The objective of this study was to systematically review the relationship between low health literacy and patient-reported outcomes in patients with benign gynecologic conditions. In this specific population, we also sought to determine the current reported prevalence of low health literacy, examine demographic characteristics that may be related to low health literacy, and collate any health literacy interventions described in the literature. A systematic search of MEDLINE (Medical Literature Analysis and Retrieval System Online), Embase, The Cochrane Library, Web of Science, PubMed, and clinicaltrials.gov was performed on July 12, 2021, and repeated on October 13, 2023, for terms related to health literacy, specific health literacy measures, and benign gynecologic conditions. There were language or publication period restrictions. Inclusion required primary literature to report associations between health literacy and patient-reported outcomes, using validated tools to quantitatively measure each, in adult women with benign gynecologic conditions. Title screening, abstract screening, and full-text review were conducted with Covidence software (Melbourne, Australia) assisting with the review process. Of the 18,701 studies returned using our search strategy, 25 were selected for full-text review. Of these, no studies met inclusion criteria and reported an association between health literacy and patient-reported outcomes. This study identified a large gap in the literature. Future work should be directed at evaluating the association between health literacy and patient-reported outcomes in benign gynecology to inform patient-centered interventions and care provision.

BACKGROUND: Implementing patient-reported outcome measures (PROMs) to measure and evaluate health outcomes is increasing worldwide. Along with this emerging trend, it is important to identify which guidelines, frameworks, checklists, and recommendations exist, and if and how they have been used in implementing PROMs, especially in clinical quality registries (CQRs).
OBJECTIVE: This review aims to identify existing publications, as well as publications that discuss the application of actual guidelines, frameworks, checklists, and recommendations on PROMs\' implementation for various purposes such as clinical trials, clinical practice, and CQRs. In addition, the identified publications will be used to guide the development of a new guideline for PROMs\' implementation in CQRs, which is the aim of the broader project.
METHODS: A literature search of the databases MEDLINE, Embase, CINAHL, PsycINFO, and Cochrane Central Register of Controlled Trials will be conducted since the inception of the databases, in addition to using Google Scholar and gray literature to identify literature for the scoping review. Predefined inclusion and exclusion criteria will be used for all phases of screening. Existing publications of guidelines, frameworks, checklists, recommendations, and publications discussing the application of those methodologies for implementing PROMs in clinical trials, clinical practice, and CQRs will be included in the final review. Data relating to bibliographic information, aim, the purpose of PROMs use (clinical trial, practice, or registries), name of guideline, framework, checklist and recommendations, the rationale for development, and their purpose and implications will be extracted. Additionally, for publications of actual methodologies, aspects or domains of PROMs\' implementation will be extracted. A narrative synthesis of included publications will be conducted.
RESULTS: The electronic database searches were completed in March 2024. Title and abstract screening, full-text screening, and data extraction will be completed in May 2024. The review is expected to be completed by the end of August 2024.
CONCLUSIONS: The findings of this scoping review will provide evidence on any existing methodologies and tools for PROMs\' implementation in clinical trials, clinical practice, and CQRs. It is anticipated that the publications will help us guide the development of a new guideline for PROMs\' implementation in CQRs.
BACKGROUND: PROSPERO CRD42022366085; https://tinyurl.com/bdesk98x.
UNASSIGNED: DERR1-10.2196/52572.

BACKGROUND: The goal of this research is to identify the factors that negatively impact the achievement of the minimum clinically significant change (MCID) for the American Shoulder and Elbow Surgeons (ASES) score within the realm of various orthopedic shoulder procedures.
METHODS: We conducted a comprehensive review of studies published from 2002 to 2023, utilizing OvidMedline and PubMed databases. Our search criteria included terms such as \"minimal clinically important difference\" or \"MCID\" along with associated MeSH terms, in addition to \"American shoulder and elbow surgeon\" or \"ASES.\" We selectively included primary investigations that assessed factors linked to the failure to achieve MCID for the ASES score subsequent to orthopedic shoulder procedures, while excluding papers addressing anatomical, surgical, or injury-related aspects.
RESULTS: Our analysis identified 149 full-text articles, leading to the inclusion of 12 studies for detailed analysis. The selected studies investigated outcomes following various orthopedic shoulder procedures, encompassing biceps tenodesis, total shoulder arthroplasty, and rotator cuff repair. Notably, factors, such as gender, body mass index, diabetes, smoking habits, opioid usage, depression, anxiety, workers\' compensation, occupational satisfaction, and the preoperative ASES score, were all associated with the inability to attain MCID.
CONCLUSIONS: In summary, numerous factors exert a negative influence on the attainment of MCID following shoulder procedures, and these factors appear to be irrespective of the specific surgical technique employed. Patients presenting with these factors may perceive their surgical outcomes as less successful when compared to those without these factors. Identifying these factors can enable healthcare providers to provide more effective counseling to patients regarding their expected outcomes and rehabilitation course. Furthermore, these findings can aid in the development of a screening tool to better identify these risk factors and optimize them before surgery.

OBJECTIVE: Adult acquired buried penis (AABP) is a morbid condition often necessitating surgical intervention. Accurate assessment of pre- and postoperative symptoms is crucial to understand how AABP impacts a patients\' quality of life, verify surgical effectiveness, and practice patient-centered care. There is no validated patient-reported outcome instrument specific for AABP evaluation. We undertook a comprehensive review of existing literature on patient-reported outcome instruments post-AABP surgery to highlight the importance of developing a specific tool.
METHODS: Following the preferred reporting items for systematic reviews and meta-analysis 2020 guidelines, we queried three databases using relevant keywords (e.g., \"buried penis repair\"). Inclusion criteria were studies that discussed surgical management of AABP with patient-reported outcomes. Pediatric and congenital cases were excluded. Information collected included study design, level of evidence, number of participants included in the study, etiology of buried penis, surgical technique, preoperative or postoperative patient-reported outcomes, and patient-reported outcome instrument used.
RESULTS: Initial query identified 998 records. After abstract screening and applying the inclusion or exclusion criteria, a total of 19 articles with 440 patients were included. Eight studies implemented patient-reported outcome instruments. The international index of erectile dysfunction-5 and Likert satisfaction scales were used most frequently. Although all instruments were validated, none were validated in the specific context of AABP surgical intervention.
CONCLUSIONS: There is considerable heterogeneity within the AABP literature regarding patient symptomatology, postoperative complications, patient-reported outcomes, and instruments used. The results of this study emphasize the need for a patient-reported outcome measure to examine the influence of AABP repair on patient satisfaction and health-related quality of life.

A frequent facial abnormality called chin retrusion, also known as retrognathia, can be detrimental to a person\'s self-esteem and overall face aesthetics. Hyaluronic acid (HA) injections are one non-surgical approach to this problem that may provide individuals seeking chin augmentation with a relatively less invasive and potentially more affordable alternative. The present literature does not provide enough in-depth systematic reviews of the use of HA in chin augmentation. By completing a complete examination of the information that is currently available, this study intends to fill this knowledge gap, supporting physicians and researchers in better comprehending the efficacy and implications of HA in chin augmentation. The safety and success of any esthetic procedure should be made based on the results reported by the patients, including satisfaction and quality of life. Patients need to receive comprehensive surgical instructions from a medical professional to optimize the results of the HA injections for chin enhancement surgery. Regardless of the reported safety of using HA injections, some unwanted side effects have also been recorded. Indeed, healthcare professionals can make more informed decisions and give a patient comprehensive information about the procedure\'s risks and benefits to the patients. A systematic review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. EMBASE, OVID, and Google Scholar databases were searched up to June 2023. We concentrated on adult patients treated with HA for chin enhancement, and our research was limited to studies conducted in English. A total of 2,738 patients from 24 articles were studied, with 2,259 receiving HA injections for chin augmentation. When applicable, aesthetic outcomes were assessed using scales such as the Global Aesthetic Improvement Scale (GAIS)/FACE-Q and the Galderma Chin Retrusion Scale. Patient satisfaction increased noticeably. Among the studies, some reported complications following HA injection. While three studies found no significant negative effects, one highlighted a major necrotic complication. HA has proven to be an effective and safe alternative to chin augmentation surgery, with the majority of patients showing high satisfaction rates. However, large-scale randomized controlled trials are needed to obtain meaningful results, which will contribute to the further development of non-surgical cosmetic procedures. These studies may facilitate further innovation and refinement of these techniques and potentially expand the application of HA fillers in facial aesthetics.

UNASSIGNED: Our goal was to review current peer-reviewed articles in which the BDI (Beck Depression Inventory), PHQ-9 (Patient Health Questionnaire), or QIDS-SR16 (16-Item Quick Inventory of Depressive Symptomatology) was used as the primary or secondary outcome measure and to evaluate the quality of PRO (Patient-Reported Outcome) reporting in RCTs (Randomized Controlled Trials) according to the 2013 PRO-specific CONSORT (Consolidated Standards of Reporting Trials) extension.
UNASSIGNED: We systematically searched in electronic databases. A study would be included if it included patients diagnosed with major depressive disorder according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM) or International Classification of Diseases, version 10 (ICD-10) as participants, was a randomized controlled trial, included the BDI, PHQ-9, or QIDS-SR16 as the primary or secondary outcome measure, published between 1990 and 2013, and was in English. Two of the authors evaluated the quality of PRO reporting according to the 2013 CONSORT-PRO. Logistic regression were used to evaluate the association between reporting completeness and trial characteristics.
UNASSIGNED: A total of 116 studies were included. These studies were conducted in 25 countries. Sample sizes ranged from 12 to 750. The CONSORT-PRO was not cited in any one of the included studies. Among the 116 studies, 2 (1.72%) studies introduced the rationale for PRO assessment, 60 (51.72%) studies explicitly stated statistical approaches for dealing with missing data, 87 (75.00%) studies reported PRO outcome data at baseline and at subsequent time points. The mean score of reporting completeness was 66.24%. Significantly higher reporting completeness was found for RCTs published after 2013 (OR, 95%CI: 3.81, 1.32-10.99). Studies with a higher sample size were more completely reported than studies with a lower sample size (OR, 95%CI: 1.01, 1.00-1.02).
UNASSIGNED: The CONSORT-PRO guidance was rarely cited. The quality of PRO reporting in depression studies requires improvement. This result may be meaningful for the promotion of PRO reporting in RCTs.

OBJECTIVE: The primary objective is to systematically review primary studies, such as randomized control trials (RCTs), feasibility, exploratory, and case studies; and the secondary objective is to evaluate all secondary articles, such as reviews, guidelines, and editorials, relevant to the use of StrataXRT for the prevention and/or management of radiation dermatitis (RD) in cancer patients.
METHODS: A literature search was conducted up to February 26, 2023, for articles investigating the use of StrataXRT for the prevention and treatment of RD, in the following databases: Ovid MEDLINE, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), and Google Scholar. The keywords \"StrataXRT\", \"dermatitis\", \"radiotherapy\", and \"radiation\" were used to identify relevant articles.
RESULTS: Twenty-seven articles from 2018 to 2022 were identified to fulfill the inclusion criteria of this review, of which nine are primary studies and 18 are secondary papers. Significant heterogeneity was observed in the current literature studying the effects of StrataXRT, making it difficult to make cross-trial comparisons. There is a suggestion of the efficacy of StrataXRT in the prevention and treatment of RD.
CONCLUSIONS: The findings of this review recommend further adequately powered RCTs with robust methodology including patient and clinician assessments to determine the efficacy of StrataXRT in preventing and treating RD. This is essential to improve the quality of life of patients and identify which groups of patients would benefit most from StrataXRT.

BACKGROUND: Despite the greater sensitivity and specificity of disease-specific patient-reported outcome measures (PROM) to detect clinical change, only recently have such instruments been developed for pulmonary hypertension (PH), specifically pulmonary arterial hypertension (PAH) and chronic thromboembolic disease (CTEPH). Although these valuable tools are now being incorporated into clinical studies of PH, they have not yet reached widespread integration into routine clinical care.
OBJECTIVE: In this systematic review, the authors assess the psychometric properties of PROM developed for PH, compare PROM with other clinical outcomes in PH, and address the utility of PROM in clinical care.
METHODS: The authors performed a systematic search of papers published between January 1, 2006, and October 1, 2022, using the MEDLINE database to identify PROM developed and validated for PH. The identified PROM were found to have been developed only in groups with PAH and CTEPH. The authors evaluated the identified instruments according to established psychometric criteria. An additional search was performed to identify randomized controlled trials (RCTs) utilizing these PROM for comparison with clinical outcomes.
RESULTS: From 527 papers retrieved, a total of 35 PROM were identified. Of these, 5 disease-specific instruments were included in the final analysis. While both CAMPHOR (Cambridge Pulmonary Hypertension Outcome Review) and emPHasis-10 performed well in patients with PAH and CTEPH with regard to their psychometric properties, emPHasis-10 demonstrated superior feasibility for use in clinical practice due to its concise format. The Pulmonary Arterial Hypertension-Symptoms and Impacts Questionnaire performed well in the authors\' analysis, though additional data is needed regarding interpretability and feasibility.
CONCLUSIONS: EmPHasis-10 demonstrated strong psychometric properties and the greatest feasibility for clinical use. Further study assessing the integration of PROM into routine clinical care for PH is needed.

UNASSIGNED: This study aims to investigate the potential benefits of integrating patient-reported outcomes (PROs) into routine clinical practice for patients undergoing active anticancer treatment.
UNASSIGNED: We conducted a comprehensive systematic review of randomized controlled trials involving cancer patients undergoing active anticancer treatment, spanning various cancer types and stages. The review covered four electronic databases (Medline, EMBASE, Cochrane Library, and CINAHL) up to September 2022. Key inclusion criteria focused on the incorporation of PROs as a routine intervention. Bias assessment followed the Cochrane collaboration\'s criteria, while the synthesis of results utilized effect size measurements (Cohen\'s d). The study adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.
UNASSIGNED: Out of 1549 initially screened records, 16 published randomized controlled trials encompassing 5300 patients met the inclusion criteria. The interventions involved 18 different PROs measurements, with prominent tools being EORTC QLQ-C30 (utilized in four trials) and PRO-CTCAE (utilized in four trials). Measured endpoints included overall quality of life (12 trials), physical health (11 trials), mental health (7 trials), and social health (5 trials). Overall, the study revealed a limited number of statistically significant findings, with predominantly small to moderate effect sizes associated with the interventions.
UNASSIGNED: The findings suggest that the routine integration of PROs into clinical practice does not yield definitive advantages in terms of PROs. It is apparent that further efforts are necessary to ascertain the impact of these interventions on patient health.
UNASSIGNED: The review protocol was registered on PROSPERO (ID: CRD42022365456).

Parkinson\'s Disease (PD) affects more than 10 million individuals, with increasing incidence worldwide. As PD\'s incidence rises, research funding is increasing substantially. PD\'s core outcome set (COS) provides standardization for PD clinical trial outcomes, improves research quality, and study comparability. Our study aimed to analyze COS uptake rate before and after the PD COS publication.
We searched ClinicalTrials.gov to retrieve phase III/IV adult PD trials published between 2013 and 2023. Screening for inclusion and data extraction occurred in a masked, duplicate fashion. Trial characteristics and COS uptake rate were extracted from this sample.
In our 111 included trials, the COS uptake rate was highest for the \'Walking and Balance\' outcome and lowest for the \'Hospital Admissions\' outcome. Overall, there was a non-significant monthly increase of 0.26 % (P = 0.266, CI = [-0.20, 0.72]) in \"COS-defined outcome\" measurement when comparing pre- and post-COS publication.
Our study found no significant increase in COS uptake in PD clinical trials. We found multiple outcomes to be vastly unmeasured and heterogeneity among the measurement instruments used. These findings complicate standardizing and comparing RCT outcomes. Overcoming these barriers is vital to improving the usefulness of PD research.