-
Digestive and Liver Disease : Official... Apr 2024Celiac disease (CeD) is an immune-mediated disorder affecting the small bowel, associated with genetic factors and increasing global prevalence. (Review)
Review
BACKGROUND
Celiac disease (CeD) is an immune-mediated disorder affecting the small bowel, associated with genetic factors and increasing global prevalence.
AIM
This study explores the association between CeD, Systemic Lupus Erythematosus (SLE), primary Sjogren syndrome (pSS), and Systemic Sclerosis (SSc).
METHODS
A systematic review and meta-analysis were conducted following PRISMA guidelines. Searches across multiple databases yielded 2728 articles, with 15 studies selected. Data extraction included study characteristics, prevalence of CeD and CeD antibodies in SLE, pSS, and SSc. Quality assessment utilized the Newcastle-Ottawa Scale.
RESULTS
The meta-analysis revealed a pooled prevalence of biopsy-proven CeD in SLE, pSS, and SSc of approximately 3%. Seroprevalence of any CeD antibody in SLE, pSS, and SSc ranged from 3% to 10%. Notably, pSS exhibited the highest prevalence at 5.59%. High heterogeneity was observed in seroprevalence across autoimmune conditions. Quality assessment indicated robust methodological quality in the selected studies.
CONCLUSION
This study highlights a significantly higher prevalence of CeD, especially pSS, compared to the general population. The findings underscore the importance of recognizing elevated CeD antibodies in patients with SLE, pSS and SSc emphasizing the need for early detection and comprehensive care for gastrointestinal symptoms in these conditions.
PubMed: 38584032
DOI: 10.1016/j.dld.2024.03.015 -
Journal of Fungi (Basel, Switzerland) Mar 2022Objective: To systematically review literature enabling the comparison of the efficacy of pharmaceutical treatments for tinea pedis in adults. Design: Systematic review... (Review)
Review
Objective: To systematically review literature enabling the comparison of the efficacy of pharmaceutical treatments for tinea pedis in adults. Design: Systematic review of randomised controlled trials (RCTs) with mycological cure as the primary outcome. Secondary outcomes did include the clinical assessment of resolving infection or symptoms, duration of treatment, adverse events, adherence, and recurrence. Eligibility Criteria: Study participants suffering from only tinea pedis that were treated with a pharmaceutical treatment. The study must have been conducted using an RCT study design and recording age of the participant > 16 years of age. Results: A total of seven studies met the inclusion criteria, involving 1042 participants. The likelihood of resolution in study participants treated with terbinafine was RR 3.9 (95% CI: 2.0−7.8) times those with a placebo. Similarly, the allylamine butenafine was effective by RR 5.3 (95% CI: 1.4−19.6) compared to a placebo. Butenafine was similarly efficacious to terbinafine RR 1.3 (95% CI: 0.4−4.4). Terbinafine was marginally more efficacious than itraconazole, RR 1.3 (95% CI: 1.1−1.5). Summary/Conclusion: Topical terbinafine and butenafine treatments of tinea pedis were more efficacious than placebo. Tableted terbinafine and itraconazole administered orally were efficacious in the drug treatment of tinea pedis fungal infection. We are concerned about how few studies were available that reported the baseline characteristics for each treatment arm and that did not suffer greater than 20% loss to follow-up. We would like to see improved reporting of clinical trials in academic literature. Registration name: Treatment’s for athlete’s foot—systematic review with meta-analysis [CRD42020162078].
PubMed: 35448582
DOI: 10.3390/jof8040351 -
Menopause (New York, N.Y.) Oct 2020Genitourinary syndrome of menopause (GSM) is a chronic, progressive condition frequently manifesting as vaginal dryness and pain with intercourse. Survey data indicate...
IMPORTANCE
Genitourinary syndrome of menopause (GSM) is a chronic, progressive condition frequently manifesting as vaginal dryness and pain with intercourse. Survey data indicate this is a highly prevalent, likely underreported, condition that profoundly affects quality of life for millions of women. Vaginal lasers demonstrate promise as an effective, nonhormone therapeutic alternative for GSM; however, the risks associated with them may have been overstated.
OBJECTIVE
Despite reports of improved sexual and vaginal comfort without serious safety concerns, the Food and Drug Administration (FDA) issued a 2018 safety communication warning against it. We conducted a systematic literature review and surveyed both the FDA Manufacturer and User Facility Device Experience (MAUDE) and Bloomberg Law Databases to evaluate risks associated with laser treatment for GSM.
EVIDENCE REVIEW
A systematic literature review identified articles published before September 2019. The MAUDE database was searched by name from 2009 to 2019 for safety claims for 24 vaginal laser devices. The Bloomberg Law database was searched for product liability claims against any vaginal laser device manufacturer before July 2019.
FINDINGS
Literature review revealed 3 publications detailing 29 presumptive laser-associated complications, only 5 of which (17.2%) reported worsening symptoms after treatment. The MAUDE database contained 120 complaints; only 30 (25%) detailed potential adverse patient events, most frequently pain (n = 12) and burning (n = 10). The Bloomberg law database contained no claims asserting harm from device use.
CONCLUSIONS AND RELEVANCE
Lacking strong evidence indicating significant patient risk for vaginal laser treatment of GSM, the FDA safety communication appears unsubstantiated and implies gender bias. Identified complications suggest most reported "adverse events" represent lack of treatment effect. The well-documented benefits and low risk of adverse event suggest laser therapy for GSM is reasonable with appropriate pretreatment counseling. Additional randomized, well-controlled clinical trials are needed to further elucidate both the safety and efficacy of this nonhormone therapy.
Topics: Communication; Female; Humans; Lasers; Male; Menopause; Quality of Life; Sexism; United States; United States Food and Drug Administration
PubMed: 32796292
DOI: 10.1097/GME.0000000000001577 -
BMC Palliative Care Nov 2020Worldwide, many patients with cancer, are infrequently referred to palliative care or are referred late. Oncologists and haematologists may act as gatekeepers, and their...
BACKGROUND
Worldwide, many patients with cancer, are infrequently referred to palliative care or are referred late. Oncologists and haematologists may act as gatekeepers, and their views may facilitate or hinder referrals to palliative care. This review aimed to identify, explore and synthesise their views on referrals systematically.
METHODS
Databases of MEDLINE, CINAHL, PsycINFO, EMBASE, Scopus, Web of Science and Cochrane were searched for articles from 01/01/1990 to 31/12/2019. All studies were scored for their methodological rigour using Hawker's tool. Findings were synthesised using Popay's narrative synthesis method and interpreted using a critical realist lens and social exchange theory.
RESULTS
Out of 9336 initial database citations, 23 studies were included for synthesis. Five themes were developed during synthesis. 1. Presuppositions of oncologists and haematologists about palliative care referral: Role conflict, abandonment, rupture of therapeutic alliance and loss of hope were some of the presuppositions that hindered palliative care referral. Negative emotions and perception of self-efficacy to manage palliative care need also hindered referral. 2. Power relationships and trust issues: Oncologists and haematologists preferred to gatekeep the referral process and wished to control and coordinate the care process. They had diminished trust in the competency of palliative care providers. 3. Making a palliative care referral: A daunting task: The stigma associated with palliative care, navigating illness and treatment associated factors, addressing patient and family attitudes, and overcoming organisational challenges made referral a daunting task. Lack of referral criteria and limited palliative care resources made the referral process challenging. 4. Cost-benefit of palliative care referral: Pain and symptom management and psychosocial support were the perceived benefits, whereas inconsistencies in communication and curtailment of care were some of the costs associated with palliative care referral. 5. Strategies to facilitate palliative care referral: Developing an integrated model of care, renaming and augmenting palliative care resources were some of the strategies that could facilitate a referral.
CONCLUSION
Presuppositions, power relationships, trust issues and the challenges associated with the task of referrals hindered palliative care referral. Oncologists and haematologists appraised the cost-benefit of making a palliative care referral. They felt that an integrated model of care, changing the name of palliative care and augmenting palliative care resources might facilitate a referral.
Topics: Attitude of Health Personnel; Hematology; Humans; Medical Oncology; Palliative Care; Physicians; Referral and Consultation; Trust
PubMed: 33228651
DOI: 10.1186/s12904-020-00671-5 -
JPMA. the Journal of the Pakistan... Aug 2023To map literature on research ethics committees, institutional review boards and ethics review framework in Pakistan to identify key insights during public health...
OBJECTIVE
To map literature on research ethics committees, institutional review boards and ethics review framework in Pakistan to identify key insights during public health emergencies and normal times.
METHOD
The systematic scoping review was conducted in April 2022, and comprised literature search on PubMed, World Health Organisation Global Index Medicus and Summons databases for articles published between January 2005 and February 2022. Information extracted included authors' names, year of publication, title, study methodology, and key insights under the heads of challenges and solutions. Due to data heterogeneity, key themes were identified and analysed.
RESULTS
Of the 2,190 studies initially identified, 21(0.95%) were subjected to full-text review, and, from among them, 9(45%) were analysed in detail. There were 4 key insights identified: research ethics committees and institutional review boards in Pakistan remain unregulated as they are currently not registered or accredited by a competent national-level authority; most members of such committees are not formally trained to implement the mandate; internal and external pressures hinder independent decision-making of such committees; and other issues hindering the functionality and performance of research ethics committees and institutional review boards.
CONCLUSIONS
Despite existing publications calling for urgent policy and regulatory reforms, there is a dearth of literature and minimal policy actions underlying the fact that ethics review remains a neglected area in Pakistan.
Topics: Humans; Pakistan; Ethics Committees, Research; Learning; Databases, Factual
PubMed: 37697760
DOI: 10.47391/JPMA.8033 -
Health Research Policy and Systems Oct 2020Knowledge translation (KT) platforms are organisations, initiatives and networks that focus on supporting evidence-informed policy-making at least in part about the...
Lessons learned from descriptions and evaluations of knowledge translation platforms supporting evidence-informed policy-making in low- and middle-income countries: a systematic review.
BACKGROUND
Knowledge translation (KT) platforms are organisations, initiatives and networks that focus on supporting evidence-informed policy-making at least in part about the health-system arrangements that determine whether the right programmes, services and products get to those who need them. Many descriptions and evaluations of KT platforms in low- and middle-income countries have been produced but, to date, they have not been systematically reviewed.
METHODS
We identified potentially relevant studies through a search of five electronic databases and a variety of approaches to identify grey literature. We used four criteria to select eligible empirical studies. We extracted data about seven characteristics of included studies and about key findings. We used explicit criteria to assess study quality. In synthesising the findings, we gave greater attention to themes that emerged from multiple studies, higher-quality studies and different contexts.
RESULTS
Country was the most common jurisdictional focus of KT platforms, EVIPNet the most common name and high turnover among staff a common infrastructural feature. Evidence briefs and deliberative dialogues were the activities/outputs that were the most extensively studied and viewed as helpful, while rapid evidence services were the next most studied but only in a single jurisdiction. None of the summative evaluations used a pre-post design or a control group and, with the exception of the evaluations of the influence of briefs and dialogues on intentions to act, none of the evaluations achieved a high quality score.
CONCLUSIONS
A large and growing volume of research evidence suggests that KT platforms offer promise in supporting evidence-informed policy-making in low- and middle-income countries. KT platforms should consider as next steps expanding their current, relatively limited portfolio of activities and outputs, building bridges to complementary groups, and planning for evaluations that examine 'what works' for 'what types of issues' in 'what types of contexts'.
Topics: Developing Countries; Government Programs; Health Policy; Humans; Policy Making; Translational Research, Biomedical
PubMed: 33129335
DOI: 10.1186/s12961-020-00626-5 -
Implementation Science : IS Feb 2020Application of knowledge translation (KT) theories, models, and frameworks (TMFs) is one method for successfully incorporating evidence into clinical care. However,...
BACKGROUND
Application of knowledge translation (KT) theories, models, and frameworks (TMFs) is one method for successfully incorporating evidence into clinical care. However, there are multiple KT TMFs and little guidance on which to select. This study sought to identify and describe available full-spectrum KT TMFs to subsequently guide users.
METHODS
A scoping review was completed. Articles were identified through searches within electronic databases, previous reviews, grey literature, and consultation with KT experts. Search terms included combinations of KT terms and theory-related terms. Included citations had to describe full-spectrum KT TMFs that had been applied or tested. Titles/abstracts and full-text articles were screened independently by two investigators. Each KT TMF was described by its characteristics including name, context, key components, how it was used, primary target audience, levels of use, and study outcomes. Each KT TMF was also categorized into theoretical approaches as process models, determinant frameworks, classic theories, implementation theories, and evaluation frameworks. Within each category, KT TMFs were compared and contrasted to identify similarities and unique characteristics.
RESULTS
Electronic searches yielded 7160 citations. Additional citations were identified from previous reviews (n = 41) and bibliographies of included full-text articles (n = 6). Thirty-six citations describing 36 full-spectrum were identified. In 24 KT TMFs, the primary target audience was multi-level including patients/public, professionals, organizational, and financial/regulatory. The majority of the KT TMFs were used within public health, followed by research (organizational, translation, health), or in multiple contexts. Twenty-six could be used at the individual, organization, or policy levels, five at the individual/organization levels, three at the individual level only, and two at the organizational/policy level. Categorization of the KT TMFs resulted in 18 process models, eight classic theories, three determinant frameworks, three evaluation frameworks, and four that fit more than one category. There were no KT TMFs that fit the implementation theory category. Within each category, similarities and unique characteristics emerged through comparison.
CONCLUSIONS
A systematic compilation of existing full-spectrum KT TMFs, categorization into different approaches, and comparison has been provided in a user-friendly way. This list provides options for users to select from when designing KT projects and interventions.
TRIAL REGISTRATION
A protocol outlining the methodology of this scoping review was developed and registered with PROSPERO (CRD42018088564).
Topics: Delivery of Health Care; Humans; Models, Organizational; Research Design; Translational Research, Biomedical
PubMed: 32059738
DOI: 10.1186/s13012-020-0964-5 -
Indian Journal of Pharmacology 2021Registration of study protocols brings about transparency and traceability and the amount of publication bias can be estimated. In this study, we have collected and... (Meta-Analysis)
Meta-Analysis
INTRODUCTION
Registration of study protocols brings about transparency and traceability and the amount of publication bias can be estimated. In this study, we have collected and presented data regarding clinical study registries, preclinical, in vitro and in silico study registries across the globe.
MATERIALS AND METHODS
We searched via Google Search Engine with appropriate keywords e.g. name of country (n = 198), name of continent (n = 7), registry, study registry, animal, in silico, virtual, simulation, preclinical, animal, clinical trial. The overall pooled prevalence of clinical study registries and WHO primary registries in per continent was calculated using Medcalc software.
RESULTS
The overall pooled prevalence of clinical study registries were 13% in each continent. The prevalence of WHO primary study registries were 8.9% of the countries per continent. Overall, there are 17 primary registries associated with WHO ICTRP as primary registries, 2 partner registries and 6 registries are affiliated to ICMJE. However, the amount of preclinical animal study registry was quite less (n = 4). Regarding in vitro studies, only country specific in vitro fertilization registries were available, however, in other research domains, registries were absent. Only one simulation study registry was available.
CONCLUSION
At priori study registration is essential to deal with selective reporting. Comparison between study protocol and final report allows us to know the protocol deviations and allows us to evaluate risk of bias and internal validity of the research findings. Although trialists are responsible for the completeness of records, yet the registries must have some measures for their periodic update and quality control of the data.
Topics: Animals; Clinical Protocols; Clinical Trials as Topic; Drug Evaluation, Preclinical; Humans; Registries; World Health Organization
PubMed: 34100401
DOI: 10.4103/ijp.ijp_1090_20 -
Journal of Affective Disorders Mar 2023Currently, there is no clear answer to the question of how long antidepressants should be continued or when they can be safely discontinued. (Review)
Review
BACKGROUND
Currently, there is no clear answer to the question of how long antidepressants should be continued or when they can be safely discontinued.
METHODS
Pubmed/Medline was systematically searched from inception to Feb 20, 2021. Double-blind, randomized placebo-controlled trials (RCTs) with maintenance phase were selected to examine the relationship between relapse rate and treatment duration. Among 5351 screened records, 37 RCTs meeting inclusion criteria were selected. Odds ratios were calculated from relapse rates for each study and pooled in random-effect models. Possible predictors of effect sizes, i.e., open-label treatment duration, double-blind phase duration, age, medication type, history of recurrence, were analyzed by meta-regression.
RESULTS
The random-effects model showed the superiority of active medication over placebo for relapse during the follow-up phase (OR = 0.37; 95 % CI, 0.32-0.42). The meta-regression did not show a relationship between treatment duration and the effect sizes. Other clinical variables were not related with effect sizes. Subgroup analysis revealed that, for atypical ADs the effect size increased as the treatment duration increased. Further analysis showed that the relapse rate in the placebo group decreased as function of time, which reduced the absolute benefit of continued treatment.
CONCLUSION
The results may indicate that long term use of antidepressants may not be justified, and this strategy may expose the patients to more adverse effects.
Topics: Humans; Randomized Controlled Trials as Topic; Antidepressive Agents; Depressive Disorder, Major; Double-Blind Method; Recurrence
PubMed: 36623560
DOI: 10.1016/j.jad.2023.01.024 -
BioDrugs : Clinical Immunotherapeutics,... May 2024Hesitation about using biosimilars still exists among healthcare professionals (HCPs), despite extensive experience with their use. Globally, several health...
BACKGROUND
Hesitation about using biosimilars still exists among healthcare professionals (HCPs), despite extensive experience with their use. Globally, several health organisations and societies from various specialties have issued biosimilar position statements to guide the use of biosimilars in their specialties. However, it is uncertain how similar or different their positions or recommendations are or whether these positions have evolved with the increased experience and availability of new evidence.
OBJECTIVES
The study aimed to describe and assess the recommendations of published position statements regarding several aspects of biosimilars across specialties and determine whether these positions have changed with the emergence of new evidence.
METHODS
We systematically searched for published position statements of biosimilars in online databases and included statements written in English. The search was from the inception of the databases until May 2023. Two reviewers independently extracted the data. Only position statements that included recommendations to guide the use of biosimilars in clinical practice and were issued by health organisations and societies, including expert panels, were included. We synthesised recommendations on five aspects: prescribing practice, extrapolation of indication, interchangeability, treatment initiation with biosimilars in biologic-naïve patients, and pharmacovigilance.
RESULTS
The review included 25 papers involving eight specialties, 16 of which were from European countries, 1 from an international organisation representing 49 countries, and 6 from various countries. The papers were published between 2009 and 2020, with 19 published between 2015 and 2020. Of the five aspects of biosimilars assessed, nearly half (11 of 25) of the papers at the time they were published did not base their positions on a scientific or evidence-based approach. Only 4 of the 25 position papers were identified as revisions of their previous papers. With increasing experience in biosimilars and the emergence of new evidence, about 60% (16 of 25) of the papers contained outdated recommendations, particularly on two aspects. They were extrapolations of indications and interchangeability (including switching). The recommendations for most papers for three other aspects were still appropriate. These were prescribing biosimilars by their brand name and active ingredient, initiating treatment with biosimilars in biologic-naïve patients, and monitoring the long-term safety of biosimilars through pharmacovigilance. For four of the revised papers, their position evolved from opposing indication extrapolation for biosimilars to accepting it, while the position of two papers shifted from not recommending biosimilar switching to permitting the practice. Meanwhile, most papers were against automatic substitution by pharmacists because the evidence for this practice was still limited.
CONCLUSIONS
Across specialties, the variability among the position statements is seen for extrapolation of indications for biosimilars and interchangeability (including switching). This requires a revision, considering the latest evidence and growing experience with the use of biosimilars in extrapolated indications and with switching.
Topics: Biosimilar Pharmaceuticals; Humans; Pharmacovigilance; Practice Guidelines as Topic
PubMed: 38472644
DOI: 10.1007/s40259-024-00649-2