Patient Related Outcome Measures最新文献

Purpose: Treatment process attributes can affect health state utilities associated with therapy. For intravenous iron, used to treat iron deficiency and iron deficiency anemia, research into process attributes is still lacking. This study estimated utilities associated with process attributes for intravenous iron infusions.

Methods: An online survey including seven health state vignettes and time trade-off tasks was administered to participants, who were not patients living with iron deficiency or iron deficiency anemia, from a Chinese online panel. Vignettes used an identical description of iron deficiency and iron deficiency anemia but differed in the annual number of infusions, infusion duration, and infusion-associated risk of hypophosphatemic osteomalacia. Disutilities and their rate of change as the number of infusions increased were examined using a power model.

Results: The survey was completed by 1091 participants. The highest utilities were observed for one annual infusion of 15-30 minutes or 30-60 minutes, without risk of hypophosphatemic osteomalacia (0.754 and 0.746, respectively). In comparison, more infusions and infusions with a risk of hypophosphatemic osteomalacia were associated with lower utilities. Utility continued to decrease, but at a diminishing rate, as the annual number of infusions increased, with utility decrements of 0.006 and 0.002, respectively, when going from zero to one and from four to five infusions per year. All marginal disutilities were small (values <0.01).

Conclusion: This study suggested that treatment attributes of intravenous iron infusions affect health state utilities. Using intravenous iron formulations that allow for fewer and shorter infusions without the risk of hypophosphatemic osteomalacia can reduce the number of visits required and increase patients' quality of life.

Purpose: Depression and other aspects of emotional health in people with HIV (PWH) can affect functional independence, disease progression, and overall life quality. This study used the NIH Toolbox Emotion Battery (NIHTB-EB), which assesses many features of emotional health, to more comprehensively investigate differences among adults living with and without HIV, and to identify factors associated with emotional health for PWH.

Patients and methods: Participants (n=1451; age: M=50.19, SD=16.84; 47.90% women) included 433 PWH living in southern California seen from 2003 to 2021 (64.72% AIDS, 92.25% on antiretroviral therapy) and 1018 healthy participants from NIHTB-EB national normative cohort. Participants completed the NIHTB-EB and PWH underwent comprehensive HIV disease and psychiatric evaluations. We investigated differences in emotional health by HIV status via independent samples t-tests (continuous scores) and Chi² tests ("problematic" emotional health scores). Multivariable linear regression models examined correlates of emotional health among PWH.

Results: PWH had significantly worse emotional health than people without HIV across Social Satisfaction (Cohen's d=0.71, p<0.001), Psychological Well-Being (Cohen's d=0.49, p<0.001) and Negative Affect (Cohen's d=0.19, p<0.01) summary T-scores, and most component scales. PWH also had higher rates of "problematic" emotional health, particularly in Social Satisfaction (45% vs 17%, p<0.0001). Poor emotional health among PWH was associated with lifetime Major Depressive and Substance Use Disorders, relationship status (lost relationship versus in relationship), unemployment, and cognitive difficulties and loss of functional independence.

Conclusion: The NIHTB-EB identified that difficulties with multiple aspects of emotional health are common among PWH, and appear to be relatively independent of cognitive impairment as well as HIV disease and treatment history, but are strongly associated with everyday functioning. Given the cross-sectional nature of this study, longitudinal studies should be employed to evaluate causality pertaining to predictors of emotional health in PWH. These findings may inform interventions to promote emotional wellbeing in PWH.

Introduction: Atherosclerotic Cardiovascular Disease (ASCVD) is the leading cause of death worldwide. In Diabetics, ASCVD is associated with poor prognosis and a higher case fatality rate compared with the general population. Sub-Saharan Africa is facing an epidemiological transition with ASCVD being prevalent among young adults. To date, over 20 million people have been living with DM in Africa, Tanzania being one of the five countries in the continent reported to have a higher prevalence. This study aimed to identify an individual's 10-year ASCVD absolute risk among a diabetic cohort in Tanzania and define contextual risk enhancing factors.

Methods: A prospective observational study was conducted at the Aga Khan hospital, Mwanza, for a period of 8 months. The hospital is a 42-bed district-level hospital in Tanzania. Individuals 10-year risk was calculated based on the ASCVD 2013 risk calculator by ACC/AHA. Pearson's chi-square or Fischer's exact test was used to compare categorical and continuous variables. Multivariable analysis was applied to determine contextual factors for those who had a high 10-year risk of developing ASCVD.

Results: The overall cohort included 573 patients. Majority of the individuals were found to be hypertensive (n = 371, 64.7%) and obese (n = 331, 58%) having a high 10-year absolute risk (n = 343, 60%) of suffering ASCVD. The study identified duration of Diabetes Mellitus (>10 years) (OR 8.15, 95% CI 5.25-14.42), concomitant hypertension (OR 1.82 95% CI 1.06-3.06), Diabetic Dyslipidemia (OR 1.44, 95% CI 1.08-1.92) and deranged serum creatinine (OR 1.03, 95% CI 1.02-1.03) to be the risk enhancing factors amongst our population.

Conclusion: The study confirms the majority of diabetic individuals in the lake region of Tanzania to have a high 10-year ASCVD risk. The high prevalence of obesity, hypertension and dyslipidemia augments ASCVD risk but provides interventional targets for health-care workers to decrease these alarming projections.

Background: Patients undergoing surgery frequently experience unfavorable anesthetic outcomes. They may have an impact on body systems and result in more serious postoperative morbidities. This study was conducted to determine the incidence of postoperative undesirable anesthetic outcomes among surgical patients at referral hospitals in Amhara region, Ethiopia.

Methods: A total of 412 patients, who underwent surgical procedures between August 1 and October 30 of 2022, were included in this study. The Leiden Perioperative Care Patient Satisfaction Questionnaire's (LPPSq) dimension "discomfort and needs" was used to collect data on the first postoperative day. Data entry and analysis were performed using SPSS version 20. To assess how risk factors affected the outcome variable, logistic regression analysis was utilized. In multivariable logistic regression analysis, a variable with a P-value of less than 0.05 was statistically considered as significant.

Results: The proportion of those who had "at least a little bit" of unfavorable outcomes was calculated to estimate their overall prevalence, and the prevalence of those who had "more than moderate" levels of unfavorable outcomes was determined to appreciate how severe these outcomes were. The percentages of postoperative pain, the most common undesired result, for "at least a little bit" and "more than moderate" were 87.7% and 32.3%, respectively. In this study, postoperative cold was the least prevalent (51.4%) undesirable anesthetic outcome. The remaining undesirable postoperative outcomes were reported less frequently.

Conclusion and recommendation: Undesirable postoperative anesthetic outcomes were still common. The most frequent unfavorable result was postoperative pain. Adequate postoperative patient follow-up and quality service are paramount.

Background: The most reliable and meaningful approach for inclusion of patient-reported outcomes (PROs) in the evaluation of real-world clinical effectiveness of biologics in the treatment of autoimmune diseases is u ncertain. This study aimed to assess and compare the proportions of patients who had abnormalities in PROs measuring important general health domains at the initiation of treatment with biologics, as well as the effects of baseline abnormalities on subsequent improvement.

Methods: PROs were collected for patient participants with inflammatory arthritis, inflammatory bowel disease, and vasculitis using Patient-Reported Outcomes Measurement Information System instruments. Scores were reported as T-scores normalized to the general population in the United States. Baseline PROs scores were collected near the time of biologic initiation, and follow-up scores were collected 3 to 8 months later. In addition to summary statistics, the proportion of patients with PROs abnormalities (scores ≥5 units worse than the population norm) was determined. Baseline and follow-up scores were compared, and an improvement of ≥5 units was considered significant.

Results: There was wide variation across autoimmune diseases in baseline PROs scores for all domains. For example, the proportion of participants with abnormal baseline pain interference scores ranged from 52% to 93%. When restricted to participants with baseline PROs abnormalities, the proportion of participants experiencing an improvement of ≥5 units was substantially higher.

Conclusion: As expected, many patients experienced improvement in PROs following initiation of treatment with biologics for autoimmune diseases. Nevertheless, a substantial proportion of participants did not exhibit abnormalities in all PROs domains at baseline, and these participants appear less likely to experience improvement. For PROs to be reliably and meaningfully included in the evaluation of real-world medication effectiveness, more knowledge and careful consideration are needed to select the most appropriate patient populations and subgroups for inclusion and evaluation in studies measuring change in PROs.

Background: Traumatic brain injury is a major list of health and socioeconomic problems especially in low- and middle-income countries which influences productive age groups. Differences in patient characteristics, socioeconomic status, intensive care unit admission thresholds, health-care systems, and the availability of varying numbers of intensive care unit (ICU) beds among hospitals had shown to be the causes for the variation on the incidence in mortality following traumatic brain injury across different continents. The aim of this study was to assess the incidence and predictors of mortality among patients with traumatic brain injury at University of Gondar Comprehensive Specialized Hospital.

Methods: A retrospective follow-up study was conducted based on chart review and selected patient charts admitted from January, 2017 to January, 2022. Participants in the study were chosen using a simple random sample procedure that was computer generated. Data was entered with epi-data version 4.6 and analyzed using SPSS version 26. Both bivariate and multivariate logistic regression analyses were used, and in multivariate logistic regression analysis, P-value <0.05 with 95% CI was considered statistically significant.

Results: The magnitude of mortality was 28.8%. Most of the injuries were caused by assault followed by road traffic accident (RTA). About 30% of the subjects presented with severe head injuries and epidural hematoma (EDH) followed by skull fracture were the most common diagnoses on admission. The independent predictors of mortality were male sex (AOR: 6.12, CI: 1.82, 20.5), severe class injury with Glasco coma scale (GCS <9) (AOR: 5.96, CI: 2.07, 17.12), intraoperative hypoxia episode (AOR: 10.5, CI: 2.6-42.1), hyperthermia (AOR: 25, CI: 5.54, 115.16), lack of pre-hospital care (AOR: 2.64 CI: 1.6-4.2), abnormal appearance on both eyes (AOR: 13.4, CI: 5.1-34.6), in-hospital hypoxia episode and having extra-cranial concomitant injury were positively associated with mortality, while on admission, systolic blood pressure (SBP) of 100-149 (AOR: 0.086, CI: 0.016-0.46) was negatively associated with mortality.

Conclusion: The overall mortality rate was considerably high. As a result, traumatic brain injury management should be focused on modifiable factors that increase patient mortality, such as on-admission hypotension, a lack of pre-hospital care, post-operative complications, an intraoperative hypoxia episode, and hyperthermia.

Background: Surveys of back pain sufferers in the United States, China, Russia, and Germany were performed to better understand self-reported causes of acute nonspecific back pain and acute lower back pain among individuals engaging in sports and their preferred treatments.

Methods: In each country, 1000 participants were surveyed (Step 1) to identify a population of nonspecific acute back pain sufferers, understand pain and treatment characteristics, and generate profiles for individuals with long-lasting (≥7 days) acute lower back pain. Subsequently, 200 participants with acute lower back pain episodes (7-21 days) and sports participation were identified in each country and completed surveys (Step 2) about sociodemographic, pain, treatment characteristics, and causes/triggers of long-lasting acute lower back pain episodes.

Results: In the United States, China, Russia, and Germany, respectively, 59%, 49%, 61%, and 63% of respondents reported ≥1 episode of nonspecific acute back pain in the previous 6 months. Average numbers of monthly nonspecific acute back pain episodes in the United States, Russia, Germany, and China were 2.5, 1.8, 1.3, and 0.8, respectively. Prevalence of acute lower back pain associated with sports/leisure activities ranged from 20% (Russia and Germany) to 46% (China). Onset of long-lasting acute lower back pain was between ages 30 and 33 years, limiting usual activities and reducing walking distance in 60% to 85% of respondents across all countries. Acute lower back pain started post-exercise within the first day for ≥75% of respondents. Most popular nonprescription and prescription treatments for acute lower back pain were creams/gels in Russia, creams/gels and oral painkillers in Germany, oral painkillers in the United States, and hot/cold patches in China.

Conclusion: These results help to better understand acute back pain triggers, features, and treatment preferences among sports participants in different countries. Further research is warranted to develop preventative strategies.

Trial registration: Not applicable.

Purpose: Many patients seeking bariatric surgery experience reduced health-related quality of life (HRQOL). A simple clinical tool, the Patient-Reported Outcomes in Obesity (PROS), was developed to address patients' HRQOL concerns during clinical consultations and facilitate meaningful dialogue. The present study aims to explore its sensitivity to change.

Patients and methods: A prospective study of patients undergoing bariatric surgery was conducted. The patients responded to items on the PROS and the Obesity-related Problems Scale (OP) before surgery and three, 12 and 24 months after surgery. Longitudinal mixed-effects models were applied to estimate the change in PROS and OP scores over time.

Results: Thirty-eight patients were included. A significant change over time was detected for the PROS with the largest effect size at 24 months (effect size -1.34, p ˂ 0.001), while the corresponding effect size for the OP was -1.32 (p ˂ 0.001). In all items of the PROS, the majority of patients responded not bothered at 24 months. The items physical activity, pain, sleep and self-esteem showed the largest change in the percentage of patients reporting not bothered from baseline to 24 months after surgery.

Conclusion: The PROS is sensitive to change over time and may be used as a brief, easy to administer tool to facilitate a conversation about obesity-specific quality of life in clinical consultations.

Patient-reported outcomes (PROs) provide a valid, standardized way of assessing symptoms, adverse events and the subjective benefit of treatment from the patient's perspective. Assessment of PROs is critical in ovarian cancer due to the high morbidity of the disease and its treatments. Several well-validated PRO measures are available to assess PROs in ovarian cancer. Their inclusion in clinical trials can provide evidence on the benefits and harms of new treatments based on patients' experiences to guide improvements in clinical practice and health policy. Aggregate PRO data collected in clinical trials can be used to inform patients about likely treatment impacts and assist them to make informed treatment decisions. In clinical practice, PRO assessments can facilitate monitoring of a patient's symptoms throughout treatment and follow-up to guide their clinical management; in this context, an individual patient's responses can facilitate communication with their treating clinician about troublesome symptoms and their impact on their quality of life. This literature review aimed to provide clinicians and researchers with a better understanding of why and how PROs can be incorporated into ovarian cancer clinical trials and routine clinical practice. We discuss the importance of assessing PROs throughout the ovarian cancer disease and treatment trajectory in both clinical trials and clinical practice, and provide examples from existing literature to illustrate the uses of PROs as the goals of treatment change in each setting.

Systemic lupus erythematosus (SLE) is a chronic, autoimmune disease, characterised by a relapsing-remitting pattern of inflammatory activity, with each relapse contributing to irreversible end-organ damage with detrimental effects on patients' course, adding up to morbidity burden and shortening life-length. Along with several other demographic, socioeconomic, and life-style factors, high inflammatory activity and accrued organ damage have been coupled with adverse health-related quality of life (HRQoL) within physical, mental, and psychosocial aspects. The management of SLE has improved substantially during the last decades, owing to a technological explosion that has advanced drug development towards more targeted options. Being the first drug to be approved for SLE in more than half a century and the first in history biological agent for SLE, the introduction in 2011 of the monoclonal antibody belimumab that specifically binds to the soluble counterpart of B cell activating factor (BAFF) was a breakthrough in SLE drug development. The efficacy and favourable safety profile of belimumab has been demonstrated across several clinical trials and observational studies. Herein, we reviewed the literature and provide a summary on the effects of belimumab on SLE patients' HRQoL based on 23 studies. Belimumab has been shown to induce clinically important improvements in physical aspects of HRQoL and in fatigue, the latter being a common and major complaint within the SLE population. People with SLE overall benefit more from belimumab within physical compared with mental aspects of HRQoL. However, despite improvements of clinical and immunological features upon therapy with belimumab, HRQoL perception remains unsatisfactory for a substantial percentage of the patients. Finally, our review made apparent an urgent need for optimisation of the use of patient-reported outcome measures, both in research and clinical practice.