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Orthopedic Research and Reviews 2024Capitellum and trochlea fractures, also referred to as coronal shear fractures of the distal humerus, are infrequent yet challenging intra-articular fractures of the... (Review)
Review
PURPOSE
Capitellum and trochlea fractures, also referred to as coronal shear fractures of the distal humerus, are infrequent yet challenging intra-articular fractures of the elbow. There are a variety of surgical approaches and fixation methods with often variable outcomes. This systematic review investigates interventions, outcomes and complications of capitellum and trochlea fractures.
METHODS
A systematic review of studies published in MEDLINE, EMBASE, Web of Science and Cumulative Index to Nursing and Allied Health literature (CINAHL) was conducted to assess the clinical outcomes of capitellum and trochlea fractures managed surgically. Data on patient demographics, surgical approach, implant usage, postoperative outcomes and complications were compiled.
RESULTS
Forty-one studies met the inclusion criteria with a total of 700 patients. Surgical interventions primarily utilized either the lateral (79%) or antero-lateral (15%) approaches with headless compression screws as the most common fixation method (68%). Clinical outcomes were measured using the Mayo Elbow Performance Index (MEPI) with a mean score of 89.9 (±2.6) and the DASH score with a mean of 16.9 (±7.3). Elbow range of motion showed a mean flexion of 126.3° (±19.4), extension of 5.71° (±11.8), pronation of 75.23° (±12.2), and supination of 76.6° (±9.8). The mean flexion-extension arc was 113.7° (±16.9), and the mean pronation-supination arc was 165.31° (±9.41). Complications occurred in 19.8% of cases, with re-interventions required in 8.3% of cases, mainly due to symptomatic implants and elbow stiffness requiring surgical release. Other complications included implant removal (10.4%), overall reported stiff elbows (6%), nerve palsies (2%), non-union (1.5%), and infection (1.2%).
CONCLUSION
The treatment of capitellum and trochlea fractures yields satisfactory outcomes but has a considerable rate of complications and reoperations primarily due to symptomatic implants and elbow stiffness. There is noteworthy variability in the achieved range of motion, suggesting unpredictable outcomes. Deficits in functionality and range of motion are common after surgery, especially with more complex injury patterns.
PubMed: 38947420
DOI: 10.2147/ORR.S472482 -
Prehospital Emergency Care Jun 2024Cognitive load refers to the working memory resources required during a task. When the load is too high or too low this has implications for an individual's task... (Review)
Review
Cognitive load refers to the working memory resources required during a task. When the load is too high or too low this has implications for an individual's task performance. In the context of paramedicine and emergency medical services (EMS) broadly, high cognitive load could potentially put patient and personnel safety at risk. This systematic review aimed to determine the current understanding of the role of cognitive load in paramedical contexts. To do this, five databases were searched (Elsevier Embase, ProQuest Psychology, CINAHL, Ovid Medline, and Ovid PsychINFO) using synonyms of cognitive load and paramedical contexts. Included articles were full text, peer reviewed empirical research, with a focus on cognitive load and EMS work. Two reviewers screened titles, abstracts, and full text using a traffic light system against the inclusion and exclusion criteria. The quality of evidence was assessed using the GRADE framework. This study was registered on PROSPERO (CRD42022384246). No funding was received for this research. The searches identified 73 unique articles and after title/abstract and full text screening, 25 articles were included in the final review. Synthesis of the research revealed 10 categories of findings in the area. These are clinical performance, cognitive processes, emotional responses, physical expenditure, physiological responses, equipment and ergonomics, expertise and experience, multiple loads, cognitive load measures, and task complexity. From these findings it was determined that there is agreement in terms of what factors influence cognitive load in paramedical contexts, such as cognitive processes, task complexity, physical expenditure, level of experience, multiple types of loads, and the use of equipment. Cognitive load influences clinical task performance and has a bi-directional relationship with emotion. However, the literature is mixed regarding physiological responses to cognitive load, and how they are best measured. These findings highlight potential intervention points where cognitive load can be managed or reduced to improve working conditions for EMS clinicians and safety for their patients.
PubMed: 38922409
DOI: 10.1080/10903127.2024.2370491 -
Diagnostics (Basel, Switzerland) Jun 2024The early management of neonates with meconium ileus (MI) and cystic fibrosis (CF) is highly variable across countries and is not standardized. We conducted a systematic... (Review)
Review
The early management of neonates with meconium ileus (MI) and cystic fibrosis (CF) is highly variable across countries and is not standardized. We conducted a systematic review according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses statement. The protocol was registered in PROSPERO (CRD42024522838). Studies from three providers of academic search engines were checked for inclusion criteria, using the following search terms: meconium ileus AND cystic fibrosis OR mucoviscidosis. Regarding the patient population studied, the inclusion criteria were defined using our predefined PICOT framework: studies on neonates with simple or complicated meconium which were confirmed to have cystic fibrosis and were conservatively managed or surgically treated. Results: A total of 566 publications from the last 10 years were verified by the authors of this review to find the most recent and relevant data, and only 8 met the inclusion criteria. Prenatally diagnosed meconium pseudocysts, bowel dilation, and ascites on ultrasound are predictors of neonatal surgery and risk factor for negative 12-month clinical outcomes in MI-CF newborns. For simple MI, conservative treatment with hypertonic solutions enemas can be effective in more than 25% of cases. If repeated enemas fail to disimpact the bowels, the Bishop-Koop stoma is a safe option. No comprehensive research has been conducted so far to determine the ideal surgical protocol for complicated MI. We only found three studies that reported the types of stomas performed and another study comparing the outcomes of patients depending on the surgical management; the conclusions are contradictory especially since the number of cases analyzed in each study was small. Between 18% and 38% of patients with complicated MI will require reoperation for various complications and the mortality rate varies between 0% and 8%. Conclusion: This study reveals a lack of strong data to support management decisions, unequivocally shows that the care of infants with MI is not standardized, and suggests a great need for international collaborative studies.
PubMed: 38893705
DOI: 10.3390/diagnostics14111179 -
Archives of Dermatological Research Jun 2024Steven Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), grouped together under the terminology of epidermal necrolysis (EN), are a spectrum of... (Review)
Review
Steven Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), grouped together under the terminology of epidermal necrolysis (EN), are a spectrum of life-threatening dermatologic conditions. A lack of standardization and validation for existing endpoints has been identified as a key barrier to the comparison of these therapies and development of evidenced-based treatment. Following PRISMA guidelines, we conducted a systematic review of prospective studies involving systemic or topical treatments for EN, including dressing and ocular treatments. Outcomes were separated into mortality assessment, cutaneous outcomes, non-cutaneous clinical outcomes, and mucosal outcomes. The COSMIN Risk of Bias tool was used to assess the quality of studies on reliability and measurement error of outcome measurement instruments. Outcomes across studies assessing treatment in the acute phase of EN were varied. Most data came from prospective case reports and cohort studies representing the lack of available randomized clinical trial data available in EN. Our search did not reveal any EN-specific validated measures or scoring tools used to assess disease progression and outcomes. Less than half of included studies were considered "adequate" for COSMIN risk of bias in reliability and measurement error of outcome measurement instruments. With little consensus about management and treatment of EN, consistency and validation of measured outcomes is of the upmost importance for future studies to compare outcomes across treatments and identify the most effective means of combating the disease with the highest mortality managed by dermatologists.
Topics: Humans; Stevens-Johnson Syndrome; Reproducibility of Results; Outcome Assessment, Health Care; Treatment Outcome; Bandages
PubMed: 38878166
DOI: 10.1007/s00403-024-03062-5 -
JMIR Biomedical Engineering May 2024In recent years, researchers have delved into the relationship between the anatomy and biomechanics of sacroiliac joint (SIJ) pain and dysfunction in endurance runners...
BACKGROUND
In recent years, researchers have delved into the relationship between the anatomy and biomechanics of sacroiliac joint (SIJ) pain and dysfunction in endurance runners to elucidate the connection between lower back pain and the SIJ. However, the majority of SIJ pain and dysfunction cases are diagnosed and managed through a traditional athlete-clinician arrangement, where the athlete must attend regular in-person clinical appointments with various allied health professionals. Wearable sensors (wearables) are increasingly serving as a clinical diagnostic tool to monitor an athlete's day-to-day activities remotely, thus eliminating the necessity for in-person appointments. Nevertheless, the extent to which wearables are used in a remote setting to manage SIJ dysfunction in endurance runners remains uncertain.
OBJECTIVE
This study aims to conduct a systematic review of the literature to enhance our understanding regarding the use of wearables in both in-person and remote settings for biomechanical-based rehabilitation in SIJ dysfunction among endurance runners. In addressing this issue, the overarching goal was to explore how wearables can contribute to the clinical diagnosis (before, during, and after) of SIJ dysfunction.
METHODS
Three online databases, including PubMed, Scopus, and Google Scholar, were searched using various combinations of keywords. Initially, a total of 4097 articles were identified. After removing duplicates and screening articles based on inclusion and exclusion criteria, 45 articles were analyzed. Subsequently, 21 articles were included in this study. The quality of the investigation was assessed using the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) evidence-based minimum set of items for reporting in systematic reviews.
RESULTS
Among the 21 studies included in this review, more than half of the investigations were literature reviews focusing on wearable sensors in the diagnosis and treatment of SIJ pain, wearable movement sensors for rehabilitation, or a combination of both for SIJ gait analysis in an intelligent health care setting. As many as 4 (19%) studies were case reports, and only 1 study could be classified as fully experimental. One paper was classified as being at the "pre" stage of SIJ dysfunction, while 6 (29%) were identified as being at the "at" stage of classification. Significantly fewer studies attempted to capture or classify actual SIJ injuries, and no study directly addressed the injury recovery stage.
CONCLUSIONS
SIJ dysfunction remains underdiagnosed and undertreated in endurance runners. Moreover, there is a lack of clear diagnostic or treatment pathways using wearables remotely, despite the availability of validated technology. Further research of higher quality is recommended to investigate SIJ dysfunction in endurance runners and explore the use of wearables for rehabilitation in remote settings.
PubMed: 38875697
DOI: 10.2196/46067 -
Drugs & Aging Jun 2024International guidelines discourage antipsychotic use for delirium; however, concerns persist about their continued use in clinical practice.
BACKGROUND
International guidelines discourage antipsychotic use for delirium; however, concerns persist about their continued use in clinical practice.
OBJECTIVES
We aimed to describe the prevalence and patterns of antipsychotic use in delirium management with regard to best-practice recommendations. Primary outcomes investigated were prevalence of use, antipsychotic type, dosage and clinical indication.
METHODS
Eligibility criteria: studies of any design that examined antipsychotic use to manage delirium in adults in critical care, acute care, palliative care, rehabilitation, and aged care were included. Studies of patients in acute psychiatric care, with psychiatric illness or pre-existing antipsychotic use were excluded.
INFORMATION SOURCES
we searched five health databases on 16 August, 2023 (PubMed, CINAHL, Embase, APA PsycInfo, ProQuest Health and Medical Collection) using MeSH terms and relevant keywords, including 'delirium' and 'antipsychotic'. Risk of bias: as no included studies were randomised controlled trials, all studies were assessed for methodological quality using the Mixed Methods Appraisal Tool.
SYNTHESIS OF RESULTS
descriptive data were extracted in Covidence and synthesised in Microsoft Excel.
RESULTS
Included studies: 39 studies published between March 2004 and August 2023 from 13 countries (n = 1,359,519 patients). Most study designs were retrospective medical record audits (n = 16).
SYNTHESIS OF RESULTS
in 18 studies, participants' mean age was ≥65 years (77.79, ±5.20). Palliative care had the highest average proportion of patients with delirium managed with antipsychotics (70.87%, ±33.81%); it was lower and varied little between intensive care unit (53.53%, ±19.73%) and non-intensive care unit settings [medical, surgical and any acute care wards] (56.93%, ±26.44%) and was lowest in in-patient rehabilitation (17.8%). Seventeen different antipsychotics were reported on. In patients aged ≥65 years, haloperidol was the most frequently used and at higher than recommended mean daily doses (2.75 mg, ±2.21 mg). Other antipsychotics commonly administered were olanzapine (mean 11 mg, ±8.54 mg), quetiapine (mean 64.23 mg, ±43.20 mg) and risperidone (mean 0.97 mg, ±0.64 mg).
CONCLUSIONS
The use of antipsychotics to manage delirium is strongly discouraged in international guidelines. Antipsychotic use in delirium care is a risk for adverse health outcomes and a longer duration of delirium, especially in older people. However, this study has provided evidence that clinicians continue to use antipsychotics for delirium management, the dose, frequency and duration of which are often outside evidence-based guideline recommendations. Clinicians continue to choose antipsychotics to manage delirium symptoms to settle agitation and maintain patient and staff safety, particularly in situations where workload pressures are high. Sustained efforts are needed at the individual, team and organisational levels to educate, train and support clinicians to prioritise non-pharmacological interventions early before deciding to use antipsychotics. This could prevent delirium and avert escalation in behavioural symptoms that often lead to antipsychotic use.
Topics: Humans; Delirium; Antipsychotic Agents; Aged; Adult; Hospitals
PubMed: 38856874
DOI: 10.1007/s40266-024-01122-z -
Primary Care Diabetes Jun 2024Multidisciplinary collaborative care has been widely recommended as an effective strategy for managing diabetes; however, the cardiovascular risk factors of patients... (Review)
Review
The effects of multidisciplinary collaborative care on cardiovascular risk factors among patients with diabetes in primary care settings: A systematic review and meta-analysis.
BACKGROUND
Multidisciplinary collaborative care has been widely recommended as an effective strategy for managing diabetes; however, the cardiovascular risk factors of patients with diabetes are often inadequately managed in primary care settings. This study aimed to assess the effect of multidisciplinary collaboration on cardiovascular risk factors among patients with diabetes in primary care settings.
METHODS
Five databases (i.e., Medline, Embase, CINAHL, SCOPUS and CENTRAL) were systematically searched to retrieve randomised controlled trials. Studies were eligible for inclusion if the interventions included a multidisciplinary team with professionals from at least three health disciplines and focused on patients with diabetes in primary care settings. A random-effects model was used to calculate the pooled effects.
RESULTS
In total, 19 studies comprising 6538 patients were included in the meta-analysis. The results showed that compared with usual care, multidisciplinary collaborative care significantly reduced cardiovascular risk factors, including mean systolic blood pressure (-3.27 mm Hg, 95 % confidence interval [CI]: -4.72 to -1.82, p < 0.01), diastolic blood pressure (-1.4 mm Hg, 95 % CI: -2.32 to -0.47, p < 0.01), glycated haemoglobin (-0.42 %, 95 % CI: -0.59 to -0.25, p < 0.01), low-density lipoprotein (-0.16 mmol/L, 95 % CI: -0.26 to -0.06, p < 0.01) and high-density lipoprotein (0.06 mmol/L, 95 % CI: 0.00-0.12, p < 0.05). The subgroup analysis showed multidisciplinary collaboration was more effective in reducing cardiovascular risk factors when it comprised team members from a number of different disciplines, combined pharmacological and non-pharmacological components, included both face-to-face and remote interactions and was implemented in high-income countries.
CONCLUSION
Multidisciplinary collaborative care is associated with reduced cardiovascular risk factors among patients with diabetes in primary care. Further studies need to be conducted to determine the optimal team composition.
PubMed: 38852029
DOI: 10.1016/j.pcd.2024.05.003 -
The Cochrane Database of Systematic... Jun 2024Mental health problems contribute significantly to the overall disease burden worldwide and are major causes of disability, suicide, and ischaemic heart disease. People... (Review)
Review
BACKGROUND
Mental health problems contribute significantly to the overall disease burden worldwide and are major causes of disability, suicide, and ischaemic heart disease. People with bipolar disorder report lower levels of physical activity than the general population, and are at greater risk of chronic health conditions including cardiovascular disease and obesity. These contribute to poor health outcomes. Physical activity has the potential to improve quality of life and physical and mental well-being.
OBJECTIVES
To identify the factors that influence participation in physical activity for people diagnosed with bipolar disorder from the perspectives of service users, carers, service providers, and practitioners to help inform the design and implementation of interventions that promote physical activity.
SEARCH METHODS
We searched MEDLINE, PsycINFO, and eight other databases to March 2021. We also contacted experts in the field, searched the grey literature, and carried out reference checking and citation searching to identify additional studies. There were no language restrictions.
SELECTION CRITERIA
We included qualitative studies and mixed-methods studies with an identifiable qualitative component. We included studies that focused on the experiences and attitudes of service users, carers, service providers, and healthcare professionals towards physical activity for bipolar disorder.
DATA COLLECTION AND ANALYSIS
We extracted data using a data extraction form designed for this review. We assessed methodological limitations using a list of predefined questions. We used the "best fit" framework synthesis based on a revised version of the Health Belief Model to analyse and present the evidence. We assessed methodological limitations using the CASP Qualitative Checklist. We used the GRADE-CERQual (Confidence in the Evidence from Reviews of Qualitative research) guidance to assess our confidence in each finding. We examined each finding to identify factors to inform the practice of health and care professionals and the design and development of physical activity interventions for people with bipolar disorder.
MAIN RESULTS
We included 12 studies involving a total of 592 participants (422 participants who contributed qualitative data to an online survey, 170 participants in qualitative research studies). Most studies explored the views and experiences of physical activity of people with experience of bipolar disorder. A number of studies also reported on personal experiences of physical activity components of lifestyle interventions. One study included views from family carers and clinicians. The majority of studies were from high-income countries, with only one study conducted in a middle-income country. Most participants were described as stable and had been living with a diagnosis of bipolar disorder for a number of years. We downgraded our confidence in several of the findings from high confidence to moderate or low confidence, as some findings were based on only small amounts of data, and the findings were based on studies from only a few countries, questioning the relevance of these findings to other settings. We also had very few perspectives of family members, other carers, or health professionals supporting people with bipolar disorder. The studies did not include any findings from service providers about their perspectives on supporting this aspect of care. There were a number of factors that limited people's ability to undertake physical activity. Shame and stigma about one's physical appearance and mental health diagnosis were discussed. Some people felt their sporting skills/competencies had been lost when they left school. Those who had been able to maintain exercise through the transition into adulthood appeared to be more likely to include physical activity in their regular routine. Physical health limits and comorbid health conditions limited activity. This included bipolar medication, being overweight, smoking, alcohol use, poor diet and sleep, and these barriers were linked to negative coping skills. Practical problems included affordability, accessibility, transport links, and the weather. Workplace or health schemes that offered discounts were viewed positively. The lack of opportunity for exercise within inpatient mental health settings was a problem. Facilitating factors included being psychologically stable and ready to adopt new lifestyle behaviours. There were positive benefits of being active outdoors and connecting with nature. Achieving balance, rhythm, and routine helped to support mood management. Fitting physical activity into a regular routine despite fluctuating mood or motivation appeared to be beneficial if practised at the right intensity and pace. Over- or under-exercising could be counterproductive and accelerate depressive or manic moods. Physical activity also helped to provide a structure to people's daily routines and could lead to other positive lifestyle benefits. Monitoring physical or other activities could be an effective way to identify potential triggers or early warning signs. Technology was helpful for some. People who had researched bipolar disorder and had developed a better understanding of the condition showed greater confidence in managing their care or providing care to others. Social support from friends/family or health professionals was an enabling factor, as was finding the right type of exercise, which for many people was walking. Other benefits included making social connections, weight loss, improved quality of life, and better mood regulation. Few people had been told of the benefits of physical activity. Better education and training of health professionals could support a more holistic approach to physical and mental well-being. Involving mental health professionals in the multidisciplinary delivery of physical activity interventions could be beneficial and improve care. Clear guidelines could help people to initiate and incorporate lifestyle changes.
AUTHORS' CONCLUSIONS
There is very little research focusing on factors that influence participation in physical activity in bipolar disorder. The studies we identified suggest that men and women with bipolar disorder face a range of obstacles and challenges to being active. The evidence also suggests that there are effective ways to promote managed physical activity. The research highlighted the important role that health and care settings, and professionals, can play in assessing individuals' physical health needs and how healthy lifestyles may be promoted. Based on these findings, we have provided a summary of key elements to consider for developing physical activity interventions for bipolar disorder.
Topics: Humans; Bias; Bipolar Disorder; Caregivers; Exercise; Health Personnel; Qualitative Research; Quality of Life; Systematic Reviews as Topic; Meta-Analysis as Topic
PubMed: 38837220
DOI: 10.1002/14651858.CD013557.pub2 -
World Journal of Surgery Jun 2024The aim of this systematic review was to assess the estimated incidence of pseudoaneurysm (PSA) with follow-up computed tomography (CT) for adult splenic injury with...
BACKGROUND
The aim of this systematic review was to assess the estimated incidence of pseudoaneurysm (PSA) with follow-up computed tomography (CT) for adult splenic injury with nonoperative management (NOM).
METHODS
A systematic literature search was conducted in MEDLINE, Central, CINAHL, Clinical Trials, and ICTRP databases between January 1, 2010, and December 31, 2023. Quality assessment was performed using the Risk of Bias in Non-randomized Studies of Exposures (ROBINS-E) tool. Adult splenic injury patients who were initially managed with NOM and followed-up by protocolized CT were included. The primary outcome was the incidence of delayed PSA. Secondary outcome measures were delayed angiography and delayed splenectomy. Subgroup analyses were performed between NOM patients without initial splenic angioembolization (SAE) and NOM patients with initial SAE.
RESULTS
Twelve studies were enrolled, including 11 retrospective studies and one prospective study, with 1746 patients in total. The follow-up CT rate in the included patients was 94.9%. The estimated incidence of PSA was 14% (95% confidence interval (CI), 8%-21%). The estimated delayed angiography and delayed splenectomy incidence rates were 7% (95% CI, 4%-12%) and 2% (95% CI, 1%-6%), respectively. Subgroup analyses showed that the estimated PSA incidence was 12% in NOM patients without initial SAE (95% CI, 7%-20%) and was also 12% in NOM patients with SAE (95% CI, 5%-24%).
CONCLUSIONS
The estimated incidence of delayed PSA after follow-up CT for adult splenic injury with NOM was 14%. The estimated incidence of PSA in NOM with initial SAE was similar to that in NOM without initial SAE.
PubMed: 38831256
DOI: 10.1002/wjs.12238 -
JAMA Network Open Jun 2024Published research suggests that patient-reported outcomes (PROs) are neither commonly collected nor reported in randomized clinical trials (RCTs) for solid tumors....
IMPORTANCE
Published research suggests that patient-reported outcomes (PROs) are neither commonly collected nor reported in randomized clinical trials (RCTs) for solid tumors. Little is known about these practices in RCTs for hematological malignant neoplasms.
OBJECTIVE
To evaluate the prevalence of PROs as prespecified end points in RCTs of hematological malignant neoplasms, and to assess reporting of PROs in associated trial publications.
EVIDENCE REVIEW
All issues of 8 journals known for publishing high-impact RCTs (NEJM, Lancet, Lancet Hematology, Lancet Oncology, Journal of Clinical Oncology, Blood, JAMA, and JAMA Oncology) between January 1, 2018, and December 13, 2022, were searched for primary publications of therapeutic phase 3 trials for adults with hematological malignant neoplasms. Studies that evaluated pretransplant conditioning regimens, graft-vs-host disease treatment, or radiotherapy as experimental treatment were excluded. Data regarding trial characteristics and PROs were extracted from manuscripts and trial protocols. Univariable analyses assessed associations between trial characteristics and PRO collection or reporting.
FINDINGS
Ninety RCTs were eligible for analysis. PROs were an end point in 66 (73%) trials: in 1 trial (1%) as a primary end point, in 50 (56%) as a secondary end point, and in 15 (17%) as an exploratory end point. PRO data were reported in 26 of 66 primary publications (39%): outcomes were unchanged in 18 and improved in 8, with none reporting worse PROs with experimental treatment. Trials sponsored by for-profit entities were more likely to include PROs as an end point (49 of 55 [89%] vs 17 of 35 [49%]; P < .001) but were not significantly more likely to report PRO data (20 of 49 [41%] vs 6 of 17 [35%]; P = .69). Compared with trials involving lymphoma (18 of 29 [62%]) or leukemia or myelodysplastic syndrome (18 of 28 [64%]), those involving plasma cell disorders or multiple myeloma (27 of 30 [90%]) or myeloproliferative neoplasms (3 of 3 [100%]) were more likely to include PROs as an end point (P = .03). Similarly, compared with trials involving lymphoma (3 of 18 [17%]) or leukemia or myelodysplastic syndrome (5 of 18 [28%]), those involving plasma cell disorders or multiple myeloma (16 of 27 [59%]) or myeloproliferative neoplasms (2 of 3 [67%]) were more likely to report PROs in the primary publication (P = .01).
CONCLUSIONS AND RELEVANCE
In this systematic review, almost 3 of every 4 therapeutic RCTs for blood cancers collected PRO data; however, only 1 RCT included PROs as a primary end point. Moreover, most did not report resulting PRO data in the primary publication and when reported, PROs were either better or unchanged, raising concern for publication bias. This analysis suggests a critical gap in dissemination of data on the lived experiences of patients enrolled in RCTs for hematological malignant neoplasms.
Topics: Humans; Patient Reported Outcome Measures; Hematologic Neoplasms; Clinical Trials, Phase III as Topic; Randomized Controlled Trials as Topic
PubMed: 38829615
DOI: 10.1001/jamanetworkopen.2024.14425