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1.
medRxiv ; 2024 Mar 25.
Article in English | MEDLINE | ID: mdl-38585914

ABSTRACT

Background: Randomised controlled trials (RCTs) inform healthcare decisions. Unfortunately, some published RCTs contain false data, and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs which have been conducted on a given topic. This means that any of these 'problematic studies' are likely to be included, but there are no agreed methods for identifying them. The INSPECT-SR project is developing a tool to identify problematic RCTs in systematic reviews of healthcare-related interventions. The tool will guide the user through a series of 'checks' to determine a study's authenticity. The first objective in the development process is to assemble a comprehensive list of checks to consider for inclusion. Methods: We assembled an initial list of checks for assessing the authenticity of research studies, with no restriction to RCTs, and categorised these into five domains: Inspecting results in the paper; Inspecting the research team; Inspecting conduct, governance, and transparency; Inspecting text and publication details; Inspecting the individual participant data. We implemented this list as an online survey, and invited people with expertise and experience of assessing potentially problematic studies to participate through professional networks and online forums. Participants were invited to provide feedback on the checks on the list, and were asked to describe any additional checks they knew of, which were not featured in the list. Results: Extensive feedback on an initial list of 102 checks was provided by 71 participants based in 16 countries across five continents. Fourteen new checks were proposed across the five domains, and suggestions were made to reword checks on the initial list. An updated list of checks was constructed, comprising 116 checks. Many participants expressed a lack of familiarity with statistical checks, and emphasized the importance of feasibility of the tool. Conclusions: A comprehensive list of trustworthiness checks has been produced. The checks will be evaluated to determine which should be included in the INSPECT-SR tool.

3.
CMAJ ; 196(9): E282-E294, 2024 Mar 10.
Article in English | MEDLINE | ID: mdl-38467416

ABSTRACT

BACKGROUND: Adult survivors of childhood cancer are at elevated risk of morbidity and mortality compared to the general population, but their adherence to lifelong periodic surveillance is suboptimal. We aimed to examine adherence to surveillance guidelines for high-yield tests and identify risk factors for nonadherence in adult survivors of childhood cancer. METHODS: In this retrospective, population-based cohort study, we used health care administrative data from Ontario, Canada, to identify adult survivors of childhood cancer diagnosed between 1986 and 2014 who were at elevated risk of therapy-related colorectal cancer, breast cancer, or cardiomyopathy. Using a Poisson regression framework, we assessed longitudinal adherence and predictors of adherence to the Children's Oncology Group surveillance guideline. RESULTS: Among 3241 survivors, 327 (10%), 234 (7%), and 3205 (99%) were at elevated risk for colorectal cancer, breast cancer, and cardiomyopathy, respectively. Within these cohorts, only 13%, 6%, and 53% were adherent to recommended surveillance as of February 2020. During a median follow-up of 7.8 years, the proportion of time spent adherent was 14% among survivors at elevated risk for colorectal cancer, 10% for breast cancer, and 43% for cardiomyopathy. Significant predictors of adherence varied across the risk groups, but higher comorbidity was associated with adherence to recommended surveillance. INTERPRETATION: Survivors of childhood cancer in Ontario are rarely up to date for recommended surveillance tests. Tailored interventions beyond specialized clinics are needed to improve surveillance adherence.


Subject(s)
Breast Neoplasms , Cancer Survivors , Cardiomyopathies , Colorectal Neoplasms , Adult , Humans , Child , Female , Retrospective Studies , Cohort Studies , Survivors , Breast Neoplasms/epidemiology , Breast Neoplasms/therapy , Breast Neoplasms/diagnosis , Disease Progression , Ontario/epidemiology , Colorectal Neoplasms/epidemiology , Colorectal Neoplasms/therapy , Colorectal Neoplasms/diagnosis
4.
BMJ Open Gastroenterol ; 11(1)2024 Mar 22.
Article in English | MEDLINE | ID: mdl-38519049

ABSTRACT

INTRODUCTION: In liver cirrhosis, acute variceal bleeding (AVB) is associated with a 1-year mortality rate of up to 40%. Data on early or pre-emptive transjugular intrahepatic portosystemic stent-shunt (TIPSS) in AVB is inconclusive and may not reflect current management strategies. Randomised controlled trial of EArly transjugular intrahepatiC porTosystemic stent-shunt in AVB (REACT-AVB) aims to investigate the clinical and cost-effectiveness of early TIPSS in patients with cirrhosis and AVB after initial bleeding control. METHODS AND ANALYSIS: REACT-AVB is a multicentre, randomised controlled, open-label, superiority, two-arm, parallel-group trial with an internal pilot. The two interventions allocated randomly 1:1 are early TIPSS within 4 days of diagnostic endoscopy or secondary prophylaxis with endoscopic therapy in combination with non-selective beta blockers. Patients aged ≥18 years with cirrhosis and Child-Pugh Score 7-13 presenting with AVB with endoscopic haemostasis are eligible for inclusion. The primary outcome is transplant-free survival at 1 year post randomisation. Secondary endpoints include transplant-free survival at 6 weeks, rebleeding, serious adverse events, other complications of cirrhosis, Child-Pugh and Model For End-Stage Liver Disease (MELD) scores at 6 and 12 months, health-related quality of life, use of healthcare resources, cost-effectiveness and use of cross-over therapies. The sample size is 294 patients over a 4-year recruitment period, across 30 hospitals in the UK. ETHICS AND DISSEMINATION: Research ethics committee of National Health Service has approved REACT-AVB (reference number: 23/WM/0085). The results will be submitted for publication in a peer-reviewed journal. A lay summary will also be emailed or posted to participants before publication. TRIAL REGISTRATION NUMBER: ISRCTN85274829; protocol version 3.0, 1 July 2023.


Subject(s)
End Stage Liver Disease , Esophageal and Gastric Varices , Portasystemic Shunt, Transjugular Intrahepatic , Humans , Adolescent , Adult , Portasystemic Shunt, Transjugular Intrahepatic/adverse effects , Esophageal and Gastric Varices/complications , Esophageal and Gastric Varices/surgery , Quality of Life , State Medicine , Gastrointestinal Hemorrhage/surgery , Gastrointestinal Hemorrhage/etiology , Severity of Illness Index , Liver Cirrhosis/complications , Liver Cirrhosis/surgery , Stents/adverse effects , Randomized Controlled Trials as Topic , Multicenter Studies as Topic
5.
BMJ Open ; 14(3): e084164, 2024 Mar 11.
Article in English | MEDLINE | ID: mdl-38471680

ABSTRACT

INTRODUCTION: Randomised controlled trials (RCTs) inform healthcare decisions. It is now apparent that some published RCTs contain false data and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs that have been conducted on a given topic. While it is usual to assess methodological features of the RCTs in the process of undertaking a systematic review, it is not usual to consider whether the RCTs contain false data. Studies containing false data therefore go unnoticed and contribute to systematic review conclusions. The INveStigating ProblEmatic Clinical Trials in Systematic Reviews (INSPECT-SR) project will develop a tool to assess the trustworthiness of RCTs in systematic reviews of healthcare-related interventions. METHODS AND ANALYSIS: The INSPECT-SR tool will be developed using expert consensus in combination with empirical evidence, over five stages: (1) a survey of experts to assemble a comprehensive list of checks for detecting problematic RCTs, (2) an evaluation of the feasibility and impact of applying the checks to systematic reviews, (3) a Delphi survey to determine which of the checks are supported by expert consensus, culminating in, (4) a consensus meeting to select checks to be included in a draft tool and to determine its format and (5) prospective testing of the draft tool in the production of new health systematic reviews, to allow refinement based on user feedback. We anticipate that the INSPECT-SR tool will help researchers to identify problematic studies and will help patients by protecting them from the influence of false data on their healthcare. ETHICS AND DISSEMINATION: The University of Manchester ethics decision tool was used, and this returned the result that ethical approval was not required for this project (30 September 2022), which incorporates secondary research and surveys of professionals about subjects relating to their expertise. Informed consent will be obtained from all survey participants. All results will be published as open-access articles. The final tool will be made freely available.


Subject(s)
Evidence-Based Medicine , Research Design , Humans , Consensus , Evidence-Based Medicine/methods , Informed Consent , Randomized Controlled Trials as Topic , Systematic Reviews as Topic
6.
Implement Sci ; 19(1): 19, 2024 Feb 23.
Article in English | MEDLINE | ID: mdl-38395903

ABSTRACT

BACKGROUND: Childhood cancer treatment while often curative, leads to elevated risks of morbidity and mortality. Survivors require lifelong periodic surveillance for late effects of treatment, yet adherence to guideline-recommended tests is suboptimal. We created ONLOOP to provide adult survivors of childhood cancer with detailed health information, including summaries of their childhood cancer treatment and recommended surveillance tests for early detection of cardiomyopathy, breast cancer, and/or colorectal cancer, with personalized reminders over time. METHODS: This is an individually randomized, registry-based pragmatic trial with an embedded process and economic evaluation to understand ONLOOP's impact and whether it can be readily implemented at scale. All adult survivors of childhood cancer in Ontario overdue for guideline-recommended tests will be randomly assigned to one of two arms: (1) intervention or (2) delayed intervention. A letter of information and invitation will detail the ONLOOP program. Those who sign up will receive a personalized toolkit and a screening reminder 6 months later. With the participants' consent, ONLOOP will also send their primary care clinician a letter detailing the recommended tests and a reminder 6 months later. The primary outcome will be the proportion of survivors who complete one or more of the guideline-recommended cardiac, breast, or colon surveillance tests during the 12 months after randomization. Data will be obtained from administrative databases. The intent-to-treat principle will be followed. Based on our analyses of administrative data, we anticipate allocating at least 862 individuals to each trial arm, providing 90% power to detect an absolute increase of 6% in targeted surveillance tests completed. We will interview childhood cancer survivors and family physicians in an embedded process evaluation to examine why and how ONLOOP achieved success or failed. A cost-effectiveness evaluation will be performed. DISCUSSION: The results of this study will determine if ONLOOP is effective at helping adult survivors of childhood cancer complete their recommended surveillance tests. This study will also inform ongoing provincial programs for this high-risk population. TRIAL REGISTRATION: ClinicalTrials.gov NCT05832138.


Subject(s)
Breast Neoplasms , Cancer Survivors , Adult , Humans , Child , Female , Ontario , Early Detection of Cancer , Survivors , Breast Neoplasms/diagnosis , Randomized Controlled Trials as Topic
7.
Article in English | MEDLINE | ID: mdl-38191778

ABSTRACT

OBJECTIVE: To pragmatically assess the clinical and cost-effectiveness of water fluoridation for preventing dental treatment and improving oral health in a contemporary population of adults and adolescents, using a natural experiment design. METHODS: A 10-year retrospective cohort study (2010-2020) using routinely collected NHS dental treatment claims data. Participants were patients aged 12 years and over, attending NHS primary dental care services in England (17.8 million patients). Using recorded residential locations, individuals exposed to drinking water with an optimal fluoride concentration (≥0.7 mg F/L) were matched to non-exposed individuals using propensity scores. Number of NHS invasive dental treatments, DMFT and missing teeth were compared between groups using negative binomial regression. Total NHS dental treatment costs and cost per invasive dental treatment avoided were calculated. RESULTS: Matching resulted in an analytical sample of 6.4 million patients. Predicted mean number of invasive NHS dental treatments (restorations 'fillings'/extractions) was 3% lower in the optimally fluoridated group (5.4) than the non-optimally fluoridated group (5.6) (IRR 0.969, 95% CI 0.967, 0.971). Predicted mean DMFT was 2% lower in the optimally fluoridated group (IRR 0.984, 95% CI 0.983, 0.985). There was no difference in the predicted mean number of missing teeth per person (IRR 1.001, 95% CI 0.999, 1.003) and no compelling evidence that water fluoridation reduced social inequalities in dental health. Optimal water fluoridation in England 2010-2020 was estimated to cost £10.30 per person (excludes initial set-up costs). NHS dental treatment costs for optimally fluoridated patients 2010-2020 were 5.5% lower, by £22.26 per person (95% CI -£21.43, -£23.09). CONCLUSIONS: Receipt of optimal water fluoridation 2010-2020 resulted in very small positive health effects which may not be meaningful for individuals. Existing fluoridation programmes in England produced a positive return on investment between 2010 and 2020 due to slightly lower NHS dental care utilization. This return should be evaluated against the projected costs and lifespan of any proposed capital investment in water fluoridation, including new programmes.

8.
Nat Med ; 29(12): 3259-3267, 2023 Dec.
Article in English | MEDLINE | ID: mdl-38066209

ABSTRACT

Research participants often do not represent the general population. Systematic exclusion of particular groups from research limits the generalizability of research findings and perpetuates health inequalities. Groups considered underserved by research include those whose inclusion is lower than expected based on population estimates, those with a high healthcare burden but limited research participation opportunities and those whose healthcare engagement is less than others. The REP-EQUITY toolkit guides representative and equitable inclusion in research. The toolkit was developed through a methodological systematic review and synthesis and finalized in a consensus workshop with 24 participants. The REP-EQUITY toolkit describes seven steps for investigators to consider in facilitating representative and equitable sample selection. This includes clearly defining (1) the relevant underserved groups, (2) the aims relating to equity and representativeness, (3) the sample proportion of individuals with characteristics associated with being underserved by research, (4) the recruitment goals, (5) the strategies by which external factors will be managed, (6) the methods by which representation in the final sample will be evaluated and (7) the legacy of having used the toolkit. Using the REP-EQUITY toolkit could promote trust between communities and research institutions, increase diverse participation in research and improve the generalizability of health research. National Institute for Health and Care Research PROSPERO identifier: CRD42022355391.


Subject(s)
Delivery of Health Care , Research Design , Humans
9.
medRxiv ; 2023 Nov 13.
Article in English | MEDLINE | ID: mdl-37873409

ABSTRACT

Introduction: Randomised controlled trials (RCTs) inform healthcare decisions. It is now apparent that some published RCTs contain false data and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs that have been conducted on a given topic. While it is usual to assess methodological features of the RCTs in the process of undertaking a systematic review, it is not usual to consider whether the RCTs contain false data. Studies containing false data therefore go unnoticed and contribute to systematic review conclusions. The INSPECT-SR project will develop a tool to assess the trustworthiness of RCTs in systematic reviews of healthcare related interventions. Methods and analysis: The INSPECT-SR tool will be developed using expert consensus in combination with empirical evidence, over five stages: 1) a survey of experts to assemble a comprehensive list of checks for detecting problematic RCTs, 2) an evaluation of the feasibility and impact of applying the checks to systematic reviews, 3) a Delphi survey to determine which of the checks are supported by expert consensus, culminating in 4) a consensus meeting to select checks to be included in a draft tool and to determine its format, 5) prospective testing of the draft tool in the production of new health systematic reviews, to allow refinement based on user feedback. We anticipate that the INSPECT-SR tool will help researchers to identify problematic studies, and will help patients by protecting them from the influence of false data on their healthcare.

10.
J Med Imaging Radiat Sci ; 54(4): 611-619, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37718151

ABSTRACT

BACKGROUND: Time is a valuable commodity that impacts hospital flow, patient experience and economic resources. This study aims to identify factors that affect daily treatment time over a course of radiation therapy (RT) in patients who underwent adjuvant breast RT. METHODS: In all adjuvant breast/chestwall RT patients treated from October 2017 to May 2018, daily set-up, beam delivery time, and overall treatment times were collected. A multivariable linear regression analysis was conducted to identify significant predictive factors related to treatment time. A general linear regression model was used to determine whether there was a learning curve effect throughout the course of treatment that decreased treatment time as patient and staff familiarity with the treatment procedure increased. RESULTS: A total of 567 patients were included with a median age of 61 years. The average overall treatment time for 2-field and 4-field RT was 8.3 (SD 2.4) and 13.1 (SD 5.6) minutes, respectively. Factors that significantly increased overall treatment times in patients prescribed 2-field RT were: bilateral techniques, breath-hold (BH) techniques, prone techniques (PR), reverse decubitus techniques (RD), wide tangents techniques, the use of bolus and number of segments delivered. (p < 0.05). Factors that significantly increased overall treatment times in patients who received 3-field and 4-field RT were: wide tangents volumes, a higher number of monitor units (MUs), bilateral techniques and BH techniques (p < 0.05). Older patients (≥60) who underwent 3-field and 4-field RT demonstrated a statistically significant increase in set-up time (p < 0.0001). Overall treatment time decreased from 10.0 to 9.3 min over the course of treatment, suggesting a minor learning curve (p = 0.009). CONCLUSION: The use of bilateral RT, BH, PR, RD, wide tangents, bolus, increasing treatment volumes, and increasing plan complexity were associated with increased treatment times. Future research should quantify the impact of other factors (BMI, mobility, patient care assessments, and imaging protocols) and utility of technological tools (time-predicting models, machine learning tools, and operations research models) on treatment time to optimize RT scheduling and improve resource management.


Subject(s)
Neoplasms , Humans , Middle Aged , Ontario , Radiotherapy, Adjuvant , Breath Holding , Time Factors
11.
Pediatr Blood Cancer ; : e30534, 2023 Jun 30.
Article in English | MEDLINE | ID: mdl-37391864

ABSTRACT

BACKGROUND: Approximately 70% of children diagnosed with a medulloblastoma will become long-term survivors. Medulloblastoma therapy frequently causes long-term morbidities in survivors, which places a considerable burden on parental caregivers. We aimed to explore the experience of parental caregivers caring for medulloblastoma survivors. METHODS: We conducted a qualitative study using grounded theory thematic analysis. We used semi-structured parental caregiver interviews to explore family experiences, social circumstances, and family-reported impact within families of children who had survived medulloblastoma. Parental caregivers were recruited from specialized survivor clinics at two large quaternary centers in Toronto, Canada. RESULTS: Sixteen of 22 eligible families participated, and 20 parental caregiver interviews were completed. Survivors were a median age of 6 years (range: 1-9 years) at diagnosis, and were 9.5 years (range: 5-12 years) from treatment at the time of the interview. Three major themes and associated subthemes emerged: (i) parental caregivers described significant long-term challenges associated with their child's survivorship. Subthemes included medical treatment sequelae, school issues and behavioral concerns, and surveillance and access to care. (ii) Parental caregivers recognized the impact that their child's quality of life (QOL) had on both their personal and family QOL. Subthemes included parental QOL, parental mental health and coping, spousal relationships, and effects on the family unit as a whole. (iii) Parental caregivers reported experiencing conflicting emotions related to their child's survivorship status and long-term effects. Subthemes included feeling happiness with concurrent worry, fear, and stress, as well as concerns about the future. CONCLUSIONS: Parental caregivers of medulloblastoma survivors experience long-term challenges, with personal and family impacts. Further work is needed to improve care models and support systems for families with a child who has survived medulloblastoma.

13.
Curr Diab Rep ; 23(8): 207-216, 2023 Aug.
Article in English | MEDLINE | ID: mdl-37284921

ABSTRACT

PURPOSE OF REVIEW: Multiple studies report an increased incidence of diabetes following SARS-CoV-2 infection. Given the potential increased global burden of diabetes, understanding the effect of SARS-CoV-2 in the epidemiology of diabetes is important. Our aim was to review the evidence pertaining to the risk of incident diabetes after COVID-19 infection. RECENT FINDINGS: Incident diabetes risk increased by approximately 60% compared to patients without SARS-CoV-2 infection. Risk also increased compared to non-COVID-19 respiratory infections, suggesting SARS-CoV-2-mediated mechanisms rather than general morbidity after respiratory illness. Evidence is mixed regarding the association between SARS-CoV-2 infection and T1D. SARS-CoV-2 infection is associated with an elevated risk of T2D, but it is unclear whether the incident diabetes is persistent over time or differs in severity over time. SARS-CoV-2 infection is associated with an increased risk of incident diabetes. Future studies should evaluate vaccination, viral variant, and patient- and treatment-related factors that influence risk.


Subject(s)
COVID-19 , Diabetes Mellitus , Humans , SARS-CoV-2 , Diabetes Mellitus/epidemiology , Incidence
15.
Support Care Cancer ; 31(4): 236, 2023 Mar 27.
Article in English | MEDLINE | ID: mdl-36971851

ABSTRACT

BACKGROUND AND PURPOSE: Patients undergoing radiotherapy (RT) for breast cancer may receive adjuvant or neoadjuvant chemotherapy prior to the initiation of RT treatment. In the present study, baseline Edmonton Symptom Assessment System (ESAS) scores of patients who received neoadjuvant and adjuvant chemotherapy were collected prior to RT and compared to assess the association of each chemotherapy intent with pre-RT symptom burden. MATERIAL AND METHODS: The ESAS and Patient-Reported Functional Status (PRFS) tools were used to collect patient-reported symptoms at baseline. Patient and treatment-related factors were collected prospectively from February 2018 to September 2020. Univariate general linear regression analysis was applied to compare baseline scores between adjuvant and neoadjuvant chemotherapy patients. RESULTS: A total of 338 patients were included for analysis. Comparison of baseline ESAS scores revealed that patients who received adjuvant chemotherapy were more likely to report higher scores, reflecting higher symptom burden, compared to patients receiving neoadjuvant chemotherapy, including tiredness (p = 0.005), lack of appetite (p = 0.0005), shortness of breath (p < 0.0001), and PRFS (p = 0.012). CONCLUSION: This study suggests an association between patients who have received adjuvant chemotherapy for breast cancer and higher RT baseline ESAS scores when compared to patients who received neoadjuvant chemotherapy. Due to these findings, considerations should be made by healthcare providers of the symptom burden during RT for patients who receive adjuvant chemotherapy.


Subject(s)
Breast Neoplasms , Radiation Oncology , Humans , Female , Breast Neoplasms/drug therapy , Breast Neoplasms/diagnosis , Neoadjuvant Therapy , Symptom Assessment , Chemotherapy, Adjuvant
16.
J Med Imaging Radiat Sci ; 54(2): 281-290, 2023 06.
Article in English | MEDLINE | ID: mdl-36804014

ABSTRACT

BACKGROUND AND PURPOSE: As breast cancer radiotherapy (RT) has been shown to give rise to adverse pulmonary outcomes, such as radiation pneumonitis, trends in patient-reported shortness of breath (SOB) associated with RT were investigated. Adjuvant RT is commonly administered for local and/or regional control of breast cancer and was therefore included. METHODS: The Edmonton Symptom Assessment System (ESAS) was used to observe changes in SOB during RT, up to 6 weeks after RT completion, and one to three months post-RT. Patients with at least one completed ESAS were included in the analysis. Generalized linear regression analysis was performed to identify associations between demographic factors and SOB. RESULTS: A total of 781 patients were included in the analysis. There was a significant association between ESAS SOB scores and adjuvant chemotherapy when compared to neoadjuvant chemotherapy (p=0.0012). Meanwhile, loco-regional RT had no significant impact on ESAS SOB scores in comparison to local RT. SOB scores were stable over time (p>0.05) from baseline to follow-up appointments. CONCLUSION: The findings of this study suggest that RT was not associated with changes in SOB from baseline to 3 months post-RT. However, patients who underwent adjuvant chemotherapy reported significant higher SOB scores over time. Additional research is recommended to analyze the lasting effects of adjuvant breast cancer RT on SOB during physical activity.


Subject(s)
Breast Neoplasms , Humans , Female , Breast Neoplasms/radiotherapy , Breast Neoplasms/diagnosis , Radiotherapy, Adjuvant , Breast , Dyspnea/etiology , Patient Reported Outcome Measures
17.
J Racial Ethn Health Disparities ; 10(5): 2588-2599, 2023 10.
Article in English | MEDLINE | ID: mdl-36329308

ABSTRACT

Asian American, Native Hawaiians, and Other Pacific Islander (AANHPI) populations experience significant disparities in cardiovascular health. AANHPI populations also have strong, family-centered social relationships and networks. Since social networks may influence health behaviors, this review aimed to summarize research on the relationship between family social networks and cardiovascular health behaviors among AANHPI individuals. Current evidence suggests that family social network structures may play a particularly important role in smoking, dietary pattern, and physical activity behaviors among AANHPI individuals. Family networks may hinder or promote healthy behaviors through several social network mechanisms including social support, social influence, and social control. These effects vary across different AANHPI subgroups. Recommendations for future research on the role of social networks in health behaviors among AANHPI individuals are provided. Drawing on methodological advances and interventions that leverage social networks in AANHPI populations may be an avenue to improve health and reduce disparities.


Subject(s)
Asian , Native Hawaiian or Other Pacific Islander , Humans , Pacific Island People , Health Behavior , Social Networking
18.
J Clin Oncol ; 41(6): 1250-1264, 2023 02 20.
Article in English | MEDLINE | ID: mdl-36493331

ABSTRACT

PURPOSE: Radiation dermatitis (RD) is common in patients undergoing breast radiotherapy. Mepitel film (MF) can reduce RD, but the results from two randomized controlled trials are conflicting. We aimed to conduct a confirmatory randomized controlled trial in patients at risk of RD. METHODS: Patients were randomly assigned to receive MF or standard care (2:1 ratio). Patients with large breasts after lumpectomy (bra size ≥ 36 inches or cup size ≥ C) or after mastectomy were eligible. Stratification factors included surgery type, dose fractionation, and administration of boost/bolus. The primary end point was grade (G) 2 or 3 RD using the Common Terminology Criteria for Adverse Events v5.0. Secondary end points included patient- and clinician-reported outcomes. RESULTS: Between January 2020 and May 2022, 376 patients were included in the modified intention-to-treat analysis. The incidence of G2 or 3 RD was significantly lower in MF patients compared with standard care (n = 39/251, 15.5%; 95% CI, 11.3 to 20.6% v n = 57/125, 45.6%; 95% CI, 36.7 to 54.8% respectively, odds ratio (OR): 0.20, P < .0001). Benefits of MF remained significant in patients who developed G 3 RD (n = 7, 2.8%; 95% CI, 1.1 to 5.7% v n = 17, 13.6%; 95% CI, 8.1 to 20.9%, OR: 0.19) and moist desquamation (n = 20, 8.0%; 95% CI, 4.9 to 12.0% v n = 24, 19.2%; 95% CI, 12.7 to 27.1%, OR: 0.36). When evaluating the combined patient and health care provider score using Radiation-Induced Skin Reaction Assessment Scale, the MF arm had significantly lower scores (P < .0001). Individual items on the Radiation-Induced Skin Reaction Assessment Scale also favored the MF for both patient- and clinician-reported outcomes. Blistering/peeling, erythema, pigmentation, and edema were significantly reduced in the MF arm. Three patients removed the film prematurely because of rash (n = 2) and excessive pruritus (n = 1). CONCLUSION: MF significantly reduces RD in patients undergoing breast radiotherapy.


Subject(s)
Breast Neoplasms , Radiodermatitis , Humans , Female , Breast Neoplasms/radiotherapy , Breast Neoplasms/surgery , Breast Neoplasms/complications , Mastectomy/adverse effects , Radiodermatitis/etiology , Radiodermatitis/prevention & control , Silicones , Randomized Controlled Trials as Topic
19.
Phys Ther Sport ; 59: 103-114, 2023 Jan.
Article in English | MEDLINE | ID: mdl-36528003

ABSTRACT

OBJECTIVE: This review explores the literature on multi-domain assessments used in concussion recovery, to inform evidence-based and ecologically valid return-to-play. It asks: What simultaneous, dynamic multi-domain paradigms are used to assess recovery of youth and adults following concussion? METHODS: Five databases were searched (CINAHL, EMBASE, MEDLINE, PsycInfo, SPORTDiscus) until September 30, 2021. Records were limited to those published in peer-reviewed journals, in English, between 2002 and 2021. Included studies were required to describe the assessment of concussion recovery using dynamic paradigms (i.e., requiring sport-like coordination) spanning multiple domains (i.e., physical, cognitive, socio-emotional functioning) simultaneously. RESULTS: 7098 unique articles were identified. 64 were included for analysis, describing 36 unique assessments of 1938 concussed participants. These assessments were deconstructed into their constituent tasks: 13 physical, 17 cognitive, and one socio-emotional. Combinations of these "building blocks" formed the multi-domain assessments. Forty-six studies implemented level walking with a concurrent cognitive task. The most frequently implemented cognitive tasks were 'Q&A' paradigms requiring participants to answer questions aloud during a physical task. CONCLUSIONS: A preference emerged for dual-task assessments, specifically combinations of level walking and Q&A tasks. Future research should balance ecological validity and clinical feasibility in multi-domain assessments, and work to validate these assessments for practice.


Subject(s)
Athletic Injuries , Brain Concussion , Military Personnel , Sports , Adolescent , Humans , Athletic Injuries/diagnosis , Brain Concussion/diagnosis , Physical Examination
20.
Clin Obstet Gynecol ; 66(1): 4-13, 2023 03 01.
Article in English | MEDLINE | ID: mdl-36162089

ABSTRACT

In the U.S., disparities in the healthcare workforce have led to inadequate health outcomes in communities of historically underserved groups. To address the lack of resources and opportunities in health career education for historically underserved group students, Project MED was established. The mission is to expose high school students to the breadth of opportunities in the healthcare field and to prepare students for successful careers in healthcare. Through 3 main pillars-Learn, Lead, and Launch-Project MED has developed a robust repository of 20 workshops, recruited and trained eight mentors, and curated a database of ≥100 opportunities for over 50 students.


Subject(s)
Medicine , Minority Groups , Humans , Delivery of Health Care , Minority Groups/education , Technology
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