Patient Related Outcome Measures最新文献

[This retracts the article DOI: 10.2147/PROM.S297871.].

Background: Despite the fact that stroke has been reported as one of the top three leading causes of death and morbidity in Ethiopia, there are limited data regarding the management of stroke and clinical outcomes. Hence, the present study aimed to evaluate the pharmacotherapy of stroke and factors associated with poor treatment outcomes.

Methods: A retrospective cross-sectional study was conducted at Jimma University Medical Center (JUMC) among adult stroke patients managed from 2014 to 2017. Clinical characteristics, treatment, and outcomes data were analyzed by using SPSS version 21. Multivariable logistic regression was performed to identify the predictors of poor treatment outcomes. Two-sided P < 0.05 was accepted as statistically significant.

Results: A total of 153 illegible patient cases were included in this study. The majority, 111 (72.5%), were male and the mean age of the patients was 57±13.7 years. Among 153 stroke patients, 112 (73.2%) patients presented with ischemic stroke. Aspirin and statins (78.6%) were the most commonly used treatment among ischemic stroke patients, whereas enalapril was used in about (43%) of stroke patients to treat high blood pressure. About 61 (40%) stroke patients had poor treatment outcomes; of this, 36 (23.5%) died in hospital. Older age (AOR = 1.034; 95% CI: 1.003-1.069), history of heart failure (AOR = 4.26; 95% CI: 1.58-11.48), loss of consciousness diabetes (AOR = 3.05 95% CI: 1.25-7.44), and aspiration pneumonia (AOR = 5.94; 95% CI: 2.46-14.32) were significantly associated with poor treatment outcomes.

Conclusion: Overall, treatment of stroke patients was sub-optimal and almost half of the patients had poor treatment outcomes. Availing of thrombolytic therapy, devising appropriate preventive measures of risk factors (hypertension), and decreasing preventable complication such as aspiration pneumonia could improve patient outcomes.

Purpose: PRESORS ClinRO completed by clinicians and ObsRO completed by caregivers were developed to characterize the clinical course of respiratory syncytial virus (RSV) infection. This study describes preliminary analysis of PRESORS' measurement properties using clinical trial data.

Patients and methods: PRESORS ClinRO and ObsRO data were collected in a 28-day randomized, double-blind, Phase 1b trial of JNJ-53718678 or placebo in infants and children ≤24 months of age treated for RSV infection in hospitals. PRESORS data were scored and key psychometric properties of scores were evaluated, including ability to discriminate between known groups and to detect change over time. Time to resolution of RSV signs was explored using two responder definitions.

Results: Daily completion rates for PRESORS ClinRO and ObsRO were high for the 44 children in the study (median: 100% and 93%, respectively). Large floor effects were observed at baseline for signs of severe RSV infection that were either absent (cyanosis, fever, apnea) or rarely reported (reduced urination/dehydration, vomiting). Implausible ObsRO ratings suggested some caregivers could not accurately measure heart rate. Known-group validity was confirmed: children in poor health based on baseline ClinRO had mean baseline composite scores that were significantly worse for both ObsRO (p=0.001) and ClinRO (p<0.001) compared to those with better overall health. ObsRO (p=0.009) and ClinRO (p<0.001) composite scores were responsive to change in overall health status from baseline to Day 3. Mean scores for RSV sign dimensions decreased rapidly from baseline to Day 7 except for coughing and sleep ratings by caregivers. Time to recovery varied greatly depending on definitions used.

Conclusion: PRESORS ClinRO and ObsRO can inform endpoints and enable monitoring the clinical course of RSV in pediatric trials. Improved alignment between ClinRO and ObsRO and revisions ensuring caregivers can assess all signs will be addressed in revised PRESORS.

Purpose: Health-related quality of life (HRQoL) is difficult to measure in rare diseases, especially in paediatric populations, yet capturing HRQoL is critical to evaluating treatment, including the cost-effectiveness of treatments. Given the ultra-rare nature of AADC deficiency indirect elicitation of HRQoL data through proxy caregiver/parent ratings is not feasible. In these circumstances, HRQoL data may be derived through vignette studies using the general population. The aim of the study was to generate health utility values specific for France for AADC deficiency using vignettes.

Methods: The study was completed online by panel participants from a French representative sample. Five health state vignettes, reflecting key milestones in the eladocagene exuparvovec clinical trials and economic model, were presented to the participants: "bedridden", "head control", "sitting unsupported", "standing with assistance" and "walking with assistance". The vignettes had been previously developed with input from parents of patients with AADC deficiency, patients and expert opinion. Participants also completed the Health Utilities Index-3 for the "bedridden" health state.

Results: A total of 1001 participants (51% females; mean age 46 years) completed the vignettes. Utilities increased linearly as the health state improved for both the time trade-off (TTO): 0.47 (standard deviation, SD 0.36) to 0.54 (SD 0.36) and standard gamble (SG): 0.61 (SD 0.29) to 0.67 (SD 0.27). A significant minority had incongruent responses (high utilities for the bedridden compared to walking health states) for the vignette (27%). When these were removed, the TTO health utilities (N=729) ranged from 0.39 (SD 0.36) to 0.56 (SD 0.38) and 0.61 (SD 0.30) to 0.69 (SD 0.27) for the SG.

Conclusion: Health utilities were derived for AADC deficiency which will be used for a cost-effectiveness model of an AADC deficiency treatment.

Background: Approximately 10% of deliveries are considered as high risk, which may require cesarean section. Besides, a rise in cesarean section delivery is a real public health concern; cesareans are costly and carry 8-12 and 8 times higher feto-maternal morbidity and mortality, respectively, as compared to vaginal delivery. Like in other countries where unnecessary cesarean delivery is performed, it is also rising in our country, posing potential risk to the mothers and their newborns.

Objective: To assess the indications and outcome of cesarean section delivery among pregnant women utilizing delivery services in selected hospitals.

Methods: A case-control study design was used among 488 randomly selected pregnant women attending delivery services in Bedelle and Mettu-Kharl Hospitals. Data were collected by interviewer-administered questionnaire and entered into EPI-data version 3.1 and exported to SPSS version 20 for cleaning and analyses. Binary logistic regression analysis was used to control for possible confounders. Association was declared at 95% CI and P-value <0.05 to assess the association between dependent and independent variables. Variables with P-values <0.05 at bivariate analysis were entered to final logistic regression model.

Results: Nearly 30% and 24.6% of fetuses had been exposed to unfavorable outcome among those delivered following cesarean and vaginal delivery, respectively. The mean age of study participants was 25.79 (SD 6.76) for mothers who underwent cesarean delivery and 24.76 (SD 4.956) for their counterparts. Unfavorable maternal outcome was experienced by 20.5% and 14.7% of pregnant women who gave birth by cesarean and vaginal delivery, respectively. Those not having antenatal care follow-up were five times more likely to encounter unfavorable outcome than attendees (AOR 5.22, 95% CI 1.85-14.69), while mothers of newborns with low 5th minute Apgar score were 3 times (AOR 2.96, 95% CI 1.07, 8.16), multi-parity 7 times (AOR 7.22, 95% CI 1.45, 36.05) and rural residence were 1.29 times (AOR 1.29, 95% CI 5.09, 12.88) more likely to develop unfavorable feto-maternal outcome.

Conclusion: Vaginal delivery results in more favorable feto-maternal outcomes than does cesarean delivery.

The objective of this study was to identify patient-reported outcome measures (PROMs), which aim to measure the affective component of pain and to assess their content validity, unidimensionality, measurement invariance, and Internal consistency in patients with chronic pain. The study was reported according to the PRISMA guidelines. A protocol of the review was submitted to PROSPERO before data extraction. Eligible studies were any type of study that investigated at least one of the domains: PROM development, content validity, dimensionality, internal consistency, or measurement invariance of any type of scale that claimed to measure the affective component of pain among patients with chronic pain. The databases Medline, Embase, PsycINFO, and the Cochrane Library were searched for eligible studies. The database search was supplemented by looking for relevant articles in the reference list of included studies, ie backtracking. All included studies were assessed independently by two authors according to the "COSMIN methodology on Systematic Reviews of Patient-Reported Outcome Measures". Descriptive data synthesis of the identified PROMs was conducted. The search yielded 11,242 titles of which 283 were assessed at the full-text level. Full-text screening led to the inclusion of 11 studies and an additional 28 studies were identified via backtracking, leading to the inclusion of 39 studies in total in the review. Included studies described the development and validity of 10 unique PROMs, all of which we assessed to have potentially inadequate content validity and doubtful psychometric properties. No studies reported whether the PROMs possessed invariant measurement properties. The existing PROMs measuring affective components of chronic pain potentially lack content validity and have inadequate psychometric measurement properties. There is a need for new PROMs measuring the affective component of chronic pain that possess high content validity and adequate psychometric measurement properties.

Background: Despite the negative impact of tuberculosis (TB) on patients' quality of life, TB control programs focus on biological and clinical parameters to manage and monitor TB patients. In our setting, patients' perception of their experience with TB and the impacts of TB on patients' physical, mental, and social wellbeing remain unknown.

Objective: The objective of this study was to evaluate the health-related quality of life (HRQOL) among rifampicin/multidrug-resistant TB (RR/MDR-TB) in comparison to drug-susceptible TB (DS-TB) patients in Eritrea.

Methods: A cross-sectional study was conducted in RR/MDR-TB and DS-TB patients under treatment. Anonymized data collected using the WHOQOL-BREF questionnaire were analyzed using SPSS version 23. Frequency, mean and standard deviation were used to describe the data. Mean group score comparison and relationship between variables were assessed using t-test. Domain score was calculated with a mean score of items within each domain and scaled positively, a higher (increasing) score denoting a higher quality of life. Internal consistency was measured using Cronbach's alpha and statistical significance was set at p < 0.05.

Results: A total of 92 patients (46 RR/MDR-TB and 46 DS-TB) participated in the study. Environmental (40.63 ± 10.72) and physical domains (61.80 ±17.18) were the two most affected domains in RR/MDR-TB and DS-TB patients, respectively. The psychological domain was the least affected domain in RR/MDR-TB (48.28 ± 20.83) and DS-TB patients (76.63 ±15.32). RR/MDR-TB patients had statistically lower mean scores in all domains than DS-TB patients.

Conclusion: HRQOL was impaired in both groups, but RR/MDR-TB patients had a worse health-related quality of life.

Objective: The objectives of this study were to 1) assess the content validity of generic preference-based measures (GPBMs), and (2) examine the convergent validity of the EuroQol 5 Dimension 5 Level (EQ-5D-5L), against the Patient Generated Index (PGI) in Amyotrophic Lateral Sclerosis (ALS).

Methods: Participants were recruited from 3 clinical sites across Canada. The PGI, EQ-5D-5L and Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) were administered through an online or hardcopy survey and scores compared for convergent validation. Domains nominated by participants as important to their health-related quality of life were generated using the PGI, classified using the International Classification of Functioning, Disability and Health (ICF) and mapped onto GPBMs to determine content coverage.

Results: Fifty-two participants (N=28 female; 61.3 ± 11.6 mean age ± standard deviation (SD); 3.5 ± 2.9 mean ± SD years since diagnosis) completed this study. The top three ICF domains identified by participants were recreation and leisure, lower limb mobility, and interpersonal relationships. The Quality of Well-Being Self-Administered (QWB-SA) scale had the highest content coverage (87%) and the Health Utilities Index 3 (HUI3) had the lowest (33%). Two domains were covered by all GPBMs and no GPBM included all domains identified as important by participants. A moderate correlation coefficient of 0.52 between the PGI and EQ-5D-5L was found.

Conclusion: The majority of GPBMs covered only approximately half of the domains important to individuals with ALS suggesting the need for an ALS specific preference-based measure to better reflect the health-related quality of life of this population.

Background: Functional disability is defined as limitations in performing socially defined roles and tasks expected within a sociocultural and physical environment. Functionality is a result of good mental health care. This study aimed to assess the magnitude and determinants of functional disability among patients with a mood disorders treated at St Paul's Hospital outpatient psychiatry clinic, Addis Ababa, Ethiopia in 2019.

Methods: This was a cross-sectional study. We used consecutive sampling to select respondents. Data were collected through face-to-face interviews using the 12-item World Health Organization Disability Assessment Schedule version 2.0. Data were entered into EpiData 3.1 and exported to SPSS 22.0 for analysis. Linear regression analysis was used to identify significant variables associated with outcomes.

Results: This study enrolled 235 respondents with a 100% nonresponse rate, and 62.5% were diagnosed with major depressive disorder. Mean disability score was 30.2%±32.4%. Nearly a quarter of respondents had had difficulties every day with day-to-day activity for the past 30 days. Current level of improvement (no change, β=10.5, 95% CI 3.85-17.2), relapse (β=6.15, 95% CI 1.34-10.9) and self-stigma (β=4.36, 95% CI 1.39-7.33) were strong predictors of disability score (P<0.05).

Conclusion: This study found a mean disability score of 30.2%. Current level of improvement and self-stigma were variables associated with disability, so working with stakeholders to focus on patients' clinical improvement from their illness and self-stigma will be vital to enhance their functionality.

Purpose: According to World Health Organization (WHO), cataract is the leading cause of blindness and visual impairment throughout the world. Post-operative refractive error is one of the commonest reasons for poor visual outcome after cataract surgery especially in developing countries where the standard modern biometry equipments are not available. The objective of this study was to assess the refractive outcome of cataract surgery done at University of Gondar (UoG) Tertiary Eye Care and Training Center, North West Ethiopia.

Methods: A descriptive cross-sectional study was done on 66 patients who had undergone manual small incision cataract surgery (MSICS) and fulfilled the inclusion criteria at UoG Tertiary Eye Care and Training Center from July 15 2019 to October 15 2019.

Results: From 90 post-operatively refracted eyes, 58 (64.4%) eyes achieved a target refraction of ±1.00 Diopter (D). The right and left eyes achieved mean post-operative refraction SE of -0.073±1.45D and -0.93±1.70 D, respectively. But only 54 (60%) eyes were implanted with the calculated IOL power and for the remaining 40% the calculated IOL was not available at the store. And the target (Good) post-operative uncorrected visual acuity (UCVA) and best corrected visual acuity (BCVA) was achieved in 66.7% and 82.2% eyes, respectively.

Conclusion: The post-operative refractive outcome after cataract surgery at the center is low. For over one-third of operated eyes, the calculated IOL was not implanted due to the absence of the required IOL power at the store and, therefore, a wide range of IOL power should be available at the center.