BACKGROUND: The quality of life of people with disorders of sex development depends largely on the availability of good psychosocial and psychosexual management. There is a lack of qualitative systematic reviews of the literature on the experiences of people with disorders of sex development.
DESIGN: The seven steps of qualitative meta-ethnography were employed in this review.
DATA SOURCES: The following electronic databases were systematically searched until January 2017: Science Direct, Scopus, Sage online, CINAHL, PsycINFO, Medline, Wiley Online Library, and Google Scholar. Search terms for this review were "disorders of sex development," "intersex," "ambiguous genitalia," "experiences," "qualitative study," and "method".
REVIEW METHOD: A 13-item scale was applied to evaluate the quality of the selected studies and synthesized using the principles of meta-ethnography.
FINDINGS: Twelve studies met the eligibility criteria. Six major themes described the experiences of people with disorders of sex development. These included a range of physical, psychological, social, and sexual experiences which affect their quality of life. Different coping strategies were employed by individuals who live with the lifelong condition.
CONCLUSION: Disorders of sex development affect the quality of life of people living with these disorders. Nurses are tasked with providing holistic care for people with disorders of sex development in order to improve their quality of lives. As such, there is a need to explore the experiences of nurses in the management of disorders of sex development.
METHODS: Using data from 18,101 individuals (aged 18-97 years) from the baseline Census 2012, Health Round 2013, and Verbal Autopsies 2012-2023 of the South East Asia Community Observatory (SEACO) health and demographic surveillance system, latent class analysis was performed on 13 chronic health conditions to identify statistically and clinically meaningful groups. Multinomial logistic regression and Cox proportional hazards regression models were conducted to investigate the adjusted association of multimorbidity patterns with the risk factors and mortality, respectively. HRQoL was analyzed by linear contrasts in conjunction with ANCOVA adjusted for baseline confounders.
RESULTS: Four distinct multimorbidity latent classes were identified: (1) relatively healthy (n = 10,640); (2) cardiometabolic diseases (n = 2428); (3) musculoskeletal, mobility and sensory disorders (n = 2391); and (4) complex multimorbidity (a group with more severe multimorbidity with combined profiles of classes 2 and 3) (n = 699). Significant variations in associations between socio-demographic characteristics and multimorbidity patterns were discovered, including age, sex, ethnicity, education level, marital status, household monthly income and employment status. The complex multimorbidity group had the lowest HRQoL across all domains compared to other groups (p
METHODS: This multicentre, randomised, placebo-controlled, phase 2b trial was done at 60 hospitals and clinics in 20 countries. Eligible study participants were aged between 12 and 75 years with a documented history of GPP as per the European Rare and Severe Psoriasis Expert Network criteria, with a history of at least two past GPP flares, and a GPP Physician Global Assessment (GPPGA) score of 0 or 1 at screening and random assignment. Patients were randomly assigned (1:1:1:1) to receive subcutaneous placebo, subcutaneous low-dose spesolimab (300 mg loading dose followed by 150 mg every 12 weeks), subcutaneous medium-dose spesolimab (600 mg loading dose followed by 300 mg every 12 weeks), or subcutaneous high-dose spesolimab (600 mg loading dose followed by 300 mg every 4 weeks) over 48 weeks. The primary objective was to demonstrate a non-flat dose-response curve on the primary endpoint, time to first GPP flare.
FINDINGS: From June 8, 2020, to Nov 23, 2022, 157 patients were screened, of whom 123 were randomly assigned. 92 were assigned to receive spesolimab (30 high dose, 31 medium dose, and 31 low dose) and 31 to placebo. All patients were either Asian (79 [64%] of 123) or White (44 [36%]). Patient groups were similar in sex distribution (76 [62%] female and 47 [38%] male), age (mean 40·4 years, SD 15·8), and GPP Physician Global Assessment score. A non-flat dose-response relationship was established on the primary endpoint. By week 48, 35 patients had GPP flares; seven (23%) of 31 patients in the low-dose spesolimab group, nine (29%) of 31 patients in the medium-dose spesolimab group, three (10%) of 30 patients in the high-dose spesolimab group, and 16 (52%) of 31 patients in the placebo group. High-dose spesolimab was significantly superior versus placebo on the primary outcome of time to GPP flare (hazard ratio [HR]=0·16, 95% CI 0·05-0·54; p=0·0005) endpoint. HRs were 0·35 (95% CI 0·14-0·86, nominal p=0·0057) in the low-dose spesolimab group and 0·47 (0·21-1·06, p=0·027) in the medium-dose spesolimab group. We established a non-flat dose-response relationship for spesolimab compared with placebo, with statistically significant p values for each predefined model (linear p=0·0022, emax1 p=0·0024, emax2 p=0·0023, and exponential p=0·0034). Infection rates were similar across treatment arms; there were no deaths and no hypersensitivity reactions leading to discontinuation.
INTERPRETATION: High-dose spesolimab was superior to placebo in GPP flare prevention, significantly reducing the risk of a GPP flare and flare occurrence over 48 weeks. Given the chronic nature of GPP, a treatment for flare prevention is a significant shift in the clinical approach, and could ultimately lead to improvements in patient morbidity and quality of life.
FUNDING: Boehringer Ingelheim.
METHODS: We conducted one-on-one in-depth interviews with ARM and HD patients aged ≥ 11 years who had undergone surgery at four tertiary referral centers. All interviews were audio-recorded and transcribed verbatim. We analyzed transcripts for recurring themes, and data were collected until data saturation was reached. Three researchers independently coded the transcripts for major themes using thematic analysis approach.
RESULTS: We interviewed 16 participants (11 males) between October 2022 and April 2023. Ages ranged from 11 to 26 years. Five major themes emerged: (1) personal impact (subthemes: physical, emotional and mental health, social, school), (2) impact on family, (3) perceptions of their future (subthemes: relationships, career, state of health), (4) sources of support (subthemes: family, peers, partner), and (5) transition care (subthemes: concerns, expectations). Only females expressed concerns regarding future fertility.
CONCLUSION: This study highlights the evolving problems faced by adolescents and young adults with ARM and HD, especially gender-specific concerns. Our findings can inform efforts to provide individualized care.
METHODS: We recruited PWE who received treatment at specialized medical facilities for epilepsy in Japan, Malaysia (Chinese, Malay), and Turkey from February to October 2023. The Epilepsy Self-Stigma Scales (ESSS), Neurological Disorders Depression Inventory for Epilepsy (NDDI-E), and Generalized Anxiety Disorder 7 (GAD-7) in local languages were used to assess self-stigma, depressive symptoms, and anxiety.
RESULTS: The ESSS total scores were significantly higher among the Turkish and Japanese cohorts (F [3, 406] = 6.57, p
METHODS: A prospective cohort study was conducted among children with primary simple unilateral congenital ptosis and their parent/guardian who attended three tertiary hospitals from 2022 to 2024. The patients and their parents/guardians answered Spence Children's Anxiety Scale-Social Anxiety and the PedsQL 4.0 Generic Core Scale, at the time of recruitment and 3 months after ptosis surgery.
RESULTS: This study involved 45 children, of which 26 (57.8%) were female. At enrollment, 18 (40.0%) had severe ptosis, and 15 (33.3%) had amblyopia. All surgeries were successful, with a mean margin to reflex distance (MRD) 1 and mean intereye MRD1 difference of 4.07 ± 0.62 and 0.29 ± 0.46 mm, respectively. Significant improvements in both social anxiety and HRQoL of children and parent were observed following surgery (p < 0.001). A decrease in intereye MRD1 difference postoperatively was the only significant factor affecting social anxiety of children with ptosis following surgery (p < 0.001). Together with the presence of amblyopia (p < 0.001), the intereye MRD1 difference was found to have a significant impact on the improvement in HRQoL (p = 0.021). Age, sex, and education level of parent/guardians were found to significantly affect the change in social anxiety following ptosis surgery (p < 0.05), while the factor most associated with improvement of parental HRQoL was an improvement in the MRD1 of the ptotic eye (p < 0.001).
CONCLUSIONS: Ptosis surgery significantly improved social anxiety and HRQoL in children with congenital ptosis and their parents/guardians. Psychosocial function should be a consideration when identifying indications for surgery in children with congenital ptosis.
MATERIALS AND METHODS: A total of 728 male workers were recruited in March-July 2005 from 2 major automotive assembly plants in Selangor and Pahang. In this cross-sectional study, information on socio-demography, psychosocial work factors using the 97-item Job Content Questionnaire (JCQ) and an abbreviated 26-item version of the World Health Organization Quality of Life-Brief Version (WHOQOL-BREF) questionnaire containing 4 domains (physical health, psychological, social relationship, and environment) was self-administered to all workers involved.
RESULTS AND CONCLUSION: The prevalence of reported good or very good overall HRQOL and general health was 64.9% and 53.7%, respectively. Multiple linear regression analysis indicated that created skill was positively associated with physical health and psychological domains; whilst, skill discretion was positively associated with social relationship and environment domains. Social support was positively associated with physical health and environment domains; whilst, co-worker support was positively associated with psychological and social relationship domains. Job insecurity and hazardous condition were negatively associated with all domains, whilst psychological job demands was negatively associated with the environment domain of HRQOL.
METHODS: We searched PubMed, Embase, and Web of Science through August 2024 for randomized controlled trials evaluating ensifentrine in COPD patients over a minimum of four weeks. Data extraction and screening utilized Knowledge software, and meta-analyses were performed using R v4.4 with a random-effects model.
RESULTS: From 206 studies identified, four met our inclusion criteria. Ensifentrine improved FEV1 significantly at a dose of 3 mg (LS mean difference: 40.90 mL; 95 % CI: 19.65-62.15). It also improved dyspnea as measured by the Transition Dyspnea Index (TDI) (LS mean difference: 0.91; 95 % CI: 0.61-1.21) and quality of life according to the St. George's Respiratory Questionnaire-C (SGRQ-C) scores (LS mean difference: -1.92; 95 % CI: -3.28 to -0.55). Safety profiles were comparable between the ensifentrine and placebo groups, with no significant increase in treatment-emergent adverse events (TEAEs) (RR: 1.02; 95 % CI: 0.94-1.10).
CONCLUSION: Ensifentrine significantly enhances lung function, reduces dyspnea, and improves quality of life in COPD patients, especially at a 3 mg dose. These benefits, coupled with a stable safety profile, support its use as an adjunctive therapy in COPD management.
METHODS: Oxy-PICU was a pragmatic, multicentre, open-label, randomised controlled trial in England and Scotland. Eligible children were older than 38 weeks and younger than 16 years and had been admitted for emergency care in one of 15 participating PICUs, where they received invasive respiratory support for abnormal gas exchange. Participants were randomly assigned (1:1) to either a conservative oxygenation target (SpO2 88-92%) or liberal oxygenation target (SpO2 >94%). Survival status was assessed at 90 days and 1 year, and health-related quality of life (HRQoL), quality-adjusted life-years (QALYs), health-care costs, and incremental net monetary benefit were assessed at 1 year after the index hospital admission and randomisation. HRQoL was measured with age-appropriate Paediatric Quality of Life Generic Core Scales and mapped onto the Child Health Utility 9D index score. HRQoL and survival data were combined to construct QALYs. Costs at 1 year were derived from use of hospital, outpatient, and community health services. The trial was registered in the ISRCTN registry (ISRCTN92103439).
FINDINGS: 2040 children were enrolled between Sept 1, 2020 and May 15, 2022. 1868 (91·6%) children were included in the 90-day survival analysis; of these 930 (49·8%) had been assigned liberal oxygen and 938 (50·2%) conservative oxygen. 1867 (91·5%) children were included in the 1-year survival analysis; 930 (49·8%) had been assigned liberal oxygenation and 937 (50·2%) conservative oxygen. At 90 days, 35 (3·7%) patients in the conservative oxygenation group and 45 (4·8%) patients in the liberal oxygenation group had died (adjusted hazard ratio [aHR] 0·75 [95% CI 0·48 to 1·17]). By 1 year, 52 (5·5%) patients in the conservative oxygenation group and 66 (7·1%) patients in the liberal oxygenation group had died (aHR 0·77 [95%CI 0·53 to 1·10]). Overall, mean HRQoL, life-years, and QALYs at 1 year were similar in the two groups. The adjusted incremental effect on cost of conservative oxygenation versus liberal oxygenation was -£879 (95% CI -9036 to 7278), whereas the incremental difference in QALYs was estimated at 0·001 (-0·010 to 0·011), leading to an incremental net monetary benefit of £894 (-7290 to 9078) associated with conservative oxygenation relative to liberal oxygenation. These results did not vary by age (<12 months vs ≥12 months), comorbidity at baseline, age-adjusted heart rate, or haemoglobin level at admission and were robust to alternative assumptions.
INTERPRETATION: Compared with usual care (SpO2 >94%) for invasively ventilated children who are admitted as an emergency to a PICU, conservative oxygenation (SpO2 88-92%) was not associated with differences in longer-term survival, costs, or cost-effectiveness. Taken together with previous findings of Oxy-PICU that conservative oxygenation compared with liberal oxygenation leads to better patient-centred and parent-centred outcomes at 30 days, these findings support the use of conservative oxygenation targets for this population.
FUNDING: UK National Institute for Health and Social Care Research Health Technology Assessment Programme.
METHODS: A total of 88 BC women were randomly assigned into one of four groups: i) omega-3 fatty acid (ω3) group; ii) vitamin D (VitD) group; iii) ω3+VitD group, and iv) the control. Participants were received either two 300 mg ω3 capsules daily, or one 50,000IU VitD tablet weekly, or both supplementation for 9-weeks. The QoL status was assessed by the European Organization for Research and Treatment of Cancer (EORTC) instruments of QLQ-C30 and QLQ-BR23 tools, while blood inflammatory markers of TNF-α hsCRP were used. All measurements were taken from baseline to the end of the intervention period. The detailed procedures of the present study were registered on ClinicalTrial.gov with the identifier NCT05331807.
RESULTS: At the end of the trial, participants in the ω3+VitD group showed a significant increase in overall global health status (p
METHODS AND ANALYSIS: This RCT will recruit 126 patients with MDD who will be randomised using stratified permuted block randomisation into three groups, which are the combined e-ACT programme, ACT-only and TAU control groups in a 1:1:1 allocation ratio. The participants in the e-ACT and ACT-only intervention groups will undergo once a week intervention sessions for 8 weeks. Assessments will be carried out through three time points, such as the pre-intervention assessment (t0), assessment immediately after completion of the intervention at 8 weeks (t1) and assessment at 24 weeks after completion of the intervention (t2). During each assessment, the primary outcome to be assessed includes the severity of depression symptoms, while the secondary outcomes to be assessed are the severity of anxiety symptoms, experiential avoidance, QoL and depression biomarkers.
ETHICS AND DISSEMINATION: Approval of this study was obtained from the Human Research Ethics Committee of Universiti Sains Malaysia (USM/JEPeM/PP/23050420). The findings of the study will be published in academic peer-reviewed journals.
TRIAL REGISTRATION NUMBER: NCT05812001 (ClinicalTrials.gov). Registered on 12 April 2023.
METHODS: A cross-sectional study was conducted among 244 breast cancer women in The Medical City Teaching Oncology Hospital, Baghdad, Iraq, from August 2023 to October 2023. QOL, coping skills, and psychological factors were assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Group Core-30 (QLQ-C30), BRIEF COPE-28, and Hospital Anxiety and Depression Scale (HADS) scale, respectively. Sociodemographic and clinical characteristics were also assessed. The associations between the association factors and quality of life were assessed using multiple linear regression.
RESULT: The mean (SD) quality of life scores for global, functional, and symptom domains were (53.24 ± 16.80, 46.23 ± 25.16, and 53.82 ± 22.10), respectively. Multiple linear regression analysis revealed significant factors influencing global quality of life were age, marital status, disease duration, hormonal therapy, passive coping, and anxiety. Age, disease duration, passive coping, and anxiety were significant factors for the functional domain. The symptom domain was notably affected by menstrual status, mastectomy, passive coping, and depression.
CONCLUSION: These results provide crucial insights for developing targeted interventions to enhance the quality of life for breast cancer patients in Iraq.
METHODS: In a single-centered, randomized, double-blinded, placebo-controlled pilot trial conducted from 2019 to 2022, fatigued cancer survivors ≥21 years old were recruited to receive the XBYRT intervention or placebo (5% diluted) once daily for the duration of 8 weeks. Patient-reported outcomes for QOL, CRF, cognition, blood samples for biomarker testing, and adverse events were collected at baseline (T0), 4 weeks (T1), 8 weeks (T2), and 10 weeks (T3) after baseline. Linear regression was performed to evaluate differences between groups at T2 and T3.
RESULTS: A total of 1502 patients were screened, with 672 patients considered eligible. Of the eligible, 15 XBYRT and 13 placebo subjects with similar mean ages (58.5 vs 58.4) were recruited. Both groups were predominantly Chinese (93% vs 62%), breast cancer patients (87% vs 62%), and diagnosed with stage 2 cancer (60% vs 46%). Although no significant difference was found in QOL between groups, the XBYRT group exhibited improved emotional fatigue at T3 (P = .045) and higher BDNF levels at T2 (P = .047) and T3 (P = .029). After baseline adjustment, XBYRT was associated with better perceived cognitive impairment at T2 (P = .011) and T3 (P = .017), as well as overall perceived cognitive function at T3 (P = .028). XBYRT is well tolerated, with grade 3 adverse events reported in three XBYRT (20%) and two placebo (15%) subjects.
CONCLUSION: In this pilot study, XBYRT as an integrative therapy is safe and generates encouraging improvements in cognitive and fatigue symptoms. Difficulties with recruitment limited the generalizability of trial findings, thus findings should be verified through a larger, multi-centered trial.