SF-36 Mental Component Summary Scores Research Articles

Spanish Version of the Anterior Cruciate Ligament-Quality of Life Questionnaire: Translation, Cross-cultural Adaptation, and Validation.

The Anterior Cruciate Ligament-Quality of Life (ACL-QOL) questionnaire is a patient-reported outcome measure used to assess the effect of an anterior cruciate ligament (ACL) injury on the lives of patients. It was originally written in English, which may affect its use when completed by nonnative English speakers. To translate and adapt the ACL-QOL to Spanish and provide evidence of its psychometric properties. Cohort study (diagnosis); Level of evidence, 2. A total of 183 patients with an ACL injury from 4 Catalan hospitals were included: 99 patients who had undergone ACL reconstruction (ACLR) completed the Spanish version of the ACL-QOL (ACL-QOL-Sp) twice (mean interval, 15.2 days) in 2 weeks for test-retest reliability, and 84 patients completed the ACL-QOL-Sp, the Lysholm knee scoring scale, the Knee injury and Osteoarthritis Outcome Score (KOOS), Tegner Activity Scale, and the 12-item Short Form Health Survey (SF-12) before and at 4 and 9 months after ACLR to assess responsiveness. The association between the ACL-QOL-Sp and the other outcome measures was evaluated with the Spearman correlation coefficient. The ACL-QOL-Sp showed good internal consistency (Cronbach alpha = 0.96) and test-retest reliability (intraclass correlation coefficient = 0.97). The standard error of measurement was 3.6, also suggesting the precision of measurements. The smallest detectable change was 9.98 in 94% of patients. No association was found between the ACL-QOL-Sp score and the Tegner score or SF-12 mental component summary score; however, a moderate correlation was found with the overall KOOS score (r = -0.545), Lysholm score (r = 0.509), and SF-12 physical component summary score (r = 0.607). The correlation ranged from weak for the KOOS-Symptoms subscore (r = -0.290) to moderate for the KOOS-Quality of Life subscore (r = -0.698). No ceiling or floor effects were observed. The ACL-QOL-Sp showed a moderate effect size (0.73) at 4 months but a large effect size (1.70) at 9 months. The ACL-QOL-Sp showed adequate internal consistency, test-retest reliability, and responsiveness in evaluating quality of life after ACLR in Spanish-speaking patients.

Validation of the Foot and Ankle Outcome Score (FAOS) for Osteochondral Lesions of the Ankle.

The purpose of this study was to validate the Foot and Ankle Outcome Score (FAOS) for osteochondral lesions of the talus (OLTs). We hypothesize that the FAOS will meet all 4 psychometric criteria for validity in this patient population. From 2008 to 2014, a total of 208 patients with OLTs were included in the construct validity portion of the study. All patients completed FAOS and 12-Item Short-Form Health Survey (SF-12) scores. Twenty additional patients were prospectively recruited and were asked to complete questionnaires to determine the relevance of each of the FAOS questions as it related to their OLT. Forty-four patients completed the FAOS 1 month after the first FAOS to assess reliability via Spearman correlation coefficient. Responsiveness of the FAOS was assessed with 54 patients who had both preoperative and postoperative FAOS scores via Student paired t test with significance determined as P < .05. In total, 229 unique patients were included in this study. Statistically significant associations were found between all FAOS and SF-12 subscales (P < .01). The FAOS symptoms subscale demonstrated the lowest correlation with the SF-12 physical health domains. No floor or ceiling effects were identified. Weak correlations were calculated between the 5 FAOS subscales and the SF-12 mental component summary score. All FAOS domains met the threshold for acceptable content validity (score > 2.0). All FAOS subscales demonstrated acceptable test-retest reliability, with ICC values ranging from 0.81 (ADL) to 0.92 (Pain). This study demonstrates the acceptable yet moderate construct and content validity, reliability, and responsiveness of the FAOS for patients with OLTs of the ankle joint. We endorse the use of the FAOS in evaluating ankle OLTs in both the research and clinical setting and consider it a useful patient-reported, self-administered instrument following surgical intervention. Level IV, retrospective case study.

Do Outcomes Differ After Proximal Hamstring Repair for Patients Receiving Workers' Compensation?

Patients with workers' compensation (WC) insurance claims are often shown to experience inferior patient-reported outcomes (PROs) after an orthopaedic surgical intervention compared with patients without WC claims. To compare the postoperative PROs of patients with WC claims (WC patients) versus those without WC claims (non-WC patients) after proximal hamstring repair (PHR). Cohort study; Level of evidence, 3. WC patients who underwent PHR between November 2011 and to September 2020 were propensity score matched at a 1:2 ratio to non-WC patients according to age, sex, and body mass index. Comorbidity data were collected as well as minimum 1-year postoperative PRO scores for the Lower Extremity Functional Scale (LEFS), the Hip Outcome Score (HOS), and the 12-Item Short From Health Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS). The type of work was characterized according to national WC insurance guidelines as light (maximum 20 lbs [9.1 kg]), medium (maximum 50 lbs [22.7 kg]), or heavy (≥50 lbs) [>/=22.7 kg]. A total of 30 patients (10 WC and 20 non-WC) were included. The work type and baseline demographic characteristics of patients did not differ between groups. There were no significant between-group differences in postoperative PRO scores as measured by the LEFS (P = .488), HOS (P = .233), or SF-12 PCS (P = .521). However, the WC cohort showed inferior SF-12 MCS scores compared with the non-WC group (49.28 ± 9.97 vs 54.26 ± 9.69, respectively; P = .032). The WC status was also associated with an increased time needed for patients to return to full-duty work capacity (21 ± 9 vs 9 ± 8 weeks; P = .005). Our findings suggest that WC and non-WC patients who undergo PHR have comparable outcomes. Differences in SF-12 MCS scores and return to work time for full-duty capacity warrant further investigation.

Quality of Life in Teduglutide-Treated Patients with Short Bowel Syndrome Intestinal Failure-A Nested Matched Pair Real-World Study.

Quality of life (QoL) data of chronic intestinal failure (cIF) patients treated with the GLP-2 analogue teduglutide are scarce. This study aims to analyze QoL changes over time in teduglutide-treated patients and compare the results to a matched non-treated cIF control group in a real-world setting. QoL data (SF-36 and SBS-QoLTM) were obtained from adult cIF patients being treated with teduglutide and compared to previously collected QoL data from a PNLiver trial (DRKS00010993), during which patients had been therapy naive. The dataset was then extended by a pairwise matched control group (non-teduglutide-treated PNLiver trial patients) and follow-up data from this group were collected accordingly. Median teduglutide treatment duration and the follow-up period of controls were both 4.3 years. SBS-QoLTM subscales and the SBS-QoLTM sum score showed significant improvements over time in teduglutide-treated patients, as well as for the SF-36 physical and mental component summary scores (all p < 0.02), while non-treated patients showed no significant changes in any of the mentioned scores. Significant differences of QoL changes between treated and non-treated patients were seen for both SF-36 summary scores (p = 0.031 and 0.012). We herein demonstrate for the first time that QoL significantly improved during teduglutide treatment in SBS-cIF patients in a real-world setting compared to individually matched non-treated SBS-cIF patients, indicating relevant clinical benefits.

Construct validity of the PROMIS PF-10 in patients with inflammatory rheumatic diseases and severe limitations in physical functioning

Objective Assessing the construct validity of the Patient-Reported Outcomes Measurement Information System Physical Function 10-Item Short Form (PROMIS PF-10) in a subpopulation of rheumatoid arthritis (RA) or axial spondyloarthritis (axSpA) patients with severe limitations in physical functioning (PF). Method RA/axSpA patients with severe functional limitations completed the PROMIS PF-10, Health Assessment Questionnaire – Disability Index (HAQ-DI for RA) or Bath Ankylosing Spondylitis Functional Index (BASFI for axSpA), 36-item Short Form Health Survey (SF-36), EuroQol 5-dimensions 5-level (index score, EQ-VAS), and performed the Six-Minute Walk Test (6MWT). Construct validity was assessed by computing Spearman rank or Pearson correlation coefficients and testing hypotheses about correlations between the PROMIS PF-10 and measures of PF and quality of life. Results Data from 316 patients (180 RA/136 axSpA, 91.7%/47.8% female, mean ± sd age 58.6 ± 13.2/54.0 ± 11.3 years) were analysed. The median (IQR) PROMIS PF-10 score was 34.5 (31.4–37.6) in RA and 36.0 (32.8–38.3) in axSpA patients. The PROMIS PF-10 correlated strongly with the HAQ-DI, BASFI, and EQ-5D-5L index score (r > 0.6), moderately with the SF-36 Physical Component Summary score, EQ-VAS, and 6MWT (0.30 ≤ r ≤ 0.60), and weakly with the SF-36 Mental Component Summary score (r < 0.30). Five of six hypotheses (83%) were confirmed in both groups. Conclusion The overall strong correlation of the PROMIS PF-10 with measures of PF and moderate to weak correlations with outcomes measuring different constructs were confirmed in subpopulations of RA and axSpA patients with severe functional limitations, supporting its construct validity.

The Impact of Depression and Anxiety on Adult Cancer Patients' Health-Related Quality of Life.

Cancer patients are at high risk for mental illness and, in turn, poorer health-related quality of life. This study used nationally representative United States (US) data to examine nuances of the impact of depression and/or anxiety on HRQoL in different cancer groups (e.g., cancer only, cancer and depression, cancer and anxiety, cancer and both conditions). Adult patients aged 18 years and older with a cancer diagnosis were identified from the Medical Expenditure Panel Survey data for 2012-2016. HRQoL was measured using the SF-12 Physical and Mental Component Summary (PCS & MCS) scores. Multivariate linear regressions were used, controlling for a multitude of factors. Around 12% of the 1712 identified patients with cancer had depression, 13% had anxiety, and 8.4% had both depression and anxiety. Patients with comorbid depression and anxiety had the lowest mean scores of both PCS and MCS compared to patients in other groups. In addition, cancer patients with either depression and/or anxiety were more likely to have lower MCS scores compared to those with cancer only (depression: β = -6.554; anxiety: β = -3.916; both conditions: β = -11.759, p < 0.001). Interestingly, patients with comorbid depression and anxiety were more likely to have higher PCS scores compared to those with cancer only. The psychological burden of cancer is immense, with a substantial impact on patients' HRQoL. Routine screening for depression and anxiety, especially for women and those with low poverty status and comorbidities, should be conducted by healthcare providers to identify those with high odds of having a lower HRQoL. Additionally, early psychiatric interventions, such as psychotherapy and prescription drugs, may positively impact patients' mental well-being and HRQoL.

Health-Related Quality of Life Impairment Among Patients with Severe Chronic Rhinosinusitis with Nasal Polyps in the SINUS-24 Trial.

Chronic rhinosinusitis with nasal polyps (CRSwNP) is a predominantly type 2 inflammatory disease with a high symptom burden. Data are lacking on the comparative health status of patients with CRSwNP. This analysis compared baseline physical and mental health-related quality of life (HRQoL) and overall health status of patients with severe CRSwNP enrolled in a Phase 3 clinical trial with general population norms and with other chronic diseases. In this post hoc cross-sectional analysis of baseline data from the SINUS-24 study (NCT02912468), HRQoL was measured using the 36-item Short Form (SF-36) questionnaire and general health status was measured using the EuroQol-5 Dimension visual analog scale (EQ-VAS). Analyses included the intention-to-treat (ITT) population and subgroups defined by prior sinonasal surgery, systemic corticosteroid use, and coexisting asthma or non-steroidal anti-inflammatory drug-exacerbated respiratory disease (NSAID-ERD). Scores were compared with published values for population norms (50for SF-36 physical component summary (PCS) and mental component summary (MCS), 70.4-83.3 for EQ-VAS) and for rheumatoid arthritis, type 2 diabetes, and asthma. In the ITT population (n=276), mean SF-36 physical component summary (PCS), SF-36 mental component summary (MCS), and EQ-VAS scores were below general population norms (46.4, 48.6, and 66.0, respectively). Mean SF-36 PCS and EQ-VAS scores were below population norms across all subgroups; mean SF-36 MCS scores were below the population norm in all subgroups except no prior surgery. SF-36 PCS and MCS scores from SINUS-24 were generally similar to other chronic diseases, except SF-36 PCS which was lower in rheumatoid arthritis. EQ-VAS scores in SINUS-24 were lower than in other chronic diseases. HRQoL scores weakly correlated with objective measures of disease severity. In patients with severe CRSwNP, including those with coexisting asthma/NSAID-ERD, HRQoL was worse than population norms and as burdensome as diseases such as type 2 diabetes, asthma, and rheumatoid arthritis.

Effects of microvascular decompression on quality-of-life in trigeminal neuralgia patients aged 70 years and older.

Trigeminal neuralgia (TN) occasionally affects older adults, frequently worsens, and becomes refractory to medication. Older adult patients with TN may consider microvascular decompression (MVD) for their treatment. No study examines MVD effects on older adult TN patients' health-related quality of life (HRQoL). The present study evaluates the HRQoL of TN patients aged 70 years and older before and after MVD. Adult TN patients who underwent MVD evaluated their HRQoL using the 36-Item Short-form (SF-36) Health Survey before and 6 months after MVD. The patients were divided into four groups according to their decade of age. The clinical parameters and operative outcomes were analyzed statistically. The SF-36 physical, mental, and role social component summary scores and eight domain scale scores were analyzed using a twoway repeated-measures analysis of variance (ANOVA) to compare the effects of age group and preoperative and postoperative time points. Among 57 adult patients (34 women, 23 men; mean age, 69 years; range, 30-89 years), 21 patients were in their seventies, and 11 were in their eighties. The SF-36 scores of patients in all age groups improved after MVD. Two-way repeated-measures ANOVA demonstrated a significant age group effect on the physical component summary and its physical functioning domain. A time point effect was significant on all component summaries and domains. There was a significant interaction between age group and time point effects on the bodily pain domain. These results suggested that patients 70 years and older had significant postoperative HRQoL improvement, but their improvement of physical-related HRQoL and multiple physical pain issues were limited. Impaired HRQoL in TN patients aged 70 years and older can improve after MVD. Careful management of multiple comorbidities and surgical risks enables MVD to be an appropriate treatment for older adult patients with refractory TN.

Association of First Metatarsal Phalangeal Joint Fusion for Hallux Rigidus With Patient-Reported Pain and Mental Health Outcomes in Patients Taking Psychotropic Medications.

Limited literature examines the relationship between surgical outcomes in chronic foot and ankle conditions and concurrent psychiatric care. The present study aimed to investigate patient-reported and surgical outcomes of patients treated for a psychiatric disorder undergoing first metatarsophalangeal (MTP) fusion for hallux rigidus. We hypothesized that patients on psychotropic medications would have greater subjective pain preoperatively and less improvement in physical and mental functionality postoperatively when compared with nonmedicated patients. A single-center, retrospective review of prospectively collected data was conducted on 92 patients undergoing first MTP fusion with a preoperative diagnosis of hallux rigidus from 2015 to 2019. At their preoperative, 6-month postoperative, and 1-year postoperative visits, patients were administered visual analog pain scale (VAS) and 36-Item Short Form Health Survey (SF-36) functionality surveys. Patients were subsequently identified by chronic use of psychotropic medication preoperatively and grouped for analysis (MED, n = 42; NO MED, n = 50). Postoperative mean VAS pain scores were lower for all studied patients at 6 months (VAS = 1.6 ± 2.3) and 1 year postoperatively (VAS = 1.1± 1.8) relative to the preoperative visit (VAS = 4.7 ± 2.8) (P ≤ .0001 and P ≤ .0001, respectively). No differences in mean VAS pain scores nor SF-36 physical component summary scores were detected at preoperative, 6-month, or 1-year visits between NO MED and MED groups. Mean SF-36 mental component summary scores for those in the MED group were lower at preoperative (NO MED = 83.8, MED = 71.8, P = .006) and 6-month postoperative (NO MED = 86.1, MED = 72.7, P = .037) visits than those in the NO MED group, a trend not observed at the 1-year postoperative mark (NO MED = 84.1, MED = 76.8, P = .228). There were no observed differences in operative time (P = .219), tourniquet time (P = .359), nor time to full weightbearing (P = .512) between MED and NO MED groups. Additionally, no differences in postoperative complication rates were observed between groups. In patients treated with psychotropically active medications with hallux rigidus, MTP Fusion appears to be a reasonable treatment choice with similar outcomes for patients requiring psychotropically active medications to the outcomes of those patients not requiring psychotropically active medications. Level III, retrospective comparative study.

Self-care time and rating of health state in persons with diabetes: results from the population-based KORA survey in Germany

BackgroundThe amount of empirical research on whether people in fact include health-related changes in leisure time into health state valuations is limited and the results are inconclusive. In this exploratory study, we analyse whether time aspects of diabetes self-care might explain the ratings of the health state (HSR) in addition to the effects of physical and mental health-related quality of life.MethodsUsing the data from participants with diagnosed type 2 diabetes in the population-based KORA FF4 study (n = 190, 60% Male, mean age 69 ± 10 years), multiple logistic regression models were fitted to explain HSR (good vs. poor) in terms of the SF-12 physical and mental component summary (PCS and MCS) scores, time spent on diabetes self-care and a number of background variables.ResultsThere was no significant association between time spent on diabetes self-care and HSR in models without interaction. Significant interaction term was found between the SF-12 PCS score and time spent on self-care. In models with interaction self-care time has a small, but significant impact on the HSR. In particular, for a PCS score under 40, more time increases the chance to rate the health state as “good”, while for a PCS score above 40 there is a reverse effect.ConclusionsThe additional impact of self-care time on HSR in our sample is small and seems to interact with physical health-related quality of life. More research is needed on whether inclusion of health-related leisure time changes in the denominator of cost-effectiveness analysis is sufficient.

Association of Frailty With Health-Related Quality of Life in Liver Transplant Recipients

Frailty has been recognized as a risk factor for mortality after liver transplant (LT) but little is known of its association with functional status and health-related quality of life (HRQL), termed global functional health, in LT recipients. To evaluate the association between pre-LT and post-LT frailty with post-LT global functional health. This prospective cohort study was conducted at 8 US LT centers and included adults who underwent LT from October 2016 to February 2020. Frail was defined by a pre-LT Liver Frailty Index (LFI) score of 4.5 or greater. Global functional health at 1 year after LT, assessed using surveys (Short Form-36 [SF-36; summarized by physical component scores (PFC) and mental component summary scores (MCS)], Instrumental Activities of Daily Living scale) and performance-based tests (LFI, Fried Frailty Phenotype, and Short Physical Performance Battery). Of 358 LT recipients (median [IQR] age, 60 [53-65] years; 115 women [32%]; 25 [7%] Asian/Pacific Islander, 21 [6%] Black, 54 [15%] Hispanic White, and 243 [68%] non-Hispanic White individuals), 68 (19%) had frailty pre-LT. At 1 year post-LT, the median (IQR) PCS was lower in recipients who had frailty vs those without frailty pre-LT (42 [31-53] vs 50 [38-56]; P = .002), but the median MCS was similar. In multivariable regression, pre-LT frailty was associated with a -5.3-unit lower post-LT PCS (P < .001), but not MCS. The proportion who had difficulty with 1 or more Instrumental Activities of Daily Living (21% vs 10%) or who were unemployed/receiving disability (38% vs 29%) was higher in recipients with vs without frailty. In a subgroup of 210 recipients with LFI assessments 1 year post-LT, 13% had frailty at 1 year post-LT. Recipients who had frailty post-LT reported lower adjusted SF-36-PCS scores (coefficient, -11.4; P < .001) but not SF-36-MCS scores. Recipients of LT who had frailty vs those without frailty 1 year post-LT also had worse median (IQR) Fried Frailty Phenotype scores (1 [1-2] vs 1 [0-1]) and higher rates of functional impairment by a Short Physical Performance Battery of 9 or less (42% vs 20%; P = .01). In this cohort study, pre-LT frailty was associated with worse global functional health 1 year after LT. The presence of frailty after LT was also associated with worse HRQL in physical, but not mental, subdomains. These data suggest that interventions and therapeutics that target frailty that are administered before and/or early post-LT may help to improve the health and well-being of LT recipients.

Trajectories of physical and mental functioning over 25years before onset of frailty: results from the Whitehall II cohort study.

Research on frailty, a major contributor to heterogeneity in health, is undertaken on older adults although the processes leading to frailty are likely to begin earlier in the life course. Using repeat data spanning 25years, we examined changes in physical and mental functioning before the onset of frailty, defined using Fried's frailty phenotype (FFP). Functioning was measured using the Short-Form 36 General Health Survey (SF-36) on nine occasions from 1991 (age range 40-63years) to 2015 (age range 63-85years). The poorest of four FFP scores from 2002, 2007, 2012 and 2015 was used to classify participants as frail, pre-frail, or robust. We used linear mixed models with a backward timescale such that time 0 was the person-specific date of frailty classification for frail and pre-frail participants and the end of follow-up for robust participants. Analyses adjusted for socio-demographic factors, health behaviours, body mass index and multi-morbidity status were used to compare SF-36 physical (PCS) and mental (MCS) component summary scores over 25years before time 0 as a function of FFP classification, with estimates extracted at time 0, -5, -10, -15, -20 and -25years. We also used illness-death models to examine the prospective association between SF-36 component summary scores at age 50 and incident FFP-defined frailty. Among 7044 participants of the Whitehall II cohort study included in the analysis [29% female, mean age 49.7 (SD=6.0) at baseline in 1991], 2055 (29%) participants remained robust, and 4476 (64%) became pre-frail and 513 (7%) frail during follow-up. Frail compared with robust participants had lower SF-36 scores at t=-25 before onset of frailty with a difference of 3.4 [95% confidence interval (CI) 1.6, 5.1] in PCS and 1.8 (-0.2, 3.8) in MCS. At t=0, the differences increased to 11.5 (10.5, 12.5) and 9.1 (8.0, 10.2), respectively. The differences in SF-36 between the robust and pre-frail groups, although smaller [at t=0, 1.7 (1.2, 2.2) in PCS and 4.0 (3.4, 4.5) in MCS], were already observed 20 and 25years, respectively, before the onset of pre-frailty. Prospective analyses showed that at age 50, scores in the bottom quartiles of PCS [hazard ratio (HR) compared with the top quartile=2.39, 95% CI 1.85, 3.07] and MCS [HR=1.49 (1.15, 1.93)] were associated with a higher risk of FFP-defined frailty at older ages. Differences in trajectories of physical and mental functioning in individuals who developed physical frailty at older ages were observable 25years before onset of FFP-defined frailty. These findings highlight the need for a life course approach in efforts to prevent frailty.

Effectiveness of game-based exercise interventions on modifiable cardiovascular risk factors of individuals with type two diabetes mellitus: A systematic review and meta-analysis.

Sedentary lifestyles have been identified as a major risk factor for cardiovascular complications for individuals with type 2 diabetes mellitus (T2DM). Using video-gaming components, game-based exercise interventions can encourage these individuals to engage in regular physical activity (PA), given their favorable interactive interfaces, feedback, and on-demand flow experiences. To evaluate the effectiveness of game-based exercise interventions, on modifiable cardiovascular risk factors, quality of life, and PA levels among individuals with T2DM. Published and unpublished studies were retrieved from eight electronic databases and reference lists of the included studies. Articles included in this study were from the inception of the databases to January 2022. Two reviewers performed screening, quality appraisal, and data extraction independently. Meta-analyses were conducted for the primary and secondary outcomes through RevMan. The protocol was registered on PROSPERO (CRD42022298894). Of the 11 selected studies involving 1045 individuals of both genders with T2DM, 9 were included in the meta-analyses for glycosylated hemoglobin, blood pressure (BP), low-density lipoprotein cholesterol, quality of life, and physical activity levels. The meta-analyses reported very small to large effect sizes favoring game-based exercise interventions. Large effect sizes were reported for systolic BP, diastolic BP, and quality of life measured through SF-12 Mental Component Summary scores. Game-based exercise interventions may improve modifiable cardiovascular risk factors, quality of life, and PA levels among individuals with T2DM. Supervision, PA levels, or motivation can affect the effectiveness of game-based exercise interventions.

Sleep and health-related quality of life in women following a cancer diagnosis: results from the Women’s Wellness after Cancer Program in Australia

PurposeSleep disturbance after cancer treatment could compromise recovery. This paper examined the associations between post-treatment sleep problems and health-related quality of life (HRQoL), and the effectiveness of an e-enabled lifestyle intervention on sleep outcomes.MethodsThe Women’s Wellness after Cancer Program (WWACP) was examined in a single blinded, multi-centre randomised controlled trial. Data were collected from 351 women (Mage = 53.2, SD = 8.8; intervention n = 175, control group n = 176) who had completed surgery, chemotherapy and/or radiotherapy for breast, gynaecological or blood cancers within the previous 24 months. Participants completed the Pittsburgh Sleep Quality Index (PSQI) at baseline (prior to intervention randomisation), and at 12 and 24 weeks later. Sociodemographic information, menopausal symptoms (Greene Climacteric Scale) and HRQoL (36-Item Short Form Health Survey; SF-36) were also collected. Linear panel regression was used to examine the association between sleep variables and SF36 Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. A difference-in-difference regression model approach was used to examine the intervention effect on the sleep outcomes.ResultsAfter adjustment for potential confounders, the sleep variables (except sleep duration) significantly predicted physical, but not mental, HRQoL. There was no statistically significant effect of the intervention on sleep outcomes at 12 or 24 weeks.ConclusionWomen who have completed treatment for cancer experience sleep problems that are associated with decreased physical HRQoL. Improving sleep through targeted interventions should improve their physical HRQoL. Improved targeting of the sleep components of the WWACP should be explored.

Pilot study of an online-delivered mindfulness meditation in Ehlers-Danlos syndrome (hEDS): effect on quality-of-life and participant lived experience

Purpose Ehlers-Danlos syndromes (EDS) are connective tissue disorders with multi-systemic symptoms. Management of chronic pain and other symptoms of EDS is a challenge for patients and clinicians. Mindfulness-based approaches for chronic pain produce improvement in pain symptoms. Mindfulness meditation could be an acceptable and readily accessible therapy for pain in EDS. This study evaluated the effect of daily practice of mindfulness meditation on pain experience and quality-of-life in EDS. Materials and methods A pre-post design enabled assessment of change in quality-of-life (SF-36) after practicing internet-delivered mindful meditation for two weeks. Thematic analysis of interviews (n = 10) documented lived experience of meditation practice for pain symptoms. One hundred fifty-seven were recruited from UK EDS charities mailing lists. Seventy six completed the two-week intervention. Results There was a statistically significant improvement in the SF-36 mental component summary score of medium effect size; the change was clinically important. Thematic analysis revealed three key themes of lived experience relating to increased body awareness, reduction in pain intensity, and barriers to practicing meditation. Conclusions This study provides novel evidence about the effect and experience of meditation for symptoms in people with EDS. The outcomes warrant further research with appropriate control groups to determine efficacy. Implications for rehabilitation Mindfulness-based interventions are effective for chronic pain relief. Hypermobile Ehlers–Danlos syndrome (hEDS) patients experience chronic pain that affects quality-of-life. Online-delivered mindfulness meditation was clinically significant in reducing pain intensity and improving quality-of-life outcomes. hEDS patients found the online-delivered intervention acceptable and recommended development to make it flexible to meet their specific needs by varying types and duration of meditations offered.

Effect of risankizumab on health-related quality of life in patients with Crohn's disease: results from phase 3 MOTIVATE, ADVANCE and FORTIFY clinical trials.

Crohn's disease has a substantial negative impact on health-related quality of life (HRQoL). To examine the effects of risankizumab on HRQoL in Crohn's disease METHODS: We analysed data from patients with Crohn's disease from 12-week induction trials ADVANCE (N=850) and MOTIVATE (N=569) with risankizumab 600 mg or 1200 mg intravenous (IV) versus placebo IV and a 52-week maintenance trial FORTIFY (N=462) with risankizumab 180 or 360 mg subcutaneous (SC) versus placebo SC. Outcomes included Inflammatory Bowel Disease Questionnaire (IBDQ), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), 36-item Short Form Health Survey (SF-36), EuroQol 5-Dimension-5-Level (EQ-5D-5L) and work productivity. The mean change and percentages of patients achieving clinically meaningful improvement in all outcomes were determined at weeks 12 and 52. At week 12, more patients in the risankizumab 600 or 1200 mg groups achieved IBDQ response than with placebo (ADVANCE: 70.2%, 75.5% vs. 47.8%, p ≤ 0.001; MOTIVATE: 61.7%, 68.5% vs. 48.2%, p ≤ 0.01) and FACIT-F response (ADVANCE: 51.3%, 48.0% vs. 35.7%, p ≤ 0.01; MOTIVATE: 44.2%, 49.1% vs. 33.7%, p < 0.05). These improvements persisted at week 52 with risankizumab maintenance treatment. Similar trends were observed for SF-36 physical and mental component summary scores, EQ-5D-5L and activity impairment within work productivity measures. Risankizumab induction therapy (600 or 1200 mg IV) led to clinically meaningful improvements in disease-specific and general patient-reported outcomes, including fatigue, in patients with moderate to severe Crohn's disease. These improvements were sustained after 52 weeks of risankizumab (180 or 360 mg SC) maintenance therapy.

Impaired insight in schizophrenia: impact on patient-reported and physician-reported outcome measures in a randomized controlled trial

BackgroundImpaired insight poses a challenge in the treatment of patients with schizophrenia because of its potential to jeopardize therapeutic engagement and medication adherence. This study explored how insight impairment, graded from none to extreme, is related to patient-reported mental health status, depression, and neurocognition in schizophrenia.MethodsIn a post hoc analysis of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) study (NCT00014001), insight was measured using the Positive and Negative Syndrome Scale (PANSS) Item G12 (lack of insight). Additional assessments for this analysis included the 12-Item Short-Form Health Survey (SF-12) Mental Component Summary (MCS), physician- and patient-reported Clinical Global Impression–Severity (CGI-S), MATRICS Consensus Cognitive Battery, and Calgary Depression Scale for Schizophrenia. Relationships between patient-reported outcomes and PANSS total and Item G12 ratings were evaluated.ResultsAmong 1431 CATIE study participants in this analysis, increasingly impaired insight at baseline was significantly associated with better patient-reported quality of life (QoL), lower baseline depression, and greater divergence between physician- and patient-reported illness severity. Patients with more severely impaired insight reported milder illness compared with physician reports, particularly those with moderate-severe to extreme impairment (PANSS Item G12 rating ≥ 5), approximately 10% (138/1431) of CATIE participants. For the 90% of patients with PANSS Item G12 ratings < 5, patient-reported QoL decreased with increasing symptoms. SF-12 MCS scores were linearly related to baseline PANSS total score only in patients with PANSS total score < 90 (moderately ill or better), and better symptom scores were associated with higher QoL. No significant relationship between insight and neurocognition was observed.ConclusionsIn the small subgroup (10%) of CATIE study patients with schizophrenia and PANSS Item G12 ratings ≥5, moderate-severe–severe/extreme insight impairment was associated with significantly more positive perception of QoL and illness severity by the patient versus the treating physician. This was not observed in the remaining 90% of patients with normal to moderately impaired insight, suggesting that poor insight as a threat to the validity of self-report is uncommon.

The Social and Psychological Impact of Acne Treatment: A Cross-Sectional Study of Blood Donors.

Acne in adolescence and adulthood is believed to have a long-term impact on socioeconomic status (SES) and health-related quality-of-life (HRQoL) in adults. To estimate the cross-sectional prevalence of medically treated (MedTreAc) and untreated acne (UnTreAc) and to characterize its long-term impact in adults. A nationwide cross-sectional study on 17 428 blood donors aged 18-35 was performed. Associations among acne and HRQoL, depressive symptoms, total income, and SES were investigated via linear/logistic/multinomial logistic regression analyses adjusted for relevant covariables. HRQoL was measured by the Short Form-12, and depressive symptoms by the Major Depression Inventory. The data were self-reported. Of the participants, 3591 (20.6%) and 1354 (7.8%) identified as the MedTreAc and UnTreAc phenotype, respectively. Neither phenotype was associated with a long-term impact on total income, but the MedTreAc group was associated with being an apprentice/student (OR = 1.26; 95% CI: 1.12, 1.42; P = 1.3×10-4) or high skill-level employee (OR = 1.22, 95% CI: 1.07; 1.39, P = .0023), while self-employment was more common for those with UnTreAc (OR = 1.53; 95% CI: 1.12, 2.06, P = .0061). Additionally, the UnTreAc group was associated with a lower mental HRQoL (SF-12 mental component summary score -1.05, 95% CI: -1.56, -0.54; P = 1.4×10-9) and increased odds ratio of depressive symptoms (OR = 1.44; 95% CI: 1.00, 2.02, P = .046). In this population of blood donors, the cumulative prevalence of MedTreAc and UnTreAc were 20.6% and 7.8%, respectively. Untreated acne had a long-term impact on psychosocial well-being in adulthood. It was associated with lower mental HRQoL and higher occurrence of depressive symptoms. Acne was not associated with a lower salary or SES.

Long-term air pollution exposure, greenspace and health-related quality of life in the ECRHS study

BackgroundAssociations of long-term exposure to air pollution and greenspace with health-related quality of life (HRQOL) are poorly studied and few studies have accounted for asthma-rhinitis status. ObjectiveTo assess the associations of air pollution and greenspace with HRQOL and whether asthma and/or rhinitis modify these associations. MethodsThe study was based on the participants in the second (2000–2002, n = 6542) and third (2011–2013, n = 3686) waves of the European Community Respiratory Health Survey (ECRHS) including 19 centres. The mean follow-up time was 11.3 years. HRQOL was assessed by the SF-36 Physical and Mental Component Summary scores (PCS and MCS). NO2, PM2.5 and PM10 annual concentrations were estimated at the residential address from existing land-use regression models. Greenspace around the residential address was estimated by the (i) mean of the Normalized Difference Vegetation Index (NDVI) and by the (ii) presence of green spaces within a 300 m buffer. Associations of each exposure variable with PCS and MCS were assessed by mixed linear regression models, accounting for the multicentre design and repeated data, and adjusting for potential confounders. Analyses were stratified by asthma-rhinitis status. ResultsThe mean (SD) age of the ECRHS-II and III participants was 43 (7.1) and 54 (7.2) years, respectively, and 48 % were men. Higher NO2, PM2.5 and PM10 concentrations were associated with lower MCS (regression coefficients [95%CI] for one unit increase in the inter-quartile range of exposures were −0.69 [−1.23; −0.15], −1.79 [−2.88; −0.70], −1.80 [−2.98; −0.62] respectively). Higher NDVI and presence of forests were associated with higher MCS. No consistent associations were observed for PCS. Similar association patterns were observed regardless of asthma-rhinitis status. ConclusionEuropean adults who resided at places with higher air pollution and lower greenspace were more likely to have lower mental component of HRQOL. Asthma or rhinitis status did not modify these associations.

A prospective, one-year follow-up study of patients newly diagnosed with neurosarcoidosis

MethodsTwenty patients with newly diagnosed neurosarcoidosis were examined for multiple outcomes in an observational cohort study with 12-month follow-up. ResultsThe patients' contrast-enhancing lesions on MRI scans reduced during treatment (p < 0.0001). The mean modified Rankin Score improved from 3.0 to 1.8 (p < 0.0001), and 75% of patients experienced clinically important improvement. Patients improved on the Symbol Digit Modalities Test (p < 0.0001) and on SF-36 Physical (p = 0.003) and Mental Component Summary scores (p = 0.03). Proportions of patients with substantial fatigue (75%) and high depression score (35%) were unchanged. Conclusions12-month immunosuppression improved several outcomes, and 75% of patients experienced clinically important improvement.