OBJECTIVES: We determined the proportion of PIOs in neonatal RCTs included in Cochrane Neonatal reviews.
METHODS: We extracted up to 5 outcomes from each RCT included in Cochrane Neonatal reviews published until January 2018, with independent determination of PIOs among authors followed by a discussion leading to a consensus. We defined PIOs as outcomes that matter to patient care, such as clinical events or physiological or laboratory parameters that are widely used to guide management.
RESULTS: Among 6,832 outcomes extracted from 1,874 RCTs included in 276 reviews, 5,349 (78.3%) were considered PIOs; 461 studies (24.5%) included 5 or more PIOs, 1,278 (68.2%) included 1-4 PIOs, while 135 (7.2%) had no PIO included. PIOs were observed more often among dichotomous than among continuous outcomes (94.9 vs. 61.5%; RR: 1.54; 95% CI: 1.50-1.58), and more among subjective than among objective outcomes (95.9 vs. 76.8%; RR: 1.25; 95% CI: 1.22-1.28). Newer studies were more likely to have a greater number of PIOs (adjusted OR: 1.033 [95% CI: 1.025-1.041] with each publication year).
CONCLUSIONS: The large and increasing representation of PIOs over the years suggests an improving awareness by neonatal trialists of the need to incorporate important outcomes in order to justify the utilization of resources. Further research should explore the reasons for non-inclusion or non-reporting of PIOs in a small proportion of RCTs.
METHODS: Adult patients (≥18 years) tested positive for COVID-19 via reverse transcription-polymerase chain reaction (RT-PCR) and admitted in Hospital Tuanku Ja'afar Seremban, Malaysia, were recruited in this study. Patients completed a questionnaire via telephone interview comprising the following details: age, sex, ethnicity, comorbidities, general and otorhinolaryngological symptoms, onset and duration of olfactory and gustatory dysfunction. Patients with persistent olfactory and gustatory dysfunction at the time of the initial interview were followed-up every 3 to 5 days till resolution.
RESULTS: A total of 145 patients were included in our study. The mean age of patients was 43.0 ± 17.7 (range: 18-86). Fever (44.1%) and cough (39.3%) were the most prevalent general symptoms. Thirty-one patients (21.4%) reported olfactory dysfunction and 34 (23.4%) reported dysgeusia. There was a significant association between both olfactory and gustatory dysfunction (P patients (13.6%) reported isolated sudden-onset anosmia. The median duration of olfactory and gustatory dysfunctions was 7 days. Complete recovery was achieved for 70.5% of the patients within 7 days of symptom onset. Only 6 (19.4%) of the 31 patients with olfactory dysfunction experienced nasal obstruction or rhinorrhea. Olfactory dysfunction was not significantly associated with nasal obstruction or rhinorrhea. Olfactory dysfunction was significantly associated with younger age (P = .002), female (P = .011), and hyperlipidemia (P = .012). Gustatory dysfunction was significantly associated with fever (P = .019) and cough (P = .039).
CONCLUSION: Olfactory and gustatory dysfunction is a pertinent manifestation of COVID-19. Most of the affected patients achieve rapid and complete recovery. Sudden onset of olfactory and gustatory dysfunction should be recognized as a major symptom of COVID-19 as we implore to contain this pandemic.
Objective: This study assessed feasibility of using quality improvement (QI) tools to improve management of perioperative pain in hospitals in multiple developing countries.
Methods: The International Pain Registry and Developing Countries working groups, from the International Association for the Study of Pain (IASP), sponsored the project and PAIN OUT, a QI and research network, coordinated it, and provided the research tools. The IASP published a call about the project on its website. Principal investigators (PIs) were responsible for implementing a preintervention and postintervention study in 1 to 2 surgical wards in their hospitals, and they were free to choose the QI intervention. Trained surveyors used standardized and validated web-based tools for collecting findings about perioperative pain management and patient reported outcomes (PROs). Four processes and PROs, independent of surgery type, assessed effectiveness of the interventions.
Results: Forty-three providers responded to the call; 13 applications were selected; and PIs from 8 hospitals, in 14 wards, in 7 countries, completed the study. Interventions focused on teaching providers about pain management. Processes improved in 35% and PROs in 37.5% of wards.
Conclusions: The project proved useful on multiple levels. It offered PIs a framework and tools to perform QI work and findings to present to colleagues and administration. Management practices and PROs improved on some wards. Interpretation of change proved complex, site-dependent, and related to multiple factors. PAIN OUT gained experience coordinating a multicentre, international QI project. The IASP promoted research, education, and QI work.
PATIENTS AND METHODS: Materials and methods: The study included 165 patients admitted with STEMI within 12 hours of the onset of symptoms be¬tween January 2020 and August 2021. All patients underwent primary PCI according to the guidelines, followed by standard examination and treatment at the hospital. Blood samples for biomarker analysis (MMP-9, cTnI) and other routine tests were taken on admission. At six months after the event, all patients underwent clinical follow-up. Patients were contacted either by phone, through family members or their physicians 1 year after the event.
RESULTS: Results: The composite endpoint reached 9% of patients at one-year follow-up. ROC analysis of MMP-9 with the one-year com¬posite endpoint showed an AUC=0.711, with 91.7% sensitivity, and 47.4% specificity, 95% CI - 0.604 to 0.802, p=0.0037. ROC analysis of EQ-5D questionnaire with the one-year composite endpoint showed AUC = 0.73, the 95% CI - 0.624 to 0.820, p< 0.0195, with sensitivity 54.5% and specificity 94.7%. A logistic regression model showed a statistical association with the com¬posite endpoint at one year after STEMI in both EQ-5D (OR=0.89, 95% CI: 0.8313- 0.9725, p=0.0079) and MMP-9 (OR=1.0151, 95% CI:1.0001-1.0304, p=0.0481).
CONCLUSION: Conclusions: The level of MMP-9 more than 194 ng/ml and <55 points in EQ-5D predicts major adverse cardiovascular events, in¬cluding cardiovascular mortality and progressive heart failure, as well as other elements of composite endpoints, during a 1-year follow-up in patients with STEMI after primary PCI. Future studies are needed to clarify this result.
OBJECTIVE: To establish consensus on a core set of clinician- and patient-reported outcome measures recommended for use in clinical practice and to establish the appropriate interval within which these measures should be applied.
EVIDENCE REVIEW: Clinician- and patient-reported HS measures and studies describing their psychometric properties were identified through literature reviews. Identified measures comprised an item reduction survey and subsequent electronic Delphi (e-Delphi) consensus rounds. In each consensus round, a summary of outcome measure components and scoring methods was provided to participants. Experts were provided with feasibility characteristics of clinician measures to aid selection. Consensus was achieved if at least 67% of respondents agreed with use of a measure in clinical practice.
FINDINGS: Among HS experts, response rates for item reduction, e-Delphi round 1, and e-Delphi round 2 surveys were 76.4% (42 of 55), 90.5% (38 of 42), and 92.9% (39 of 42), respectively; among patient research partners (PRPs), response rates were 70.8% (17 of 24), 100% (17 of 17), and 82.4% (14 of 17), respectively. The majority of experts across rounds were practicing dermatologists with 18 to 19 years of clinical experience. In the final e-Delphi round, most PRPs were female (12 [85.7%] vs 2 males [11.8%]) and aged 30 to 49 years. In the final e-Delphi round, HS experts and PRPs agreed with the use of the HS Investigator Global Assessment (28 [71.8%]) and HS Quality of Life score (13 [92.9%]), respectively. The most expert-preferred assessment interval in which to apply these measures was 3 months (27 [69.2%]).
CONCLUSIONS AND RELEVANCE: An international group of HS experts and PRPs achieved consensus on a core set of HS measures suitable for use in clinical practice. Consistent use of these measures may lead to more accurate assessments of HS disease activity and life outcomes, facilitating shared treatment decision-making in the practice setting.
PATIENTS AND METHODS: Patients were part of a prospective multicentre observational study recruiting people with bladder cancer for a urine biomarker study (DETECT II; ClinicalTrials.gov: NCT02781428). A mixed-methods approach comprising (1) a questionnaire to assess patients' experience with cystoscopy and patients' preference for cystoscopy vs urinary biomarker, and (2) semi-structured interviews to understand patient views, choice and reasons for their preference.
RESULTS: A urine biomarker with an MAS of 90% would be accepted by 75.8% of patients. This was despite a high self-reported prevalence of haematuria (51.0%), dysuria/lower urinary tract symptoms (69.1%) and urinary tract infection requiring antibiotics (25.8%). There was no association between MAS with patient demographics, adverse events experienced, cancer characteristics or distance of patients' home to hospital. The qualitative analysis suggested that patients acknowledge that cystoscopy is invasive, embarrassing and associated with adverse events but are willing to tolerate the procedure because of its high sensitivity. Patients have confidence in cystoscopy and appreciate the visual diagnosis of cancer. Both low- and high-risk patients would consider a biomarker with a reported sensitivity similar to that of cystoscopy.
CONCLUSION: Patients value the high sensitivity of cystoscopy despite the reported discomfort and adverse events experienced after it. The sensitivity of a urinary biomarker must be close to cystoscopy to gain patients' acceptance.
METHODS: Clinical, laboratory, and PRO data (Chronic Liver Disease Questionnaire-nonalcoholic steatohepatitis [NASH], Functional Assessment of Chronic Illness Therapy-Fatigue, and the Work Productivity and Activity Index) were collected from NAFLD patients seen in real-world practices and enrolled in the Global NAFLD/NASH Registry encompassing 18 countries in 6 global burden of disease super-regions.
RESULTS: Across the global burden of disease super-regions, NAFLD patients (n = 5691) were oldest in Latin America and Eastern Europe and youngest in South Asia. Most men were enrolled at the Southeast and South Asia sites. Latin America and South Asia had the highest employment rates (>60%). Rates of cirrhosis varied (12%-21%), and were highest in North Africa/Middle East and Eastern Europe. Rates of metabolic syndrome components varied: 20% to 25% in South Asia and 60% to 80% in Eastern Europe. Chronic Liver Disease Questionnaire-NASH and Functional Assessment of Chronic Illness Therapy-Fatigue PRO scores were lower in NAFLD patients than general population norms (all P < .001). Across the super-regions, the lowest PRO scores were seen in Eastern Europe and North Africa/Middle East. In multivariate analysis adjusted for enrollment region, independent predictors of lower PRO scores included younger age, women, and nonhepatic comorbidities including fatigue (P < .01). Patients whose fatigue scores improved over time experienced a substantial PRO improvement. Nearly 8% of Global NAFLD/NASH Registry patients had a lean body mass index, with fewer metabolic syndrome components, fewer comorbidities, less cirrhosis, and significantly better PRO scores (P < .01).
CONCLUSIONS: NAFLD patients seen in real-world practices in different countries experience a high comorbidity burden and impaired quality of life. Future research using global data will enable more precise management and treatment strategies for these patients.
METHODS: The study encompassed a comprehensive three-stage approach to the development and validation of the PROM. Initially, during the preliminary design stage, the necessity for a new PROM was recognized, an expert panel was formed, and semi-structured qualitative interviews were carried out with GSM patients. In the second stage, the study used the five-step pre-validation methodology established by Prior et al. to generate and refine the PROM items. The third and final stage encompassed the determination of scale and item content validity indexes to ensure validity. Additionally, the reliability of each construct was evaluated using Cronbach's α.
RESULTS: The resulting PROM was named GSM-SVTAQ (GSM-symptoms and vaginal treatments acceptability questionnaire). It demonstrated excellent validity in assessing symptoms burden, health-related and sexual quality of life, and vaginal treatment acceptability, with high content validity indices and strong internal consistency. The scale content validity indices and Cronbach's α coefficients for the three domains were (0.926, 0.939), (0.875, 0.947), and (0.824, 0.855), respectively.
CONCLUSION: The GSM-SVTAQ stands as the first GSM-specific, valid, and reliable PROM capable of comprehensively measuring the three components of GSM and the acceptability of vaginal treatments. Its implementation has the potential to significantly enhance patient care and outcomes in GSM management.
MATERIAL AND METHODS: Thirty-four patients (mean age 60.70 ± 8.7 years) received telescopic crown or locator attachments for ISOD and completed OHIP-14 (Malaysian version) and DS questionnaires, at baseline (T0 ) with new conventional complete dentures (CCD) and 3 months (T1 ) and 3 years (T2 ) after ISOD conversion. Mandibular bone volume was calculated from cone beam computed tomography (CBCT) datasets using Mimics software. Mean changes (MC) in OHIP-14 and DS at intervals were analyzed using the Wilcoxon signed-rank test and effect size (ES). The association of bone volume, implant attachment type, and other patient variables with the change in OHIP-14 and DS were determined using multivariate linear regression analysis.
RESULTS: The MC in OHIP-14 and DS scores from T0 to T1 and T2 showed significant improvement with moderate and large ES, respectively. Regression analyses for the change in OHIP-14 score from T0 to T2 showed significant association with implant attachment type (P = 0.043), bone volume (P = 0.004), and baseline OHIP-14 (P = 0.001), while for DS, the association was only significant with baseline DS score (P = 0.001).
CONCLUSION: Improvement in patients' OHRQoL and satisfaction with ISOD was associated with their baseline ratings. Mandibular bone volume had a stronger association for improvement in OHRQoL compared to type of attachment.
METHODS: Breast cancer patients were recruited from three Malaysian hospitals between June and November 2017. We compared the proportion of patients who rated PROs as very important (scored 7-9 on a 9-point Likert scale) between Malaysian patients and data collected from patients in HICs via the ICHOM questionnaire development process, using logistic regression. A two-step cluster analysis explored differences in PROs among Malaysian patients.
RESULTS: The most important PROs for both cohorts were survival, overall well-being, and physical functioning. Compared with HIC patients (n = 1177), Malaysian patients (n = 969) were less likely to rate emotional (78% vs 90%), cognitive (76% vs 84%), social (72% vs 81%), and sexual (30% vs 56%) functioning as very important outcomes (P patient expectation of services and refine the assessment of cancer care outcomes.
METHODS: A questionnaire survey was sent by e-mail to members of AOSpine to evaluate their familiarity and use of PROMs instruments and to assess the barriers to their use in spine care practice in LA, EU, AP, NA, and ME.
RESULTS: A total of 1634 AOSpine members from LA, EU, AP, NA, and ME answered the electronic questionnaire. The percentage of spine surgeons who were familiar with the generic health-related quality of life questionnaire was 71.7%. In addition, 31.9% of respondents did not use any PROMs routinely. The main barriers to implementing PROMs were lack of time to administer the questionnaires (57%) followed by lack of staff to assist in data collection (55%), and the long time to fill out the questionnaires (46%). The routine use of questionnaires was more frequent in NA and EU and less common in LA and ME (P < 0.001).
CONCLUSIONS: We found that 31.9% of spine surgeons do not use the PROMs questionnaire routinely. This appears to occur because of lack of knowledge regarding their importance, absence of reimbursement for this extra work, minimal financial support for clinical research, the cost of implementation, and lack of concern among physicians.
METHODS: The open-label, Phase II ECLIPSE study evaluated patient-reported outcomes (PROs) in transfusion-dependent thalassemia or lower-risk myelodysplastic syndromes patients randomized 1:1 to receive deferasirox DT or FCT over 24 weeks as a secondary outcome of the study. Three PRO questionnaires were developed to evaluate both deferasirox formulations: 1) Modified Satisfaction with Iron Chelation Therapy Questionnaire; 2) Palatability Questionnaire; 3) Gastrointestinal (GI) Symptom Diary.
RESULTS: One hundred seventy three patients were enrolled; 87 received the FCT and 86 the DT formulation. FCT recipients consistently reported better adherence (easier to take medication, less bothered by time to prepare medication and waiting time before eating), greater satisfaction/preference (general satisfaction and with administration of medicine), and fewer concerns (less worry about not swallowing enough medication, fewer limitations in daily activities, less concern about side effects). FCT recipients reported no taste or aftertaste and could swallow all their medicine with an acceptable amount of liquid. GI summary scores were low for both formulations.
CONCLUSIONS: These findings suggest a preference in favor of the deferasirox FCT formulation regardless of underlying disease or age group. Better patient satisfaction and adherence to chelation therapy may reduce iron overload-related complications.
TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02125877; registered April 26, 2014.
Materials and Methods: We reviewed prospectively collected data in our tertiary hospital arthroplasty registry and identified patients who underwent revision THA between 2001 and 2014, with a minimum of two years follow-up. The study group (two-stage revision THA for PJI) consists of 23 patients and the control group (one-stage revision THA for aseptic reasons) consists of 231 patients. Patient demographics, Western Ontario and McMaster Universities Arthritis Index (WOMAC), Oxford Hip Score (OHS), Short Form-36 (SF-36) scores and patient reported satisfaction were evaluated. Student's t-test was used to compare continuous variables between the two groups. Statistical significance was defined as p <0.05.
Results: The pre-operative demographics and clinical scores were relatively similar between the two groups of patients. At two years, patients who underwent revision THA for PJI reported a better WOMAC Pain Score and OHS as compared to aseptic revision THA. A similar proportion of patients were satisfied with their results of surgery in both groups (p=0.093).
Conclusions: Although patients who underwent revision THA for PJI had poorer pre-operative functional scores (WOMAC function and SF-36 PF), at two years follow-up, these two groups of patients have comparable post-operative outcomes. Interestingly, patients who had revision THA for PJI reported a better clinical outcome in terms of OHS and WOMAC Pain score as compared to the aseptic group. We conclude that the revision THA for PJI is not inferior to aseptic revision THA in terms of patient satisfaction and clinical outcomes.