, and 9 completed their final follow-up surveys 2 months later. Scores for perceived cognition, fatigue, sleep, anxiety, spiritual-well being and mindfulness improved over these time points. Completed HRQoL patient-reported outcome questionnaires with positive trends noted from the mean (SD) post-chemo/in-person visit change from baseline and the follow-up change from baseline were: FACT-Cog perceived Cognitive Impairments subscale 4.11(13.55), 9.14(16.77); FACT-G total -5.48(16.02), 7.02(13.44); FACT-Br total -3.15(24.76), 13.17(23.37); FACIT-F -5(7.68), 0(7.92); and the FACIT-Sp12 -1.38(7.6), 2.17(4.88). Trail making Part A completion times from baseline to follow up decreased over time in 8/9 subjects and 7/9 subjects in Part B. Per the final follow up survey, 7/9 subjects continued their meditation practices after the training sessions and subjectively noted benefits with their stress and anxiety. Conclusion: Despite this small sample size, this mindfulness meditation intervention did positively impact patient-report outcomes of HRQoL in this patient population, thereby larger randomized studies are warranted.

scholarly journals Effect of a telemedicine intervention for diabetes-related foot ulcers on health, well-being and quality of life: Secondary outcomes from a cluster randomized controlled trial (DiaFOTo)

2020 ◽  
Author(s):  
Marjolein Memelink Iversen ◽  
Jannicke Igland ◽  
Hilde Smith-Strøm ◽  
Truls Østbye ◽  
Grethe Seppola Tell ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Foot Ulcer ◽  
Well Being ◽  
Foot Ulcers ◽  
Control Group ◽  
Patient Reported ◽  
Reported Health ◽  
Cluster Randomized

Abstract BACKGROUND Follow-up care provided via telemedicine (TM) is intended to be a more integrated care pathway to manage diabetes-related foot ulcers (DFU) than traditionally-delivered healthcare. However, knowledge of the effect of TM follow-up on PROMs including self-reported health, well-being and QOL in patients with DFUs is lacking and often neglected in RCT reports in general. Therefore, in this study of secondary outcomes from the DiaFOTo trial, the aim was to compare changes in self-reported health, well-being and QOL between patients with DFUs receiving telemedicine follow-up care in primary healthcare in collaboration with specialist healthcare, and patients receiving standard outpatient care. METHODS The current study reports secondary endpoints from a cluster randomized controlled trial whose primary endpoint was ulcer healing time. The trial included 182 adults with diabetes-related foot ulcers (94/88 in the telemedicine/standard care groups) in 42 municipalities/districts, recruited from three clinical sites in Western Norway. Mean (SD) diabetes duration for the study population was 20.8 (15.0). The intervention group received care in the community in collaboration with specialist healthcare using an asynchronous telemedicine intervention. The intervention included an interactive web-based ulcer record and a mobile phone enabling counseling and communication between the community nurses and specialist healthcare; the control group received standard outpatient care. In total 156 participants (78/78) reported on secondary endpoints: self-reported health, well-being and quality of life evaluated by generic and disease-specific patient-reported outcome measures (e.g. Euro-QOL, the Hospital Anxiety and Depression Scale (HADS), Problem Areas in Diabetes (PAID), Neuropathy and Foot Ulcer–Specific Quality of Life Instrument (NeuroQOL)). Linear mixed-effects regression was used to investigate possible differences in changes in the scores between the intervention and control group at the end of follow-up. RESULTS In intention to treat analyses, differences between treatment groups were small and non-significant for the health and well-being scale scores, as well as for diabetes-related distress and foot ulcer-specific quality of life. CONCLUSIONS There were no significant differences in changes in scores for the patient reported outcomes between the intervention and control group, indicating that the intervention did not affect the participants’ health, well-being and quality of life. Trial registration: clinicaltrials.gov, NCT01710774. Registered October 19th, 2012https://clinicaltrials.gov/ct2/show/NCT01710774?term=iversen+marjolein&draw=2&rank=1

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