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Plastic and Reconstructive Surgery Jul 2023Nipple-sparing mastectomy (NSM) has emerged as an alternative procedure for skin-sparing mastectomy (SSM), followed by immediate breast reconstruction. Because oncologic... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Nipple-sparing mastectomy (NSM) has emerged as an alternative procedure for skin-sparing mastectomy (SSM), followed by immediate breast reconstruction. Because oncologic safety appears similar, patient-reported outcomes (PROs) and complication risks may guide decision-making in individual patients. Therefore, the aim of this systematic review was to compare PROs and complication rates after NSM and SSM.
METHODS
A systematic literature review evaluating NSM versus SSM was performed using the Embase, MEDLINE, and Cochrane databases. Methodologic quality of the included studies was assessed using the Newcastle-Ottawa Quality Assessment Form for Cohort Studies. Primary outcomes were PROs and complications. Studies that evaluated BREAST-Q scores were used to perform meta-analyses on five BREAST-Q domains.
RESULTS
Thirteen comparative studies including 3895 patients were selected from 1202 articles found. Meta-analyses of the BREAST-Q domains showed a significant mean difference of 7.64 in the Sexual Well-being domain ( P = 0.01) and 4.71 in the Psychosocial Well-being domain ( P = 0.03), both in favor of NSM. Using the specifically designed questionnaires, no differences in overall satisfaction scores were found. There were no differences in overall complication rates between the two groups.
CONCLUSIONS
Patient satisfaction scores were high after both NSM and SSM; however, NSM led to a higher sexual and psychosocial well-being. No differences in complication rates were found. In combination with other factors, such as oncologic treatments, complication risk profile, and fear of cancer recurrence, the decision for NSM or SSM has to be made on an individual basis and only if NSM is considered to be oncologically safe.
Topics: Humans; Female; Mastectomy; Nipples; Quality of Life; Breast Neoplasms; Mammaplasty; Retrospective Studies
PubMed: 36728484
DOI: 10.1097/PRS.0000000000010155 -
Journal of Medical Internet Research Oct 2022With no current cure for mild cognitive impairment (MCI), delaying its progression could significantly reduce the disease burden and improve the quality of life for... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
With no current cure for mild cognitive impairment (MCI), delaying its progression could significantly reduce the disease burden and improve the quality of life for patients with MCI. Computerized cognitive training (CCT) has recently become a potential instrument for improvement of cognition. However, the evidence for its effectiveness remains limited.
OBJECTIVE
This systematic review aims to (1) analyze the efficacy of CCT on cognitive impairment or cognitive decline in patients with MCI and (2) analyze the relationship between the characteristics of CCT interventions and cognition-related health outcomes.
METHODS
A systematic search was performed using MEDLINE, Cochrane, Embase, Web of Science, and Google Scholar. Full texts of randomized controlled trials of CCT interventions in adults with MCI and published in English language journals between 2010 and 2021 were included. Overall global cognitive function and domain-specific cognition were pooled using a random-effects model. Sensitivity analyses were performed to determine the reasons for heterogeneity and to test the robustness of the results. Subgroup analyses were performed to identify the relationship between the characteristics of CCT interventions and cognition-related effectiveness.
RESULTS
A total of 18 studies with 1059 participants were included in this review. According to the meta-analysis, CCT intervention provided a significant but small increase in global cognitive function compared to that in the global cognitive function of the control groups (standardized mean difference=0.54, 95% CI 0.35-0.73; I=38%). CCT intervention also resulted in a marginal improvement in domain-specific cognition compared to that in the control groups, with moderate heterogeneity. Subgroup analyses showed consistent improvement in global cognitive behavior in the CCT intervention groups.
CONCLUSIONS
This systematic review suggests that CCT interventions could improve global cognitive function in patients with MCI. Considering the relatively small sample size and the short treatment duration in all the included studies, more comprehensive trials are needed to quantify both the impact of CCT on cognitive decline, especially in the longer term, and to establish whether CCT should be recommended for use in clinical practice.
TRIAL REGISTRATION
PROSPERO International Prospective Register of Systematic Reviews CRD42021278884; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=278884.
Topics: Humans; Quality of Life; Cognitive Dysfunction; Cognition; Cognition Disorders; Time Factors
PubMed: 36301590
DOI: 10.2196/38624 -
JAMA Network Open Sep 2023Testing new medical devices or procedures in terms of safety, effectiveness, and durability should follow the strictest methodological rigor before implementation. (Meta-Analysis)
Meta-Analysis
IMPORTANCE
Testing new medical devices or procedures in terms of safety, effectiveness, and durability should follow the strictest methodological rigor before implementation.
OBJECTIVES
To review and analyze studies investigating devices and procedures used in intracranial aneurysm (IA) treatment for methods and completeness of reporting and to compare the results of studies with positive, uncertain, and negative conclusions.
DATA SOURCES
Embase, MEDLINE, Web of Science, and The Cochrane Central Register of Clinical Trials were searched for studies on IA treatment published between January 1, 1995, and the October 1, 2022. Grey literature was retrieved from Google Scholar.
STUDY SELECTION
All studies making any kind of claims of safety, effectiveness, or durability in the field of IA treatment were included.
DATA EXTRACTION AND SYNTHESIS
Using a predefined data dictionary and analysis plan, variables ranging from patient and aneurysm characteristics to the results of treatment were extracted, as were details pertaining to study methods and completeness of reporting. Extraction was performed by 10 independent reviewers. A blinded academic neuro-linguist without involvement in IA research evaluated the conclusion of each study as either positive, uncertain, or negative. The study followed Preferring Reporting Items for Systematic Reviews and Meta-Analyses guidelines.
MAIN OUTCOMES AND MEASURES
The incidence of domain-specific outcomes between studies with positive, uncertain, or negative conclusions regarding safety, effectiveness, or durability were compared. The number of studies that provided a definition of safety, effectiveness, or durability and the incidence of incomplete reporting of domain-specific outcomes were evaluated.
RESULTS
Overall, 12 954 studies were screened, and 1356 studies were included, comprising a total of 410 993 treated patients. There was no difference in the proportion of patients with poor outcome or in-hospital mortality between studies claiming a technique was safe, uncertain, or not safe. Similarly, there was no difference in the proportion of IAs completely occluded at last follow-up between studies claiming a technique was effective, uncertain, or noneffective. Less than 2% of studies provided any definition of safety, effectiveness, or durability, and only 1 of the 1356 studies provided a threshold under which the technique would be considered unsafe. Incomplete reporting was found in 546 reports (40%).
CONCLUSIONS AND RELEVANCE
In this systematic review and meta-analysis of IA treatment literature, studies claiming safety, effectiveness, or durability of IA treatment had methodological flaws and incomplete reporting of relevant outcomes supporting these claims.
Topics: Humans; Intracranial Aneurysm; Hospital Mortality; Neurology; Uncertainty
PubMed: 37656458
DOI: 10.1001/jamanetworkopen.2023.31798 -
BMJ Open Jun 2023This systematic review examined the potential benefit of all group-based performing arts interventions for primary anxiety and/or depression.
OBJECTIVES
This systematic review examined the potential benefit of all group-based performing arts interventions for primary anxiety and/or depression.
SETTING
Scholarly literature from any country or countries globally.
DATA SOURCES
Three key bibliographic databases, Google Scholar and relevant citation chasing.
PRIMARY AND SECONDARY OUTCOME MEASURES
Depression and/or anxiety symptom severity, well-being, quality of life, functional communication or social participation.
RESULTS
Database searches returned a total of 63 678 records, of which 56 059 remained following dededuplication. From these database searches, a total of 153 records proceeded to full-text screening. These were supplemented by 18 additional unique full-text screening records from Google Scholar searches and citation chasing (12% of total). From a total of 171 records at the full-text screening stage, 12 publications (7%) were eligible for inclusion in this systematic review, each reporting on a separate study. Published from 2004 to 2021, these studies involved a total of 669 participants with anxiety and/or depression from nine countries and covered five broad artistic modalities: dance, music therapy, art therapy, martial arts and theatre. Dance was the most studied artistic modality (five studies), while there were three studies on art therapy, two on music therapy and one each on martial arts and theatre. The evidence was clearest for a benefit of arts therapies on depression and/or anxiety symptoms.
CONCLUSIONS
This systematic review addresses all group-based active arts interventions in a focused population of primary anxiety and/or depression. The evidence suggests that the arts may be a useful therapeutic medium in this population. However, a substantial limitation of the evidence base is the lack of studies directly comparing different artistic modalities. Moreover, not all artistic modalities were assessed for all outcome domains. Therefore, it is not currently possible to determine which artistic modalities are most beneficial for which specific outcomes.
Topics: Adult; Humans; Depression; Quality of Life; Anxiety; Anxiety Disorders; Art Therapy
PubMed: 37380205
DOI: 10.1136/bmjopen-2022-069310 -
British Journal of Anaesthesia Apr 2023Mortality, morbidity, and organ failure are important and common serious harms after surgery. However, there are many candidate measures to describe these outcome...
BACKGROUND
Mortality, morbidity, and organ failure are important and common serious harms after surgery. However, there are many candidate measures to describe these outcome domains. Definitions of these measures are highly variable, and validity is often unclear. As part of the International Standardised Endpoints in Perioperative Medicine (StEP) initiative, this study aimed to derive a set of standardised and valid measures of mortality, morbidity, and organ failure for use in perioperative clinical trials.
METHODS
Three domains of endpoints (mortality, morbidity, and organ failure) were explored through systematic literature review and a three-stage Delphi consensus process using methods consistently applied across the StEP initiative. Reliability, feasibility, and patient-centredness were assessed in round 3 of the consensus process.
RESULTS
A high level of consensus was achieved for two mortality time points, 30-day and 1-yr mortality, and these two measures are recommended. No organ failure endpoints achieved threshold criteria for consensus recommendation. The Clavien-Dindo classification of complications achieved threshold criteria for consensus in round 2 of the Delphi process but did not achieve the threshold criteria in round 3 where it scored equivalently to the Post Operative Morbidity Survey. Clavien-Dindo therefore received conditional endorsement as the most widely used measure. No composite measures of organ failure achieved an acceptable level of consensus.
CONCLUSIONS
Both 30-day and 1-yr mortality measures are recommended. No measure is recommended for organ failure. One measure (Clavien-Dindo) is conditionally endorsed for postoperative morbidity, but our findings suggest that no single endpoint offers a reliable and valid measure to describe perioperative morbidity that is not dependent on the quality of deli-vered care. Further refinement of current measures, or development of novel measures, of postoperative morbidity might improve consensus in this area.
Topics: Humans; Perioperative Care; Consensus; Reproducibility of Results; Perioperative Medicine; Morbidity; Delphi Technique
PubMed: 36697275
DOI: 10.1016/j.bja.2022.12.012 -
Family Medicine and Community Health Nov 2022Artificial intelligence (AI) will have a significant impact on healthcare over the coming decade. At the same time, health inequity remains one of the biggest...
OBJECTIVE
Artificial intelligence (AI) will have a significant impact on healthcare over the coming decade. At the same time, health inequity remains one of the biggest challenges. Primary care is both a driver and a mitigator of health inequities and with AI gaining traction in primary care, there is a need for a holistic understanding of how AI affect health inequities, through the act of providing care and through potential system effects. This paper presents a systematic scoping review of the ways AI implementation in primary care may impact health inequity.
DESIGN
Following a systematic scoping review approach, we searched for literature related to AI, health inequity, and implementation challenges of AI in primary care. In addition, articles from primary exploratory searches were added, and through reference screening.The results were thematically summarised and used to produce both a narrative and conceptual model for the mechanisms by which social determinants of health and AI in primary care could interact to either improve or worsen health inequities.Two public advisors were involved in the review process.
ELIGIBILITY CRITERIA
Peer-reviewed publications and grey literature in English and Scandinavian languages.
INFORMATION SOURCES
PubMed, SCOPUS and JSTOR.
RESULTS
A total of 1529 publications were identified, of which 86 met the inclusion criteria. The findings were summarised under six different domains, covering both positive and negative effects: (1) access, (2) trust, (3) dehumanisation, (4) agency for self-care, (5) algorithmic bias and (6) external effects. The five first domains cover aspects of the interface between the patient and the primary care system, while the last domain covers care system-wide and societal effects of AI in primary care. A graphical model has been produced to illustrate this. Community involvement throughout the whole process of designing and implementing of AI in primary care was a common suggestion to mitigate the potential negative effects of AI.
CONCLUSION
AI has the potential to affect health inequities through a multitude of ways, both directly in the patient consultation and through transformative system effects. This review summarises these effects from a system tive and provides a base for future research into responsible implementation.
Topics: Humans; Artificial Intelligence; Health Inequities; Gray Literature; PubMed; Primary Health Care
PubMed: 36450391
DOI: 10.1136/fmch-2022-001670 -
Women's Health (London, England) 2023Female pelvic organ prolapse is a common condition associated with significant impact on women's lives from a biopsychosocial perspective. The aim of this systematic... (Review)
Review
Female pelvic organ prolapse is a common condition associated with significant impact on women's lives from a biopsychosocial perspective. The aim of this systematic review is to identify, appraise and summarize the biopsychosocial profile of women with pelvic organ prolapse. Searches were completed from inception to October 2022 from PubMed, Web of Science, EMBASE, CINAHL, Cochrane, PsycINFO and PEDro using a search string and in line with the Preferred Reporting Information for Systematic reviews and Meta-Analyses protocol. English language studies (randomized controlled trials, cohort studies, case-control studies, qualitative research) investigating female pelvic organ prolapse and using a validated patient-reported outcome measure and validated pelvic organ prolapse objective measurement were examined. Two reviewers independently screened titles, abstracts and full articles for eligibility. Data extraction included participant characteristics, pelvic organ prolapse grading and outcome measures. Risk of bias was assessed using the appropriate Joanna Briggs Institute Tool. Baseline mean score for each questionnaire or questionnaire domain in each category was presented in tertiles (low, moderate and high impact) to allow simple classification of impact. Of 8341 articles identified, 18 were included (n = 2075 women, age range = 22-85 years, parity range = 0-10). One objective outcome measure graded pelvic organ prolapse: Pelvic Organ Prolapse Quantification measurement. Eleven validated patient-reported outcome measures were utilized; two pelvic organ prolapse-specific (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, Pelvic Organ Prolapse Quality of Life Questionnaire), the remainder pelvic health (International Consultation on Incontinence Questionnaire-Vaginal Symptoms, International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form, Pelvic Floor Distress Inventory-20, Incontinence Impact Questionnaire-7, Female Sexual Function Index, Urinary Distress Inventory-6, Kings Health Questionnaire, Pelvic Floor Impact Questionnaire-7) or general health questionnaires (Short Form-36). Patient-reported outcome measures included in the review reported moderate levels of pain with sexual intercourse and low levels of bodily pain. Pelvic organ prolapse had a low to moderate impact in sleep/energy and quality of life and sexual function domains. Its impact on physical symptoms and general health perception domains was low. Patient-reported outcome measures results for physical functioning varied from low to high impact. More impact was demonstrated when using pelvic organ prolapse-specific patient-reported outcome measures. There are opportunities for improvement in the use of patient-reported outcome measures in clinical research which would facilitate increased understanding of the biopsychosocial profile of women with pelvic organ prolapse.
Topics: Adult; Aged; Aged, 80 and over; Female; Humans; Middle Aged; Pregnancy; Young Adult; Case-Control Studies; Pain; Pelvic Organ Prolapse; Quality of Life
PubMed: 37387355
DOI: 10.1177/17455057231181012 -
PloS One 2023Fear of falling (FoF) is a major concern among older adults and is associated with negative outcomes, such as decreased quality of life and increased risk of falls.... (Review)
Review
Fear of falling (FoF) is a major concern among older adults and is associated with negative outcomes, such as decreased quality of life and increased risk of falls. Despite several systematic reviews conducted on various specific domains of FoF and its related interventions, the research area has only been minimally covered by scoping reviews, and a comprehensive scoping review mapping the range and scope of the research area is still lacking. This review aims to provide such a comprehensive investigation of the existing literature and identify main topics, gaps in the literature, and potential opportunities for bridging different strains of research. Using the PRISMA-ScR guidelines, we searched the Cochrane Database of Systematic Reviews, CINAHL, Embase, MEDLINE, PsycInfo, Scopus, and Web of Science databases. Following the screening process, 969 titles and abstracts were chosen for the review. Pre-processing steps included stop word removal, stemming, and term frequency-inverse document frequency vectorization. Using the Non-negative Matrix Factorization algorithm, we identified seven main topics and created a conceptual mapping of FoF research. The analysis also revealed that most studies focused on physical health-related factors, particularly balance and gait, with less attention paid to cognitive, psychological, social, and environmental factors. Moreover, more research could be done on demographic factors beyond gender and age with an interdisciplinary collaboration with social sciences. The review highlights the need for more nuanced and comprehensive understanding of FoF and calls for more research on less studied areas.
Topics: Accidental Falls; Fear; Quality of Life; Natural Language Processing
PubMed: 37906616
DOI: 10.1371/journal.pone.0293554 -
Journal of Advanced Nursing Jul 2018To report the development of a core set of outcome domains for clinical research involving adults with incontinence-associated dermatitis or at risk, independently from... (Review)
Review
AIM
To report the development of a core set of outcome domains for clinical research involving adults with incontinence-associated dermatitis or at risk, independently from any geographical location or skin colour.
BACKGROUND
The management of incontinence-associated dermatitis is important in caring for incontinent patients. The lack of comparability of clinical trial outcomes is a major challenge in the field of evidence-based incontinence-associated dermatitis prevention and treatment. Core outcome sets may therefore be helpful to improve the value of clinical incontinence-associated dermatitis research.
DESIGN
Systematic literature review, patient interviews and consensus study using Delphi procedure.
METHODS
A list of outcome domains was generated through a systematic literature review (no date restrictions-April 2016), consultation of an international steering committee and three patient interviews. The project team reviewed and refined the outcome domains prior to starting a three-round Delphi procedure conducted between April-September 2017. The panellists, including healthcare providers, researchers and industry were invited to rate the importance of the outcome domains.
RESULTS
We extracted 1,852 outcomes from 244 articles. Experts proposed 56 and patients 32 outcome domains. After refinement, 57 panellists from 17 countries rated a list of 58 outcome domains. The final list of outcome domains includes erythema, erosion, maceration, IAD-related pain and patient satisfaction.
CONCLUSION
Erythema, erosion, maceration, incontinence-associated dermatitis -related pain and patient satisfaction are the most important outcome domains to be measured in incontinence-associated dermatitis trials. Based on this international consensus on what to measure, the question of how to measure these domains now requires consideration. Registration: This project has been registered in the Core Outcome Measures in Effectiveness Trials (COMET Initiative) database and is part of the Cochrane Skin Group-Core Outcomes Set Initiative (CSG-COUSIN).
Topics: Caregivers; Clinical Trials as Topic; Cost of Illness; Delphi Technique; Dermatitis; Humans; Pain; Patient Satisfaction; Prognosis; Pruritus; Quality of Life; Urinary Incontinence
PubMed: 29520848
DOI: 10.1111/jan.13562 -
Journal of Foot and Ankle Research Jul 2022Ongoing colonisation produces inequity in healthcare delivery and inequality in healthcare outcomes for Aboriginal and Torres Strait Islander Peoples. As a consequence,... (Review)
Review
BACKGROUND
Ongoing colonisation produces inequity in healthcare delivery and inequality in healthcare outcomes for Aboriginal and Torres Strait Islander Peoples. As a consequence, within the domain of lower limb health, foot disease has severe impacts for First Nations Peoples. Central to developing culturally safe healthcare and driving positive foot health change for First Nations Peoples, is the need for health professionals to develop understanding of First Nations perspectives of foot health. The aim of this systematic review was to evaluate studies investigating Aboriginal and Torres Strait Islander Peoples' perceptions of foot and lower limb health.
METHODS
PubMeD, Ovid (Embase, Emcare, Medline), CINAHL, Informit Indigenous collection, and grey literature sources were searched to 23 July 2021. We included any published reports or studies that examined Aboriginal and Torres Strait Islander Peoples' perceptions of foot and lower limb health, or meanings of, or attitudes to, foot and lower limb health.
RESULTS
Four studies with a total of 1515 participants were included. Studies found that Aboriginal and Torres Strait Islander people self-assessed foot health with a demonstrated ability to perceive their feet as healthy relative to Western clinical measures of peripheral blood supply and neurological function. Footwear, including ill-fitting or lack of footwear was considered a contributing factor to reduced foot and lower limb health. Foot pain affected up to 60% of participants with up to 70% of foot pain untreated. Lack of access to culturally safe health care delivered by culturally capable health professionals was perceived to contribute to worse foot and lower limb health outcomes.
CONCLUSIONS
Aboriginal and Torres Strait Islander Peoples' perceptions of foot and lower limb health are influenced by multiple complex interrelated factors. The limited number of studies in this area indicates ongoing failings to consult First Nations Peoples regarding their own lower limb and foot health. It is therefore essential that healthcare service and cultural capability implementation is led by Aboriginal and Torres Strait Islander Peoples in co-design. Urgent need for further research that exemplifies design and delivery of culturally safe care is required.
Topics: Delivery of Health Care; Foot; Health Status; Humans; Lower Extremity; Native Hawaiian or Other Pacific Islander; Pain
PubMed: 35869536
DOI: 10.1186/s13047-022-00557-0