Quality Of Life Participation Research Articles

Abstract LB-154: Disruption of essential services after Hurricanes Irma and Maria and quality of life among women with gynecological cancer receiving care in Puerto Rico

Abstract Objectives: Cancer patients have increased risk of poor outcomes after disasters. On September 2017 Hurricanes Irma and María affected Puerto Rico (PR), causing the population to experience major stressors. We describe the disruption of essential services among women with gynecologic cancer in PR after hurricanes Irma and Maria and its impact on quality of life (QoL). We also compare QoL of these women before and after the hurricanes. Methods: This ongoing cross-sectional study is recruiting women aged ≥21 years diagnosed between September 2016-September 2018 and receiving care in PR; we have conducted 110 phone interviews from September 2019-December 2019. Patients' interviews address stressors (including disruptions and time in essential services such as power, electricity and telecommunications) and multilevel responses experienced by the women in the aftermath of the hurricanes. QoL was measured by using a scale from the BRFSS, which includes six items within two domains: physical and mental health; these items were assessed at two time periods (30 days and 3 months) before and after the hurricanes. The association between disruption of essential services and QoL was evaluated with the Chi-square test. Paired McNemar's test was used to compare women's QoL before and after the hurricanes. Results: Mean age of study participants is 63.7±12.1 years; 64.5% of women had a diagnosis of endometrial cancer, 15.5% cervical, 15.5% ovarian, 3.6% vulvar, and 1.0% vaginal. 100% of patients reported disruptions in electric power, 84.5% in potable water, and 75.2% in telecommunications. On average, patients endured 114 days (±88.8) without electric power, 63 days (±62.8) without potable water, and 62 days (±56.3) without telecommunications. We did not find significant differences between the disruption of essential services and QoL indicators (p>0.05). Nonetheless, QoL indicators were worst after the hurricanes than before. Frequent activity limitations (before=22.3% vs. after=39.1%), frequent mental distress (before=26.4% vs. after= 59.1%) and feeling dissatisfied/very dissatisfied with life (before=6.2% vs. after= 21.7%) increased (p<0.001). Frequent physical distress (33.6% vs. 40.9%) and fair/poor general health status (33.9% vs. 50.9%) also increased after the hurricanes, these results were marginally significant (p<0.10). Conclusion: Most of the patients experienced long interruptions in essential services, after hurricanes. The fact that all patients experienced some kind of disruption may explain the lack of association of these variables with QoL. Nonetheless, this study shows that participant's QoL worsened after the hurricanes. Study results should guide the development of a disaster management plan for cancer patients that focuses on minimizing the adverse effects on QoL in the aftermath of a catastrophic event. Acknowledgement: NCI Grant #R21CA239457 Citation Format: Ana P. Ortiz, Sandra García-Camacho, Andrea Pacheco-Díaz, William Calo, Sharee A. Umpierre, Pablo Méndez-Lazaro, Istoni DaLuz-Santana, Lianeris Estremera-Rodriguez, Mirza Rivera, Guillermo Tortolero-Luna. Disruption of essential services after Hurricanes Irma and Maria and quality of life among women with gynecological cancer receiving care in Puerto Rico [abstract]. In: Proceedings of the Annual Meeting of the American Association for Cancer Research 2020; 2020 Apr 27-28 and Jun 22-24. Philadelphia (PA): AACR; Cancer Res 2020;80(16 Suppl):Abstract nr LB-154.

A Curriculum to Promote a Culture of Wellness Among Medical Students and Faculty.

Self-care has not been traditionally taught in medical education, but the epidemic of burnout among health professionals necessitates a change in culture, and consequently a change in curriculum. Burnout begins early in training and negatively impacts health professionals, patients, and institutions. Interventions that prevent and avert burnout are necessary at all stages of a doctor's career to assure well-being over a lifetime. Evidence-based strategies supporting both personal and system wellness have begun to emerge, but more research is needed. We present a collaborative and comprehensive wellness program: "A Culture of Wellness." We offered this pilot jointly for first-year medical students and faculty volunteers at the Geisel School of Medicine at Dartmouth. We gave participants the following: (1) time-60 minutes per week for 8 weeks; (2) tools-weekly cases highlighting evidence-based wellness strategies; and (3) permission-opportunities to discuss and apply the strategies personally and within their community. Pre- and postsurvey results show that dedicated time combined with student-faculty collaboration and application of strategies was associated with significantly lower levels of burnout and perceived stress and higher levels of mindfulness and quality of life in participants. Components of the curriculum were reported by all to add value to personal well-being. This pilot presents a feasible and promising model that can be reproduced at other medical schools and disseminated to enhance personal health and promote a culture of well-being among medical students and faculty.

Health Literacy Research in Malaysia: Health Literacy and Other Aging Challenges Among Malaysian Public Employees.

This report focuses on a study that addresses the role of health literacy in the challenges surrounding aging. The study was conducted among n=533 public employees ages 40 to 60 years old in Johor state, Malaysia. The validated Malay version of World Health Organization Quality of Life Instrument (WHOQOL-BREF) and the Short-Form Health Literacy Instrument (HLS-SF12) were used to assess perceived quality of life and general health literacy respectively. The WHOQOL-BREF comprises 26 items with six outcomes and the HLS-SF12 consists 12 items. This study provides an overview of participant quality of life, which was operationalized as a precondition of active aging. The participants' preconditions related to active aging were worrisome as 28% perceived their quality of life as poor and 34% were dissatisfied with their health. More positively, health literacy was found to be a significant determinant that may enable active aging.

Safety and Efficacy of Apixaban vs Enoxaparin for Preventing Postoperative Venous Thromboembolism in Women Undergoing Surgery for Gynecologic Malignant Neoplasm

Current guidelines recommend a 28-day course of enoxaparin for thromboprophylaxis after surgery for gynecologic cancer. The high cost of this medication and the low adherence rates observed in prior studies provide an opportunity to benefit patients by demonstrating the safety of a more cost-effective, easier to use thromboprophylactic. To investigate the safety and efficacy of an oral treatment alternative for thromboprophylaxis in postoperative patients with gynecologic cancer. This was a patient-based, multicenter, open-label, blinded, end point, randomized clinical trial conducted May 2015 to March 2019 in outpatient and inpatient gynecologic oncology settings. Women undergoing surgery for suspected or confirmed gynecologic cancer were approached for recruitment. The trial compared rates of major bleeding and clinically relevant nonmajor bleeding events during a 90-day follow-up period in patients taking apixaban or enoxaparin for postoperative thromboprophylaxis using a modified intent-to-treat analysis. Data analysis was performed from October to December 2019. Women were randomized to 28 days of apixaban (2.5 mg orally twice daily) or enoxaparin (40 mg subcutaneously daily). The primary outcome was major bleeding and clinically relevant nonmajor bleeding events. Secondary outcomes included incidence of venous thromboembolic events, adverse events, medication adherence, participant quality of life, and medication satisfaction. Of 500 women recruited for the study, 400 were enrolled and randomized (median age, 58.0 years; range, 18.0-89.0 years); 204 received apixaban and 196 received enoxaparin. Treatment groups did not differ in terms of race/ethnicity, cancer stage, or surgery modality (open vs robotic). There were no statistically significant differences between the apixaban and enoxaparin groups in terms of rates of major bleeding events (1 patient [0.5%] vs 1 patient [0.5%]; odds ratio [OR], 1.04; 95% CI, 0.07-16.76; P > .99), clinically relevant nonmajor bleeding events (12 patients [5.4%] vs 19 patients [9.7%]; OR, 1.88; 95% CI, 0.87-4.1; P = .11), venous thromboembolic events (2 patients [1.0%] vs 3 patients [1.5%]; OR, 1.57; 95% CI, 0.26-9.50; P = .68), adverse events, medication adherence, or quality of life between the groups. Participant satisfaction was significantly greater in the apixaban group with regard to ease of taking the medication (186 patients [98.9%] vs 110 patients [58.8%]; OR, 0.06; 95% CI, 0.01-0.25; P < .001) and pain associated with taking the medication (4 patients [2.1%] vs 92 patients [49.2%]; OR, 9.20; 95% CI, 2.67-31.82; P < .001). These findings suggest that oral apixaban is a potentially safe, less painful, and easier-to-take alternative to subcutaneous enoxaparin for thromboprophylaxis after surgery for gynecologic cancer. The efficacy of apixaban to prevent venous thromboembolic events is hypothesized as being equivalent. ClinicalTrials.gov Identifier: NCT02366871.

Internalized Stigma among Bedouin and Jews with Mental Illness: Comparing Self-Esteem, Hope, and Quality of Life.

The aim of this study was to assess the differences in internalized-stigma, self-esteem, hope, and quality of life in individuals with mental illness from two diverse cultures (Bedouins and Jews) and to examine the relationships between self-stigma and self-esteem, hope, and quality of life in participants from both cultures. Two hundred participants with mental illness in Israel were assessed on the Internalized Stigma of Mental Illness (ISMI) scale. The Arab Bedouin participants tended to internalize stigma to a greater extent than the Jewish participants. Overall, there was a significant negative correlation between self-stigma, self-esteem, and hope and between alienation and quality of life in both groups although the correlation was stronger among the Arab Bedouin participants. By contrast, the associations between self-stigma and quality of life were only significant for two of the self-stigma dimensions (alienation and discrimination) among the Jewish participants. These results contribute to a better understanding of the role internalized stigma may play in the life of people with mental illness from diverse cultures. They may help design culturally appropriate intervention programs for people with mental illness.

Inhaled mannitol for cystic fibrosis.

Inhaled mannitol for cystic fibrosis.

The relationship between serum 25-hydroxy vitamin D and blood pressure and quality of life in overweight and obese patients with type 2 diabetes mellitus compared with healthy subjects.

Background:Vitamin D is one of the known lipoprotein hormones with metabolic properties. We aimed to determine the serum 25-hydroxy vitamin D concentration in overweight/obese subjects with diabetes mellitus type Ⅱ (DM Ⅱ) in association with systolic and diastolic blood pressure and quality of life compared with healthy participants.Methods:The current case-control study was carried out among 80 overweight/obese subjects with DM Ⅱ, and 77 healthy subjects matched by sex, age and body mass index (BMI). Serum 25-hydroxyvitamin D concentration was measured by ELISA method. In order to examine the quality of life, the Persian version of SF36 questionnaire was used.Results:There was significant difference between diabetic and healthy subjects considering serum 25-hydroxyvitamin D concentration (p=0.012). Serum 25-hydroxyvitamin D concentration was inversely correlated with diastolic blood pressure (p=0.02) and positively associated with physical function (p<0.001), social function (p<0.001) and general health (p<0.001) components of quality of life in diabetic subjects and physical health sub-scale (p=0.004) in all participants.Conclusion:Serum 25-hydroxyvitamin D concentration was significantly lower in diabetic subjects in comparison with healthy controls. There was a significant reverse relationship between serum concentrations of 25-hydroxyvitamin D with diastolic blood pressure and on the other hand, a significant positive relationship with physical function, social function and general health components and physical health subscale of quality of life in participants with DM Ⅱ.

Patient-reported outcomes and quality of life in recessive dystrophic epidermolysis bullosa: A global cross-sectional survey

A spectrum of skin disease severity exists in patients with recessive dystrophic epidermolysis bullosa (RDEB). To characterize the patient-reported outcomes and quality of life (QOL) in patients with RDEB. A cross-sectional study of patients with RDEB surveyed through the global EBCare Registry. Patient-reported outcomes included skin disease severity, wound characteristics, pain, itch, extracutaneous symptoms, and medications. QOL was measured by using the validated Quality of Life in Epidermolysis Bullosa instrument. A total of 85 patients with RDEB reported 1226 wounds (937 recurrent wounds and 289 chronic open wounds). Overall skin disease severity was self-reported as mild (26%; 22/83), moderate (48%; 40/83), or severe (25%; 21/83). Worsening skin disease severity was significantly associated with larger wounds, increased opiate use, anemia, gastrostomy tube use, infections, osteoporosis, and squamous cell carcinoma. Larger wound size was associated with worse quality of life scores. All data were self-reported from an online epidermolysis bullosa patient registry. This study shows a significant correlation between larger wound size with worsening skin disease severity and quality of life in participants with RDEB. Worsening skin disease severity significantly correlated with key clinical manifestations. These results show that patients with RDEB are able to self-report their skin disease severity and wounds.

Clinical Efficacy and Safety of Miniscalpel-Needle Treatment for Tension-Type Headache: A Systematic Review and Meta-Analysis.

To investigate the clinical efficacy and safety of miniscalpel-needle (MSN) treatment for tension-type headache (TTH). Seven medical databases were searched to identify randomized controlled trials (RCTs) evaluating the effect and safety of MSN treatment. All articles published up to November 15, 2018 were retrieved. A meta-analysis was conducted for the included studies, and the risk of bias was assessed. Primary outcomes were visual analogue scale (VAS) or numeric rating scale (NRS) score. Secondary outcomes were clinical effective rates including total effective rate (TER), markedly effective rate (MER), and totally cured rate (TCR) determined by improvement in clinical symptoms or VAS scores, the frequency of adverse events (AEs) that occurred during the study, and participant quality of life (QOL). Seven RCTs involving 724 participants were included. MSN treatment showed significantly higher MER and TCR [relative risk (RR) 1.27, 95% confidence interval (CI) 1.01 to 1.61; RR 1.31, 95% CI 1.09 to 1.57, respectively], but not TER (RR 1.03, 95% CI 0.96 to 1.10) compared to acupuncture. MSN treatment plus conventional treatment showed significant lower VAS and higher TER, MER, and TCR (mean difference -3.54, 95% CI -3.80 to -3.28; RR 1.14, 95% CI 1.06 to 1.23; RR 2.31, 95% CI 1.50 to 3.58; RR 3.01, 95% CI 2.25 to 4.02, respectively) compared to conventional treatment. According to current evidence, MSN treatment as a monotherapy or as an adjunctive treatment to other existing treatments might have benefits on treating TTH. However, since the number and the sample size of studies included were both small and the methodological quality was poor, the findings of this review should be interpreted with great caution, and our confidence in the results is low. A high quality RCT using objective outcomes should be performed on this topic.

Pain, Sports Participation, and Physical Function in Adolescents With Patellofemoral Pain and Osgood-Schlatter Disease: A Matched Cross-sectional Study

To compare pain, physical activity, quality of life, strength, and knee function in adolescents with patellofemoral pain (PFP) and Osgood-Schlatter disease (OSD) to those in pain-free controls. Cross-sectional study. Self-report questionnaires were used to describe pain, physical activity, knee function, and quality of life in participants with PFP (n = 151) or OSD (n = 51) and in pain-free controls (n = 50) between 10 and 14 years of age. Hip and knee strength were measured by handheld dynamometry. Physical activity levels were measured using wearable accelerometers. Adolescents were highly active (accumulating greater than 120 minutes of vigorous physical activity per day), with no differences between the OSD, PFP, and control groups. Adolescents with PFP or OSD scored 22 to 56 points lower (P<.001) on the Knee injury and Osteoarthritis Outcome Score subscales compared with controls, with the lowest scores on the "sport and recreation" and "quality of life" subscales. Adolescents with OSD had lower knee extension strength compared to controls (P<.05; effect size, 1.25). Adolescents with PFP had lower hip extension strength compared to controls (P<.05; effect size, 0.73). Adolescents with PFP or OSD had high physical activity levels, despite reporting long-standing knee pain and impaired knee function that impacted on their sports participation and quality of life. Clinicians treating adolescents with PFP or OSD may use these findings to target treatment to the most common deficits to restore sports-related function and sports participation. J Orthop Sports Phys Ther 2020;50(3):149-157. Epub 6 Jan 2020. doi:10.2519/jospt.2020.8770.

Vitamin D status and quality of life in people with Irritable Bowel Syndrome

AbstractIrritable Bowel Syndrome (IBS) is a chronic and debilitating functional disorder of the gastrointestinal tract with serious and detrimental impacts on quality of life. Its aetiology is largely unknown, and the identification of effective management strategies remains far from complete. Research suggests that people with IBS have a high prevalence of vitamin D deficiency, which may impact on symptom severity and quality of life.A double-blind, placebo-controlled, 2-arm, parallel-design study is underway to investigate the effect of a 12 week, 3,000IU vitamin D p.d. supplementation on symptom severity and quality of life in participants with a clinical diagnosis of IBS. This report assesses whether relationships exist between vitamin D status, IBS severity and quality of life in the baseline (cross-sectional) data.Eighty males and females with a clinical diagnosis of IBS were recruited in phase I of the trial in January-April 2018. Mixed-type IBS and constipation-predominant IBS were the more frequent subtypes (36% and 33%), while diarrhoea-predominant had a lower prevalence (23%). More females (n = 65) than males (n = 15) were recruited to the study which reflects the reported greater prevalence of IBS in women. Baseline serum 25(OH)D levels in participants were classified as deficient 23.1% (n = 18) (&lt; 30nmol/L), insufficient 37.2% (n = 29) (31–49 nmol/L) and sufficient 39.7% (n = 31) (&gt; 50 nmol/L) respectively. The sample median for serum vitamin D at baseline was 42.2 (± 28.3) nmol/L. Quality of Life was significantly associated with two IBS sub-symptoms: pain (p = 0.037, r = 0.233) and distension severity (p = 0.009, r = 0.291). Neither Quality of Life, nor IBS symptom severity score, correlated with vitamin D status in the sample.This study found no relationship between baseline vitamin D status and symptom severity or quality of life in this subsample. Two publications report vitamin D intervention improves quality of life in participants with IBS. It is possible that the unusual homogeneity of these studies enabled identification of these relationships.These initial observations agree with previous reports of widespread vitamin D insufficiency in people with IBS. Analysis of full trial outcomes (July 2019) will determine whether vitamin D supplementation is beneficial for either symptoms severity or quality of life in people with IBS.

People with dementia attending farm-based day care in Norway - Individual and farm characteristics associated with participants' quality of life.

Farm-based day care for people with dementia is supposed to improve the participants quality of life by using activities and resources of the farm environment to promote mental and physical health. In this paper, we describe the characteristics of those attending farm-based day care services in Norway and explore the association between individual and farm characteristics and the quality of life. A sample of 94 people with dementia who attended farm-based day care was recruited from 25 farms between January 2017 and January 2018. The data collection was performed using standardized instruments. Information about the farms was retrieved from a former study. The association between the participants' quality of life and their individual and/or farm characteristics was examined with a linear multilevel regression model. The participants had a mean age of 76years, 62% were men, and 68% had additional education after primary school. Most of them had mild (54.3%) or questionable dementia (18.3%). A few participants used antipsychotics (3.7%), tranquilizers (9.9%) and painkillers (13.6%), while a higher number used antidepressants (30.9%). Quality of life was associated with the experience of having social support (p=.023), a low score on depressive symptoms (p<.001), and spending time outdoors at the farm (p<.001). The variation between the farm-based day care services in the participants' reported quality of life was related to time spent outdoors at the farm. In light of the present study, it seems as farm-based day care is addressing people with dementia in an early stage, dominated by men, with quite good physical and medical condition. The strong association between quality of life and spending time outdoors underscores that facilitation for outdoor activity should be prioritized in all types of dementia care.

Long-term effects of solriamfetol on quality of life in participants with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnoea

Long-term effects of solriamfetol on quality of life in participants with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnoea

Prospective follow-up of quality of life for participants undergoing risk-reducing salpingo-oophorectomy or ovarian cancer screening in GOG-0199: An NRG Oncology/GOG study

BackgroundRisk-reducing salpingo-oophorectomy (RRSO) and ovarian cancer screening (OCS) are management options for women at increased risk of ovarian cancer. Long-term effects of these interventions on quality of life (QOL) are not well understood. MethodsGOG-0199 is a prospective cohort study of women at increased ovarian cancer risk who chose either RRSO or OCS as their risk management intervention. At study entry, 6, 12, 24 and 60 months of follow-up, participants completed the QOL questionnaire, which included the Medical Outcome Study Short Form-36, the Impact of Events Scales, the Center for Epidemiological Studies Depression Scale, the State-Trait Anxiety Inventory, the Functional Assessment of Cancer Therapy – Endocrine Subscale, and the Sexual Activity Questionnaire. QOL measures were compared between the RRSO and OCS cohort at baseline and over time. ResultsFive-hundred-sixty-two participants in the RRSO cohort and 1,010 in the OCS completed the baseline and at least one follow-up questionnaire. At baseline, participants selecting RRSO reported lower health-related QOL (HRQOL), greater ovarian cancer-related stress, greater anxiety, and more depressive symptomatology, which improved during follow-up, especially for ovarian cancer-related stress. Screening was not found to adversely impact HRQOL. Hormone-related menopausal symptoms worsened and sexual functioning declined during follow-up in both cohorts, but more so among participants who underwent RRSO. ConclusionsHRQOL improved after surgery among women who chose RRSO and remained stable among participants undergoing screening. The adverse effects of RRSO and screening on short-term and long-term sexual activity and sexual functioning warrant consideration in the decision-making process for high-risk women.

Pretend Play as an Intervention for Children With Cancer: A Feasibility Study.

Children with cancer suffer from symptoms and burdensome treatments that often cause distress to children and their families. Mortality is one aspect of cancer diagnosis, while another is the quality of life and well-being during and after the treatment. By supporting children's communication, self-efficacy and coping ability in the care situation, children are given the possibilities for increased independence and participation and are allowed to develop an influence over their care. The aim of this study was to develop and evaluate the feasibility and acceptability of an adult-facilitated pretend play intervention for children with cancer. Five children with ongoing treatment for cancer were invited to a play intervention that consisted of six to eight sessions of structured pretend play aimed at increasing participation, independence, and well-being. A mixed method design was used to evaluate the feasibility and acceptability of the play intervention. Measures were collected before and after interventions, and in conjunction with every play session. Results suggest that the children enjoyed the play intervention. Findings indicate small improvements regarding self-efficacy in care situations and equal or increased quality of life for participants. A main finding was that no adverse events or increased worrying was reported in conjunction with play sessions. Therefore, the intervention is regarded as safe, feasible, and acceptable as reported by participants and their primary caregivers and a possible means of increasing participation and independence in children with a cancer diagnosis.

“Moments of Failure”: Coping With Attention Deficit Hyperactivity Disorder, Sleep Deprivation, and Being Overweight

People living with attention deficit hyperactivity disorder (ADHD) often have to cope with additional comorbid disorders. In daily practice, practitioners observe that ADHD not only causes a decline in participants' quality of life, but the presence of sleep and eating disorders also has an impact on daily functioning. The aims of this study are to give meaning to the experiences of participants who are living with ADHD and sleep deprivation and are overweight and to provide additional knowledge and data that will inform integrated treatment in the long term. The following research questions were formulated: METHOD: A qualitative design based on a Parse research method provided the best research framework to answer our questions. The method aims for data saturation, employing six steps in which data collection alternates with data analysis. This iterative process with double hermeneutics enlarges participants' perspectives on their experiences. Participants' daily life is continuously influenced by their experiences with (binge) eating, irregular sleeping patterns, and loss of emotional control. These complex phenomena are often caused by their ADHD, because of underdeveloped coping skills. An everyday struggle with life and difficulty making choices are the leading themes in participant narratives. Continuous feelings of failure, referred to in this report as everyday "failure moments," cause negative self-esteem and negative body image. According to participants, standardized care should include opportunities for participants to tell their life stories as well as an individualized analysis of how ADHD core symptoms affect daily decision making, taking into account sleeping and eating patterns. The experience of failure moments, the struggle with making choices, and negative self-esteem and body image all develop in a different way for each participant. When professionals treat participants by solely focusing on the core symptoms using a one-dimensional cognitive behavioral approach, they may overlook underlying (biological) interactions.

Early Recovery After Surgery Protocol in Improving Quality of Life in Participants With Stage 0-IIIC Gastric Cancer Undergoing Surgery

Early Recovery After Surgery Protocol in Improving Quality of Life in Participants With Stage 0-IIIC Gastric Cancer Undergoing Surgery

Nocturnal temperature-controlled laminar airflow device for adults with severe allergic asthma: the LASER RCT.

Severe asthma exacerbations are costly to patients and the NHS, and occur frequently in severely allergic patients. To ascertain whether or not nocturnal temperature-controlled laminar airflow (TLA) device usage over 12 months can reduce severe exacerbations and improve asthma control and quality of life compared with a placebo device, while being cost-effective and acceptable to adults with severe allergic asthma. A pragmatic, multicentre, randomised, double-blind, placebo-controlled, parallel-group, superiority trial with qualitative interviews. The trial included an internal pilot with qualitative focus groups. Fourteen hospitals in the UK that manage patients with severe asthma. Adults (16-75 years) with severe, poorly controlled, exacerbation-prone asthma despite high-intensity treatment, and who are sensitised to a perennial indoor aeroallergen. Nocturnal, home-based TLA treatment using an Airsonett® (Airsonett AB, Ängelholm, Sweden) device. The comparator was a placebo device that was identical to the active device except that it did not deliver the laminar airflow. Participants were allocated 1 : 1 to TLA therapy or placebo, minimised by site, origin of case, baseline severe exacerbation frequency, maintenance oral corticosteroid use and pre-bronchodilator forced expiratory volume in 1 second. Primary outcome - frequency of severe asthma exacerbations occurring within the 12-month follow-up period, defined as worsening of asthma requiring systemic corticosteroids [≥ 30 mg of prednisolone or equivalent daily (or ≥ 50% increase in dose if on maintenance dose of ≥ 30 mg of prednisolone)] for ≥ 3 days. Secondary outcomes - changes in asthma control, lung function, asthma-specific and global quality of life for participants, adherence to the intervention, device acceptability, health-care resource use and cost-effectiveness. Between May 2014 and January 2016, 489 patients consented to participate in the trial, of whom 249 failed screening and 240 were randomised (n = 119 in the treatment group and n = 121 in the placebo group); all were analysed. In total, 202 participants (84%) reported use of the device for 9-12 months. Qualitative analyses showed high levels of acceptability. The mean [standard deviation (SD)] rate of severe exacerbations did not differ between groups [active 1.39 (1.57), placebo 1.48 (2.03); risk ratio 0.92, 95% CI 0.66 to 1.27; p = 0.616]. There were no significant differences in secondary outcomes for lung function, except for a reduction in mean daily peak expiratory flow [mean (SD) difference 14.7 l/minute (7.35 l/minute), 95% CI 0.32 to 29.1 l/minute; p = 0.045) for those in the active device group. There were no differences in asthma control or airway inflammation and no serious harms related to the device. No significant difference between the groups in quality-adjusted life-years gained over 1 year was observed. In addition, there was no difference in generic or disease-specific health-related quality of life overall, although statistically significant higher quality of life at month 6 was observed. Increases in quality of life were not sufficient to offset the annual costs associated with use of the TLA device. Missing outcome data could have resulted in an underestimation of exacerbations and rendered the study inconclusive. Within the limits of the data, no consistent benefits of the active device were demonstrated, and the differences observed were not sufficient to make the device cost-effective. The types of patients who may benefit from the TLA device, and the reasons for large reductions in exacerbation frequency in severe asthma trials, which also incorporate other methods of recording exacerbations, need to be explored. Current Controlled Trials ISRCTN46346208. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 29. See the NIHR Journals Library website for further project information.

Factors Affecting the Change in Quality of Life in Participants of a Cancer Exercise Program

Factors Affecting the Change in Quality of Life in Participants of a Cancer Exercise Program

Peanut-allergic patient experiences after epicutaneous immunotherapy: peanut consumption and impact on QoL

Immunoglobulin E (IgE)-mediated food allergy impacts 8% of US children,1 with peanut allergy prevalence steadily increasing.2 Food allergy affects everyday activities for food-allergic children and their parents,3 which can increase anxiety and reduce health-related quality of life (QoL).4,5 Although several peanut-desensitization methods are being studied, no approved treatments exist for peanut-allergic patients.6,7 Current research is mainly focused on efficacy and safety; however, considering participant quality of life (QoL) after peanut-immunotherapy clinical trials is important.