Comparison of physical activity and quality of life between obese individuals with obstructive sleep apnea syndrome and individuals with obesity hypoventilation syndrome.

PURPOSE: Obstructive Sleep Apnea Syndrome (OSAS) and Obesity Hypoventilation Syndrome (OHS) share common causal factors and comorbidities but may have a variable effect on physical activity and associated quality of life, due to differences in pathophysiology. The aim of this study was to compare the levels of physical activity, mental health and quality of life between matched obese patients with either OSAS or OHS, aiming to identify which of the two syndromes may impose the most severe impact on these variables, for the first time in literature. METHODS: A total of 76 obese patients (OSAS: Ν1 = 48, OHS: N2 = 26) of similar age (58.2 ± 12.2 vs. 63.6 ± 9.8; p > 0.05), BMI (37.2 ± 6.2 vs. 40.3 ± 7.3; p > 0.05), and Apnea-Hypopnea Index (AHI) under non-invasive ventilation, completed International Physical Activity Questionnaire (IPAQ), Short-Form Health Questionnaire (SF-36), Personal Well-Being (PWB) Scale and Hospital Anxiety and Depression Scale (HADS-A and HADS-D), in this cross-sectional study. RESULTS: Both groups had similar scores in SF-36, HADS-A and HADS-D, while prevalence of clinical cases of anxiety (HADS-A > 8) and depression (HADS-D > 8) were also similar. OSAS patients scored significantly higher in physical activity [absolute IPAQ values 1100.75(7753.5) for OSAS vs. 518(3806) for OHS; p = 0.029]. Group comparisons yielded significant differences in physical functioning (p < 0.05) and general health perceptions (p < 0.05), in favor of the OSAS group. CONCLUSION: Both syndromes significantly affect patients' quality of life and physical activity, with the burden being heavier for OHS patients. Daily physical activity seems to be more impaired among obese OHS patients perhaps due to daytime hypercapnia.

Clinical and Sociodemographic Factors Associated With Health-Related Quality of Life in Patients With Adult Congenital Heart Disease　- A Nationwide Cross-Sectional Multicenter Study.

BACKGROUND: Little is known about clinical or sociodemographic factors that influence health-related quality of life (HRQoL) in patients with adult congenital heart disease (ACHD).Methods and Results: We conducted a nationwide prospective cross-sectional multicenter study at 4 large ACHD centers in Japan. From November 2016 to June 2018, we enrolled 1,223 ACHD patients; 1,025 patients had an HRQoL score. Patients completed a questionnaire survey, including sociodemographic characteristics, and the 36-Item Short-Form Health Survey (SF-36). To determine factors associated with HRQoL, correlations between 2 SF-36 summary scores (i.e., physical component score [PCS] and mental component score [MCS]) and other clinical or sociodemographic variables were examined using linear regression analysis. In multivariable analysis, poorer PCS was significantly associated with 11 variables, including older age, higher New York Heart Association class, previous cerebral infarction, being unemployed, and limited participation in physical education classes and sports clubs. Poorer MCS was associated with congenital heart disease of great complexity, being part of a non-sports club, current smoking, and social drinking. Student status and a higher number of family members were positively correlated with MCS. CONCLUSIONS: This study demonstrates that HRQoL in ACHD patients is associated with various clinical and sociodemographic factors. Further studies are needed to clarify whether some of these factors could be targets for future intervention programs to improve HRQoL outcomes.

Effects of concurrent exercise on health-related quality of life in middle-aged women.

OBJECTIVE: This study aimed to evaluate the influence of a 16-week concurrent exercise program on health-related quality of life in middle-aged women. METHODS: A total of 150 middle-aged women from the FLAMENCO project (age range 45-60 years) were randomized into a counseling (n = 75) or an exercise (n = 75) group. The exercise group followed a 16-week (3 days/week, 60 min/session) concurrent exercise program (aerobic + resistance training). The counseling group attended conferences on a healthy lifestyle. Participants' health-related quality of life was assessed with the EuroQol plus, a visual analog scale and the 36-item Short Form Health Survey (SF-36), where greater values indicate a better health-related quality of life. RESULTS: The visual analog scale increased by 9.0% in the exercise group, whereas it only increased by 3.5% in the counseling group (p = 0.040). The SF-36 physical function, physical role, bodily pain, vitality and emotional role increased by 5.5%, 11.3%, 10.8%, 9.6% and 8.9%, respectively, in the exercise group, whereas these only increased by 0.6%, decreased by 0.7% and increased by 1.4%, 3.8% and 0.6% in the counseling group (all p < 0.05). CONCLUSIONS: Our results suggest that a 16-week concurrent exercise program adapted for midlife women improved their health-related quality of life. CLINICALTRIALS.GOV IDENTIFIER: NCT02358109. Date of registration: 05/02/2015.

Laparoscopic Adrenalectomy Is Beneficial for the Health-Related Quality of Life of Older Patients with Primary Aldosteronism.

OBJECTIVE: Laparoscopic adrenalectomy (LADX) improves hypertension in patients with primary aldosteronism (PA). However, the antihypertensive impact of LADX appears restricted in older patients with PA. In this study, we evaluated the impact of LADX in older patients focusing on the health-related quality of life (HRQoL). METHODS: A total of 156 patients with PA who underwent LADX in a single institution were enrolled in this prospective cohort study. The patients were divided into 2 groups, with a boundary of 60 years. The HRQoL was evaluated using the Medical Outcomes Study's 36-Item Short-Form Health Survey version 2 (SF-36v2) questionnaire before and after LADX. Demographics, clinical features, antihypertensive drugs before and after surgery, and perioperative evaluation were recorded. We compared all scale scores and summed scores between groups. Multivariate regression models were used to determine the associations between various covariables and the HRQoL. RESULTS: In the older PA patients, most subscales of HRQoL at baseline were lower than the national standard values. The antihypertensive drug-free rate by LADX was only 21% in older patients, compared to 58% in younger patients. However, a significant improvement in mental HRQoL was observed after LADX (p = 0.002). The much preoperative antihypertensive drugs, lower preoperative potassium level, and smaller degree of comorbidities were predictors of improved mental HRQoL by LADX on multivariate analyses. CONCLUSION: The older PA patients showed lower mental HRQOL than the national standard populations. Although antihypertensive effects were limited for these patients, LADX was beneficial as PA treatment via improvement of mental HRQoL.

Long-term treatment effects of inotersen on health-related quality of life in patients with hATTR amyloidosis with polyneuropathy: Analysis of the open-label extension of the NEURO-TTR trial.

INTRODUCTION/AIMS: Hereditary transthyretin-mediated amyloidosis with polyneuropathy (hATTR-PN) progressively affects patients' functionality and compromises health-related quality of life (HRQL). The aim of this study was to quantify the projected long-term treatment effects of inotersen vs placebo on HRQL measures. METHODS: The inotersen phase 2/3 randomized, double-blind, placebo-controlled trial NEURO-TTR (NCT01737398, 65 weeks) and its subsequent open-label extension (OLE; NCT02175004, 104 weeks) included 172 (112 inotersen and 60 placebo) patients. Placebo double-blind period and overall inotersen-inotersen (double-blind/OLE) treatment period (170 weeks) data were used to extrapolate the long-term placebo-placebo effect using mixed-effects models with repeated measures. Changes from baseline in the Norfolk Quality of Life-Diabetic Neuropathy (QoL-DN) and 36-Item Short Form Health Survey version 2 (SF-36v2) in hATTR-PN were estimated. Differences in changes were compared between the inotersen-inotersen and extrapolated placebo-placebo arms. RESULTS: Inotersen-inotersen patients maintained their HRQL with an observed change ranging from 10.3% improvement (Norfolk QoL-DN item "Pain kept you awake at night") to 11.6% deterioration (SF-36v2 Activities of Daily Living subdomain). The extrapolated placebo-placebo results suggest greater deterioration over time compared with inotersen-inotersen treatment on Norfolk QoL-DN total score (23.6; 95% confidence interval [CI], 8.9-38.3; P < .01), Activities of Daily Living (4.6; 95% CI, 2.0-7.3; P < .001), and "Pain kept you awake at night" (1.2; 95% CI, 0.4-1.9; P < .01). Similarly, greater deterioration was expected for the SF-36v2 Physical Component Summary (8.0; 95% CI, 3.2-12.8, P < .01), Bodily Pain (7.8; 95% CI, 2.0-13.5; P < .01), and Physical Functioning (10.6; 95% CI, 5.5-15.6; P < .0001). DISCUSSION: Long-term (>3 years) inotersen treatment was associated with slowing and, in some domains, halting of deterioration in key HRQL outcome measures, particularly physical functioning and pain.

Comparison of Two Different Pulsed Radiofrequency Modes for Prevention of Postherpetic Neuralgia in Elderly Patients With Acute/Subacute Trigeminal Herpes Zoster.

OBJECTIVE: Trigeminal postherpetic neuralgia (PHN) is often refractory to treatment. Pulsed radiofrequency (PRF) neuromodulation can help in preventing PHN after herpes zoster. This study aimed to compare the efficacy and safety of two different PRF modes on gasserian ganglion neuromodulation in elderly patients with acute/subacute trigeminal herpes zoster. MATERIALS AND METHODS: A total of 120 elderly patients with acute or subacute (within past three months) trigeminal herpes zoster were randomized to receive either a single cycle of high-voltage, long-duration PRF (HL-PRF group; N = 60) or three cycles of standard PRF (S-PRF group; N = 60). Patients were followed up for six months after treatment. Visual analog scale (VAS) pain score, 36-Item Short Form Health Survey (SF-36) score, and pregabalin at baseline and at different time points during follow-up were recorded. RESULTS: VAS and SF-36 scores declined significantly from baseline levels in both groups (p < 0.001). The scores were significantly lower in the HL-PRF group than in the S-PRF group at some time points (p < 0.05). The mean dose of pregabalin was significantly lower in the HL-PRF group than in the S-PRF group on days 3, 14, and 28 after treatment (p < 0.05). No serious adverse events occurred in either group. CONCLUSION: HL-PRF neuromodulation of the gasserian ganglion appears to be more effective than S-PRF for preventing PHN in the elderly. CLINICAL TRIAL REGISTRATION: ChiCTR2000038775.

Short-Term Continuous Positive Air Pressure Treatment: Effects on Quality of Life and Sleep in Patients with Obstructive Sleep Apnea.

Background and Objectives: The aim of this study was to evaluate short-term continuous positive air pressure (CPAP) treatment for health-related quality of life (HRQL) in patients with obstructive sleep apnea. Materials and Methods: Our subjects were 18−65 years old, diagnosed with moderate-to-severe obstructive sleep apnea and treated with CPAP between January 2020 and June 2021 in Hospital of Lithuanian University of Health Sciences Kaunas clinics. All the patients completed the Epworth Sleepiness Scale (ESS), the 36-Item Short Form Health Survey (SF-36), the and Pittsburgh Sleep Quality Index (PSQI) before and after 3 months of treatment. Polysomnography was also repeated. Statistical analyses were performed using SPSS 27.0 software. The value of p < 0.05 was considered as statistically significant. Results: The active-treatment group comprised 17 subjects with a mean age of 51.9 ± 8.9 years. The total SF-36 questionnaire score improved from 499.8 ± 122.3 to 589.6 ± 124.7 (p = 0.012). The SF-36 role limitations due to emotional problems (p = 0.021), energy (fatigue) (p = 0.035), and general health (p = 0.042) domains score significantly improved after CPAP treatment for 3 months. The PSQI mean score at baseline was 12.6 ± 2.9 and in the post-treatment group, it was −5.5 ± 2.3 (p = 0.001). The ESS also changed significantly from a pretreatment mean score of 10.9 ± 5.7 to −5.3 ± 3.2 (p = 0.002) after 3 months. Conclusions: Improvement in HRQL is seen even after a short treatment period with CPAP. Questionnaires are a good tool to evaluate CPAP treatment efficacy.

Curcuma longa extract improves serum inflammatory markers and mental health in healthy participants who are overweight: a randomized, double-blind, placebo-controlled trial.

BACKGROUND: The dietary spice Curcuma longa, also known as turmeric, has various biological effects. Both a water extract and a supercritical carbon dioxide extract of C. longa showed anti-inflammatory activities in animal studies. However, the anti-inflammatory effect in humans of a mixture of these two C. longa extracts (CLE) is poorly understood. Therefore, we investigated the effect of CLE containing anti-inflammatory turmeronols on chronic inflammation and general health. METHODS: We performed a randomized, double-blind, placebo-controlled study in healthy subjects aged 50 to 69 years with overweight. Participants took two capsules containing CLE (CLE group, n = 45) or two placebo capsules (placebo group, n = 45) daily for 12 weeks, and serum inflammatory markers were measured. Participants also completed two questionnaires: the Medical Outcomes Study (MOS) 36-Item Short-Form Health Survey (SF-36) and the Profile of Mood States (POMS) scale. Treatment effects were analyzed by two way analysis of variance followed by a t test (significance level, p <  0.05). RESULTS: After the intervention, the CLE group had a significantly lower body weight (p <  0.05) and body mass index (p < 0.05) than the placebo group and significantly lower serum levels of C-reactive protein (p < 0.05) and complement component 3 (p < 0.05). In addition, the CLE group showed significant improvement of the MOS SF-36 mental health score (p < 0.05) and POMS anger-hostility score (p < 0.05). CONCLUSION: CLE may ameliorate chronic low-grade inflammation and thus help to improve mental health and mood disturbance. TRIAL REGISTRATION: UMIN-CTR, UMIN000037370. Registered 14 July 2019, https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000042607.

The effect of parathyroidectomy on quality of life in primary hyperparathyroidism: evaluation with using sf-36 and phpqol questionnaire.

Quality of life (QoL) typically improves with a parathyroidectomy (PTx) in cases of primary hyperparathyroidism (PHPT), but the effect of surgery on QoL is not yet fully understood. This study evaluated the impact of PTx on health-related QoL (HRQoL). Patients who underwent PTx for PHPT between January 2016 and December 2019 were asked to complete the 36-Item Short Form Health Survey (SF-36) and the Primary Hyperparathyroidism Quality of Life (PHPQoL) questionnaire before surgery and 1 year later. A 5-point Likert scale was used: negative responses received a lower score and positive responses scored high. Forty-one of 50 patients completed the questionnaires before and 12 months after the surgery. The median patient age was 64 years (min-max: 32-83 years). In the study group, 33 were female, and 8 were male. The SF-36 results indicated that significant improvements had been observed in all 8 domains a year after surgery, particularly in the physical functioning and role, general health, energy, and mental health scales. The PHPQoL scores also improved significantly after PTx (p < 0.05). The improvement in the physical and mental health components was 50% and 76%, respectively. In conclusion, this study demonstrated that PTx for PHPT improved QoL.

Short-Term Peripheral Nerve Stimulation Relieve Pain for Elder Herpes Zoster Ophthalmicus Patients: A Retrospective Study.

OBJECTIVE: Ophthalmic postherpetic neuralgia (PHN) is the final stage of herpes zoster (HZ) ophthalmicus and a severe refractory neuropathic pain, thus there is no curative treatment that could alleviate pain and reduce the incidence of ophthalmic PHN now. The purpose of this study is to evaluate therapeutic efficacy of short-term peripheral nerve stimulation (PNS) for elder patients with HZ ophthalmicus. MATERIALS AND METHODS: We performed a retrospective study from March 2015 to August 2019 in our pain department. All the HZ ophthalmicus patients underwent supraorbital nerve short-term PNS were included. The patients' data, including numeric rating scale (NRS), 36-Item short form health survey (SF-36), and analgesic consumptions, were retrospectively analyzed. Severe side effects also were recorded. RESULTS: A total of 68 patients were enrolled in this study. The NRS scores were significantly decreased at different time points after short-term PNS compared to baseline (p < 0.001). The SF-36 scores, including general health, social function, emotional role, mental health, bodily pain, physical functioning, physical role, and vitality, were significantly improved at different time points after treatment (p < 0.001). The average dosages of tramadol and pregabalin administered (mg/d) were both significantly reduced compared to baseline (p < 0.001). There was no bleeding, infection, pain increase, and other side effects after treatment. CONCLUSIONS: Short-term PNS is an effective and safe therapeutic alternative for elder patients with HZ ophthalmicus and could reduce the incidence of ophthalmic PHN.

Minimal Clinically Important Differences for Burke-Fahn-Marsden Dystonia Rating Scale and 36-Item Short-Form Health Survey.

BACKGROUND: Although an increasing number of trials are reported on the treatment of generalized or segmental isolated dystonia, the minimal clinically important difference thresholds for the most frequently reported outcome measures are still undetermined. OBJECTIVES: To estimate the minimal clinically important difference for the Burke-Fahn-Marsden Dystonia Rating Scale and the 36-Item Short-Form Health Survey in generalized or segmental dystonia. METHODS: A total of 898 paired examinations of 198 consecutive patients, aged >18 years, with idiopathic and inherited (torsin family 1 member A positive) segmental and generalized isolated dystonia were analyzed. To calculate the minimal clinically important difference thresholds, both anchor- and distribution-based methods were used simultaneously. RESULTS: Any improvement >16.6% or worsening larger than 21.5% on the Burke-Fahn-Marsden Dystonia Rating Scale indicates a minimal, yet clinically relevant, change. Threshold values for the Burke-Fahn-Marsden Dystonia Disability Scale were 0.5 points for both decline and improvement. Cut-off scores for the Physical Component Summary, the Mental Component Summary, and the Global (Total or Overall) Score of the 36-Item Short-Form Health Survey were 5.5 and 5.5, 6.5 and 7.5, and 7.5 and 8.5 points for clinically meaningful improvement and deterioration, respectively. CONCLUSIONS: The minimal clinically important difference represents the smallest change in an outcome measure that is meaningful to patients. Our estimates for the Burke-Fahn-Marsden Dystonia Rating Scale and the 36-Item Short-Form Health Survey may allow more reliable judgment of the clinical relevance of different treatments for segmental and generalized isolated dystonia. © 2020 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.

The anterior-to-psoas approach for interbody fusion at the L5-S1 segment: clinical and radiological outcomes.

OBJECTIVE: Over the last few decades, many surgical techniques for lumbar interbody fusion have been reported. The anterior-to-psoas (ATP) approach is theoretically supposed to benefit from the advantages of both anterior and lateral approaches with similar complication rates, even in L5-S1. At this segment, the anterior lumbar interbody fusion (ALIF) requires retroperitoneal dissection and retraction of major vessels, whereas the iliac crest does not allow the lateral transpsoas approach. This study aimed to investigate clinical-radiological outcomes and complications of the ATP approach at the L5-S1 segment in a single cohort of patients. METHODS: This is a prospective single-center study, conducted from 2016 to 2019. Consecutive patients who underwent ATP at the L5-S1 segment for degenerative disc disease or revision surgery after previous posterior procedures were considered for eligibility. Complete clinical-radiological documentation and a minimum follow-up of 12 months were set as inclusion criteria. Clinical patient-reported outcomes, such as the visual analog scale for low-back pain, Oswestry Disability Index, and 36-Item Short Form Health Survey (SF-36) scores, as well as spinopelvic parameters, were collected preoperatively, 6 weeks after surgery, and at the last follow-up visit. Intraoperative and perioperative complications were recorded. The fusion rate was evaluated on CT scans obtained at 12 months postoperatively. RESULTS: Thirty-two patients met the inclusion criteria. The mean age at the time of surgery was 57.6 years (range 44-75 years). The mean follow-up was 33.1 months (range 13-48 months). The mean pre- and postoperative visual analog scale (7.9 ± 1.3 vs 2.4 ± 0.8, p < 0.05), Oswestry Disability Index (52.8 ± 14.4 vs 22.9 ± 6.0, p < 0.05), and SF-36 (37.3 ± 5.8 vs 69.8 ± 6.1, p < 0.05) scores significantly improved. The mean lumbar lordosis and L5-S1 segmental lordosis significantly increased after surgery. The mean pelvic incidence-lumbar lordosis mismatch and pelvic tilt significantly decreased. No intraoperative complications and a postoperative complication rate of 9.4% were recorded. The fusion rate was 96.9%. One patient needed a second posterior revision surgery for residual foraminal stenosis. CONCLUSIONS: In the present case series, ATP fusion for the L5-S1 segment has resulted in valuable clinical-radiological outcomes and a relatively low complication rate. Properly designed clinical and comparative trials are needed to further investigate the role of ATP for different L5-S1 conditions.

Motor Function and Perception of Health in Women with Provoked Vestibulodynia.

BACKGROUND: Provoked vestibulodynia (PVD) is a prevalent and disabling condition in women that may be associated with reduced quality of life and impairment of physical functioning. AIM: To investigate whether women with PVD have different motor functions, posture and breathing patterns, and whether they perceive their physical health differently, compared with asymptomatic controls. METHODS AND MAIN OUTCOME MEASURE: The Standardized Mensendieck Test (SMT) and the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) were used to assess differences between 35 women with PVD and 35 healthy controls. RESULTS: There were no statistically significant differences in any of the 5 motor domains of the SMT between the women with PVD and those without PVD: standing posture, 4.0 (0.6) vs 5.0 (0.6); gait, 4.7 (0.6) vs 4.8 (0.6); movement, 4.8 (0.8) vs 5.1 (0.6); sitting posture, 4.7 (1.0) vs 4.9 (0.8); respiration, 4.7 (1.0) vs 4.7 (0.9). Women with PVD scored significantly lower in all domains on the SF-36 (adjusted Bonferroni P = .002) except physical functioning. CLINICAL IMPLICATIONS: Given the lack of difference in the SF-36 physical functioning domain and in all 5 domains of the SMT between women with PVD and those without PVD, the value of interventions focusing on general physical function is unclear. STRENGTHS & LIMITATIONS: A study strength is the use of an assessor-blinded case-control design, trained physiotherapists to conduct the tests, and valid and reliable outcome measures. A limitation is the homogeneity of the sample of young nulliparous women, which limits the generalizability of our findings to other study populations. CONCLUSION: Young nulliparous women with PVD did not score differently from a group of healthy controls on assessment of overall physical functioning or on standing posture, gait, movement, sitting posture, and respiration. However, the score for perception of general health was lower in the women with PVD compared with controls. I. Næss, H.C. Frawley, K. Bø. Motor Function and Perception of Health in Women with Provoked Vestibulodynia. J Sex Med 2019;16:1060-1067.

Long-term clinical outcomes after bilateral laminotomy or total laminectomy for lumbar spinal stenosis: a single-institution experience.

OBJECTIVELumbar spinal stenosis (LSS) is the most common spinal disease in the geriatric population, and is characterized by a compression of the lumbosacral neural roots from a narrowing of the lumbar spinal canal. LSS can result in symptomatic compression of the neural elements, requiring surgical treatment if conservative management fails. Different surgical techniques with or without fusion are currently treatment options. The purpose of this study was to provide a description of the long-term clinical outcomes of patients who underwent bilateral laminotomy compared with total laminectomy for LSS.METHODSThe authors retrospectively reviewed all the patients treated surgically by the senior author for LSS with total laminectomy and bilateral laminotomy with a minimum of 10 years of follow-up. Patients were divided into 2 treatment groups (total laminectomy, group 1; and bilateral laminotomy, group 2) according to the type of surgical decompression. Clinical outcomes measures included the visual analog scale (VAS), the 36-Item Short-Form Health Survey (SF-36) scores, and the Oswestry Disability Index (ODI). In addition, surgical parameters, reoperation rate, and complications were evaluated in both groups.RESULTSTwo hundred fourteen patients met the inclusion and exclusion criteria (105 and 109 patients in groups 1 and 2, respectively). The mean age at surgery was 69.5 years (range 58-77 years). Comparing pre- and postoperative values, both groups showed improvement in ODI and SF-36 scores; at final follow-up, a slightly better improvement was noted in the laminotomy group (mean ODI value 22.8, mean SF-36 value 70.2), considering the worse preoperative scores in this group (mean ODI value 70, mean SF-36 value 38.4) with respect to the laminectomy group (mean ODI 68.7 vs mean SF-36 value 36.3), but there were no statistically significant differences between the 2 groups. Significantly, in group 2 there was a lower incidence of reoperations (15.2% vs 3.7%, p = 0.0075).CONCLUSIONSBilateral laminotomy allows adequate and safe decompression of the spinal canal in patients with LSS; this technique ensures a significant improvement in patients' symptoms, disability, and quality of life. Clinical outcomes are similar in both groups, but a lower incidence of complications and iatrogenic instability has been shown in the long term in the bilateral laminotomy group.

PROMIS measures can be used to assess symptoms and function in long-term hematopoietic cell transplantation survivors.

BACKGROUND: Patient-reported outcomes for hematopoietic cell transplantation (HCT) survivors are well characterized with established measures; however, there is little experience with the new, freely available Patient-Reported Outcomes Measurement Information System (PROMIS) measures in this population. The aim of this study was to compare the performance of the PROMIS measures in the HCT setting with the performance of the commonly used 36-Item Short Form Health Survey (SF-36). METHODS: Adult HCT survivors from the Fred Hutchinson Cancer Research Center (n = 4446) were mailed a survey that included the following as part of an annual follow-up survey: the Patient-Reported Outcomes Measurement Information System-Global Health (PROMIS-GH; 10 questions), the 29-Item Patient-Reported Outcomes Measurement Information System Profile (PROMIS-29), and the SF-36. RESULTS: Both the SF-36 and PROMIS measures were available for 1634 HCT recipients (503 autologous recipients and 1131 allogeneic recipients). The overall response rate was 46%. The median time after transplantation for allogeneic and autologous recipients was 12.0 years (range, 0.4-44.1 years) and 6.1 years (range, 0.4-30.1 years), respectively. With the SF-36 or PROMIS-GH, overall physical functioning was somewhat lower in comparison with the general population, but mental functioning was similar. Component and domain scores with similar contents were strongly correlated by Pearson correlation coefficients: the Global Health-Physical and SF-36 Physical Component Summary scores for autologous (r = 0.82) and allogeneic recipients (r = 0.83) and the PROMIS-29 and SF-36 physical function, pain, and vitality/fatigue scores for allogeneic (0.87, -0.82, and -0.82, respectively) and autologous recipients (0.84, -0.82, and -0.81, respectively). The correlation between the Global Health-Mental and SF-36 Mental Component Summary scores was lower (0.70 for autologous recipients and 0.72 for allogeneic recipients). CONCLUSIONS: Physical and mental symptoms and function in autologous and allogeneic HCT survivors can be adequately assessed with PROMIS-29 and PROMIS-GH. Cancer 2018;124:841-9. © 2017 American Cancer Society.

A randomised, double-blind, cross-over trial to evaluate bread, in which gluten has been pre-digested by prolyl endoprotease treatment, in subjects self-reporting benefits of adopting a gluten-free or low-gluten diet.

The aim of the present study was to determine if the enzyme Aspergillus niger prolyl endoprotease (ANPEP), which degrades the immunogenic proline-rich residues in gluten peptides, can be used in the development of new wheat products, suitable for gluten-sensitive (GS) individuals. We have carried out a double-blind, randomised, cross-over trial with two groups of adults; subjects, self-reporting benefits of adopting a gluten-free or low-gluten diet (GS, n 16) and a control non-GS group (n 12). For the trial, volunteers consumed four wheat breads: normal bread, bread treated with 0·8 or 1 % ANPEP and low-protein bread made from biscuit flour. Compared with controls, GS subjects had a favourable cardiovascular lipid profile - lower LDL (4·0 (sem 0·3) v. 2·8 (sem 0·2) mmol/l; P=0·008) and LDL:HDL ratio (3·2 (sem 0·4) v. 1·8 (sem 0·2); P=0·005) and modified haematological profile. The majority of the GS subjects followed a low-gluten lifestyle, which helps to reduce the gastrointestinal (GI) symptoms severity. The low-gluten lifestyle does not have any effect on the quality of life, fatigue or mental state of this population. Consumption of normal wheat bread increased GI symptoms in GS subjects compared with their habitual diet. ANPEP lowered the immunogenic gluten in the treated bread by approximately 40 %. However, when compared with the control bread for inducing GI symptoms, no treatment effects were apparent. ANPEP can be applied in the production of bread with taste, texture and appearance comparable with standard bread.

Validation of heart failure quality of life tool and usage to predict all-cause mortality in acute heart failure in Uganda: the Mbarara heart failure registry (MAHFER).

BACKGROUND: The health-related quality of life (HRQoL) is an important treatment goal that could serve as low-cost prognostication tool in resource poor settings. We sought to validate the Kansas City Cardiomyopathy Questionnaire (KCCQ) and evaluate its use as a predictor of 3 months all-cause mortality among heart failure participants in rural Uganda. METHODS: The Mbarara Heart Failure Registry Cohort study observes heart failure patients during hospital stay and in the community in rural Uganda. Participants completed health failure evaluations and HRQoL questionnaires at enrollment, 1 and 3 months of follow-up. We used Cronbach's alpha coefficients to define internal consistency, intraclass correlation coefficients as a reliability coefficient, and Cox proportional hazard models to predict the risk of 3 months all-cause mortality. RESULTS: Among the 195 participants who completed HRQoL questionnaires, the mean age was 52 (standard deviation (SD) 21.4) years, 68% were women and 29% reported history of hypertension. The KCCQ had excellent internal consistency (87% Cronbach alpha) but poor reliability. Independent predictors of all-cause mortality within 3 months included: worse overall KCCQ score (Adjusted Hazard ratio (AHR) 2.9, 95% confidence interval (CI) 1.1, 8.1), highest asset ownership (AHR 3.6, 95% CI 1.2, 10.8), alcoholic drinks per sitting (AHR per 1 drink 1.4, 95% CI 1.0, 1.9), New York Heart Association (NYHA) functional class IV heart failure (AHR 2.6, 95% CI 1.3, 5.4), estimated glomerular filtration rate (eGFR) 30 to 59 ml/min/1.73 m2 (AHR 3.4, 95% CI 1.1, 10.8), and eGFR less than 15 ml/min/1.73 m2 (AHR 2.7, 95% CI 1.0, 7.1), each 1 pg/mL increase in Brain Natriuretic Peptide (BNP) (AHR, 1.0, 95% CI 1.0, 1.0), and each 1 ng/mL increase in Creatine-Kinase MB isomer (CKMB) (AHR 1.0, 95% CI 1.0, 1.1). CONCLUSION: The KCCQ showed excellent internal consistency. Worse overall KCCQ score, highest asset ownership, increasing alcoholic drink per sitting, NYHA class IV, decreased estimated glomerular filtration rate, BNP, and CKMB predicted all-cause mortality at 3 months. The KCCQ could be an additional low-cost tool to aid in the prognostication of acute heart failure patients.

Association between six-minute walk test parameters and the health-related quality of life in patients with pulmonary Mycobacterium avium complex disease.

BACKGROUND: Pulmonary Mycobacterium avium complex (pMAC) disease is a chronic, slowly progressive disease. The aim of the present study was to determine the association of six-minute walk test (6MWT) parameters with pulmonary function and the health-related quality of life (HRQL) in patients with pMAC disease. METHODS: This cross-sectional study included adult patients with pMAC and was conducted at Keio University Hospital. We investigated the relationship of 6MWT parameters with clinical parameters, including pulmonary function, and HRQL, which was assessed using the 36-Item Short Form Health Survey (SF-36) and St. George's Respiratory Questionnaire (SGRQ). RESULTS: In total, 103 consecutive patients with pMAC participated in 6MWT (median age, 64 years; 80 women) and completed SF-36 and SGRQ. The six-minute walk distance (6MWD) showed significant negative and positive correlations with all SGRQ domain scores [ρ = (- 0.54)-(- 0.32)] and the physical component summary (PCS) score (ρ = 0.39) in SF-36, respectively; the opposite was observed for the final Borg scale (FBS) score (all SGRQ scores, ρ = 0.34-0.58; PCS score, ρ = - 0.50). The distance-saturation product showed significant negative and positive correlations with all SGRQ scores [ρ = (- 0.29)-(- 0.55)] and the PCS score (ρ = 0.40), respectively. Multivariate analysis revealed that 6MWD and the FBS score were significant predictors of HRQL. CONCLUSIONS: Our findings suggest that 6MWD and the FBS score are useful parameters for evaluating HRQL in patients with pMAC. Further studies should investigate the impact of 6WMT parameters on disease progression, treatment responses, and prognosis.

Cost-effectiveness of adult spinal deformity surgery in a military healthcare system.

OBJECTIVEAdult spinal deformity surgery is an effective way of treating pain and disability, but little research has been done to evaluate the costs associated with changes in health outcome measures. This study determined the change in quality-adjusted life years (QALYs) and the cost per QALY in patients undergoing spinal deformity surgery in the unique environment of a military healthcare system (MHS).METHODSPatients were enrolled between 2011 and 2017. Patients were eligible to participate if they were undergoing a thoracolumbar spinal fusion spanning more than 6 levels to treat an underlying deformity. Patients completed the 36-Item Short Form Health Survey (SF-36) prior to surgery and 6 and 12 months after surgery. The authors used paired t-tests to compare SF-36 Physical Component Summary (PCS) scores between baseline and postsurgery. To estimate the cost per QALY of complex spine surgery in this population, the authors extended the change in health-related quality of life (HRQOL) between baseline and follow-up over 5 years. Data on the cost of surgery were obtained from the MHS and include all facility and physician costs.RESULTSHRQOL and surgical data were available for 49 of 91 eligible patients. Thirty-one patients met additional criteria allowing for cost-effectiveness analysis. Over 12 months, patients demonstrated significant improvement (p < 0.01) in SF-36 PCS scores. A majority of patients met the minimum clinically important difference (MCID; 83.7%) and substantive clinical benefit threshold (SCBT; 83.7%). The average change in QALY was an increase of 0.08. Extended across 5 years, including the 3.5% discounting per year, study participants increased their QALYs by 0.39, resulting in an average cost per QALY of $181,649.20. Nineteen percent of patients met the < $100,000/QALY threshold with half of the patients meeting the < $100,000/QALY mark by 10 years. A sensitivity analysis showed that patients who scored below 60 on their preoperative SF-36 PCS had an average increase in QALYs of 0.10 per year or 0.47 over 5 years.CONCLUSIONSWith a 5-year extended analysis, patients who receive spinal deformity surgery in the MHS increased their QALYs by 0.39, with 19% of patients meeting the $100,000/QALY threshold. The majority of patients met the threshold for MCID and SCBT at 1 year postoperatively. Consideration of preoperative functional status (SF-36 PCS score < 60) may be an important factor in determining which patients benefit the most from spinal deformity surgery.

Centralized patient-reported outcome data collection in transplantation is feasible and clinically meaningful.

BACKGROUND: Allogeneic hematopoietic cell transplantation (HCT) cures many patients, but often with the risk of late effects and impaired quality of life. The value of quantifying patient-reported outcomes (PROs) is increasingly being recognized, but the routine collection of PROs is uncommon. This study evaluated the feasibility of prospective PRO collection by an outcome registry at multiple time points from unselected HCT patients undergoing transplantation at centers contributing clinical data to the Center for International Blood and Marrow Transplant Research (CIBMTR), and then it correlated the PRO data with clinical and demographic data. METHODS: The Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT), 36-Item Short Form Health Survey (SF-36), and Pediatric Quality of Life Inventory measures were administered before HCT, on day 100, and at 6 and 12 months. Patients were recruited by the transplant center, but posttransplant PRO collection was managed centrally by the CIBMTR. RESULTS: There were 580 eligible patients, and 390 (67%) enrolled. Feasibility was shown by high time-specific retention rates (176 of 238 at 1 year or 74%) and participant satisfaction. Factors associated with higher response rates were an age > 50 years (odds ratio [OR], 1.58; 95% confidence interval [CI], 1.03-2.41; P = .0355), white race (OR, 4.61; 95% CI, 2.66-7.99; P < .0001), and being married (OR, 2.28; 95% CI, 1.42-3.65; P = .0006) for adults and a higher family income for children (OR, 4.99; 95% CI, 2.12-11.75; P = .0002). Importantly, pre-HCT PRO scores independently predicted survival after adjustments for patient-, disease-, and transplant-related factors. The adjusted probabilities of 1-year survival were 56%, 67%, 75%, and 76% by increasing quartiles of the pre-HCT FACT-BMT score and 58%, 72%, 62%, and 82% by increasing quartiles of the pre-HCT SF-36 physical component score. CONCLUSIONS: A hybrid model of local consent for centralized PRO collection is feasible, and pretransplant PROs provide critical prognostic information for HCT outcomes. Cancer 2017;123:4687-4700. © 2017 American Cancer Society.