SF-36 MCS Scores Research Articles

Economic and Humanistic Burden of Cervical Cancer in the United States: Results from a Nationally Representative Survey.

Objective: To measure the economic and humanistic burden of cervical cancer in the United States.Materials and Methods: This was a retrospective analysis of Medical Expenditure Panel Survey data (2006–2015). Cervical cancer cases were identified using International Classification of Diseases, Ninth Revision, Clinical Modification code “180” or clinical classification software code “26”. The control group included women without any cancer diagnosis. Study outcomes included health care resource use (institutional inpatient and outpatient, emergency room, and physician office visits), costs, limitations in activities of daily living, and quality of life (general health status, 12-Item Short Form Health Survey [SF-12] physical and mental component summary [MCS], EuroQol-5D and Short-Form Six-Dimension health utility, and Patient Health Questionnaire-2 depression severity). Generalized linear models, controlling for sociodemographic and clinical covariates, were conducted to compare outcomes between cases and controls.Results: The analytic cohort included 275,246 cervical cancer cases and 146,061,609 noncancer controls. Cases were significantly older (mean age [years]: 42.03 vs. 36.98) and had a higher Charlson comorbidity burden (mean score: 1.06 vs. 0.46) versus controls. Multivariate analyses suggested that compared to controls, cancer cases had significantly higher costs: institutional outpatient ($1,610 vs. $502), physician visit ($2,422 vs. $1,321), and total health care ($10,031 vs. $4,913). Cases were 1.99 (odds ratio [OR]: 1.991; 95% confidence interval [CI]: 1.23–3.22) and 2.56 (OR: 2.562; 95% CI: 1.78–3.68) times as likely to report activity limitations and poor general health versus controls. Cervical cancer patients had significantly lower SF-12 physical and MCS score, health utility, and higher depression severity.Conclusions: Cervical cancer is associated with significant economic burden, activity limitations, and quality of life impairment among ambulatory women in the United States.

Quality of Life Improves with Alemtuzumab Over 6Years in Relapsing-Remitting Multiple Sclerosis Patients with or without Autoimmune Thyroid Adverse Events: Post Hoc Analysis of the CARE-MS Studies.

IntroductionIn clinical trials of alemtuzumab, autoimmune thyroid adverse events (AEs) were frequent. Here, we assess the impact of thyroid AEs on health-related quality of life (HRQL) in alemtuzumab-treated patients with relapsing-remitting multiple sclerosis (RRMS).MethodsIn phase 3 CARE-MS I (NCT00530348) and II (NCT00548405) trials, patients with RRMS were administered alemtuzumab 12 mg/day on 5 consecutive days at baseline and on 3 consecutive days 12 months later. Patients could participate in an extension study (NCT00930553) through year 6. HRQL was assessed at baseline and annually using the Functional Assessment of Multiple Sclerosis (FAMS), EuroQoL-5 Dimension Visual Analog Scale (EQ-5D VAS), and 36-Item Short-Form Survey (SF-36) questionnaires. Outcomes were analyzed in patients with or without thyroid AEs (nonserious or serious). A subset of patients with thyroid AEs was analyzed to assess HRQL before and during the onset of thyroid AEs.ResultsA total of 811 CARE-MS patients were treated with alemtuzumab. Of these, 342 (42%) patients experienced thyroid AEs over 6 years; serious thyroid AEs occurred in 44 (5%) patients. At year 6, HRQL outcomes generally remained slightly improved or similar to core study baseline in alemtuzumab-treated patients with or without thyroid AEs: FAMS (least-squares mean change from baseline without thyroid AEs, 0.7; with nonserious thyroid AEs, 5.1; with serious thyroid AEs, − 5.3), EQ-5D VAS (2.0; 3.0; − 6.8), SF-36 mental component summary (MCS [0.6; 1.6; − 2.8]), SF-36 physical component summary (PCS [0.8; 1.0; 1.1]). Over 6 years, 63–82% of patients in each group had improved/stable SF-36 MCS and PCS scores. Among patients with thyroid AE onset in year 3 (peak incidence), there were minimal differences between HRQL outcomes before onset (year 2) and after onset (year 3).ConclusionAutoimmune thyroid AEs (serious and nonserious) had minimal impact on HRQL in alemtuzumab-treated patients. These data may aid therapeutic decisions in patients with relapsing MS.Electronic supplementary materialThe online version of this article (10.1007/s40120-020-00191-7) contains supplementary material, which is available to authorized users.

Predictors of Low-Level Disease-Specific Knowledge in Patients with Chronic Obstructive Pulmonary Disease.

BackgroundDisease-specific knowledge is associated with outcomes of patients, but the knowledge level of chronic obstructive pulmonary disease (COPD) patients is known to be low.ObjectiveWe measured the level of disease-specific knowledge and defined factors associated with poor disease knowledge in COPD patients.Materials and MethodsA cross-sectional survey was performed in five hospitals in South Korea. At enrolment, all patients completed the Bristol COPD Knowledge Questionnaire (BCKQ), Satisfaction with Life Scale (SWLS), Personal Resource Questionnaire (PRQ), St. George’s Respiratory Questionnaire (SGRQ), 36-item Short-Form Health Survey (SF-36), and the Hospital Anxiety and Depression Scale (HADS). The data were analyzed via linear regression to identify factors associated with low-level knowledge of COPD.ResultsA total of 245 COPD patients were enrolled in this study. The mean total BCKQ score was 28.1 (SD, 7.4). The lowest scores were seen for items exploring knowledge of “Oral steroids” and “Inhaled steroids”. In univariate analysis, higher level of education (r = 0.17), low income (r = 0.13), the post-bronchodilator FEV1, % predicted (r = −0.24), the post-bronchodilator FEV1/FVC ratio (r = −0.13), SWLS (r = 0.15), PRQ (r = 0.16), SF-36 MCS (r = 0.13), HADS-A (r = −0.17), and HADS-D (r = −0.28) scores correlated with the BCKQ score (all p < 0.05). FEV1 (r = −0.25, p < 0.001) and HADS-D score (r = −0.29, p < 0.001) were significantly associated with the total BCKQ score in multivariate analysis.ConclusionOur Korean patients with COPD lacked knowledge on oral and inhaled steroid treatments. In particular, patients with higher-level lung function and/or depressive symptoms exhibited poorer disease-specific knowledge; such patients may require additional education.

Personality traits predict residual pain after total hip and knee arthroplasty.

We assessed the role of personality traits, anxiety, and depression in residual pain among patients who underwent total hip (THA) and knee (TKA) arthroplasty. Eighty-three patients (40 THA and 43 TKA) were interviewed pre-operatively (t0); fivedays (t1) after surgery; and one (t2), three (t3), six (t4), and 12months (t5) after surgery. Personality (TCI-R), pain (VAS), anxiety and depression (HADS), quality of life (SF-12), functionality (HHS/KSS), and disability (WOMAC) were evaluated. Pain reduction and functional improvement were reported at t5 (both p < 0.001) in both THA and TKA patients. THA patients showed earlier and greater functional improvement after surgery (both p < 0.001) in comparison with TKA. Residual pain (VAS > 30mm) was noted in 15% of the THA patients and 25% of the TKA patients, and it correlated with the SF-12 PCS (r2 = - 0.412; p < 0.001), SF-12 MCS (r2= - 0.473; p < 0.001), HADS-A (r2 = 0.619; p = <0.001), HADS-D (r2 = 0.559; p < 0.001), functionality (r2 = - 0.482; p < 0.001), and WOMAC (r2 = 0.536; p < 0.001) scores at t5. High pre-operative harm avoidance, persistence, and anxiety scores were predictive of residual pain after both THA and TKA (p < 0.001). The proportion of patients complaining of residual pain in this study was similar to that in previous findings. Multiple predictors of residual pain after THA and TKA have been previously described, and several studies evaluated the influence of psychological factors on the outcome of joint arthroplasty; however, only four studies investigated the role of personality traits in the outcome of THA and TKA patients, and a unique study out of these investigations demonstrated the effect of personality on persisting pain. The current study demonstrated that personality traits and anxiety predict residual pain; thus, pre-operative evaluation of these factors could be helpful in identifying patients at risk for residual pain.

Learning curve assessment for total ankle replacement using the transfibular approach

BackgroundTotal ankle arthroplasty is an increasingly effective option for the treatment of end-stage arthritis. One recent innovation utilizes a transfibular, lateral approach. Like any new system, there is likely a learning curve associated with its use. We analyzed a series of patients who received a total ankle arthroplasty via a transfibular approach to state if it is possible to identify and to evaluate effects of a learning curve in the use of this novel total ankle replacement system. Methods76 consecutive patients meeting inclusion and exclusion criteria were retrospectively analyzed. All patients had a minimum of 24 months of follow-up. Intraoperative parameters, preoperative and postoperative subjective outcome scores, radiographic parameters, and complications were recorded and evaluated. ResultsThere were significant learning curve effects on various surgical and postoperative parameters. Surgical time decreased with the curve stabilizing after the 16th patient. With regard to patient outcomes, a learning curve was identified for the VAS, AOFAS, and SF-12 MCS scores. The number of patients required to stabilize these curves were 21, 13, and 16, respectively. Alignment as measured by alpha and gamma angles also improved with experience, with the curves stabilizing at 18 and 15 patients, respectively. There was a larger number cases required for complication rates, with the curve stabilizing after the 39th patient. No significant learning curve was found for ankle ROM, SF-12 PCS, beta angle, tibio-talar ratio (TTR), or tibio-talar surface angle (TTS). ConclusionsThis study demonstrates a significant learning curve with respect to operative time, patient outcomes, and radiographic parameters. Extrapolating this information, we urge surgeons to adequately familiarize themselves with any new implant through a training program in a high-volume center. Level of evidenceIV, case series.

The Influence of Preoperative Mental Health on PROMIS Physical Function Outcomes Following Minimally Invasive Transforaminal Lumbar Interbody Fusion.

Retrospective. To demonstrate whether preoperative mental health status can be predictive of postoperative functional outcomes as measured by Patient-Reported Outcome Measurement Information System Physical Function (PROMIS PF) following minimally invasive transforaminal lumbar interbody fusion (MIS TLIF). There is a paucity of scientific investigations into the association between preoperative mental health as evaluated by a validated questionnaire such as the Short Form-12 Mental Health Composite Score (SF-12 MCS) and postoperative outcomes following MIS TLIF. Patients undergoing a primary MIS TLIF were retrospectively reviewed and stratified into cohorts based on preoperative SF-12 MCS scores. The Physical Function scores of PROMIS, of which there are other domains including Pain Interference, Sexual Function, and Cognitive Function, were compared between the cohorts. In addition, the improvement in PROMIS scores based on preoperative SF-12 MCS scores following MIS TLIF was analyzed using multivariate linear regression. One hundred seventy-two patients were included: 85 patients (49.4%) had a preoperative SF-12 MCS score <50 and 87 (50.6%) had a preoperative SF-12 MCS score ≥50. Patients with poorer mental health demonstrated significantly worse PROMIS PF scores preoperatively (33.8 vs. 36.5, P < 0.001), as well as at all postoperative timepoints: 6-weeks (35.1 vs. 38.4, P < 0.001), 3-months (38.9 vs. 42.9, P < 0.001), 6-months (41.4 vs. 45.5, P < 0.001), and 1-year (42.4 vs. 47.6, P < 0.001). However, at the 1-year timepoint, patients with worse mental health reported experiencing significantly less improvement from baseline (postoperative change of 8.6 vs. 11.1, P = 0.002). Patients with worse preoperative mental health not only demonstrated worse preoperative PROMIS PF scores, but also continued to have significantly worse postoperative outcomes. However, the postoperative improvement experienced by patients was similar in the short-term following surgery regardless of preoperative mental health status. Patients with poor mental health experienced significantly less postoperative improvement only at the 1-year timepoint. 3.

Clinical Characterization and Cytokine Profile of Fatigue in Patients with Chronic Gvhd

Introduction Chronic graft-versus-host disease (cGVHD) is an autoimmune-like condition caused by allogeneic hematopoietic stem cell transplantation. It is the major cause of non-relapse mortality and morbidity after transplant. The majority of patients with cGVHD experience longstanding fatigue that is associated with decreased quality of life and impaired physical functioning. The pathophysiology and clinical characteristics of fatigue in cGVHD remain poorly understood and no effective treatments exist. Methods This cross-sectional study aimed to describe characteristics of fatigue experienced by patients with cGVHD using SF-36 self-report vitality scale as the primary outcome. 109 patients with fatigue and 72 patients without fatigue were prospectively enrolled and compared using a set of clinical, demographic and behavioral data along with 7 potential cytokine biomarkers of active cGVHD (IFN- γ, IL-6, CXCL-10, MCP-1, CXCL-9, BAFF, ST2). IFN- γ, IL-6, IP-10, and MCP-1 were assayed using V-PLEX by from Meso-ScaleDiscovery (MSD). The BAFF, CXCL9, and ST2 high sensitive assays were developed and customized for clinical testing using MSD electrochemiluminescence immunoassay technology with antibody pairs obtained from R&amp;D Systems. A patient was considered fatigued if SF-36 vitality score was &gt;10 points below the mean of the general population (&lt;40). Results The median Lee cGVHD symptom scale energy score was 6 (1-12) in fatigued individuals as compared to 3 (0-9) in non-fatigued individuals (P=0.0001) suggesting internal validity of the primary endpoint definition. SF-36 MCS and PCS scores were also significantly lower in the fatigued group by 10 points (P=0.0001 for both). Several measures including walk velocity, human activity profile, SF-36 physical and mental health self-report scales were potential predictors of fatigue in univariate analysis (Table 1). Patients with increasing levels of joint involvement were more likely to be fatigued (72% vs 60% with any involvement, p= 0.0067 for increasing involvement score). In addition, fatigued individuals had higher Lee cGVHD symptom burden in skin, breathing, muscles and joints and mental domains. None of the tested cytokines showed significant association with fatigue, even after stratification for time elapsed after cGVHD diagnosis to study enrollment. However, BAFF was shown to decrease in a consistent manner when more time elapsed from cGVHD diagnosis to study enrolment (p=0.015). BAFF levels were significantly associated with NIH joint score, NIH skin score, intensity of immunosuppression and Karnofsky performance status, thus confirming the usefulness of BAFF as a marker of cGVHD activity or severity, but not fatigue. Similarly, none of standard clinical laboratory serum markers of inflammation (e.g. ESR, CRP, C3, C4, albumin) showed significant association with fatigue. Multivariable analysis revealed that NIH joint score (P=0.03), Lee symptom scale sleep (P=0.0004) and depression (P=0.03) questions and PG-SGA nutrition score (P=0.0007) were predictors of fatigue after adjusting for confounders. Antidepressant use or sleep medication use did not differ significantly between the 2 groups (p=0.63 and 0.51, respectively), although patients reporting depression and sleep problems were more likely to be in the fatigued group, thus delineating a potential area for intervention and increasing quality of life. After adjusting for NIH lung score and performance status, known poor predictors of survival in this patient population, fatigue was associated with a slight trend toward lower probability of survival, median 130.6 months vs. median not reached (p=0.074) for fatigued and non-fatigued respectively (HR: 1.45, CI 0.88 to 2.40). Conclusions These results demonstrate that the pathophysiology of fatigue in cGVHD may involve mechanisms other than those reflected by cytokine markers of inflammation known to be associated with disease activity or severity. Musculoskeletal and lung involvement as well as decreased functional performance and capacity are significant features of fatigued patients with cGVHD. Sleep, nutrition and depression may be important therapeutic targets in these patients affected by clinically significant fatigue. Further studies involving longitudinal follow-up and deeper studies of biology are imperative to better understand or treat fatigue in cGVHD patients. Disclosures No relevant conflicts of interest to declare.

Predictors of health-related quality of life after non-catastrophic injury sustained in a road traffic crash.

Health-related quality of life (HRQoL) is an important patient-reported outcome that warrants greater attention in individuals who sustained a non-catastrophic injury in a road traffic crash. Additional robust data on HRQoL outcomes after a non-catastrophic injury are needed to effectively identify potential targets for studies of tertiary prevention of poor recovery after a crash. We assessed the association between non-catastrophic road traffic crash injuries and HRQoL and factors that independently affect long-term HRQoL. In this inception cohort study, injured participants (≥17years old) were identified from various sources including hospital emergency departments by a medical examination by a registered healthcare professional in New South Wales (Australia) and followed up after 12months. HRQoL was measured by the European Quality of Life-5 Dimensions (EQ-5D-3L) and Medical Outcomes Survey Short Form 12 items (SF-12). A range of socio-demographic, pre-injury health, psychological, and injury-related factors were considered potential predictors of HRQoL in regression analyses. Among 2019individuals identified, 1201 (59.5%) were followed up after 12months. HRQoL significantly improved between baseline and 12-month follow-up: EQ-5D-3L summary score (0.41-unit difference); SF-12 physical component summary score (PCS; 13.6-unit difference) and mental component summary score (MCS; 3.5-unit difference). Over 12months, HRQoL score was lower for people claiming compensation than others (P<0.0001). Key predictors of better 12-month EQ-5D-3L summary score and visual analogue scale score for pain were age, not claiming compensation, reduced body mass index, less pain severity, less pain-related disability, and less general psychological distress. Significant predictors of SF-12 PCS score were injury to the neck (P=0.02) or head or face (P=0.01), being a driver or passenger at the time of the crash (P<0.0001), hospital admission (P<0.0001) and pain severity (P<0.0001). Baseline variables associated with 12-month SF-12 MCS scores were head or face injury (P=0.02), pre-injury health (P=0.04), pre-injury psychological conditions (P=0.04), trauma-related distress (P=0.0002) and general psychological distress (P<0.0001). A wide spectrum of biopsychosocial factors contribute to HRQoL after a road traffic crash injury. These epidemiological data are potentially important because they could identify potential targets for studies of tertiary prevention of persistently poor HRQoL after such an injury.

Remission vs low disease activity: function, quality of life and structural outcomes in the Early Rheumatoid Arthritis Study and Network.

ObjectivesTo examine associations between function, quality of life and structural outcomes in patients achieving remission vs low disease activity in early RA.MethodsDemographic, clinical and radiographic variables were collected at baseline and then annually from the Early Rheumatoid Arthritis Study (ERAS) and Early Rheumatoid Arthritis Network (ERAN) inception cohorts in routine care from 1986 to 2012. Disease activity was categorized: mean DAS28 score between years 1 and 5: remission [mean remission DAS (mRDAS) <2.6] or low [mean low DAS (mLDAS) 2.6–3.2]; sustained low/remission DAS28 (sLDAS/sRDAS) at years 1 and 2; and sustained Boolean remission (sBR) at years 1 and 2. Changes in HAQ and Short Form 36 Health Survey Questionnaire [SF-36; physical (PCS) and mental (MCS) component score]) and total Sharp van der Heijde (SvdH) scores for each disease activity category were modelled using multi-level models. Covariates included year of onset, age, gender and DMARD use at first visit.ResultsOf 2701 patients, 562 (21%) were categorized mRDAS, 330 (12%) mLDAS, 279 (10%) sRDAS, 203 (7.5%) sLDAS and 93 (3%) sBR. Patients categorized as mRDAS had increasingly divergent improved HAQ, SF-36 PCS, MCS and total SvdH scores compared with mLDAS (P-values 0.001 to <0.0001, all time points). Patients categorized as sRDAS had better HAQ, SF-36 PCS and MCS scores (P-values 0.05 to <0.0001, all time points) and SvdH scores (P = 0.05, years 3–5) over sLDAS. sBR was associated with better HAQ, and SF-36 PCS and MCS scores over sLDAS (P-values 0.002 to <0.0001, all time points).ConclusionThese findings from routine care support ACR/EULAR guidelines that remission is a preferable goal over low disease activity in early RA.

SF36 Is a Reliable Patient-Oriented Outcome Evaluation Tool in Surgically Treated Degenerative Cervical Myelopathy Cases: A Systematic Review and Meta-Analysis.

BackgroundDegenerative spinal disorders have adverse impacts on patients’ quality of life. Because the main objectives of any surgical intervention are to improve health-related quality of life and to reduce disability, instruments capable of measuring patient-oriented outcomes are now increasingly used. The aim of this study was to evaluate the use of the Short Form 36 Health Survey Questionnaire (SF36) for assessing patient-oriented outcomes of degenerative cervical myelopathy surgery.Material/MethodsA literature search was conducted in electronic databases (Google Scholar, Ovid SP, PubMed, Science Direct, and Springer). Studies were included if they reported SF36 scores by following patients for at least 12 months. Random effects meta-analyses were performed to estimate changes in SF36 physical/mental component summary (SF36-PCS/MCS), SF36 dimensional, Japanese Orthopedics Association (JOA)/modified JOA (mJOA), and Neck Disability Index (NDI) scores by latest follow-up.ResultsFourteen studies (1966 patients; age 58.2 years [95% confidence interval (CI), 56.6 to 59.9]; 60% males [95% CI, 55 to 64]; follow-up 24.8 months [95% CI, 20.9 to 28.7]) were included in meta-analysis. SF36-PCS (6.60 [95% CI, 4.91 to 8.28]; p<0.00001), SF36-MCS (6.33 [95% CI, 4.31 to 8.35]; p<0.00001) and SF36 dimensional (p<0.05) scores improved significantly at latest follow-up. Surgery significantly improved JOA/mJOA (3.43 [95% CI, 2.80 to 4.06]; p<0.00001) and NDI (−13.70 [95% CI, −17.35 to −10.06]; p<0.00001) scores also. Change in SF36-PCS score were correlated (r=−0.554) with change in NDI score, whereas change in SF36-MCS score was correlated with change in JOA score (r=0.550).ConclusionsSurgery for degenerative cervical myelopathy is associated with significantly improved SF36-measured patient-oriented outcomes.

92 Medication Related Quality of Life (MRQoL) in Ambulatory Older Adults with Polypharmacy and Multi-morbidity – a Measurable Outcome?

Abstract Background With increasing numbers of older multi-morbid people being exposed to polypharmacy, research needs to focus on medication-related outcomes affecting quality-of-life (QoL). This study examines older-patients’ medication-related QoL (MRQoL), its relationship to medication burden/complexity, frailty, health-related QoL (HRQoL) and potentially inappropriate medications (PIMs. Methods A cross-sectional-study was conducted in older-patients attending out-patients and day-hospital services of a tertiary-teaching-hospital. Participants were aged ≥65 years, first-time attendees, taking ≥5 chronic-medications for ≥3 chronic-conditions and mini-mental state examination score ≥26/30. Demographic, medication, comorbidity, frailty status, PIMs(STOPP/STARTv.2 criteria), MRQoL (MRQoL-LS v1.0) HRQoL (Short-form-12; SF-12) and medication burden (Living with Medicines Questionnaire v.2; LMQv2) data were collected. Drg compliance was measured using the Medication Adherence Rating Scale (MARS). Lower MRQoL-LS v1.0 scores indicate better MRQoL (range 0-84). Higher LMQv2 scores indicate higher medication burden (range from 60-300). A negative age-specific mean-difference score in SF-12 physical and mental health composite scale scores (SF12-PCS, SF12-MCS) indicates poorer health. Results Over 12 months, 234 patients (attending 78 clinics) were screened, 59 met inclusion criteria and 30 were recruited; 3 patients were subsequently identified as ineligible. Eighteen patients were female (66%), mean age was 79.4 years (SD±6.2), median number of daily medications was 10 (IQR 8-13), median number of comorbidities was 11 (IQR 9-14). Participants were generally drug-compliant, median MARS score of 9 (IQR 6.5-10). Patients’ median MRQoL score was 14 (IQR 14-22.5); mean LMQ v2 score was 115.64 (SD± 25.18). Mean age specific mean-difference SF12-PCS and SF12-MCS scores were -22.61 (SD±11.7) and -22.1 (SD±17.5) respectively. There was no significant correlation between MRQoL and number of daily medications, number of comorbidities, LMQ, HRQoL, or PIMs(Pearson’s 2-tailed test). Conclusion This study demonstrates that MRQoL-LS v.1 is not applicable to most patients attending geriatric ambulatory services. Furthermore, polypharmacy, multimorbidity, presence of PIMs poorer HRQoL do not correlate significantly with MRQoL.

Meaningful changes in the Short Form 12 physical and mental summary scores after total knee arthroplasty

BackgroundThe aim of this study was to identify minimal clinically important difference (MCID), minimal important change (MIC) and minimal detectable change (MDC) for the Short Form (SF-) 12 physical and mental component summary (PCS, MCS) scores after total knee arthroplasty (TKA) using an anchor based methodology. MethodsDuring a 10-year period, 2589 TKA were performed. SF-12 PCS and MCS scores were recorded preoperatively and at one year postoperatively. At one year, patients were asked “How much did the knee replacement surgery improve the quality of your life?” Their response was recorded as: a great improvement, moderate improvement, little improvement, no improvement at all, or the quality of my life is worse. Patients recording a little (n = 211) and no (n = 115) were used to calculate the MCID and the MIC. The MDC90 was calculated using distribution based methods for the whole cohort. ResultsThe MCID was 1.8 (p = 0.04) for the PCS and 1.5 (p = 0.33) for the MCS score. The MIC was 2.7 (p = 0.04) for the PCS and −1.4 (p = 0.17) for the MCS score. The MDC90 was 8.9 for the PCS and 13.8 for the MCS score. ConclusionThe MCID for the PCS can be used to compare the outcomes between groups, and the MIC can be used to ensure that a clinical difference has been observed for a cohort of patients. The values for the MDC90 can be used to assess whether or not an individual patient has experienced a change.

Impact of Sleep Disorders and Other Factors on the Quality of Life in General Population: A Cross-Sectional Study.

The study objective was to assess if insomnia, along with other factors, can impact the physical and mental quality of life (QOL) of the Lebanese general population. This cross-sectional study, conducted between November 2017 and March 2018, enrolled 756 community-dwelling participants. A first linear regression, using the SF-12 PCS score as the dependent variable, showed that having a family history of insomnia problems (β = 1.107, p = 0.026) was significantly associated with higher physical QOL (higher SF-12 PCS score), whereas increased stress (β = 0.048, p = 0.015) was significantly associated with lower physical QOL. A second linear regression, using the SF-12 MCS score as dependent variable, showed that having increased age (β = -0.079, p < 0.001) was significantly associated with lower mental QOL. Despite its cross-sectional design and the modest sample size, this study adds to the evidence that insomnia, along with other factors (including sociodemographic and psychological factors), can have a detrimental impact on both physical and mental QOL of participants.

Demographic, Hemodynamic, and HRQL Differences between Methamphetamine-Associated and Idiopathic PAH: The Pulmonary Hypertension Association Registry

Purpose Single-center studies previously demonstrated that methamphetamine use is associated with pulmonary arterial hypertension (Meth-APAH). We sought to use the Pulmonary Hypertension Association Registry (PHAR) to compare methamphetamine-associated (Meth-APAH) to Idiopathic Pulmonary Arterial Hypertension (IPAH) in the United States. Methods PHAR is a 32-center US-based registry of 478 PAH patients new to care at a Pulmonary Hypertension Care Center. In addition to demographics and clinical parameters, baseline health-related quality of life (HRQL) is quantified by the Medical Outcomes Study Short Form-12 (SF12-PCS - generic-physical & SF12-MCS - generic-mental; higher scores denote better HRQL) and emPHasis-10 (PAH-specific; higher scores denote worse HRQL). We included adults diagnosed with Meth-APAH and, as a control group, IPAH. Differences in demographics and clinical parameters were compared by t-tests and chi-squared tests as appropriate. We tested the association of Meth-APAH and HRQL using multivariate linear regression, adjusting for age, sex, race, and education. Results Of 278 subjects included, 58 had Meth-APAH. Subjects with Meth-APAH were younger, less likely to be insured, college graduates, or married. 83% of subjects with Meth-APAH lived in the Western US. The Meth-APAH group tended to have lower cardiac index, stroke volume index, and higher right atrial pressures. The Meth-APAH group had significantly worse SF12-MCS (-3.85, 95%CI -6.48 to -1.23) and emPHasis-10 (5.79, 95%CI 1.85 to 9.74) scores compared to the IPAH group. The groups had similar SF12-PCS scores (0.79, 95%CI -1.38 to 2.96). Results were similar in incident cases (n=132, data not shown). Conclusion Meth-APAH is an aggressive phenotype most common in the Western US. It accounts for a notable proportion of PAH in PHAR centers. Routine screening for Meth-APAH is necessary, and providers should include drug rehabilitation in their therapy plan.

Health-related quality of life in patients with giant cell arteritis treated with tocilizumab in a phase 3 randomised controlled trial

BackgroundPatients with giant cell arteritis (GCA) treated with tocilizumab (TCZ) every week or every other week and prednisone tapering achieved superior rates of sustained remission to patients treated with placebo and prednisone tapering in a randomised controlled trial. Health-related quality of life (HRQOL) in patients from this trial is now reported.MethodsExploratory analyses of SF-36 PCS and MCS and domain scores, PtGA and FACIT-Fatigue were performed in patients treated with weekly subcutaneous TCZ 162 mg plus 26-week prednisone taper (TCZ-QW + Pred-26) or placebo plus 26-week or 52-week prednisone tapers (PBO + Pred-26 or PBO + Pred-52). These analyses were performed on responder and non-responder patients, including those who achieved the primary outcome and those who experienced flare and received escape prednisone doses.ResultsBaseline SF-36 PCS, MCS and domain scores were low, indicating impaired HRQOL related to GCA. At week 52, least squares mean (LSM) changes in PCS scores improved with TCZ-QW + Pred-26 but worsened in both PBO + Pred groups (p < 0.001). LSM changes in MCS scores increased with TCZ-QW + Pred-26 versus PBO + Pred-52 (p < 0.001). Treatment with TCZ-QW + Pred-26 resulted in significantly greater improvement in four of eight SF-36 domains compared with PBO + Pred-26 and six of eight domains compared with PBO + Pred-52 (p < 0.01). Improvement with TCZ-QW + Pred-26 met or exceeded minimum clinically important differences (MCID) in all eight domains compared with five domains with PBO + Pred-26 and none with PBO + Pred-52. Domain scores in the TCZ-QW + Pred-26 group at week 52 met or exceeded age- and gender-matched normative values (A/G norms). LSM changes from baseline in FACIT-Fatigue scores increased significantly with TCZ-QW + Pred-26, exceeding MCID and A/G norms (p < 0.001).ConclusionsPatients with GCA receiving TCZ-QW + Pred-26 reported statistically significant and clinically meaningful improvement in SF-36 and FACIT-Fatigue scores compared with those receiving prednisone only. Improvements in the TCZ-QW + Pred-26 group led to recovery of HRQOL to levels at least comparable to those of A/G-matched normative values at week 52 and exceeded normative values in five of eight domains.Trial registrationClinicalTrials.gov, NCT01791153. Date of registration: February 13, 2013.

Associations between the Presence of Type 2 Diabetes and Health-Related Quality of Life (HRQoL) among US Hispanic Population

Introduction: Very few studies have captured the association in health-related quality of life (HRQoL) by the presence of type 2 diabetes (T2D) among the US Hispanic population. Aim: This study was to examine the association of the presence of T2D on HRQoL measure in the US Hispanic population. Methods: This was a cross-sectional study analyzing data from the 2014-2015 Medical Expenditure Panel Survey (MEPS). This data comprised of the Hispanic population of 13,933 members (estimated population size: 36,440,400) with T2D in the US. Two multivariate regression models were used to predict HRQoL (Short Form 12) by the presence of T2D among the Hispanic population. Results: Results showed 89.1% did not have T2D condition (n=12,423), while 10.9% had T2D conditions (n=1,510). SF-12 PCS scores were 45.85 (95% CI; 44.65, 47.05) in Hispanic population with T2D and 51.23 (95 % CI; 50.77, 51.68) in Hispanic population without T2D. SF-12 MCS scores were 52.52 (95% CI; 51.98, 53.05) in patients without T2D and 49.59 (955 CI; 48.34, 50.76) in Hispanic population with T2D conditions. Conclusion: The study suggests that the presence of T2D worsens HRQoL measured by individuals' physical and mental health status among the US Hispanic population compared with non-T2D Hispanic population. Psychiatric assessment and management of T2D minority population may improve patient HRQoL.

Patient Expectations of Sexual Activity After Total Hip Arthroplasty: A Prospective Multicenter Cohort Study.

Background:This study aimed to evaluate patients’ expectations of postoperative sexual activity (SA) after total hip arthroplasty.Methods:A prospective multicenter cohort study of 1,271 patients managed with total hip arthroplasty was performed using patient-reported outcome measures of the Longitudinal Leiden Orthopaedics Outcomes of Osteo-Arthritis Study (LOAS). Preoperative SA expectations and their fulfillment after 1 year were assessed with the Hospital for Special Surgery expectations survey. The Hip disability and Osteoarthritis Outcome Score (HOOS) was used to measure functional status, and the Short Form-12 Mental and Physical Component Summary scores (SF-12 MCS and SF-12 PCS) and EuroQol-5 Dimensions (EQ-5D) questionnaire were used to measure health status. Two subgroups were defined preoperatively: the SA-Expecting Group and the No-SA-Expecting Group. The postoperative outcomes with regard to SA (i.e., the difference between postoperative and preoperative SA scores) were classified as “unfulfilled” (score, ≤−1), “fulfilled” (score, 0), or “exceeded” (score, ≥1). Multivariate regression analyses were used, with t tests to compare means between groups.Results:In total, 952 (74.9%) patients returned both preoperative and postoperative HSS questionnaires. Preoperatively, 605 patients (63.6%) expected to have postoperative SA. At 1 year, 43.5% of participants reported that this expectation was unfulfilled. In the No-SA-Expecting Group, 18.2% (63 of 347) regained SA, predominantly men. Postoperative SA fulfillment was related to preoperative musculoskeletal (p = 0.001) and non-musculoskeletal comorbidities (p = 0.004) and the postoperative HOOS, SF-12 PCS, SF-12 MCS, EQ-5D, and EQ-5D visual analog scale (VAS) scores (p < 0.001). Postoperative HOOS-symptoms (odds ratio [OR] 1.04; 95% confidence interval [CI], 1.02 to 1.06; p < 0.001), and HOOS-sport (OR, 1.01; 95% CI, 1.00 to 1.03; p = 0.032) were associated with postoperative SA fulfillment, as was older age (inversely; e.g., ≥76 years compared with ≤60 years: OR, 0.28; 95% CI, 0.13 to 0.62; p = 0.002). Correspondingly, for the No-SA-Expecting Group, higher age was also inversely associated with regaining postoperative SA (e.g., ≥76 years: OR, 0.07; 95% CI, 0.02 to 0.21; p < 0.001).Conclusions:Of the patients who expected to be sexually active after surgery, 43.5% perceived this expectation to be unfulfilled; 24.3% were still sexually inactive despite most having expected a return to normal SA. Approximately one-fifth of patients who did not expect postoperative SA in fact regained SA. During preoperative consultations, surgeons should pay attention to expectation management surrounding SA.Level of Evidence:Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

The Correlation Between Disease Activity Assessed by DAS28-ESR and Quality of Life Assessed by SF-36 in Rheumatoid Arthritis Patients

Background Rheumatoid arthritis is the most prevalent form of inflammatory arthritis. One of the key components for its multidimensional outcome is the disease activity, measured by DAS28-ESR. The physical, emotional, and social aspects of RA contribute to the quality of life, and SF-36 questionnaire can be used to measure it. This study aims to ascertain the correlation between the disease activity (DAS28-ESR) and the quality of life (SF-36) in RA patients. &#x0D; Method This study was an analytical, descriptive study with a cross sectional design that took primary data from RA patients undergoing treatment in Rheumatology Clinic of Hasan Sadikin Hospital from February to April 2015. The patient’s data included sex, age, marital status, employment status, educational level, serostatus (RF and Anti-MCV), duration of diagnosis, total number of medications, total number of DMARD, DAS28-ESR scores, and SF-36 scores. The data was analysed with the Shapiro-Wilk normality test, followed by the Rank-Spearman correlation analysis.&#x0D; Result There were 42 subjects, with an average age of 41 ± 12. The ratio between females and males was 20:1, and the majority of subjects (73,8%) had a positive serostatus (RF and/or anti-MCV). The score median of DAS28-ESR was 4,3, with the score median for SF-36 PCS being 39,8 and the score median for SF-36 MCS being 48,2. Based on the the Rank-Spearman analysis (CI of 95%), there was a correlation between DAS28-ESR score and SF-36 PCS score, with the correlation coefficient (r) of -0,577 (p &lt; 0,001), and there was also a correlation between DAS28-ESR score and SF-36 MCS score with r of -0,368 (p = 0,008).&#x0D; Conclusion There was a strong negative correlation between disease activity and physical component of quality of life, and a moderate negative correlation between disease activity and mental component of quality of life, and the two correlations were statistically significant.

Mental Health Has No Predictive Association With Self-Assessed Knee Outcome Scores in Patients After Osteochondral Allograft Transplantation of the Knee.

Background:Patient-reported outcome (PRO) measures are progressively utilized as evaluation tools in preoperative and postoperative assessments in orthopaedic practice. Identifying the potential utility of psychosocial factors to predict patient-reported pain and functional outcomes is of increasing interest to determine which patients will derive the greatest benefit from surgical treatment.Purpose/Hypothesis:The purpose of this study was to determine potential predictive associations between the preoperative 12-Item Short Form Health Survey Mental Component Summary (SF-12 MCS) score, patient characteristics or osteochondral allograft (OCA) morphology, and PROs in patients who underwent OCA transplantation. We hypothesized that poor preoperative mental health is associated with diminished PROs at final follow-up.Study Design:Case-control study; Level of evidence, 3.Methods:A total of 67 patients with a mean follow-up of 2.7 ± 1.0 years (range, 2-6 years) with complete preoperative and at least 24-month postoperative SF-12 MCS, Knee injury and Osteoarthritis Outcome Score (KOOS), Tegner, Lysholm, and International Knee Documentation Committee (IKDC) scores were included in this study. Pearson correlation coefficients and linear regression models were used to distinguish associations between age, sex, smoking status, body mass index, workers’ compensation, previous surgery, concomitant surgery, number of grafts, defect location, total graft size, SF-12 MCS score, and postoperative PRO scores as well as their improvement from baseline (delta).Results:The SF-12 MCS showed significant correlation with the KOOS Activities of Daily Living subscale (P = .015), KOOS Sport/Recreation subscale (P = .024), and IKDC (P = .039). In the multivariable linear regression models, the SF-12 MCS had no predictive association with any PRO measure. Patient sex contributed significantly to the final regression models of the KOOS Sport/Recreation (P = .042), Tegner score (P = .024), and Lysholm score (P = .031). The SF-12 MCS showed no bivariate correlation with changes in any PRO score (delta) (P > .05).Conclusion:Preoperative mental health status did not predict perceived functional outcomes as assessed by PRO measures at final follow-up. Female sex was negatively correlated with KOOS Sport/Recreation, Tegner, and Lysholm scores.

Comparison of collum femoris-preserving stems and ribbed stems in primary total hip arthroplasty

BackgroundThis retrospective study investigated the relative benefits of using a collum femoris-preserving prosthesis or ribbed stem during total hip arthroplasty (THA).MethodsThe clinical results were compared of patients who underwent THA, between January 2010 and December 2012, with either a CFP prosthesis or a ribbed stem (66 and 75 patients, respectively, aged 43.4 ± 10.8 and 42.3 ± 9.8 years). Patients were assessed using the Harris Hip Score (HHS), Western Ontario and McMaster University Osteoarthritis Index (WOMAC), 12-Item Short Form Health Survey (SF-12), and physical component summary (PCS) score. Intraoperative and postoperative complications and leg-length differences were noted.ResultsThe mean follow-up times of the CFP and ribbed groups were 67.2 ± 7.5 and 68.3 ± 7.2 months, respectively. The HHS, SF-12 MCS, SF-12 PCS, and WOMAC scores of the two groups were similar. The rates of periprosthetic femoral fractures and leg-length differences > 10 mm in the CFP group (10.6% and 13.6%, respectively) were significantly higher than those in the ribbed group (1.3% and 2.7%). The groups were similar regarding complications of osteolysis, ectopic ossification, dislocation, deep infection, deep venous thrombosis, thigh pain, and aseptic loosening. The survival rates of the CFP and ribbed groups were comparable (98.5% and 97.8%).ConclusionThe clinical results of the CFP and ribbed prostheses in young patients given THA were similar for Chinese patients. However, the CFP stem should be used with caution, given the high incidence of technical problems associated with implantation especially for Chinese patients.