scholarly journals Responsiveness and Convergent Validity of QLU-C10D and EQ-5D-3L in Assessing Short-Term Quality of Life Following Esophagectomy

2021 ◽  
Author(s):  
Norma B. Bulamu ◽  
Ravi Vissapragada ◽  
Gang Chen ◽  
Julie Ratcliffe ◽  
Louise A. Mudge ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Convergent Validity ◽  
Controlled Trial ◽  
Short Term ◽  
Role Function ◽  
Emotional Function ◽  
Ceiling Effects ◽  
The Impact ◽  
Utility Scores

Abstract Aim: This study assessed the responsiveness and convergent validity of two preference-based measures; the newly developed cancer-specific EORTC Quality of Life Utility Measure-Core 10 dimensions (QLU-C10D) relative to the generic three-level version of the EuroQol 5 dimensions (EQ-5D-3L) in evaluating short-term quality-of-life outcomes/utilities after esophagectomy.Methods: Participants were enrolled in a multicentre 2×2 factorial randomised controlled trial to determine the impact of preoperative and postoperative immunonutrition versus standard nutrition in patients with esophageal cancer. Quality-of-life was assessed seven days before and 42 days after esophagectomy. Standardized Response Mean and Effect Size were calculated to assess responsiveness. Ceiling effects for each dimension were calculated as the proportion of the best level responses for that dimension. Convergent validity was assessed using Spearman’s correlation and the level of agreement was explored using Bland–Altman plots. Regression analysis was performed to identify which demographic and clinical factors influenced quality of life. Results: Respondents were 164, predominantly male (81%) with mean age of 63 years. Quality-of-life significantly reduced on both measures with large effect sizes (>80), and greater mean difference on QLU-C10D. Ceiling effects were observed with social activities (86%), mobility (67%), anxiety (55%) and pain (19%) dimensions on EQ-5D-3L. For QLU-C10D ceiling effects were observed with emotional function (53%), physical function (16%), nausea (35%), sleep (31%), bowel problems (21%) and pain (20%). A strong correlation (r=0.71) was observed between EQ-5D-3L anxiety and QLU-C10D emotional function dimensions. Good agreement (3.7% observations outside the limits of agreement) was observed between the utility scores. Blood loss and blood transfusion predicted EQ-5D-3L utility while smoking and tumour length >3cm were predictive of QLU-C10D utility. Changes in QLQ-C30 dimensions of emotional function, role function and pain were predictive of changes in EQ-5D-3L utility while changes in physical, social and role function as well as all the symptom scales were predictive of change in QLU-C10D utility. Conclusion: Although there is strong agreement between utility scores, QLU-C10D was more sensitive to short-term utility changes following esophagectomy. Cognisant of requirements by policy makers to apply generic utility measures in cost effectiveness studies, disease-specific measures should be used alongside the generic measures. Trial registrationThe trial was registered with the Australian New Zealand Clinical Trial Registry (ACTRN12611000178943) on the 15th February 2011.

scholarly journals Responsiveness and convergent validity of QLU-C10D and EQ-5D-3L in assessing short-term quality of life following esophagectomy

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Norma B. Bulamu ◽  
Ravi Vissapragada ◽  
Gang Chen ◽  
Julie Ratcliffe ◽  
Louise A. Mudge ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Convergent Validity ◽  
Controlled Trial ◽  
Short Term ◽  
Clinical Trial Registry ◽  
Emotional Function ◽  
Ceiling Effects ◽  
Randomised Controlled ◽  
The Impact

Abstract Aim This study assessed the responsiveness and convergent validity of two preference-based measures; the newly developed cancer-specific EORTC Quality of Life Utility Measure-Core 10 dimensions (QLU-C10D) relative to the generic three-level version of the EuroQol 5 dimensions (EQ-5D-3L) in evaluating short-term health related quality of life (HRQoL) outcomes after esophagectomy. Methods Participants were enrolled in a multicentre randomised controlled trial to determine the impact of preoperative and postoperative immunonutrition versus standard nutrition in patients with esophageal cancer. HRQoL was assessed seven days before and 42 days after esophagectomy. Standardized Response Mean and Effect Size were calculated to assess responsiveness. Ceiling effects for each dimension were calculated as the proportion of the best level responses for that dimension at follow-up/post-operatively. Convergent validity was assessed using Spearman’s correlation and the level of agreement was explored using Bland–Altman plots. Results Data from 164 respondents (mean age: 63 years, 81% male) were analysed. HRQoL significantly reduced on both measures with large effect sizes (> 0.80), and a greater mean difference (0.29 compared to 0.16) on QLU-C10D. Both measures had ceiling effects (> 15%) on all dimensions at baseline. Following esophagectomy, ceiling effects were observed with self-care (86%), mobility (67%), anxiety/depression (55%) and pain/discomfort (19%) dimensions on EQ-5D-3L. For QLU-C10D ceiling effects were observed with emotional function (53%), physical function (16%), nausea (35%), sleep (31%), bowel problems (21%) and pain (20%). A strong correlation (r = 0.71) was observed between EQ-5D-3L anxiety and QLU-C10D emotional function dimensions. Good agreement (3.7% observations outside the limits of agreement) was observed between the utility scores. Conclusion The QLU-C10D is comparable to the more widely applied generic EQ-5D-3L, however, QLU-C10D was more sensitive to short-term utility changes following esophagectomy. Cognisant of requirements by policy makers to apply generic utility measures in cost effectiveness studies, the disease-specific QLU-C10D should be used alongside the generic measures like EQ-5D-3L. Trial registration: The trial was registered with the Australian New Zealand Clinical Trial Registry (ACTRN12611000178943) on the 15th of February 2011.

P–504 A randomised controlled trial comparing expectant management or intrauterine-insemination in couples with unexplained subfertility and a poor prognosis for natural conception: the impact on health-related-quality-of-life

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
F Mol ◽  
J Wessel ◽  
H A Verhoeve ◽  
J Maas ◽  
J P D Bruin ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Poor Prognosis ◽  
Intrauterine Insemination ◽  
Controlled Trial ◽  
Expectant Management ◽  
Mean Difference ◽  
Anxiety And Depression ◽  
Depression Disorders ◽  
The Impact

Abstract Study question Is health-related quality of life (HRQoL) in women with unexplained subfertility and a poor prognosis influenced by expectant management or intrauterine insemination with ovarian stimulation? Summary answer HRQoL did not differ, except for the relational domain which was lower after expectant management. Anxiety and depression disorders occurred frequently in both groups. What is known already In couples with unexplained subfertility and a poor prognosis, IUI with ovarian stimulation (IUI-OS) is a first line treatment. Not much is known about quality of live or depression and anxiety in these couples. The Fertility Quality of Life (FertiQoL) is reliable for assessment within relational and social domains, the Hospital Anxiety and Depression Scale (HADS) is a reliable tool to detect anxiety and depression disorders. Study design, size, duration We performed a multicentre RCT in couples with unexplained subfertility with a poor prognosis of conceiving naturally within one year. Women were allocated 1:1 to six months expectant management or to six months IUI-OS. HRQoL was assessed with standard self-administered psychometric measures with established reliability and validity: FertiQol and HADS. We intended to include 1091 couples but after almost 4 years, the study had to stop due to slow inclusion and therefore lack of funding. Participants/materials, setting, methods Between June 2017 and September 2020, we recruited 178 women of wich 92 were assigned expectant management and 86 IUI-OS. All women who participated and could read Dutch were eligible for the HRQoL measurements because HRQoL questionnaires in foreign languages were not yet available online. Women completed the questionnaires before randomisation, 3 and 6 months after randomisation. We used mixed model analyses to assess differences between treatment groups and the effect of time. Main results and the role of chance One hundred sixty-two women could read Dutch and were invited (162/178 (91%)). Analyzable data of the FertiQol questionnaire were available for 80% (130/162). Compared to women allocated to IUI-OS, women allocated to expectant management had a lower FertiQol score in the relational domain (mean difference –4.3 (95% CI –7.3 to –1.3) but not in the social domain (mean diff van –0.8 (95% CI –4.5 to 2.9). Data of the HADS questionnaire were available of 156 women (96% (156/162)). Both groups had comparable scores in the Anxiety (mean difference –0.20; 95% CI 0.63; –0.99 to 0.6) and Depressions score (mean difference 0.002; 95% CI –0.67 to 0.67) at all three moments. At baseline, the incidence of an anxiety disorder (definition score 8 or higher) was 19% (30/156) and increased to 30% and 29% at 3 months and 6 months respectively. The incidence of a depression disorder (definition score 8 or higher) was 5% (7/156) and increased to 16% and 18% at 3 months and 6 months respectively. The incidences of anxiety or depression disorders did not differ significantly between expectant management and IUI. Limitations, reasons for caution Our randomized controlled trial did not reach the planned sample size. The results are only applicable to women with unexplained subfertility and a poor prognosis and not to all women with unexplained subfertility. Wider implications of the findings: Although often assumed, IUI-OS does not improve HRQoL compared to expectant management in all domains. IUI might prevent loss of quality of the relationship, but the impact seems small. Future studies should look into the high incidence of anxiety and depression disorders in these women and how to support them. Trial registration number Trial register NL5455 (NTR5599)

scholarly journals Ropivacaine 75mg versus placebo in perineal infiltration for analgesic efficacy at mid- and long-term for episiotomy repair in postpartum women- The ROPISIO study: a two-center, randomized, double-blind, placebo-controlled trial.

2020 ◽  
Author(s):  
Claire CARDAILLAC ◽  
Stéphane Ploteau ◽  
Aurélie Le Thuaut ◽  
Vincent Dochez ◽  
Norbert Winer ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Perineal Pain ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Mediolateral Episiotomy ◽  
The Impact

Abstract Background Perineal pain due to episiotomy is commonly reported and can be severe enough to disturb the mother-infant dyad during the postpartum period. Its incidence at day 7 postpartum varies from 63% to 74%. Recent studies have already investigated the analgesic efficacy of perineal infiltration of ropivacaine after episiotomy, but have only focused on the immediate postpartum period (at 24 and 48 hours after birth). Large, adequately powered, multicenter, randomized controlled trials are required to evaluate the impact of ropivacaine infiltration on perineal pain and mid- and long-term quality of life before the widespread use of ropivacaine to prevent perineal pain after episiotomy can be recommended. Methods The ROPISIO study is a two-center, randomized, double-blind, placebo-controlled trial in La Roche sur Yon and Nantes, France. It will involve 272 women with vaginal singleton delivery and mediolateral episiotomy at term (≥ 37 weeks). Perineal infiltration (ropivacaine 75mg or placebo) will be administrated just after vaginal birth and before episiotomy repair. The primary outcome will be the analgesic efficacy at day 7 postpartum (mid-term), defined by the numerical rating scale of pain (ENS NRS) strictly superior to 3/10 on the perineal repair area. Secondary outcomes will be the analgesic efficacy (ENS NRS), the impact of pain on daily behavior, on the quality of life (36-Item Short Form Health Survey), on the occurrence of symptoms of postpartum depression (Edinburgh Postnatal Depression Scale) and on sexuality (Female Sexual Function Index) at 3 and 6 months (long-term) using validated online questionnaires. This study will have 90% power to show approximately 30% relative risk reduction in the incidence of perineal pain at day 7, from 70.0% to 50.0%. Discussion Ropivacaine is a promising candidate drug, inexpensive, easy to administer, and would be suitable to include in the routine management of deliveries in labor ward. This study will investigate if perineal ropivacaine infiltration just after birth can reduce mid- and long-term postpartum pain and increase quality of life in women with mediolateral episiotomy.

A Proposal of an innovative program for informal caregivers of patients with mood disorders

2017 ◽  
Vol 41 (S1) ◽  
pp. S603-S603
Author(s):  
J. Cabral ◽  
C. Barreto Carvalho ◽  
P. Castilho Freitas ◽  
C. Pato
Keyword(s):  
Quality Of Life ◽  
Mood Disorders ◽  
Negative Impact ◽  
Controlled Trial ◽  
Informal Caregivers ◽  
Well Being ◽  
Control Group ◽  
Compassion Focused Therapy ◽  
The Impact

IntroductionIntervention with informal caregivers (IC) of psychiatric patients is internationally recognized as relevant and a priority. However, the existing responses in this area are still insufficient, especially regarding caregivers of individuals with mood disorders (MD). Mindfulness and compassion focused therapy have proven to be an effective approach in stress reduction and in improving emotional and social well-being of caregivers of patients with other conditions. However, no studies testing these new approaches in IC of patients with MD have been carried out. The objective of this work is to present a research project that aims to develop, implement and empirically test the effectiveness of an innovative group program to help informal caregivers of individuals with mood disorders to cope with the negative impact of the disease and reduce caregiver burdens.MethodsThe design of this experimental study to test the program's efficacy is a non-randomised controlled trial (nrct) with 12 months follow-up, with a mixed assessment methodology (quantitative and qualitative analysis). A sample of 60 informal caregivers of individuals with chronic MD will be constituted (n = 30 Control group; n= 30 Experimental group).ResultsWe expect the program to promote significant changes in participants in terms of several emotional variables (eg: burden, stress, resilience, compassion and quality of life).ConclusionsFurther efforts to continue studying the impact of interventions in caregivers should be carried out, as a way to improve the quality of life of caregivers and their ability to provide informal care to MD patients.Disclosure of interestThe authors have not supplied their declaration of competing interest.

Harnessing Telehealth to Mitigate the Impact of the COVID-19 Pandemic on Sleep and Well-being: A Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Kathleen P. O'Hora ◽  
Raquel A. Osorno ◽  
Dena Sadeghi-Bahmani ◽  
Mateo Lopez ◽  
Allison Morehouse ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Early Treatment ◽  
Controlled Trial ◽  
Well Being ◽  
Control Group ◽  
Randomized Controlled ◽  
The Impact ◽  
Insomnia Symptoms

BACKGROUND The COVID-19 Pandemic led to drastic increases in the prevalence and severity of insomnia symptoms. These increases in insomnia complaints have been paralleled by significant decreases in well-being, including increased symptoms of depression, anxiety, and suicidality and decreased quality of life. However, the efficacy and impact of early treatment of insomnia symptoms on future sleep and well-being remains unknown. OBJECTIVE Here, we present the framework and protocol for a novel study that aims to investigate whether a brief telehealth insomnia intervention targeting new insomnia that developed during the pandemic prevents deterioration of well-being, including symptoms of insomnia, depression, anxiety, suicidality, and quality of life. METHODS The protocol details a two-arm randomized controlled trial to investigate the efficacy of a brief, telehealth-delivered, early treatment of insomnia and evaluate its potential to prevent a deterioration of well-being. Participants with clinically significant insomnia symptoms that began during the pandemic are randomized to either a treatment group or a 28-week waitlist control group. Treatment consists of 4 telehealth sessions of Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered over 5 weeks. All participants will complete assessments of insomnia symptom severity, well-being, and daily habits checklist at baseline (week 0), and at weeks 1-6, 12, 28, and 56. RESULTS The trial began enrollment June 3, 2020 and closed enrollment June 17, 2021. As of October 2021, 49 participants have been randomized to either immediate treatment or a 28-week waitlist. 23 participants are still active in the protocol. CONCLUSIONS To our knowledge, this protocol would be represent the first study to test an early sleep intervention for improving insomnia that emerged during the COVID-19 Pandemic. The findings of this study could provide information about the utility of CBT-I for symptoms that emerge in the context of other stressors before they develop a chronic course and deepen understanding of the relationship between sleep and well-being. CLINICALTRIAL NCT04409743

Outcomes

2013 ◽  
pp. 221-226
Author(s):  
David L. Scott
Keyword(s):  
Quality Of Life ◽  
Disease Activity ◽  
Short Form ◽  
Organ Damage ◽  
Confounding Factors ◽  
Short Term ◽  
Self Assessment ◽  
The Matrix ◽  
The Impact

Outcomes evaluate the impact of disease. In rheumatology they span measures of disease activity, end-organ damage, and quality of life. Some outcomes are categorical, such as the presence or absence of remission. Other outcomes involve extended numeric scales such as joint counts, radiographic scores, and quality of life measures. Outcomes can be measured in the short term—weeks and months—or over years and decades. Short-term outcomes, though readily related to treatment, may have less relevance for patients. Clinical trials focus on short-term outcomes whereas observational studies explore longer-term outcomes. The matrix of rheumatic disease outcomes is exemplified by rheumatoid arthritis. Its outcomes span disease activity assessments like joint counts, damage assessed by erosive scores, quality of life evaluated by disease-specific measures like the Health Assessment Questionnaire (HAQ) or generic measures like the Short Form 36 (SF-36), overall assessments like remission, and end result such as joint replacement or death. Outcome measures capture the impact of treating rheumatic diseases. They are influenced by disease severity and effective treatment. They also reflect many confounding factors. These include demographic factors like age, gender, and ethnicity and also deprivation, as poverty worsens outcomes. Comorbidities affect outcomes and patients with multiple comorbid conditions have worse quality of life with poorer outcomes. Patient self-assessment has grown in importance; it is simple and understandable. However, self-assessment can vary over time and does not always reflect assessors’ perspectives. Caution is needed comparing outcomes across units; the various confounding factors and measurement complexities make such comparative analyses challenging.

Sign in / Sign up

Export Citation Format

Share Document