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Breast Cancer Research and Treatment Dec 2023Adequate reporting of data specific to older populations enrolled to breast cancer trials is critical, given the high incidence of the disease among this demographic.... (Review)
Review
INTRODUCTION
Adequate reporting of data specific to older populations enrolled to breast cancer trials is critical, given the high incidence of the disease among this demographic. This study aimed to examine the completeness of reporting of older subgroups among patients recruited to registration clinical trials investigating systemic treatments for breast cancer.
METHODS
Clinical trials leading to a US food and drug administration (FDA) approval in breast cancer between 2012 and 2021 were included. Primary study reports and and all available secondary publications were systematically and objectively assessed with regard to the availability of data regarding efficacy, baseline characteristics, safety, and health-related quality of life (HRQOL) outcomes among older subgroups.
RESULTS
27 trials and 216 publications were assessed. 20.3% of patients were aged ≥65. 70.0% of patients had an eastern cooperative oncology group (ECOG) performance status of 0. Although complete reporting of primary endpoints was adequate (72.7%), most protocol-defined primary endpoints were surrogate endpoints (84.8%). Overall survival data among older populations was unavailable in 50.0% of studies. Reporting was poor for secondary efficacy endpoints (81.8% unreported), baseline characteristics (70.4% unreported), toxicity (55.6% unreported), and health-related quality of life outcomes (87.5% unreported).
CONCLUSION
The findings underline significant deficits in the reporting of age-specific data in breast cancer registration trials. The underreporting of key efficacy, safety, and HRQOL outcomes highlights the need for mandatory reporting standards and a dedicated emphasis on older populations' priorities and needs in the reporting of registration clinical trials.
Topics: Humans; Female; Breast Neoplasms; Quality of Life
PubMed: 37665474
DOI: 10.1007/s10549-023-07081-0 -
Communicable Diseases Intelligence... Aug 2023We analysed Australian Immunisation Register (AIR) data as at 3 April 2022 for children, adolescents and adults for the calendar year 2021, with data on trends from...
INTRODUCTION
We analysed Australian Immunisation Register (AIR) data as at 3 April 2022 for children, adolescents and adults for the calendar year 2021, with data on trends from previous years also presented.
CHILDREN
'Fully vaccinated' coverage in Australian children in 2021 was 0.6-0.8 of a percentage point lower than in 2020 at the 12-month (94.2%) and 60-month (94.0%) age assessment milestones, but stable at the 24-month milestone (92.1%). Due to the lag time involved in assessment at milestone ages, 'fully vaccinated' coverage figures for 2020 and 2021 predominantly reflect vaccinations due in 2019 and 2020, respectively, and hence show a small impact on childhood coverage in the first year of the coronavirus disease 2019 (COVID-19) pandemic. 'Fully vaccinated' coverage in Aboriginal and Torres Strait Islander (hereafter respectfully referred to as Indigenous) children was 0.7-1.5 percentage points lower in 2021 than 2020 at the 12-month (91.6%), 24-month (90.1%) and 60-month (96.3%) milestones, although 2.3 percentage points higher than children overall at 60 months. Influenza vaccination coverage in children aged 6-59 months was approximately 20 percentage points lower in 2021 than 2020, both for children overall (26.5%) and for Indigenous children (22.5%). 'On time' vaccination (within 30 days of the recommended age) was up to two percentage points lower in 2021 than 2020 for vaccines due at 4 and 6 months of age, suggesting possible pandemic impacts, but was similar or higher for vaccines due at 12 months of age. While on-time vaccination in Indigenous children has improved progressively since 2012, it remained 6-13 percentage points lower than in children overall in 2021. 'Fully vaccinated' coverage at the earlier milestones (3 months after due date of last scheduled vaccine) of 9, 15, 21 and 51 months was 1.5-2.8 percentage points lower for children living in the least advantaged residential area quintile than the most advantaged, a similar disparity as in 2020. Coverage at the earlier milestones was 2.3-10.0 percentage points lower for Indigenous children living in remote areas than in major cities and regional areas, with disparity at 21 months of age 2.1-2.2 percentage points higher in 2021 than in 2020, and 1.2-2.1 percentage points higher at 51 months.
ADOLESCENTS
In 2021, a total of 80.3% of girls and 77.2% of boys (and 73.3% and 66.2% of Indigenous girls and boys) had completed the human papillomavirus (HPV) vaccination schedule by 15 years of age, 0.2-0.4 of a percentage point lower than 2020 (1.7-1.8 percentage points for Indigenous), reflecting vaccinations due in school programs prior to the pandemic with possible pandemic impact on catch-up vaccination. However, the proportion of adolescents completing the two-dose HPV vaccination schedule within a calendar year was 15.3 percentage points lower in 2021 than 2020 and 26.9 percentage points lower than in 2019, likely due to pandemic-related disruption to school-based programs. Additionally, 87.3% of adolescents (83.8% for Indigenous) had received the recommended booster dose of diphtheria-tetanus-acellular pertussis (dTpa) vaccine by 15 years, and 76.1% (66.7% for Indigenous) the recommended meningococcal ACWY vaccine dose by 17 years of age.
ADULTS
Zoster vaccine coverage in 2021 remained relatively low, at just over 30%, in adults aged 70 years, but increased to 47% in those aged 71-79 years, reflecting ongoing catch-up vaccination. Coverage of 13vPCV was low in 2021, reaching 17.2% in adults aged 70 years and 20.1% in those aged 71-79 years. Influenza vaccination coverage in adults in 2021 was progressively higher with increasing age, reaching 62.1% in the 65-74 years age group (64.6% in Indigenous) and 68.5% in the 75+ years age group (67.7% in Indigenous). Influenza vaccine coverage for other National Immunisation Program (NIP)-eligible Indigenous adult age groups was only 22.0% for those aged 20-49 years, and 43.5% for those aged 50-64 years. By the end of 2021, a total of 91.6% of people in Australia aged 16+ years had received a second dose of a COVID-19 vaccine (71.8% for Indigenous), with over 99% of those aged 70+ years having received a second dose.
CONCLUSIONS
Vaccination coverage in children and adolescents remained relatively high in 2021, although with some evidence of COVID-19 pandemic impacts, particularly on receipt of two doses of HPV vaccine within the same calendar year. It will be important to ensure catch-up vaccination in children and adolescents occurs. A strengthened focus on adult vaccination is needed, as coverage remained suboptimal in 2021. The impact of mandatory reporting of all NIP vaccinations from mid-2021, on completeness of AIR data, has not yet been formally evaluated.
Topics: Child; Adult; Male; Adolescent; Female; Humans; Infant; Aged; Vaccination Coverage; Papillomavirus Infections; COVID-19 Vaccines; Influenza, Human; Pandemics; Australia; Influenza Vaccines; Papillomavirus Vaccines; COVID-19
PubMed: 37817316
DOI: 10.33321/cdi.2023.47.47 -
The Lancet. Infectious Diseases Mar 2024Non-timely reporting, selective reporting, or non-reporting of clinical trial results are prevalent and serious issues. WHO mandates that summary results be available in... (Review)
Review
Non-timely reporting, selective reporting, or non-reporting of clinical trial results are prevalent and serious issues. WHO mandates that summary results be available in registries within 12 months of study completion and published in full text within 24 months. However, only a limited number of clinical trials in infectious diseases, including those done during the COVID-19 pandemic, have their results posted on ClinicalTrials.gov. An analysis of 50 trials of eight antiviral drugs tested against COVID-19 with a completion date of at least 2 years ago revealed that only 18% had their results published in the registry, with 40% not publishing any results. Non-timely and non-reporting practices undermine patient participation and are ethically unacceptable. Strategies should include obligatory reporting of summary results within 12 months in clinical trial registries, with progress towards peer-reviewed publication within 24 months indicated. Timely publication of research papers should be encouraged through an automated flagging mechanism in clinical trial registries that draws attention to the status of results reporting, such as a green tick for trials that have reported summary results within 12 months and a red tick in case of failure to do so. We propose the inclusion of mandatory clinical trial reporting standards in the International Conference on Harmonization Good Clinical Practice guidelines, which should prohibit sponsor contract clauses that restrict reporting (referred to as gag clauses) and require timely reporting of results as part of the ethics committees' clearance process for clinical trial protocols.
Topics: Humans; Pandemics; COVID-19; Communicable Diseases; Registries; Bias
PubMed: 37837983
DOI: 10.1016/S1473-3099(23)00455-3 -
The American Surgeon Dec 2023Completion pancreatectomy (C.P.) is one acceptable treatment of choice in clinical scenarios such as management of post-pancreatectomy complications and recurrence in... (Review)
Review
BACKGROUND/OBJECTIVE (S)
Completion pancreatectomy (C.P.) is one acceptable treatment of choice in clinical scenarios such as management of post-pancreatectomy complications and recurrence in the pancreatic remnant. Studies referring to completion pancreatectomy as a distinct operation are limited, without emphasizing at the operation itself, rather reporting completion pancreatectomy as a possible option for treatment of various diseases. The identification of indications of CP in various pathologies and the clinical outcomes are therefore mandatory.
METHODS
A systematic literature search was performed in the Pubmed and Scopus Databases (February 2020),guided by the PRISMA protocol, for all studies reporting CP as a surgical procedure with reference at indications for performing it combined with postoperative morbidity and/or mortality.
RESULTS
Out of 1647 studies, 32 studies from 10 countries with 2775 patients in total, of whom 561 (20.2%) CPs met the inclusion criteria and were included in the analysis. Inclusion year ranged from 1964 to 2018 and were published from 1992 until 2019. 17 studies with a total number of 249 CPs were performed for post-pancreatectomy complications. Mortality rate was 44.5% (111 out of 249). Morbidity rate was (72.6%). 12 studies with 225 CPs were performed for isolated local recurrence after initial resection with a morbidity rate of 21.5% and 0% mortality rate in the early postoperative period. Two studies with a total number of 12 patients reported CP as a treatment option for recurrent neuroendocrine neoplasms. The mortality in those studies was 8% (1/12) and the mean morbidity rate was 58.3% (7/12). Finally, CP for refractory chronic pancreatitis was presented in one study with morbidity and mortality rates of 19% and 0%, respectively.
CONCLUSION
Completion pancreatectomy is a distinct treatment option for various pathologies. Morbidity and mortality rates depend on the indications of performing CP, the status performance of the patients and whether the operation is performed electively or urgently
Topics: Humans; Pancreatectomy; Pancreatic Neoplasms; Neoplasm Recurrence, Local; Pancreas; Pancreatitis, Chronic; Retrospective Studies; Postoperative Complications
PubMed: 37295804
DOI: 10.1177/00031348231183121 -
Journal of Studies on Alcohol and Drugs Mar 2024Alcohol overservice at on-premises establishments is associated with driving while intoxicated, violence, and other harms. This study examined rates of alcohol...
OBJECTIVE
Alcohol overservice at on-premises establishments is associated with driving while intoxicated, violence, and other harms. This study examined rates of alcohol overservice and service refusal among licensed on-premises establishments in northern California and characteristics of establishments, servers, and pseudo-patrons (PPs) that may be associated with service refusal.
METHOD
In 2022, 300 licensed on-premises establishments were sampled in nine counties representing the San Francisco Bay Area. From July 2022 to January 2023, PP and observer teams visited each establishment, and PPs attempted to buy alcohol while displaying obvious signs of intoxication. The outcome of each purchase attempt; characteristics of establishments, servers, and PPs; and month, day, and time were recorded. Descriptive and regression analyses were conducted to address study objectives.
RESULTS
Twenty-one percent of the establishments refused alcohol service to PPs. No establishment or server characteristics were significantly associated with service refusal in logistic regression analysis, nor were month, day, or time. However, service refusal was significantly more likely among female PPs (odds ratio = 3.71, 95% CI [1.67, 8.24], < .01) and PPs displaying obvious or very obvious signs of intoxication (odds ratio = 9.28, 95% CI [1.99, 43.40], < .01). There was no significant interaction effect of PP × Server Gender on the likelihood of service refusal.
CONCLUSIONS
This study indicates that alcohol overservice to obviously intoxicated patrons remains common at licensed on-premises establishments. Mandatory responsible beverage service training of servers and enforcement of alcohol overservice laws are needed to reduce overservice and related harms.
Topics: Humans; Female; Alcoholic Beverages; Alcoholic Intoxication; Ethanol; Odds Ratio; Alcohol Drinking; Restaurants
PubMed: 38095190
DOI: 10.15288/jsad.23-00253 -
Journal of Cancer Education : the... Oct 2023This scoping review aims to identify interventional training courses on tobacco cessation counseling skills of medical students, identify the most appropriate teaching... (Review)
Review
This scoping review aims to identify interventional training courses on tobacco cessation counseling skills of medical students, identify the most appropriate teaching method, and the ideal stage to provide such training. We retrieved articles published since 2000 from two electronic peer-reviewed databases (PubMed and Scopus) and hand-searched reference lists of selected articles. Articles published in English, with a clearly defined curriculum, reporting knowledge, attitude, cessation counseling skills of medical students post-training, and cessation-related outcomes of patients participating in student-led counseling sessions, were considered for inclusion. We used the York framework to guide this scoping review. First, data from studies meeting the inclusion criteria were charted using a standardized form. Subsequently, related studies were organized under three themes that emerged in the review process-lectured-based, web-based, and multi-modal curriculum. We concluded that a short but focused lecture-based curriculum combined with peer role-play or standardized/real patient interactions effectively develops the necessary knowledge and skills of undergraduate medical students to provide tobacco cessation counseling to patients. However, studies consistently report that the gains in knowledge and skills after cessation training is acute. Therefore, continued participation in cessation counseling and periodic review of cessation-related knowledge and skills post-training is warranted.
Topics: Humans; Tobacco Use Cessation; Smoking Cessation; Schools, Medical; Education, Medical, Undergraduate; Curriculum; Students, Medical
PubMed: 37188986
DOI: 10.1007/s13187-023-02309-5 -
Journal of Public Health Policy Mar 2024High salt intake is a well-known risk factor for cardiovascular disease (CVD). Some recent prospective studies have challenged the salt-CVD link. We conducted a... (Review)
Review
High salt intake is a well-known risk factor for cardiovascular disease (CVD). Some recent prospective studies have challenged the salt-CVD link. We conducted a narrative review based on a systematic search and provided a national policy update. We reviewed 14 observational prospective studies in healthy adults, reporting the association between sodium intake and excretion or reduction and CVD incidence. Validated by cohort studies, recommended sodium consumption levels (< 1.5-2 gram per day) are still relevant for the prevention of CVD in adults. We discussed the findings and policy initiatives implemented in Israel. Such initiatives included voluntary and mandatory food labeling, and culturally tailored educational programs. The Ministry of Health in Israel initiated a salt reduction policy in recent years-aimed for the future of the industry as well as the population.
Topics: Adult; Humans; Sodium Chloride, Dietary; Israel; Prospective Studies; Cardiovascular Diseases; Nutrition Policy
PubMed: 38158452
DOI: 10.1057/s41271-023-00457-y -
Psychotherapy Research : Journal of the... Oct 2023This study investigated the reasons why pedohebephilic clients disclose their sexual attraction to children in therapy and the experiences associated with this decision...
This study investigated the reasons why pedohebephilic clients disclose their sexual attraction to children in therapy and the experiences associated with this decision among English-speaking samples. : The pre-registered online survey combined (1) quantitative correlational data of self-reported improvement, alliance, therapist reaction to disclosure, and the belief that mandatory reporting laws were in place, and (2) qualitative data about reasons for disclosure or no disclosure as well as perceived consequences. The sample consisted of pedohebephilic people who have been clients in therapy and have disclosed ( = 96) or not disclosed ( = 40). While the disclosure and no disclosure groups did not differ in improvement or beliefs about mandatory reporting, those who had disclosed reported a stronger alliance. Clients who did not perceive the therapist's reaction as supportive reported less improvement than the no disclosure group. Thematic analysis of qualitative data identified three themes concerning motives for disclosing or not disclosing and a fourth regarding differential impacts of disclosure. : This study indicates that disclosing pedohebephilia does not in and of itself lead to improvement but is contingent on a therapist's reaction.
PubMed: 37848189
DOI: 10.1080/10503307.2023.2265047 -
Design, delivery and effectiveness of health practitioner regulation systems: an integrative review.Human Resources For Health Sep 2023Health practitioner regulation (HPR) systems are increasingly recognized as playing an important role in supporting health workforce availability, accessibility,...
BACKGROUND
Health practitioner regulation (HPR) systems are increasingly recognized as playing an important role in supporting health workforce availability, accessibility, quality, and sustainability, while promoting patient safety. This review aimed to identify evidence on the design, delivery and effectiveness of HPR to inform policy decisions.
METHODS
We conducted an integrative analysis of literature published between 2010 and 2021. Fourteen databases were systematically searched, with data extracted and synthesized based on a modified Donabedian framework.
FINDINGS
This large-scale review synthesized evidence from a range of academic (n = 410) and grey literature (n = 426) relevant to HPR. We identified key themes and findings for a series of HPR topics organized according to our structures-processes-outcomes conceptual framework. Governance reforms in HPR are shifting towards multi-profession regulators, enhanced accountability, and risk-based approaches; however, comparisons between HPR models were complicated by a lack of a standardized HPR typology. HPR can support government workforce strategies, despite persisting challenges in cross-border recognition of qualifications and portability of registration. Scope of practice reform adapted to modern health systems can improve access and quality. Alternatives to statutory registration for lower-risk health occupations can improve services and protect the public, while standardized evaluation frameworks can aid regulatory strengthening. Knowledge gaps remain around the outcomes and effectiveness of HPR processes, including continuing professional development models, national licensing examinations, accreditation of health practitioner education programs, mandatory reporting obligations, remediation programs, and statutory registration of traditional and complementary medicine practitioners.
CONCLUSION
We identified key themes, issues, and evidence gaps valuable for governments, regulators, and health system leaders. We also identified evidence base limitations that warrant caution when interpreting and generalizing the results across jurisdictions and professions. Themes and findings reflect interests and concerns in high-income Anglophone countries where most literature originated. Most studies were descriptive, resulting in a low certainty of evidence. To inform regulatory design and reform, research funders and governments should prioritize evidence on regulatory outcomes, including innovative approaches we identified in our review. Additionally, a systematic approach is needed to track and evaluate the impact of regulatory interventions and innovations on achieving health workforce and health systems goals.
Topics: Humans; Government Programs; Government; Accreditation; Databases, Factual; Health Education
PubMed: 37667368
DOI: 10.1186/s12960-023-00848-y -
Neuro-oncology Practice Aug 2023Comprehensive and transparent reporting of clinical trial activity is important. The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 and...
BACKGROUND
Comprehensive and transparent reporting of clinical trial activity is important. The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 and Consolidated Standards of Reporting Trials (CONSORT) 2010 statements define the items to be reported in clinical trial protocols and randomized controlled trials, respectively. The aim of this methodological review was to assess the reporting quality of adult neuro-oncology trial protocols and trial result articles.
METHODS
Adult primary and secondary brain tumor phase 3 trial protocols and result articles published after the introduction of the SPIRIT 2013 statement, were identified through searches of 4 electronic bibliographic databases. Following extraction of baseline demographic data, the reporting quality of independently included trial protocols and result articles was assessed against the SPIRIT and CONSORT statements respectively. The CONSORT-A checklist, an extension of the CONSORT 2010 statement, was used to specifically assess the abstract accompanying the trial results article. Percentage adherence (standard deviation [SD]) was calculated for each article.
RESULTS
Seven trial protocols, and 36 trial result articles were included. Mean adherence of trial protocols to the SPIRIT statement was 79.4% (SD: 0.11). Mean adherence of trial abstracts to CONSORT-A was 75.3% (SD: 0.12) and trial result articles to CONSORT was 74.5% (SD: 0.10).
CONCLUSION
The reporting quality of adult neuro-oncology trial protocols and trial result articles requires improvement to ensure comprehensive and transparent communication of planned neuro-oncology clinical trials and results within the literature. Raising awareness by clinical triallists and implementing mandatory evidence of proof of adherence by journals should improve reporting quality.
PubMed: 37457230
DOI: 10.1093/nop/npad017