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)

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 De 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 Exploratory study into the relationship between the symptoms of chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME) and fibromyalgia (FM) using a quasiexperimental design

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e041947
Author(s):  
Pamela G Mckay ◽  
Helen Walker ◽  
Colin R Martin ◽  
Mick Fleming
Keyword(s):  
Quality Of Life ◽  
Chronic Fatigue Syndrome ◽  
Chronic Fatigue ◽  
Myalgic Encephalomyelitis ◽  
Anxiety And Depression ◽  
Symptom Experience ◽  
Fatigue Syndrome ◽  
The Impact ◽  
The Relationship

ObjectiveTo explore the relationship between symptoms of chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME) and fibromyalgia (FM). The hypothesis predicated that there would be no significant differences between the group’s symptom experience.DesignA quasiexperimental design. Structural equation modelling (SEM) and invariance testing.ParticipantsMales (M) and females (F) >16 with a confirmed diagnosis of CFS/ME or FM by a general practitioner or specialist. CFS/ME (n=101, F: n=86, M: n=15, mean (M) age M=45.5 years). FM (n=107, F: n=95, M: n=12, M=47.2 years).Outcome measuresDiagnostic criteria: the American Centers for Disease Control and Prevention (CDC) for CFS/ME and the American College of Rheumatology (ACR) criteria for FM. Additional symptom questionnaires measuring: pain, sleep quality, fatigue, quality of life, anxiety and depression, locus of control and self-esteem.ResultsInvariance was confirmed with the exception of the American CDC Symptom Inventory, Fibromyalgia Impact Questionnaire and Hospital Anxiety and Depression Scale (p<0.05) based on five questions. Consequently, it was erroneous to conclude differences. Therefore, the Syndrome Model was created. SEM could not have tested the ACR previously, as it comprised a single data point. Thus, it was combined with these three questionnaires, increasing the data points, to create this new measurable model. Results confirmed no significant differences between groups (p=0.07 (p<0.05)).ConclusionParticipants responded in a similar manner to the questionnaire, confirming the same symptom experience. It is important to consider this in context with differing criteria and management guidelines, as this may influence diagnosis and the trajectory of patient’s management. With the biomedical cause currently unclear, it is the symptom experience and the impact on quality of life that is important. These findings are meaningful for patients, clinicians and policy development and support the requirement for future research.

scholarly journals Effectiveness of e-Health cardiac rehabilitation program on quality of life associated with symptoms of anxiety and depression in moderate-risk patients

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Raquel Bravo-Escobar ◽  
Alicia González-Represas ◽  
Adela María Gómez-González ◽  
Ángela Heredia-Torres
Keyword(s):  
Quality Of Life ◽  
Cardiac Rehabilitation ◽  
Rehabilitation Program ◽  
Anxiety And Depression ◽  
Depression Symptoms ◽  
Cardiac Rehabilitation Program ◽  
Moderate Risk ◽  
Risk Patients ◽  
The Impact

AbstractExploring new models of medical care requires evaluating the impact of new care strategies not only on physiological parameters but also on the quality of life of the patient. On the other hand the presence of anxiety together with depression requires further consideration when planning appropriate management strategies. The aim of this study was to examine the effectiveness of a home-based cardiac rehabilitation program incorporating an e-Health technology on health-related quality of life associated with symptoms of anxiety and depression in moderate-risk patients. A multicenter, randomized controlled clinical trial was designed to compare a traditional hospital based cardiac rehabilitation program (n = 38, 35 male) with a mixed home surveillance program where patients exercised at home with a remote electrocardiographic monitoring device (n = 33, 31 male). The Short Form-36 (SF-36) Health Survey and the Goldberg questionnaire were used to evaluate quality of life and the presence of symptoms of anxiety and depression respectively. The results of this study show that the type of cardiac rehabilitation program did not influence the improvement in quality of life (p = 0.854), but the presence of symptoms of anxiety and depression did (p = 0.001). Although both programs achieved a decrease in anxiety and depression symptoms and improved functional capacity (p ≤ 0.001), a significant interaction effect was found between the group with or without anxiety and depression symptoms and the type of program in the bodily pain dimension (p = 0.021). Trial registration: Retrospectively registered NCT02796404 (10/06/2016) in clinialtrials.gov.

Hysteroscopic management of a uterine caesarean scar defect (niche) in women with postmenstrual spotting: a randomised controlled trial

QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Hatem Hussein El-Gamal ◽  
Walid El-Basuony Mohammad ◽  
Ahmed Samir Mohamed Zeerban
Keyword(s):  
Quality Of Life ◽  
Caesarean Section ◽  
Controlled Trial ◽  
Intervention Group ◽  
Expectant Management ◽  
Control Group ◽  
Randomised Controlled ◽  
Caesarean Scar Defect ◽  
Interventional Group

Abstract Background Long-term complaints after caesarean section, such as postmenstrual spotting, dysmenorrhea, dyspareunia, or chronic pelvic pain, are frequently described in relation to the presence of a niche. A post-caesarean niche is defined as an indentation in the myometrium at the site of the uterine scar. Two independent prospective cohort studies reported that the presence of a niche after caesarean section increases the risk of postmenstrual spotting for more than 2 days from 15 to 30%. Postmenstrual spotting may be caused by a mechanical outflow problem, with the retention of menstrual blood in a niche, or by the accumulation of blood because of impaired uterine contractions at the site of the niche. Additionally, newly formed fragile vessels in the niche may play a role in the formation of blood or fluid in the niche and uterine cavity. Objective The aim of this study was to compare the effectiveness of a hysteroscopic niche resection versus no treatment in women with postmenstrual spotting and a uterine caesarean scar defect. Methods This trial is a randomised controlled trial that provides evidence for the (cost) effectiveness of hysteroscopic resection of a niche versus expectant management in women with niche related postmenstrual spotting. It was carried out on 28 cases divided into two equal group. The study was conducted at Ain Shams University on the women reporting postmenstrual spotting after a caesarean section. The primary outcome was the number of days of postmenstrual spotting 6 months after randomization. Secondary outcomes were spotting at the end of menstruation, intermenstrual spotting, dysuria, sonographic niche measurements, quality of life, women’s satisfaction, sexual function, and additional therapy. Outcomes were measured at 3 months and, also at 6 months after randomization. Results The results of this study show a significant improvement in interventional group after 3 months more than the control group in bleeding micturition characteristics which includes total days of spotting, spotting end of menstruation, intermenstral spotting, discomfort from spotting, dysmenorrhea and daily pain during micturition, after 6 months the two group improved but the interventional group was significantly higher than control group. Regarding the radiological assessment it was found that there was a significant improvement in intervention group more than the control group after 3 months, also the control group improved after 6 months also, but the intervention groups was significantly higher than the control group. The quality of life show a significant increasing in intervention group more than the control group after 3 months of intervention, at the end of follow up the intervention group was significantly higher in quality of life more than the control group. Conclusion A hysteroscopic niche resection reduces postmenstrual spotting, and the discomfort from spotting, compared with expectant management after 3 months of follow-up in women with a niche with a residual myometrium of at least 3 mm.

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.

scholarly journals Impact of Anxiety and Depression on Quality of Life among Patients Undergoing Hemodialysis: A Scoping Review

2020 ◽  
Vol 2 (3) ◽  
pp. 14
Author(s):  
Fatima I. AlNashri ◽  
Hayfa H. Almutary ◽  
Elham A. Al Nagshabandi
Keyword(s):  
Quality Of Life ◽  
Scoping Review ◽  
Short Form ◽  
Hemodialysis Patients ◽  
Anxiety And Depression ◽  
Depression And Anxiety ◽  
Life Threatening ◽  
Anxiety Depression ◽  
The Impact

Context: Chronic kidney disease (CKD) is a life-threatening problem of global concern. Living with CKD is associated with many psychological problems, including depression and anxiety, which can directly or indirectly affect the quality of life. Only one review in the existing literature has assessed these associations among CKD patients using different dialysis modalities. However, the experience of these symptoms could be higher among patients on hemodialysis therapy. In this purview, there is a need to narrow the previous work to be more focused on hemodialysis patients. Aim: This scoping review aims to determine the gaps in the knowledge about the impact of anxiety and depression concerning QOL among people undergoing hemodialysis. Methods: The studies selected were those examined the relationships between depression or/and anxiety with quality of life in adult patients on hemodialysis. The CINAHL, MEDLINE, and Pub Med databases were searched for literature published between January 2012 and December 2019. The quality of the included studies was also apprised. Eleven studies met the inclusion criteria. Results: Six studies examined the impact of depression and anxiety on the quality of life. Five studies identified from the review have examined the relationships between depression and quality of life. It was established that the prevalence of anxiety and depression was high among hemodialysis patients, and the same was associated with low quality of life. Conclusion: The literature review highlights the negative associations between anxiety, depression, and quality of life among hemodialysis patients. It is, therefore, essential to screen hemodialysis patients frequently for anxiety and depression using a short-form questionnaire. This screening would allow for providing early interventions, and the potential deterioration of quality of life could be prevented. Further longitudinal studies are needed to assess these relationships. Additionally, further research is needed to determine effective interventional programs to improve the overall quality of life.

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.

Quality of Life Following Management of Localized Prostate Cancer

2018 ◽  
Author(s):  
Louis A Aliperti ◽  
Martin G Sanda ◽  
Christopher P Filson
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Radical Prostatectomy ◽  
Expectant Management ◽  
Diagnosis And Treatment ◽  
Urinary Tract Symptoms ◽  
Related Quality ◽  
Health Related ◽  
The Impact

With a long survivorship phase after diagnosis and treatment of prostate cancer, consideration of the impact of treatment on health-related quality of life (HRQOL) is critical. For men considering treatment of prostate cancer, the domains that are impacted include urinary, sexual, and bowel-related qualities of life. This review identifies aspects of tools measuring HRQOL and covers instruments used to measure quality of life following a diagnosis and treatment of prostate cancer. We review the impact associated with radical prostatectomy, radiation and brachytherapy, and observation on men diagnosed with prostate cancer and compare the effects that each management strategy has on sexual and urinary function. This review contains 3 figures, 5 tables, 44 references. Key Words: erectile dysfunction, expectant management, lower urinary tract symptoms, prostate cancer, radical prostatectomy, radiation therapy, quality of life, urinary incontinence

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

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