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PLoS Medicine May 2024Poor representation of pregnant and lactating women and people in clinical trials has marginalised their health concerns and denied the maternal-fetal/infant dyad...
BACKGROUND
Poor representation of pregnant and lactating women and people in clinical trials has marginalised their health concerns and denied the maternal-fetal/infant dyad benefits of innovation in therapeutic research and development. This mixed-methods systematic review synthesised factors affecting the participation of pregnant and lactating women in clinical trials, across all levels of the research ecosystem.
METHODS AND FINDINGS
We searched 8 databases from inception to 14 February 2024 to identify qualitative, quantitative, and mixed-methods studies that described factors affecting participation of pregnant and lactating women in vaccine and therapeutic clinical trials in any setting. We used thematic synthesis to analyse the qualitative literature and assessed confidence in each qualitative review finding using the GRADE-CERQual approach. We compared quantitative data against the thematic synthesis findings to assess areas of convergence or divergence. We mapped review findings to the Theoretical Domains Framework (TDF) and Capability, Opportunity, and Motivation Model of Behaviour (COM-B) to inform future development of behaviour change strategies. We included 60 papers from 27 countries. We grouped 24 review findings under 5 overarching themes: (a) interplay between perceived risks and benefits of participation in women's decision-making; (b) engagement between women and the medical and research ecosystems; (c) gender norms and decision-making autonomy; (d) factors affecting clinical trial recruitment; and (e) upstream factors in the research ecosystem. Women's willingness to participate in trials was affected by: perceived risk of the health condition weighed against an intervention's risks and benefits, therapeutic optimism, intervention acceptability, expectations of receiving higher quality care in a trial, altruistic motivations, intimate relationship dynamics, and power and trust in medicine and research. Health workers supported women's participation in trials when they perceived clinical equipoise, had hope for novel therapeutic applications, and were convinced an intervention was safe. For research staff, developing reciprocal relationships with health workers, having access to resources for trial implementation, ensuring the trial was visible to potential participants and health workers, implementing a woman-centred approach when communicating with potential participants, and emotional orientations towards the trial were factors perceived to affect recruitment. For study investigators and ethics committees, the complexities and subjectivities in risk assessments and trial design, and limited funding of such trials contributed to their reluctance in leading and approving such trials. All included studies focused on factors affecting participation of cisgender pregnant women in clinical trials; future research should consider other pregnancy-capable populations, including transgender and nonbinary people.
CONCLUSIONS
This systematic review highlights diverse factors across multiple levels and stakeholders affecting the participation of pregnant and lactating women in clinical trials. By linking identified factors to frameworks of behaviour change, we have developed theoretically informed strategies that can help optimise pregnant and lactating women's engagement, participation, and trust in such trials.
Topics: Humans; Female; Pregnancy; Lactation; Clinical Trials as Topic; Patient Participation; Pregnant Women; Decision Making; Motivation; Patient Selection
PubMed: 38814991
DOI: 10.1371/journal.pmed.1004405 -
Journal of Orthopaedic Surgery and... May 2024There is a lack of relevant studies to grade the evidence on the risk factors of chronic pain after total knee arthroplasty (TKA), and only quantitative methods are used...
BACKGROUND
There is a lack of relevant studies to grade the evidence on the risk factors of chronic pain after total knee arthroplasty (TKA), and only quantitative methods are used for systematic evaluation. The review aimed to systematically identify risk factors of chronic postoperative pain following TKA and to evaluate the strength of the evidence underlying these correlations.
METHODS
PubMed, Web of Science, Cochrane Library, Embase, and CINAHL databases were searched from initiation to September 2023. Cohort studies, case-control studies, and cross-sectional studies involving patients undergoing total knee replacement were included. A semi-quantitative approach was used to grade the strength of the evidence-based on the number of investigations, the quality of the studies, and the consistency of the associations reported by the studies.
RESULTS
Thirty-two articles involving 18,792 patients were included in the final systematic review. Ten variables were found to be strongly associated with postoperative pain, including Age, body mass index (BMI), comorbidities condition, preoperative pain, chronic widespread pain, preoperative adverse health beliefs, preoperative sleep disorders, central sensitization, preoperative anxiety, and preoperative function. Sixteen factors were identified as inconclusive evidence.
CONCLUSIONS
This systematic review clarifies which risk factors could be involved in future research on TKA pain management for surgeons and patients. It highlights those factors that have been controversial or weakly correlated, emphasizing the need for further high-quality studies to validate them. Most crucially, it can furnish clinicians with vital information regarding high-risk patients and their clinical attributes, thereby aiding in the development of preventive strategies to mitigate postoperative pain following TKA.
TRIAL REGISTRATION
This systematic review has been registered on the PROSPERO platform (CRD42023444097).
Topics: Arthroplasty, Replacement, Knee; Humans; Pain, Postoperative; Risk Factors; Chronic Pain; Body Mass Index; Female; Age Factors; Male; Aged; Sleep Wake Disorders; Middle Aged; Comorbidity; Anxiety
PubMed: 38811979
DOI: 10.1186/s13018-024-04778-w -
Journal of Clinical Epidemiology May 2024To evaluate the measurement properties of Patient-reported outcome measures (PROMs) for knowledge and/or beliefs about musculoskeletal conditions.
OBJECTIVES
To evaluate the measurement properties of Patient-reported outcome measures (PROMs) for knowledge and/or beliefs about musculoskeletal conditions.
STUDY DESIGN AND SETTING
A systematic review was performed according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines. This review was prospectively registered on PROSPERO - ID: CRD42022303111. Electronic databases, reference lists, forward citation tracking, and contact with experts were used to identify studies. Eligible studies were reports developing or assessing a measurement property of a PROM measuring musculoskeletal condition specific-knowledge and/or beliefs. We assessed the methodological quality and measurement properties of included studies. A modified Grading of Recommendations Assessment Development and Evaluation approach was used to rate the quality of evidence for each PROM.
RESULTS
The literature search was performed from inception to 11th September 2023. Sixty records were included, reporting 290 individual studies, and provided information on 25 PROMs. Five PROMs presented sufficient structural validity, three presented sufficient cross-cultural validity, ten presented sufficient reliability, three presented sufficient criterion validity, six presented sufficient hypothesis-testing, and four presented sufficient responsiveness. No PROM presented sufficient evidence for content validity, internal consistency, and measurement error. Based on the available evidence, no PROM was classified as suitable for use according to the COSMIN recommendations. Twenty-four PROMs are potentially suitable for use, and one PROM is not recommended for use.
CONCLUSION
No PROM designed to assess knowledge and/or beliefs about musculoskeletal conditions meets the COSMIN criteria of suitable for use. Most PROMs identified in this systematic review were considered as potentially suitable for use and need further high-quality research to assess their measurement properties.
PubMed: 38810841
DOI: 10.1016/j.jclinepi.2024.111398 -
Plastic and Reconstructive Surgery.... May 2024Upper extremity limb loss profoundly impacts a patient's quality of life and well-being and carries a significant societal cost. Although osseointegration allows the...
BACKGROUND
Upper extremity limb loss profoundly impacts a patient's quality of life and well-being and carries a significant societal cost. Although osseointegration allows the attachment of the prosthesis directly to the bone, it is a relatively recent development as an alternative to conventional socket prostheses. The objective of this review was to identify reports on osseointegrated prosthetic embodiment for transhumeral amputations and assess the implant systems used, postoperative outcomes, and complications.
METHODS
A systematic review following PRISMA and AMSTAR guidelines assessed functional outcomes, implant longevity and retention, activities of daily living, and complications associated with osseointegrated prostheses in transhumeral amputees.
RESULTS
The literature search yielded 794 articles, with eight of these articles (retrospective analyses and case series) meeting the inclusion criteria. Myoelectric systems equipped with Osseointegrated Prostheses for the Rehabilitation of Amputees implants have been commonly used as transhumeral osseointegration systems. The transhumeral osseointegrated prostheses offered considerable improvements in functional outcomes, with participants demonstrating enhanced range of motion and improved performance of activities compared with traditional socket-based prostheses. One study demonstrated the advantage of an osseointegrated implant as a bidirectional gateway for signal transmission, enabling intuitive control of a bionic hand.
CONCLUSIONS
Osseointegrated prostheses hold the potential to significantly improve the quality of life for individuals with transhumeral amputations. Continued research and clinical expansion are expected to lead to the realization of enhanced efficacy and safety in this technique, accompanied by cost reductions over time as a result of improved efficiencies and advancements in device design.
PubMed: 38808147
DOI: 10.1097/GOX.0000000000005850 -
Clinics and Practice May 2024Human immunodeficiency virus (HIV) infection continues to present a global health issue. Recent studies have explored the potential role of the gut microbiome in HIV... (Review)
Review
Human immunodeficiency virus (HIV) infection continues to present a global health issue. Recent studies have explored the potential role of the gut microbiome in HIV infection for novel therapeutic approaches. We investigated the gut microbiome composition of people living with HIV (PLHIV) in the Asia-Pacific region. This review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. An electronic search was conducted in the PubMed/MEDLINE, Scopus, and ScienceDirect databases using keywords such as "HIV", "PLHIV", "AIDS", "gut microbiome", "gut dysbiosis", and "metagenomics". Only peer-reviewed and full-text studies published in English were included. A total of 15 studies from the Asia-Pacific region were included for analysis. Compared to healthy controls, PLHIV showed an increased abundance of Proteobacteria and its genera, which may be considered pathobionts, and decreased abundances of Bacteroidetes and several genera under Firmicutes with known short-chain fatty acid and immunoregulatory activities. Predominant taxa such as and were also associated with clinical factors such as CD4 count, the CD4/CD8 ratio, and inflammatory cytokines. This review highlights gut microbiome changes among PLHIV in the Asia-Pacific region, indicating potential bacterial signatures for prognostication. The partial restoration of the microbiome toward beneficial taxa may ensure the long-term success of treatment, promoting immune recovery while maintaining viral load suppression.
PubMed: 38804398
DOI: 10.3390/clinpract14030066 -
Heliyon May 2024Therapeutic ultrasound (US) is a treatment for knee osteoarthritis (KOA), but its efficacy and safety are unclear. The objective of this study is to quantify the effect...
BACKGROUND
Therapeutic ultrasound (US) is a treatment for knee osteoarthritis (KOA), but its efficacy and safety are unclear. The objective of this study is to quantify the effect of US on pain relief and function recovery in KOA, and to analyze the US treatment duration and parameters on treatment outcome.
METHODS
We searched PubMed, MEDLINE, EMBASE, Google Scholar, Cochrane databases and ClinicalTrials.gov databases up to April 7, 2023. RCTs that compared the efficacy of therapeutic US with the control in KOA were included in the study, and the methodological quality of the trials was assessed using the Cochrane Risk of Bias tool.
RESULTS
Twenty-one RCTs (1315 patients) were included. US had a positive effect on visual analog scale (VAS) (SMD = -0.64, 95 % CI [-0.88, -0.40], = 71 %) and Western Ontario and McMaster Universities (WOMAC) total scale (SMD = -0.45, 95 % CI [-0.69, -0.20]; = 67 %). Pulsed US with an intensity ≤2.5 W/cm reduced visual analog scale (VAS), and differed in sessions (24 sessions (SMD = -0.80, 95 % CI [-1.07, -0.53], = 0 %) vs 10 sessions (SMD = -0.71, 95 % CI [-1.09, -0.33], = 68 %)). For pulsed US, a duration of treatment of 4-8 weeks (SMD = -0.69, 95 % CI [-1.13, -0.25], = 73 %) appeared to be superior to ≤4 weeks (SMD = -0.77, 95 % CI [-1.04, -0.49], = 0 %) for reducing visual analog scale (VAS). No US treatment-related adverse events were reported.
CONCLUSION
Therapeutic US may be a safe and effective treatment for patients with KOA. The mode, intensity, frequency, and duration of US may affect the effectiveness of pain relief. Pulsed US with an intensity ≤2.5 W/cm, 24 sessions, and a treatment duration of ≤4 weeks appears to have better pain relief.
PubMed: 38803857
DOI: 10.1016/j.heliyon.2024.e30874 -
Journal of the American Medical... May 2024The aim was to synthesize evidence on the use of person-centered outcome measures to facilitate integrated palliative care for older people and build a logic model... (Review)
Review
OBJECTIVES
The aim was to synthesize evidence on the use of person-centered outcome measures to facilitate integrated palliative care for older people and build a logic model depicting the mechanisms through which person-centered outcome measures support integrated care.
DESIGN
Mixed methods systematic review using a data-based convergent synthesis design.
SETTING AND PARTICIPANTS
Older people aged ≥60 years who are approaching the end of their lives in multiple settings.
METHODS
The study was underpinned by a conceptual framework of integrated palliative care, which informed the search strategy, data extraction, analysis, and synthesis. A hybrid search strategy was implemented, with database searches (PsycINFO, MEDLINE, CINAHL, and ASSIA) complemented by snowball searches. Qualitative and quantitative data were analyzed by narrative synthesis to summarize and explain the findings. The findings informed a logic model depicting the mechanisms of using person-centered outcome measures to support integrated palliative care.
RESULTS
Twenty-six studies were included. Three mixed methods studies, 2 qualitative studies, and 21 quantitative studies were included. There was evidence that person-centered outcome measures could support integrated palliative care through informing palliative care policy development (n = 4), facilitating joint working across settings (n = 5), enabling close collaboration of multidisciplinary teams (n = 14), promoting joint education (n = 1), facilitating timing and specialist referral (n = 6), and enhancing patient-centered care (n = 3).
CONCLUSIONS AND IMPLICATIONS
This review makes an important, novel, and theoretically informed contribution to the delivery of scalable and sustainable integrated palliative care into the care of older people using person-centered outcome measures. The constructed logic model provides a conceptual framework and practical approach to how person-centered outcome measures support multilevel integration. A future area of research is the development of person-centered outcome measure interventions informed by the logic model to meet clinical needs.
PubMed: 38796168
DOI: 10.1016/j.jamda.2024.105036 -
Journal of Personalized Medicine Apr 2024Spontaneous orbital cephaloceles are a rare condition. The purpose of this study is to provide a description of a clinical case and to carry out a systematic literature... (Review)
Review
BACKGROUND
Spontaneous orbital cephaloceles are a rare condition. The purpose of this study is to provide a description of a clinical case and to carry out a systematic literature review.
METHODS
A systematic review of the English literature published on the Pubmed, Scopus, and Web of Science databases was conducted, according to the PRISMA recommendations.
RESULTS
A 6-year-old patient was admitted for right otomastoiditis and thrombosis of the sigmoid and transverse sinuses, as well as the proximal portion of the internal jugular vein. Radiological examinations revealed a left orbital mass (22 × 14 mm) compatible with asymptomatic orbital meningocele (MC) herniated from the superior orbital fissure (SOF). The child underwent a right mastoidectomy. After the development of symptoms and signs of intracranial hypertension (ICH), endovascular thrombectomy and transverse sinus stenting were performed, with improvement of the clinical conditions and reduction of the orbital MC. The systematic literature review encompassed 29 publications on 43 patients with spontaneous orbital MC. In the majority of cases, surgery was the preferred treatment.
CONCLUSIONS
The present case report and systematic review highlight the importance of ICH investigation and a pathophysiological-oriented treatment approach. The experiences described in the literature are limited, making the collection of additional data paramount.
PubMed: 38793047
DOI: 10.3390/jpm14050465 -
Journal of Clinical Medicine May 2024: Although osteoarthritis (OA) development is epidemiologically multifactorial, a primary underlying mechanism is still under debate. Understanding the pathophysiology... (Review)
Review
: Although osteoarthritis (OA) development is epidemiologically multifactorial, a primary underlying mechanism is still under debate. Understanding the pathophysiology of OA remains challenging. Recently, experts have focused on autophagy as a contributor to OA development. : To better understand the pathogenesis of OA, we survey the literature on the role of autophagy and the molecular mechanisms of OA development. To identify relevant studies, we used controlled vocabulary and free text keywords to search the MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, Web of Science, and SCOPUS database. Thirty-one studies were included for data extraction and systematic review. Among these studies, twenty-five studies investigated the effects of autophagy in aging and OA chondrocytes, six studies examined the effects of autophagy in normal human chondrocytes, and only one study investigated the effects of mechanical stress-induced autophagy on the development of OA in normal chondrocytes. : The studies suggest that autophagy activation prevents OA by exerting cell-protective effects in normal human chondrocytes. However, in aging and osteoarthritis (OA) chondrocytes, the role of autophagy is intricate, as certain studies indicate that stimulating autophagy in these cells can have a cytotoxic effect, while others propose that it may have a protective (cytoprotective) effect against damage or degeneration. : Mechanical stress-induced autophagy is also thought to be involved in the development of OA, but further research is required to identify the precise mechanism. Thus, autophagy contributions should be interpreted with caution in aging and the types of OA cartilage.
PubMed: 38792546
DOI: 10.3390/jcm13103005 -
Cancers May 2024Pancreatic cancer (PC) is a fatal malignancy with an aggressive course derived from the cells of pancreatic tissue. Gestational diabetes mellitus (GDM) is a state of... (Review)
Review
PURPOSE
Pancreatic cancer (PC) is a fatal malignancy with an aggressive course derived from the cells of pancreatic tissue. Gestational diabetes mellitus (GDM) is a state of spontaneous hyperglycemia occurring during gestation and has been suggested as a risk factor PC. Women with a history of GDM revealed a risk rate of 7.1% for the development of PC. The current systematic review aims to investigate the correlation between GDM and the degree to the prevalence of PC.
METHODOLOGY
For this systematic review, the PICO model was prepared to construct and outline the exact questions of the study, a PRISMA flow diagram was prepared and quality assessment was conducted using the Newcastle Ottawa Scale (NOS) for Cohort Studies, the NIH Quality Assessment Tool-Criteria for Case Reports and the Cochrane quality assessment tool for Systematic Reviews and Meta-analysis studies.
RESULT
A total of eight articles were retrieved from the main databases, and a table was created to summarize the information found. Even though the data found were limited, the quality assessment performed revealed that the articles were of high validity.
CONCLUSIONS
It can be concluded that GDM has an association with the development of PC and can be considered as a risk factor.
PubMed: 38791917
DOI: 10.3390/cancers16101840