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 ◽  
...  

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.

Author(s):  
Ilona Stolpner ◽  
Jörg Heil ◽  
Fabian Riedel ◽  
Markus Wallwiener ◽  
Benedikt Schäfgen ◽  
...  

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.


2010 ◽  
Vol 20 (S3) ◽  
pp. 143-148 ◽  
Author(s):  
Philip Moons

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.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Salzwedel ◽  
I Koran ◽  
E Langheim ◽  
A Schlitt ◽  
J Nothroff ◽  
...  

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


2021 ◽  
pp. bmjspcare-2020-002699
Author(s):  
Marthe Peeters ◽  
Germaine Ottenheijm ◽  
Paul Bienfait ◽  
Daniëlle Eekers ◽  
Anja Gijtenbeek ◽  
...  

IntroductionRoutine assessment of patient-reported outcomes (PROs) in oncology has shown to improve the quality of the delivered care and to prolong survival. However, for successful implementation of routine assessment of PROs, more knowledge on their usability in clinical practice is needed.ObjectiveThis study aimed to cross-sectionally assess the perspective of patients and clinicians on the practicality of routinely measuring PROs in clinical practice for glioma patients.MethodsSemistructured interviews were conducted evaluating the role of healthcare professionals (HCP) in discussing results of PRO measures (PROMs), and the preferred topics, methods and frequency of PRO assessment. Glioma patients, their proxies and HCPs involved in the treatment of glioma patients from eight centres in the Netherlands were included.ResultsTwenty-four patients, 16 proxies and 35 HCPs were interviewed. The majority of patients, proxies and HCPs (92%, 81% and 80%, respectively) were willing to discuss PRO results during consultations. Although HCPs prefer that results are discussed with the nurse specialist, only one-third of patients/proxies agreed. Functioning of daily life was considered important in all three groups. Most participants indicated that discussion of PROM results should take place during standard follow-up visits, and completed at home about 1 week in advance. On group level, there was no preference for administration of questionnaires on paper or digitally. Lastly, all centres had staff available to send questionnaires on paper.ConclusionThis study shows that routine assessment of PROs is desired by patients, proxies and HCP’s in neuro-oncological care in Dutch hospitals.


2021 ◽  
Vol 43 (1) ◽  
Author(s):  
Robert M. Kaplan ◽  
Ron D. Hays

Patient-reported outcomes are recognized as essential for the evaluation of medical and public health interventions. Over the last 50 years, health-related quality of life (HRQoL) research has grown exponentially from 0 to more than 17,000 papers published annually. We provide an overview of generic HRQoL measures used widely in epidemiological studies, health services research, population studies, and randomized clinical trials [e.g., Medical Outcomes Study SF-36 and the Patient-Reported Outcomes Measurement Information System (PROMIS®)-29]. In addition, we review methods used for economic analysis and calculation of the quality-adjusted life year (QALY). These include the EQ-5D, the Health Utilities Index (HUI), the self-administered Quality of Well-being Scale (QWB-SA), and the Health and Activities Limitation Index (HALex). Furthermore, we consider hybrid measures such as the SF-6D and the PROMIS-Preference (PROPr). The plethora of HRQoL measures has impeded cumulative science because incomparable measures have been used in different studies. Linking among different measures and consensus on standard HRQoL measurement should now be prioritized. In addition, enabling widespread access to common measures is necessary to accelerate future progress. Expected final online publication date for the Annual Review of Public Health, Volume 43 is April 2022. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.


2020 ◽  
Author(s):  
Joao Beato ◽  
Sonia Torres-Costa ◽  
Joao Esteves-Leandro ◽  
Manuel Falcão ◽  
Vitor Rosas ◽  
...  

Abstract BackgroundDiabetic retinopathy (DR) and cataract are major complications that lead to significant visual impairment of diabetic patients. This study aims to compare the changes in visual acuity, quality of life and satisfaction after phacoemulsification between type 2 diabetic and nondiabetic patients.MethodsFifty-seven diabetic patients (37 with no diabetic retinopathy [DR], 11 with mild/moderate nonproliferative DR and 9 with severe nonproliferative/proliferative DR) and 45 controls were submitted to first-eye cataract surgery by phacoemulsification alone or with co-adjuvant intravitreal injection of bevacizumab or triamcinolone. National Eye Institute Visual Function Questionnaire (NEI VFQ-25) was recorded preoperatively and 6 months after surgery; and satisfaction evaluated at 1-month. ResultsCorrected distance visual acuity (CDVA) of the operated eye at 1 and 6-months (p<0.001) was significantly higher than preoperative value in the controls and all diabetic subgroups. The final CDVA in the severe nonproliferative/proliferative DR subgroup was significantly lower compared to the controls and the remaining diabetic subgroups (p<0.05). The mean NEI VFQ-25 composite score significantly improved in both control (15.413.2 points) and diabetic (15.413.0 points) groups, without differences among the diabetic subgroups (p>0.05). Overall patient satisfaction was 93% in both control and diabetic groups. ConclusionThis study provides vision-related patient-reported outcomes that support the benefit from phacoemulsification in all stages of DR, as long as there is adequate monitoring and treatment of retinopathy.


2020 ◽  
Vol 8 (7_suppl6) ◽  
pp. 2325967120S0046
Author(s):  
◽  
Megan Flynn ◽  
Anthony Egger ◽  
Yuxuan Jin ◽  
Elizabeth Sosic ◽  
...  

Objectives: Meniscus tears are a common and significant source of knee dysfunction in active young adult patients, and no high-quality prospective cohort or RCTs studies exist evaluating patient-reported outcomes in patients in this age group with ligamentously stable knees. Our objective was to identify patient-reported outcomes and patient-specific risk factors from a prospective cohort with a minimum of one-year follow-up following meniscal repair or excision in patients with ligamentously stable knees. We hypothesized that both groups would have significant improvement in outcomes; patients undergoing meniscal repair would have a higher reoperation rate; and articular cartilage injuries, subsequent knee surgery, and certain demographic characteristics would be significant risk factors to inferior outcomes at one year. Methods: Between February 2015 and December 2017, ligamentously stable meniscal procedures were enrolled and prospectively followed using the outcomes management evaluation system (OME) at Cleveland Clinic. Patients aged 23-39 preoperatively completed a series of validated outcome measurements including the Knee Injury and Osteoarthritis Outcome Score for both Pain (KOOS Pain) and Quality of Life (KOOS QoL). At the time of surgery, physicians documented all intra-articular findings, treatment, and surgical techniques utilized. Patients were followed at minimum of 1-year postoperatively through the OME platform and asked to complete the same outcome instruments done at baseline as well as a question designed to evaluate the Patient Acceptable Symptom State (PASS). The incidence and details of any subsequent knee surgeries were also obtained. Multivariable regression analysis was used to identify significant predictors of outcomes. Results: A total of 371 patients aged 23-39 underwent meniscus excision or repair during the study period. One hundred ninety-four met inclusion criteria, and one-year follow-up was obtained on 72% (n = 139) of the cohort (67% male; median age 32). Both KOOS Pain and KOOS QoL improved significantly at one-year for the entire cohort. Fourteen percent of the cohort (9% on the ipsilateral knee, 5% on the contralateral knee) underwent subsequent surgery at a minimum of one-year postoperatively. The patient-specific risk factors for worse one-year outcomes included preoperative baseline mental capacity score (VR-12 MCS), lower baseline KOOS QoL score, and the intraoperative finding of any grade 3 or 4 chondral changes. Conclusion: Young adult patients with ligamentously stable knees undergoing meniscal surgery have significantly improved patient-reported outcomes regardless of excision or repair; however, 14% of patients underwent additional knee surgery at a minimum of one-year postoperatively. The risk factors for worse outcomes include lower baseline mental health score, lower baseline KOOS QoL score, and any grade 3 or 4 chondromalacia scene.


2020 ◽  
Vol 30 (5) ◽  
pp. 596-601
Author(s):  
Dana Chase ◽  
Helen Q Huang ◽  
Bradley J Monk ◽  
Lois Michelle Ramondetta ◽  
Richard T Penson ◽  
...  

IntroductionTo describe patient-reported outcomes and toxicities at time of treatment discontinuation secondary to progression or toxicities in advanced/recurrent cervical cancer patients receiving chemotherapy with bevacizumab.MethodsSummarize toxicity, grade, and health-related quality of life within 1 month of treatment discontinuation for women receiving chemotherapy with bevacizumab in GOG240.ResultsOf the 227 patients who received chemotherapy with bevacizumab, 148 discontinued study protocol treatment (90 for disease progression and 58 for toxicity). The median survival time from treatment discontinuation to death was 7.9 months (95% CI 5.0 to 9.0) for those who progressed versus 12.1 months (95% CI 8.9 to 23.2) for those who discontinued therapy due to toxicities. The most common grade 3 or higher toxicities included hematologic, gastrointestinal, and pain. Some 57% (84/148) of patients completed quality of life assessment within 1 month of treatment discontinuation. Those patients who discontinued treatment due to progression had a mean decline in the FACT-Cx TOI of 3.2 points versus 2.2 in patients who discontinued therapy due to toxicity. This was a 9.9 point greater decline in the FACT-Cx TOI scores than those who discontinued treatment due to progression (95% CI 2.8 to 17.0, p=0.007). The decline in quality of life was due to worsening physical and functional well-being. Those who discontinued treatment due to toxicities had worse neurotoxicity and pain.DiscussionPatients who discontinued chemotherapy with bevacizumab for toxicity experienced longer post-protocol survival but significantly greater declination in quality of life than those with progression. Future trial design should include supportive care interventions that optimize physiologic function and performance status for salvage therapies.


2018 ◽  
Vol 36 (34) ◽  
pp. 3361-3369 ◽  
Author(s):  
Anna L. Godfrey ◽  
Peter J. Campbell ◽  
Cathy MacLean ◽  
Georgina Buck ◽  
Julia Cook ◽  
...  

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.


2020 ◽  
Vol 12 (1) ◽  
Author(s):  
Petros Katsogiannos ◽  
Eva Randell ◽  
Magnus Sundbom ◽  
Andreas Rosenblad ◽  
Jan W. Eriksson ◽  
...  

Abstract Background To examine the effects of gastric bypass surgery on health-related quality of life (HRQoL) in obese patients with type 2 diabetes, and to investigate their experiences of life adjustments using quantitative and qualitative methods. Methods Thirteen patients with type 2 diabetes and obesity, (body mass index, BMI > 30 kg/m2), participating in a randomized clinical trial, completed this sub-study. HRQoL was evaluated before, and at 6 months and 2 years after gastric bypass surgery, using the RAND- 36-item health survey. At 2 years, interviews for in-depth analysis of HRQoL changes were performed. Results Significant improvement was observed from baseline to 6 months for 2 of the eight health concepts, general health, and emotional well-being. At 2 years, improvements were also seen in physical functioning, energy/fatigue, as well as sustained improvements in general health and emotional well-being. Multiple regression analyses showed mostly non-significant associations between the magnitude of decrease in weight, BMI, and HbA1c during follow-up and improvement in HRQoL. The analyses from qualitative interviews supported a common latent theme “Finding a balance between the experience of the new body weight and self-confidence”. Conclusions The improved HRQoL after gastric bypass surgery in obese patients with type 2 diabetes was not explained specifically by the magnitude of weight loss, but rather by the participants achieving a state of union between body and consciousness. Trial registration ClinicalTrials.gov Identifier NCT02729246. Date of registration 6 April 2016 – Retrospectively registered https://clinicaltrials.gov/ct2/show/NCT02729246?term=bariglykos&draw=2&rank=1


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