Outcomes Study 36-Item Short Form Research Articles

THE EXPERIENCE AND RESULTS OF CYTOREDUCTIVE SURGERY AND HIPEC USED IN ADVANCED OVARIAN CANCER

The research object was life quality of patients with ovarian cancer after complex treatment. Nowadays cytoreductive surgery and HIPEC is the mainstay of management of advanced stages ovarian cancer. Description of the problem: study was conducted to assess the effectiveness of combined treatment in IIIA-IIIC ovarian cancer, its impact on quality of life. Main scientific results: 37 patients of main group (CRS + HIPEC) were compared with 25 patients of control group (surgery + systemic chemotherapy). The quality of life was assessed with Medical Outcomes Study 36-Item Short Form Health Survey (SF-36). Comparative analysis of quality of life 6 months after treatment completion did not show significant statistical difference. Combination of cytoreduction with HIPEC improves quality of life in patients with ovarian cancer, is tolerated better and has less systemic toxicities than systemic chemotherapy. The area of practical use of research results: hyperthermic intraperitoneal chemotherapy is performed for patients suffering from malignant tumors of the abdominal cavity, including metastatic colon cancer, ovarian cancer, stomach cancer, pseudomyxoma, mesothelioma, rhabdomyosarcoma, and some other types of oncology. Innovative technological product: combination of cytoreduction with HIPEC improves quality of life in patients with ovarian cancer. Scope of application of an innovative technological product: HIPEC is an innovative treatment option for advanced cancer that has spread to the abdominal cavity (carcinomatosis) and has not gone beyond it.

Poverty, quality of life and psychological wellbeing in adults with congenital heart disease in Chile.

The objective of this study was to assess the quality of life and psychological wellbeing of adults with congenital heart disease (CHD) in Chile, and to identify other associated factors. The study enrolled 68 patients aged between 18 and 72 (median 29), 35 being females. They completed a questionnaire, which included a quality of life assessment tool (the Medical Outcome Study 36-Item Short Form Health Survey), a number of psychological scales (the General Health Questionnaire, the Basic Psychological Needs Scales and the Beck Hopelessness Scale), a socioeconomic survey, and some clinical data. CHD patients reported worse scores in those scales assessing physical dimensions of quality of life (physical function (70.5), physical role functioning (64), vitality (65.3)), and general quality of life (58.6), than in emotional or social dimensions. Female gender was associated with lower scores in physical function (59.12 versus 82.66; p<0.01) and physical role functioning (53.68 versus 75; p<0.05); poverty was associated with worse results in physical function (61.92 versus 82.96; p<0.01), role physical (53.21 versus 79.63; p<0.01), vitality (60.89 versus 71.67; p<0.05), social role functioning (70.19 versus 82.87; p<0.05) and bodily pain (65.77 versus 81.2; p<0.05). Furthermore, we found that psychological scales had an association with quality of life, but clinical variables did not show significant correlations to any dimension. Poverty has an impact on the quality of life of CHD patients. This population only has a decrease in the quality of life physical dimensions, suggesting that quality of life depends on many different factors.

Adult Measures of General Health and Health-Related Quality of Life.

s was very high (intraclass correlation coefficient 0.996). Any disagreements were resolved through a discussion between all authors. Given the large number of potentially relevant measures identified, only those measures that were used at least 4 times in the screened abstracts were selected for this review. Consequently, this report provides reviews of 4 generic health profiles: the Medical Outcomes Study Short Form 36 and Short Form 12 Health Surveys, the Nottingham Health Profile, and the Sickness Impact Profile, and 4 health utility measures: the Medical Outcomes Study Short Form 6D, the Health Utilities Index Mark 3, Quality of Well-Being Scale (selfadministered), and the Assessment of Quality of Life Scale. Although the EuroQol 5-domain is also frequently used in rheumatology, the review of this measure is included in Measures of Disability article in this issue. MEDICAL OUTCOMES STUDY SHORT FORM 36-ITEM (SF-36) AND SHORT FORM 12-ITEM (SF-12) HEALTH SURVEYS

Long-Term Outcomes and Improvements in Quality of Life in Patients with Atrial Fibrillation Treated with Catheter Ablation vs. Antiarrhythmic Drugs.

Catheter ablation (CA) is a recognized first-line treatment for atrial fibrillation (AF) in selected patients; however, the differences between CA and antiarrhythmic drugs (AADs) in terms of long-term outcomes and quality of life (QoL) have not often been compared. We performed a meta-analysis of randomized controlled trials (RCTs) to compare long-term outcomes and QoL with CA and AADs in the treatment of AF. We searched the MEDLINE database for English-language RCTs of CA or AADs in AF from 1 January 2005 to 30 October 2019 with no other restrictions. We included studies that reported sample sizes and the long-term outcomes of interest as well as sample size, mean ± standard deviation or 95% confidence intervals (CIs) for QoL outcomes with CA and AADs. We identified 20 RCTs involving 5425 participants. Compared with patients who received only AADs, patients receiving CA had a significantly decreased risk of all-cause death (relative risk [RR] 0.72; 95% CI 0.58-0.90) and cardiovascular hospitalization (RR 0.85; 95% CI 0.79-0.91). We found a significant increase in the risk of cardiac tamponade (RR 5.86; 95% CI 1.77-19.44) but no difference in the risk of heart failure, stroke or transient ischemic attack, atrial tachycardia, bleeding or hematoma, and pulmonary vein stenosis. For long-term QoL after treatment, both therapies resulted in improved scores on the Medical Outcomes Study 36-Item Short Form Survey (SF-36): weighted mean differences (WMDs) for the physical component score (PCS) were 5.89 for CA and 4.26 for AADs and for the mental component score (MCS) were 7.12 for CA and 5.06 for AADs. At the end of follow-up, groups receiving CA had significantly higher scores in both areas. The change in PCS and MCS between baseline and end of follow-up was also significantly higher in the CA groups: WMD 1.51 for change in PCS and 1.49 for change in MCS. All eight SF-36 subscale scores improved for patients receiving CA, whereas patients receiving AADs recorded no improvement in the general health and bodily pain subscales. At the end of follow-up, CA groups had significantly higher scores than AAD groups in the following subscales: physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, and role limitations due to emotional problems. In the treatment of AF, CA appeared to be superior to AADs, decreasing the risk of all-cause death and cardiovascular hospitalization and improving the long-term QoL of patients with AF. CA was better tolerated and more effective than pharmacological therapy and allowed for improved QoL.

Peripheral Occipital Nerve Decompression Surgery in Migraine Headache.

Background:Migraine headache in the occipital region is characterized by a recurrent pain of moderate to severe intensity. However, the diagnosis can be difficult because of the multitude of symptoms overlapping with similar disorders and a pathophysiology that is not well-understood. For this reason, the medical management is often complex and ineffective.Methods:A literature search according to Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines was conducted to evaluate the surgical treatment of occipital migraines. Inclusion criteria were: English language, diagnosis of migraine, occipital neuralgia, or tension headache in compliance with the classification of the International Headache Society, follow-up at minimum 3 months, and adult age. The treatment had to consist of peripheral occipital nerve surgery.Results:323 records were identified after duplicates were removed, 30 full text articles were assessed for eligibility, and 9 records were selected for inclusion. A total of 1046 patients were included in the review. General positive response after surgery (>50% reduction in occipital migraine headaches) ranged from 80.0% to 94.9%. However, many differences in the selection of patients, target of decompression surgery, and measurement outcome were described.Conclusion:Despite the decennial proven effectiveness and safeness of surgical therapy for chronic occipital migraine headaches, more significant proof is needed to definitively confirm its use as a standard therapy.

Long-term outcomes of survivors of mechanical ventilation in intensive care unit (ICU) and their views on ICU rehabilitation clinics

To describe the long-term outcomes of intensive care unit (ICU) survivors of mechanical ventilation, and investigate the views of survivors on ICU rehabilitation clinics. A single-center cross-sectional descriptive study was designed. ICU survivors of mechanical ventilation admitted to the First Affiliated Hospital of Guangzhou Medical University from January to December 2016 were enrolled. Data were collected from August 2017 to March 2018. The general information questionnaire, Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) and ICU rehabilitation clinics questionnaire were used to evaluate ICU survivors social-demographic factors, social and economic outcomes, clinical data, quality of life and the views on ICU rehabilitation clinics. A total of 248 ICU survivors of mechanical ventilation were included in the study, 130 (52.4%) of them were followed up successfully. The mean time from ICU discharge to follow-up day was (19.64±3.20) months. The average age of the survivors was (60.09±15.42) years old, and 55.4% of them were over 60 years old. Among 130 ICU survivors, severe pneumonia was the dominant ICU admission diagnosis (23.1%), followed by surgical operations (cardiac surgery 16.9%, other surgical operations 20.8%), lung transplantation (13.1%), and acute exacerbation of chronic obstructive pulmonary disease (AECOPD, 12.3%), etc. The first APACHE II score after ICU admission was 16.88±7.37, the mechanical ventilation time was (12.52±12.34) days, and the length of ICU stay was (16.71±15.11) days. In terms of social and economic outcomes, the proportion of having full-time or part-time jobs decreased from 32.3% (42/130) before ICU admission to 25.4% (33/130) by the date of follow-up, while the unemployed rate increased from 6.9% (9/130) to 18.5% (24/130). Only 45.1% (23/51) of the ICU survivors returned to the post before ICU admission. 36.2% (47/130) of the ICU survivors reported that they needed care from others, and 86.9% (113/130) reported that their treatment experiences in ICU had an impact on their lives. In terms of quality of life, physiological function dimension, which was 34.62±33.15, scored the lowest and suffered the most. The physical pain dimension and mental health dimension suffered the least, and the scores were 90.19±16.98 and 75.28±15.15, respectively. Furthermore, physical component summary (PCS) score was 61.12±17.09, and mental component summary (MCS) score was 65.97±21.85. In terms of the views of ICU rehabilitation clinics, 68.5% (89/130) of the subjects believed that the establishment of ICU rehabilitation clinics was very helpful or helpful. The long-term outcomes of ICU survivors of mechanical ventilation are not optimistic. Their quality of life is lower than that of general people. It is necessary to set up ICU rehabilitation clinics.

Quality of life in patients with uveitis: data from the ULISSE study (Uveitis: cLInical and medico-economic evaluation of a Standardised Strategy for the Etiological diagnosis)

AimsTo assess vision-related (VR-QOL) and health-related quality of life (HR-QOL) in a large series of patients with de novo uveitis at baseline and 6-month follow-up.MethodsNon-inferiority, prospective, multicentre, cluster randomised controlled...

Determinants of healthcare use by homeless people with schizophrenia or bipolar disorder: results from the French Housing First Study

ObjectivesThere is limited evidence available on the health-seeking behaviours of individuals in relation to determinants of healthcare use. This study aimed to analyse the determinants of healthcare use (including both hospital and outpatient services) among homeless people with severe mental health illnesses. Study designThe study used data from a multicentre, randomised, controlled trial conducted in four large French cities (the French Housing First Study). MethodsData were drawn from 671 homeless people enrolled in the study between August 2011 and April 2014. Mobile mental health outreach teams recruited homeless individuals with severe mental health illnesses who were living on the street or in emergency shelters, hospitals or prisons. Data collection was performed during face-to-face interviews. Healthcare service use included hospitalisations, mental health and regular emergency department (ED) visits and outpatient visits to healthcare facilities or physicians’ offices over a 6-month follow-up period. The data were analysed with zero-inflated (ZI) two-part models. ResultsIn total, 61.1% of participants had at least one hospitalisation stay over the previous 6 months, with a mean of 25 (+/− 39.2) hospital days, and the majority (51%) had visited the ED (either for regular or mental health issues) during the same time period. The results confirmed the role of financial barriers (resources and health insurance) in seeking hospital care (P < 0.05). The main predictors for hospital use in the study population were a better social functioning score (odds ratio [OR]: 1.03; P < 0.001) and having schizophrenia (OR: 1.39; P < 0.01). Higher mental health scores (assessed by the Medical Outcomes Study 36-item Short Form Health Survey) (OR: 1.03, P < 0.01) and alcohol dependence (OR: 2.13; P < 0.01) were associated with not using ED healthcare services. Being ‘absolutely homeless’ predicted an increased use of the ED and a zero use of outpatient services. Inversely, no association with factors related to the homelessness trajectory was found in hospital ZI negative binomial models. ConclusionThis study is important because a comprehensive understanding of the determinants of healthcare use enables healthcare systems to adapt and develop. The efficiency of medicosocial interventions targeting the homeless population with mental health illnesses must also be assessed. Clinical trial numberNCT01570712.

Predictors of health-related quality of life among patients with diabetes on follow-up at Nekemte specialised Hospital, Western Ethiopia: a cross-sectional study

ObjectiveTo assess health-related quality of life (HRQoL) and its predictors among patients with diabetes on follow-up at Nekemte Specialised Hospital in Western Ethiopia.Design, setting and participantsThis facility-based cross sectional study...

Improved health-related quality of life in patients treated with topical sirolimus for facial angiofibroma associated with tuberous sclerosis complex

BackgroundTuberous sclerosis complex (TSC) is a rare autosomal dominant disorder forming hamartomas throughout the body. Facial angiofibromas (FAs) occur in 75% of TSC patients, which are often enlarged, impairing the appearance of the face, and reducing the patient’s quality of life (QOL). The aim of this study was to characterize the impact of topical sirolimus treatment on the health-related QOL in patients with FA associated with TSC.MethodsWe investigated a total of 33 patients who received sirolimus gel treatment for FA associated with TSC and assessed the changes in the health-related QOL using the Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey. SF-36 surveys were performed before and after 3 months of treatment. The conditions of the patients after using the sirolimus gel were categorized into the following three categories: “improved,” “unchanged,” and “aggravated.” Adverse events were investigated using the CTCAE v5.0-JCOG.ResultsThe median age of the patients was 25 (range 14–55) years. After 3 months of sirolimus gel treatment, three scale scores of the SF-36, vitality (VT), social function (SF), and mental health (MH), were significantly improved compared to before the treatment. The VT and SF in patients who had improved FA were significantly better than those in the other patients. There were no significant differences in any scale scores between patients with and without adverse events at 3 months after the initiation of sirolimus gel treatment.ConclusionsThis is the first report regarding improved health-related quality of life in patients treated with sirolimus gel for FA associated with TSC by using the SF-36. The three scale scores associated with mental health were significantly improved compared to before the treatment. The health-related QOL in patients receiving sirolimus gel treatment is more strongly affected by the treatment efficacy than adverse events.Mini-abstractSirolimus gel treatment improves the health-related QOL in patients with FA associated with TSC.

Psychometric properties of the Chinese version of the cancer survivors' unmet needs measure.

Recognition has been growing that when developing effective and affordable survivorship care programmes, it is crucial to assess cancer survivors' unmet needs. The purpose of this study was to evaluate the psychometric properties, including construct validity, internal consistency, test-retest reliability, and concurrent validity, of the Chinese version of the Cancer Survivors' Unmet Needs measure (C-CaSUN) using a sample of Chinese adult cancer survivors. A test battery, consisting of a self-developed information sheet and four Chinese version measurement scales [CaSUN, the Benefit Finding Scale, Hospital Anxiety and Depression Scale, and the Medical Outcomes Study 12-item Short Form (SF-12)], was applied to collect data from Chinese adult cancer survivors. Statistics methods used included exploratory factor analysis, confirmatory factor analysis, Cronbach's coefficient α, Pearson's correlation, and Kappa coefficient. There were 610 cancer survivors. Factor analysis confirmed the five-factor model of C-CaSUN, including information and medical care, life perspective, relationship, comprehensive support, and quality of life. Cronbach's α for all of the C-CaSUN scales was greater than 0.845. The test-retest correlations at the scale level, including the total and the five factors between the two time points, ranged from good to excellent (r=0.713-0.833). The average Kappa coefficient at the item level was 44%. Evidence of significant negative correlations with SF-12 MCS, and positive correlations with anxiety and depression, established the concurrent validity of the C-CaSUN. Evidence indicates that the C-CaSUN is a reliable and valid measure of unmet needs in Chinese cancer survivors. Findings support the five-factor construct of C-CaSUN.

Frailty and Neurocognitive Impairment: Impacts on Quality of Life in HIV.

Little is known about the effects of aging-related conditions on health-related quality of life (HRQOL) among people living with HIV (PLWH). The purpose of our study was to examine the independent effects of neurocognitive impairment (NCI) and frailty and the interactive effects with HIV serostatus on HRQOL. Our sample consisted of 121 adults (63 PLWH and 58 HIV-uninfected) participating in the Multi-Dimensional Successful Aging among HIV-Infected Adults study at the University of California, San Diego. HRQOL was measured with the Medical Outcome Study 36-Item Short Form Health Survey scale. We found that frailty was significantly associated with HRQOL (p < .001) in the overall sample, and this effect was significantly stronger for PLWH than HIV-uninfected adults. NCI was not significantly associated with HRQOL in our sample. Frailty may be a particularly important factor in HRQOL for PLWH, highlighting the need for prevention and intervention strategies to mitigate the risks for frailty.

Relationship between multiple lifestyle behaviors and health-related quality of life among elderly individuals with prediabetes in rural communities in China: A STROBE-compliant article.

Evidence of the effect of lifestyle behaviors on health-related quality of life (HRQoL) is scarce or ambiguous. The objective of the present study was to explore the associations between multiple lifestyle behaviors and HRQoL among the elderly individuals with prediabetes.Four hundred thirty-four elderly individuals with prediabetes were included in this cross-sectional study. The Medical Outcomes Study 36-Item Short Form Health Survey Questionnaire (SF-36) was used to assess HRQoL. Multiple lifestyle behaviors, including smoking, alcohol consumption, physical activity, dietary habits, daily sedentary time and sleep duration were self-reported. The associations between HRQoL and multiple lifestyle behaviors were examined using a multivariate linear regression analysis.Lower-risk physical activities (β =3 .19, 95% CI: 1.32, 5.64), dietary habits (β = 2.60, 95% CI: 1.50, 4.72), and sedentary time (β = 2.49, 95% CI: 1.21, 4.81) were positively associated with the physical health component score (PCS) for HRQoL. Meanwhile, a lower-risk behavior, such as sleep duration (β = 2.64, 95% CI: 1.77, 4.51), was associated with a higher mental health component score (MCS) for HRQoL after adjusting for socio-demographic factors, chronic diseases, anthropometric data and all other lifestyle behaviors. Engaging in a greater number of lower-risk lifestyle behaviors was positively correlated with a better HRQoL.Multiple lifestyle behaviors were associated with HRQoL among the elderly individuals with prediabetes in rural areas. These results highlight the need for multiple lifestyle behavioral interventions to maintain and improve HRQoL in the elderly individuals with prediabetes.

Utility of the Brief Illness Perception Questionnaire to Monitor Patient Beliefs in Systemic Vasculitis.

To assess the validity and clinical utility of the Brief Illness Perception Questionnaire (BIPQ) to measure illness perceptions in multiple forms of vasculitis. Patients with giant cell arteritis (GCA), Takayasu arteritis (TA), antineutrophil cytoplasmic antibody-associated vasculitis (AAV), and relapsing polychondritis (RP) were recruited into a prospective, observational cohort. Patients independently completed the BIPQ, Multidimensional Fatigue Inventory (MFI), Medical Outcomes Study 36-item Short Form survey (SF-36), and a patient global assessment (PtGA) at successive study visits. Physicians concurrently completed a physician global assessment (PGA) form. Illness perceptions, as assessed by the BIPQ, were compared to responses from the full-length Revised Illness Perception Questionnaire (IPQ-R) and to other clinical outcome measures. There were 196 patients (GCA = 47, TA = 47, RP = 56, AAV = 46) evaluated over 454 visits. Illness perception scores in each domain were comparable between the BIPQ and IPQ-R (3.28 vs 3.47, P = 0.22). Illness perceptions differed by type of vasculitis, with the highest perceived psychological burden of disease in RP. The BIPQ was significantly associated with all other patient-reported outcome measures (rho = |0.50-0.70|, P < 0.0001), but did not correlate with PGA (rho = 0.13, P = 0.13). A change in the BIPQ composite score of ≥ 7 over successive visits was associated with concomitant change in the PtGA. Change in the MFI and BIPQ scores significantly correlated over time (rho = 0.38, P = 0.0008). The BIPQ is an accurate and valid assessment tool to measure and monitor illness perceptions in patients with vasculitis. Use of the BIPQ as an outcome measure in clinical trials may provide complementary information to physician-based assessments.

Illness uncertainty, coping, and quality of life among patients with prostate cancer

Illness uncertainty is a significant source of psychological distress that affects cancer patients' quality of life (QOL). Mishel's uncertainty in illness theory (UIT) proposes that illness uncertainty influences an individual's use of coping strategies, and directly and indirectly influences their QOL. This study tested the relationships depicted in the adapted UIT in cancer patients. This cross-sectional study is a secondary analysis of the baseline data from a randomized clinical trial (N = 263 prostate cancer patients). Patients were diagnosed with localized (64.6%), biochemical recurrent (12.6%), or advanced (22.8%) prostate cancer. Uncertainty, coping (avoidant and active coping strategies), and QOL (physical and mental well-being) were measured using the Mishel's uncertainty of illness scale, Brief COPE, and the Medical Outcomes Study 12-item short form (SF-12), respectively. We used path analysis to achieve the research aim. Patients' illness uncertainty directly, negatively influenced their physical well-being (P < .001) and mental well-being (P < .05). Patients' illness uncertainty was positively related to their avoidant coping strategies (P < .001). Patients' active and avoidant coping strategies influenced their mental well-being (P < .001). Uncertainty also negatively influenced mental well-being through avoidant coping strategies. The model had excellent fit to the data. Our findings have indicated the potential of improving QOL by decreasing illness uncertainty and reducing avoidant coping strategies. Future research is needed to better understand the complex relationships between illness uncertainty, coping strategies, and domains of QOL among patients with different types of cancer using longitudinal research.

Impact of thumb osteoarthritis on pain, function, and quality of life: a comparative study between erosive and non-erosive hand osteoarthritis.

The study was aimed to compare the impact of thumb base osteoarthritis (TBOA) on pain, function, and quality of life in patients with erosive or non-erosive hand osteoarthritis (HOA). This observational retrospective study included 232 patients: 64 with erosive HOA (EHOA) and concomitant TBOA, 36 with isolated EHOA, 97 with non-erosive HOA (non-EHOA) and TBOA, and 35 with isolated non-EHOA. Hand pain by a visual analogue scale (VAS), Functional Index for Hand Osteoarthritis (FIHOA) score, Health Assessment Questionnaire (HAQ), the Medical Outcomes Study 36-Item Short Form (SF-36), and the possible correlations between VAS and FIHOA with radiological score were assessed. No differences were found between EHOA with TBOA and isolated EHOA in VAS and FIHOA scores; opposite, there was a significant difference in VAS (p < 0.01) and FIHOA (p < 0.001) between subjects with non-EHOA and TBOA and patients with only non-EHOA. VAS and FIHOA values resulted slightly higher in patients with EHOA and TBOA vs non-EHOA and TBOA; they were significantly more elevated in EHOA and TBOA group compared to isolated non-EHOA (p ≤ 0.001) and in isolated EHOA vs isolated non-EHOA (p < 0.01 and p < 0.001, respectively). HAQ, SF-36 resulted significantly better in isolated non-EHOA patients compared to the other groups. Finally, we observed a significant correlation between FIHOA and all the Kallman scales in EHOA patients with TBOA and between FIHOA and Kallman's thumb score in non-EHOA-TBOA group. EHOA has a more severe clinical burden than non-EHOA; the presence of TBOA appeared an important determinant of pain and disability in non-EHOA.Key Points• Each subset of HOA can have a different impact on pain and functionality, with EHOA determining more severe effects on hand symptoms and disability than non-EHOA.• The presence of TBOA appeared an important determinant of pain and disability in non-EHOA, but not in EHOA.• Our findings support the need for an individualized therapy for each phenotype of hand osteoarthritis.

Association between calf muscle oxygen saturation with ambulatory function and quality of life in symptomatic patients with peripheral artery disease

ObjectiveThe objective of this study was to determine whether calf muscle hemoglobin oxygen saturation (Sto2) obtained during a standardized treadmill test is associated with ambulatory function and health-related quality of life (HRQoL) in patients with symptomatic peripheral artery disease (PAD). We hypothesized that a rapid decline in calf muscle Sto2 during walking is associated with impaired ambulatory function and HRQoL and that these associations are independent of ankle-brachial index (ABI). MethodsCalf muscle Sto2, peak walking time, and claudication onset time were obtained during a treadmill test in 151 symptomatic men and women with PAD. Patients were further characterized by demographic variables, comorbid conditions, cardiovascular risk factors, ABI, 6-minute walk distance, daily ambulatory activity, Walking Impairment Questionnaire (WIQ) score, and Medical Outcomes Study 36-Item Short Form Health Survey physical function score to assess HRQoL. ResultsThe median calf muscle Sto2 value at rest was 52%, which declined to 22% after only 1 minute of walking during the treadmill test and reached a minimum value of 9% after a median time of 87 seconds of walking. Of the various calf muscle Sto2 measurements obtained during the treadmill test, the exercise time to the minimum calf muscle Sto2 value (log transformed) had the strongest univariate associations with peak walking time (r = 0.56; P < .001), claudication onset time (r = 0.49; P < .001), 6-minute walk distance (r = 0.31; P < .001), WIQ distance score (r = 0.33; P < .001), WIQ speed score (r = 0.39; P < .001), WIQ stair-climbing score (r = 0.37; P < .001), and Medical Outcomes Study 36-Item Short Form Health Survey physical function score (r = 0.32; P < .001). In adjusted multiple regression models, these associations persisted (P < .001) after adjustment for demographic measures, cardiovascular risk factors, comorbid conditions, and ABI. ConclusionsMore rapid decline in oxygen saturation of the calf musculature during walking, indicative of impaired microcirculation, is predictive of impaired ambulatory function and HRQoL in patients with symptomatic PAD. Of particular importance, these associations are independent of ABI and other common health burdens, highlighting the clinical relevance that the microcirculation has on ambulatory function and HRQoL in patients with symptomatic PAD.

Comparison of Tightly Controlled Dose Reduction of Biologics With Usual Care for Patients With Psoriasis

Biologics revolutionized the treatment of psoriasis. Biologics are given in a fixed dose, but lower doses might be possible. To investigate whether dose reduction (DR) of biologics in patients with stable psoriasis is noninferior to usual care (UC). This pragmatic, open-label, prospective, controlled, noninferiority randomized clinical trial was conducted from March 1, 2016, to July 22, 2018, at 6 dermatology departments in the Netherlands. A total of 120 patients with plaque psoriasis and stable low disease activity who were receiving treatment with adalimumab, etanercept, or ustekinumab were studied. Patients were randomized 1:1 to DR (n = 60) or UC (n = 60). In the DR group, injection intervals were prolonged stepwise, leading to 67% and 50% of the original dose. The primary outcome was between-group difference in disease activity corrected for baseline at 12 months compared with the predefined noninferiority margin of 0.5. Secondary outcomes were Psoriasis Area and Severity Index (PASI) score and health-related quality of life (including Dermatology Life Quality Index [DLQI] and Medical Outcomes Study 36-Item Short Form Health Survey scores), proportion of patients with short and persistent flares (defined as PASI and/or DLQI scores >5 for ≥3 months), and proportion of patients with successful dose tapering. Of 120 patients (mean [SD] age, 54.0 [13.2] years; 82 [68%] male), 2 patients were lost to follow-up, 2 patients had a protocol violation, and 5 patients had a protocol deviation, leaving 111 patients for the per-protocol analysis (53 in the DR group and 58 in the UC group). The median PASI scores at month 12 were 3.4 (interquartile range [IQR], 2.2-4.5) in the DR group and 2.1 (IQR, 0.6-3.6) in the UC group (mean difference, 1.2; 95% CI, 0.7-1.8). This indicates that noninferiority was not demonstrated for DR compared to UC. The median DLQI score at month 12 was 1.0 (IQR, 0.0-2.0) in the DR group and 0.0 (IQR, 0.0-2.0) in the UC group (mean difference, 0.8; 95% CI, 0.3-1.3), indicating noninferiority for DR compared with UC. No significant difference was found regarding persistent flares between groups (n = 5 in both groups). Twenty-eight patients (53%; 95% CI, 39%-67%) in the DR group tapered their dose successfully at 12 months. No severe adverse events related to the intervention occurred. In this trial, noninferiority was not demonstrated for DR of adalimumab, etanercept, and ustekinumab based on the PASI in patients with psoriasis compared with UC with the chosen noninferiority margin. However, the strategy was noninferior based on the DLQI. Dose tapering did not lead to persistent flares or safety issues. ClinicalTrials.gov Identifier: NCT02602925.

Appraisal of Candidate Instruments for Assessment of the Physical Function Domain in Patients with Psoriatic Arthritis.

Numerous patient-reported outcome measures (PROM) exist for the measurement of physical function for psoriatic arthritis (PsA), but only a few are validated comprehensively. The objective of this project was to prioritize PROM for measuring physical function for potential incorporation into a standardized outcome measurement set for PsA. A working group of 13 members including 2 patient research partners was formed. PROM measuring physical function in PsA were identified through a systematic literature review and recommendations by the working group. The rationale for inclusion and exclusion from the original list of existing PROM was thoroughly discussed and 2 rounds of Delphi exercises were conducted to achieve consensus. Twelve PROM were reviewed and discussed. Six PROM were prioritized: Health Assessment Questionnaire (HAQ) and 4 modifications (HAQ-Disability Index, HAQ-Spondyloarthritis, modified HAQ, multidimensional HAQ), Medical Outcomes Study 36-item Short Form survey physical functioning domain, and the Patient-Reported Outcomes Measurement Information System (PROMIS) physical functioning module. Through discussion and Delphi exercises, we achieved consensus to prioritize 6 physical function PROM for PsA. These 6 PROM will undergo further appraisal using the Outcome Measures in Rheumatology (OMERACT) Filter 2.1.

QUALITY OF LIFE IN CAREGIVERS OF PEDIATRIC PATIENTS WITH CEREBRAL PALSY AND GASTROSTOMY TUBE FEEDING.

Cerebral palsy is the most common cause of physical disability in childhood. Caregivers of patients presenting tetraparesis cerebral palsy (TCP) and gastrostomy tube feeding (GTF) were selected for this study because both conditions represent a great demand for their caregivers. To describe the quality of life related to the state of health of caregivers of patients with TCP who were fed by gastrostomy, to assess the results linked to the mental health of these caregivers, to compare our data with data from other studies on children with cerebral palsy without gastrostomy and to evaluate the possible interference of gastrostomy in the quality of life. A number of 30 major caregivers were interviewed and assessed. Quality of life and mental health tools applied and analyzed only for caregivers were: Medical Outcomes Study (MOS) 36-item Short Form Health Survey (SF-36), WHOQOL-BREF and Beck scales. Other information (age, gender, marital status, number of residents per household and psychological support) was evaluated. The Spearman's rank correlation coefficient was used to analyze. A 5% significance level was adopted. Results obtained through questionnaires are as follows: moderate hopelessness in 20% of caregivers (the higher the number of residents per household the higher the level of caregiver's hopelessness); moderate and severe anxiety in 33.33% of the sample studied; moderate and severe depression identified in 46.67% of interviewed caregivers; health-related quality of life of caregivers of patients with TCP were found to be below world averages; no significant figures for suicide potential were noted for the population under this study. The HRQOL of caregivers of TCP patients who were fed by gastrostomy is below the average of the general population. Our results are very similar to those found in other studies that evaluated caregivers of patients with cerebral palsy with different degrees of neurological impairment and no report of using GTF, suggesting that the presence of gastrostomy did not negatively interfere with the caregiver's HRQOL.