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JAMA Otolaryngology-- Head & Neck... Jun 2024Patient education materials (PEMs) can promote patient engagement, satisfaction, and treatment adherence. The American Medical Association recommends that PEMs be...
IMPORTANCE
Patient education materials (PEMs) can promote patient engagement, satisfaction, and treatment adherence. The American Medical Association recommends that PEMs be developed for a sixth-grade or lower reading level. Health literacy (HL) refers to an individual's ability to seek, understand, and use health information to make appropriate decisions regarding their health. Patients with suboptimal HL may not be able to understand or act on health information and are at risk for adverse health outcomes.
OBJECTIVE
To assess the readability of PEMs on head and neck cancer (HNC) and to evaluate HL among patients with HNC.
EVIDENCE REVIEW
A systematic review of the literature was performed by searching Cochrane, PubMed, and Scopus for peer-reviewed studies published from 1995 to 2024 using the keywords head and neck cancer, readability, health literacy, and related synonyms. Full-text studies in English that evaluated readability and/or HL measures were included. Readability assessments included the Flesch-Kincaid Grade Level (FKGL grade, 0-20, with higher grades indicating greater reading difficulty) and Flesch Reading Ease (FRE score, 1-100, with higher scores indicating easier readability), among others. Reviews, conference materials, opinion letters, and guidelines were excluded. Study quality was assessed using the Appraisal Tool for Cross-Sectional Studies.
FINDINGS
Of the 3235 studies identified, 17 studies assessing the readability of 1124 HNC PEMs produced by professional societies, hospitals, and others were included. The mean FKGL grade ranged from 8.8 to 14.8; none of the studies reported a mean FKGL of grade 6 or lower. Eight studies assessed HL and found inadequate HL prevalence ranging from 11.9% to 47.0%.
CONCLUSIONS AND RELEVANCE
These findings indicate that more than one-third of patients with HNC demonstrate inadequate HL, yet none of the PEMs assessed were developed for a sixth grade or lower reading level, as recommended by the American Medical Association. This incongruence highlights the need to address the readability of HNC PEMs to improve patient understanding of the disease and to mitigate potential barriers to shared decision-making for patients with HNC. It is crucial to acknowledge the responsibility of health care professionals to produce and promote more effective PEMs to dismantle the potentially preventable literacy barriers.
PubMed: 38900443
DOI: 10.1001/jamaoto.2024.1569 -
Drugs Jun 2024Temporomandibular disorders (TMDs) encompass several conditions that cause pain and impair function of the masticatory muscles (M-TMDs) and temporomandibular joints....
OBJECTIVE
Temporomandibular disorders (TMDs) encompass several conditions that cause pain and impair function of the masticatory muscles (M-TMDs) and temporomandibular joints. There is a large interest among clinicians and researchers in the use of botulinum toxin-A (BoNT-A) as a treatment for M-TMD. However, due to the lack of consistent evidence regarding the efficacy as well as adverse events of BoNT-A, clinical decision making is challenging. Therefore, this umbrella review aimed to systematically assess systematic reviews (SRs) evaluating BoNT-A treatment effects on pain intensity, mandibular movements, and adverse events in patients with M-TMDs.
METHOD
An electronic search was undertaken in the databases MEDLINE, EMBASE, CINAHL, Cochrane Central Registry of Controlled Trials (CENTRAL), Web of Science, Epistemonikos, ClinicalTrials.gov, and ICTRP to identify SRs investigating BoNT-A effects on M-TMDs, published from the inception of each database until 6 December 2023. The quality of evidence was rated according to the critical appraisal checklist developed by the umbrella review methodology working group. Only high-quality SRs were included.
RESULTS
In total, 18 SRs were included. BoNT-A was shown to be more effective than placebo to reduce pain intensity, but not compared to standard treatments. Additionally, BoNT-A was not superior to placebo or standard treatments regarding improvement of mandibular movements. BoNT-A was considered to have a higher risk for adverse events on muscle and bony tissue compared with other treatments.
CONCLUSION
The synthesis in this umbrella review provides the highest level of evidence present. Taken together, there are indications of effectiveness of BoNT-A for treatment of M-TMDs, supported by moderate evidence. However, considering the risk of causing serious adverse events, treatment with BoNT-A is recommended to be the last treatment alternative.
PubMed: 38900335
DOI: 10.1007/s40265-024-02048-x -
Nuclear Medicine Communications Jun 2024The aim of this study was to quantify the diagnostic value of dual-tracer PET/computed tomography (CT) with 11C-acetate and fluorodeoxyglucose (FDG) in per-lesion and...
The aim of this study was to quantify the diagnostic value of dual-tracer PET/computed tomography (CT) with 11C-acetate and fluorodeoxyglucose (FDG) in per-lesion and per-patient and its effect on clinical decision-making for choosing the most appropriate management. The study protocol is registered a priori at https://osf.io/rvm75/. PubMed, Web of Science, Embase, and Cochrane Library were searched for relevant studies until 1 June 2023. Studies regarding the review question were included. The Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) was used to assess bias risk. Per-lesion and per-patient diagnostic performance were calculated for: (1) 11C-acetate alone; (2) FDG alone; and (3) dual tracer of 11C-acetate and FDG. A direct comparison of these three combinations was made. The possible sources of statistical heterogeneity were also examined. We also calculated the percentage change in clinical decision-making when dual-tracer PET/CT was added to conventional imaging routinely used for metastatic evaluation (CT/MRI). Grading of Recommendations, Assessment, Development, and Evaluations tool was used to evaluate the certainty of evidence. Eight studies including 521 patients and 672 metastatic lesions were included. Dual-tracer PET/CT had a per-lesion sensitivity of 96.3% [95% confidence interval (CI), 91.8-98.4%] and per-patient sensitivity of 95.5% (95% CI, 89.1-98.2%) which were highly superior to either of tracers alone. Per-patient specificity was 98.5% (84.1-99.9%) which was similar to either of tracers alone. Overall, 9.3% (95% CI, 4.7-13.9%) of the patients had their management beneficially altered by adding dual-tracer PET/CT to their conventional CT/MRI results. Dual-tracer PET/CT substantially outperforms single-tracer methods in detecting extrahepatic hepatocellular carcinoma metastases, evidencing its reliability and significant role in refining clinical management strategies based on robust diagnostic performance.
PubMed: 38899958
DOI: 10.1097/MNM.0000000000001870 -
Health Informatics Journal 2024Although exercise benefits female cancer survivors, clinical decision-making regarding timing, frequency, duration, and intensity is lacking. Optimizing exercise... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Although exercise benefits female cancer survivors, clinical decision-making regarding timing, frequency, duration, and intensity is lacking. Optimizing exercise interventions in this population is necessary. This study aimed to describe existing digital home-based exercises and to assess their effectiveness at improving physical health in female cancer survivors upon completion of therapy.
DESIGN
We conducted a systematic review using articles from Web of Science, Embase and Medline (Ovid). We included intervention studies examining the effects of digital home-based exercise programs on post-treatment recovery in female cancer survivors. Rob2 and ROBIN I were used to assess quality of studies. Quality-of-life, fatigue score, and physical performance were assessed using meta-analysis.
RESULTS
This study involved 1578 female cancer survivors in 21 interventions. Following guidelines and supervised exercise with coaches led to better outcomes than interventions without guidelines, programs without coaches, or lower intensity exercise. Exercise led to significant improvement in some physical performance outcomes. Significant improvements were seen in physical performance outcomes, including the 6-min walk test, metabolic equivalent task, and number of steps per day.
CONCLUSION
Providing cancer survivors with standard guidelines for home-based, coach-supervised, vigorous exercise on digital platforms could improve their physical function, health, and quality-of-life.
Topics: Humans; Cancer Survivors; Female; Exercise Therapy; Quality of Life; Exercise
PubMed: 38898568
DOI: 10.1177/14604582241263668 -
Journal of Robotic Surgery Jun 2024The aim of this review is to map the current research on the needs of gynecological patients treated with robotic surgery. Systematic Rapid Review. Pubmed, Web of... (Review)
Review
The aim of this review is to map the current research on the needs of gynecological patients treated with robotic surgery. Systematic Rapid Review. Pubmed, Web of Science, Google Scholar. Search was limited from the years 2017-2021. The Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement was followed. Rapid review is a synthesis of information produced in a shorter time than systematic reviews, which allows clinical nurses to access evidence in the decision-making process. The methodological steps implemented were the following: (1) needs assessment and topic selection, (2) study development, (3) literature search, (4) screening and study selection, (5) data extraction, (6) risk-of-bias assessment and (7) knowledge synthesis. The search yielded 815 articles, 746 were excluded after screening the title and abstract, and 69 full-text syntheses were performed. Only 10 articles were included in the final analysis. This research evaluated the effects of robotic surgery on the patient under seven themes; operative time, length of stay, complications, estimated blood loss, pain, survivor, and conversion. Five studies were on endometrial cancer, one study on gynecologic cancer, two studies on hysterectomy, one study on patient safety, and one study on cervical cancer. The results show that robotic surgery can change the needs of patients by solving ongoing problems in gynecological patients. This requires a better understanding of robotic surgery procedures while facilitating nursing care over patient care.
Topics: Humans; Robotic Surgical Procedures; Female; Patient Care; Gynecologic Surgical Procedures; Operative Time; Length of Stay; Blood Loss, Surgical; Hysterectomy; Patient Safety; Postoperative Complications; Endometrial Neoplasms; Genital Neoplasms, Female; Uterine Cervical Neoplasms
PubMed: 38896293
DOI: 10.1007/s11701-024-01955-1 -
The Cochrane Database of Systematic... Jun 2024Constipation that is prolonged and does not resolve with conventional therapeutic measures is called intractable constipation. The treatment of intractable constipation... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Constipation that is prolonged and does not resolve with conventional therapeutic measures is called intractable constipation. The treatment of intractable constipation is challenging, involving pharmacological or non-pharmacological therapies, as well as surgical approaches. Unresolved constipation can negatively impact quality of life, with additional implications for health systems. Consequently, there is an urgent need to identify treatments that are efficacious and safe.
OBJECTIVES
To evaluate the efficacy and safety of treatments used for intractable constipation in children.
SEARCH METHODS
We searched CENTRAL, MEDLINE, Embase, and two trials registers up to 23 June 2023. We also searched reference lists of included studies for relevant studies.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) comparing any pharmacological, non-pharmacological, or surgical treatment to placebo or another active comparator, in participants aged between 0 and 18 years with functional constipation who had not responded to conventional medical therapy.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methods. Our primary outcomes were symptom resolution, frequency of defecation, treatment success, and adverse events; secondary outcomes were stool consistency, painful defecation, quality of life, faecal incontinence frequency, abdominal pain, hospital admission for disimpaction, and school absence. We used GRADE to assess the certainty of evidence for each primary outcome.
MAIN RESULTS
This review included 10 RCTs with 1278 children who had intractable constipation. We assessed one study as at low risk of bias across all domains. There were serious concerns about risk of bias in six studies. One study compared the injection of 160 units botulinum toxin A (n = 44) to unspecified oral stool softeners (n = 44). We are very uncertain whether botulinum toxin A injection improves treatment success (risk ratio (RR) 37.00, 95% confidence interval (CI) 5.31 to 257.94; very low certainty evidence, downgraded due to serious concerns with risk of bias and imprecision). Frequency of defecation was reported only for the botulinum toxin A injection group (mean interval of 2.6 days). The study reported no data for the other primary outcomes. One study compared erythromycin estolate (n = 6) to placebo (n = 8). The only primary outcome reported was adverse events, which were 0 in both groups. The evidence is of very low certainty due to concerns with risk of bias and serious imprecision. One study compared 12 or 24 μg oral lubiprostone (n = 404) twice a day to placebo (n = 202) over 12 weeks. There may be little to no difference in treatment success (RR 1.29, 95% CI 0.87 to 1.92; low certainty evidence). We also found that lubiprostone probably results in little to no difference in adverse events (RR 1.05, 95% CI 0.91 to 1.21; moderate certainty evidence). The study reported no data for the other primary outcomes. One study compared three-weekly rectal sodium dioctyl sulfosuccinate and sorbitol enemas (n = 51) to 0.5 g/kg/day polyethylene glycol laxatives (n = 51) over a 52-week period. We are very uncertain whether rectal sodium dioctyl sulfosuccinate and sorbitol enemas improve treatment success (RR 1.33, 95% CI 0.83 to 2.14; very low certainty evidence, downgraded due to serious concerns with risk of bias and imprecision). Results of defecation frequency per week was reported only as modelled means using a linear mixed model. The study reported no data for the other primary outcomes. One study compared biofeedback therapy (n = 12) to no intervention (n = 12). We are very uncertain whether biofeedback therapy improves symptom resolution (RR 2.50, 95% CI 1.08 to 5.79; very low certainty evidence, downgraded due to serious concerns with risk of bias and imprecision). The study reported no data for the other primary outcomes. One study compared 20 minutes of intrarectal electromotive botulinum toxin A using 2800 Hz frequency and botulinum toxin A dose 10 international units/kg (n = 30) to 10 international units/kg botulinum toxin A injection (n = 30). We are very uncertain whether intrarectal electromotive botulinum toxin A improves symptom resolution (RR 0.96, 95% CI 0.76 to 1.22; very low certainty evidence) or if it increases the frequency of defecation (mean difference (MD) 0.00, 95% CI -1.87 to 1.87; very low certainty evidence). We are also very uncertain whether intrarectal electromotive botulinum toxin A has an improved safety profile (RR 0.20, 95% CI 0.01 to 4.00; very low certainty evidence). The evidence for these results is of very low certainty due to serious concerns with risk of bias and imprecision. The study did not report data on treatment success. One study compared the injection of 60 units botulinum toxin A (n = 21) to myectomy of the internal anal sphincter (n = 21). We are very uncertain whether botulinum toxin A injection improves treatment success (RR 1.00, 95% CI 0.75 to 1.34; very low certainty evidence). No adverse events were recorded. The study reported no data for the other primary outcomes. One study compared 0.04 mg/kg oral prucalopride (n = 107) once daily to placebo (n = 108) over eight weeks. Oral prucalopride probably results in little or no difference in defecation frequency (MD 0.50, 95% CI -0.06 to 1.06; moderate certainty evidence); treatment success (RR 0.96, 95% CI 0.53 to 1.72; moderate certainty evidence); and adverse events (RR 1.15, 95% CI 0.94 to 1.39; moderate certainty evidence). The study did not report data on symptom resolution. One study compared transcutaneous electrical stimulation to sham stimulation, and another study compared dietitian-prescribed Mediterranean diet with written instructions versus written instructions. These studies did not report any of our predefined primary outcomes.
AUTHORS' CONCLUSIONS
We identified low to moderate certainty evidence that oral lubiprostone may result in little to no difference in treatment success and adverse events compared to placebo. Based on moderate certainty evidence, there is probably little or no difference between oral prucalopride and placebo in defecation frequency, treatment success, or adverse events. For all other comparisons, the certainty of the evidence for our predefined primary outcomes is very low due to serious concerns with study limitations and imprecision. Consequently, no robust conclusions could be drawn.
Topics: Humans; Constipation; Child; Randomized Controlled Trials as Topic; Child, Preschool; Adolescent; Defecation; Botulinum Toxins, Type A; Quality of Life; Laxatives; Infant; Bias; Lubiprostone
PubMed: 38895907
DOI: 10.1002/14651858.CD014580.pub2 -
Frontiers in Veterinary Science 2024Digital clinical decision support (CDS) tools are of growing importance in supporting healthcare professionals in understanding complex clinical problems and arriving at...
Expanding access to veterinary clinical decision support in resource-limited settings: a scoping review of clinical decision support tools in medicine and antimicrobial stewardship.
INTRODUCTION
Digital clinical decision support (CDS) tools are of growing importance in supporting healthcare professionals in understanding complex clinical problems and arriving at decisions that improve patient outcomes. CDS tools are also increasingly used to improve antimicrobial stewardship (AMS) practices in healthcare settings. However, far fewer CDS tools are available in lowerand middle-income countries (LMICs) and in animal health settings, where their use in improving diagnostic and treatment decision-making is likely to have the greatest impact. The aim of this study was to evaluate digital CDS tools designed as a direct aid to support diagnosis and/or treatment decisionmaking, by reviewing their scope, functions, methodologies, and quality. Recommendations for the development of veterinary CDS tools in LMICs are then provided.
METHODS
The review considered studies and reports published between January 2017 and October 2023 in the English language in peer-reviewed and gray literature.
RESULTS
A total of 41 studies and reports detailing CDS tools were included in the final review, with 35 CDS tools designed for human healthcare settings and six tools for animal healthcare settings. Of the tools reviewed, the majority were deployed in high-income countries (80.5%). Support for AMS programs was a feature in 12 (29.3%) of the tools, with 10 tools in human healthcare settings. The capabilities of the CDS tools varied when reviewed against the GUIDES checklist.
DISCUSSION
We recommend a methodological approach for the development of veterinary CDS tools in LMICs predicated on securing sufficient and sustainable funding. Employing a multidisciplinary development team is an important first step. Developing standalone CDS tools using Bayesian algorithms based on local expert knowledge will provide users with rapid and reliable access to quality guidance on diagnoses and treatments. Such tools are likely to contribute to improved disease management on farms and reduce inappropriate antimicrobial use, thus supporting AMS practices in areas of high need.
PubMed: 38895711
DOI: 10.3389/fvets.2024.1349188 -
Frontiers in Endocrinology 2024There has been continuous progress in diabetes management over the last few decades, not least due to the widespread dissemination of continuous glucose monitoring (CGM)...
There has been continuous progress in diabetes management over the last few decades, not least due to the widespread dissemination of continuous glucose monitoring (CGM) and automated insulin delivery systems. These technological advances have radically changed the daily lives of people living with diabetes, improving the quality of life of both children and their families. Despite this, hypoglycemia remains the primary side-effect of insulin therapy. Based on a systematic review of the available scientific evidence, this paper aims to provide evidence-based recommendations for recognizing, risk stratifying, treating, and managing patients with hypoglycemia. The objective of these recommendations is to unify the behavior of pediatric diabetologists with respect to the timely recognition and prevention of hypoglycemic episodes and the correct treatment of hypoglycemia, especially in patients using CGM or advanced hybrid closed-loop systems. All authors have long experience in the specialty and are members of the Italian Society of Pediatric Endocrinology and Diabetology. The goal of treating hypoglycemia is to raise blood glucose above 70 mg/dL (3.9 mmol/L) and to prevent further decreases. Oral glucose at a dose of 0.3 g/kg (0.1 g/kg for children using "smart pumps" or hybrid closed loop systems in automated mode) is the preferred treatment for the conscious individual with blood glucose <70 mg/dL (3.9 mmol/L), although any form of carbohydrate (e.g., sucrose, which consists of glucose and fructose, or honey, sugary soft drinks, or fruit juice) containing glucose may be used. Using automatic insulin delivery systems, the oral glucose dose can be decreased to 0.1 g/kg. Practical flow charts are included to aid clinical decision-making. Although representing the official position of the Italian Society of Pediatric Endocrinology and Diabetology (ISPED), these guidelines are applicable to the global audience and are especially pertinent in the era of CGM and other advanced technologies.
Topics: Humans; Hypoglycemia; Child; Adolescent; Blood Glucose Self-Monitoring; Insulin; Hypoglycemic Agents; Blood Glucose; Diabetes Mellitus, Type 1; Insulin Infusion Systems; Risk Assessment; Practice Guidelines as Topic; Disease Management
PubMed: 38894740
DOI: 10.3389/fendo.2024.1387537 -
Cancers May 2024For biliary tract cancer (BTC), the addition of immunotherapy (durvalumab or pembrolizumab) to gemcitabine and cisplatin (GemCis) significantly improved overall survival... (Review)
Review
BACKGROUND
For biliary tract cancer (BTC), the addition of immunotherapy (durvalumab or pembrolizumab) to gemcitabine and cisplatin (GemCis) significantly improved overall survival (OS) in phase 3 clinical trials (RCTs). However, the interpretation and magnitude of the treatment effect is challenging because OS Kaplan-Meier curves violate the proportional hazards (PH) assumption. Analysis using restricted mean survival time (RMST) allows quantification of the benefits in the absence of PH. This systematic review and meta-analysis aims to assess the benefit of immunotherapy-based regimens for OS at 24 months using RMST analysis.
METHODS
A systematic review was conducted using studies published up to 8 November 2023. Only phase 3 RCTs evaluating the use of anti-PD-1/PD-L1 combined with GemCis and reporting OS were included. KM curves for OS were digitized, and the data were reconstructed. A meta-analysis for OS by RMST at 24 months was performed.
RESULTS
A total of 1754 participants from the TOPAZ-1 and KEYNOTE-966 trials were included. In TOPAZ-1, RMSTs at 24 months were 13.52 (7.92) and 12.21 (7.22) months with GemCis plus durvalumab and GemCis alone, respectively. In KEYNOTE-966, RMSTs at 24 months were 13.60 (7.76) and 12.45 (7.73) months with GemCis plus pembrolizumab and GemCis alone, respectively. Immunotherapy-based regimens showed a mean OS difference at 24 months by an RMST of 1.21 months [(95% CI: 0.49-1.93), < 0.001, I = 0%].
CONCLUSIONS
Immunotherapy-based regimens improve OS in advanced BTC. Given this magnitude of benefit, it is essential to weigh up individual patient factors, preferences, and potential risks. RMST analysis provides valuable information to patients and physicians, facilitating decision-making in a value-based medical environment.
PubMed: 38893196
DOI: 10.3390/cancers16112077 -
Cancers May 2024The increased demand for genetic testing and counseling necessitates healthcare professionals (HCPs) to improve their genetic competency through training programs. This... (Review)
Review
BACKGROUND
The increased demand for genetic testing and counseling necessitates healthcare professionals (HCPs) to improve their genetic competency through training programs. This systematic review identified HCPs' learning needs and their perspectives on essential information for families with hereditary cancer.
METHODS
This review covered studies published from 2013 to 2024 across five databases. Data were analyzed using a content analysis.
RESULTS
Thirteen studies involving 332 HCPs were analyzed. Most studies focused on the learning needs of physicians caring for families affected by Hereditary Breast and Ovarian Cancer in North America and Europe. HCPs required training emphasizing practical counseling skills over the basics of genetics. Learning needs varied by profession: physicians needed training in assessing cancer risk and supporting decision-making in risk management; nurses required information on resources and the genetic care system; genetic counselors sought guidance on family communication and planning. Essential information identified for families included risk-reducing strategies, personalized cancer risk assessment, family implications, psychological issues, (cascade) genetic testing, and social concerns.
CONCLUSIONS
The findings have implications for the development of training programs for HCPs, emphasizing the need for tailored training based on professions. Future research should explore the needs of HCPs caring for families with diverse hereditary cancers and cultural backgrounds.
PubMed: 38893084
DOI: 10.3390/cancers16111963