Quality Of Clinical Evidence Research Articles

Hormone replacement therapy and non-gynaecological cancers.

There is lack of knowledge and awareness about HRT use in non-gynaecological cancer survivors. The decision to advocate or discourage HRT in such women depends on various factors, including cancer type, hormone sensitivity, and individual patient characteristics. The paucity of available good quality clinical evidence and epidemiological data leads to lack of consensus in such cases. This article aims to address this knowledge gap by conducting a comprehensive qualitative analysis of the existing literature pertaining to HRT use in non-gynaecological cancer survivors. We conducted a literature review. A systematic review was not possible because of lack of good quality research. We excluded case reports. A total of 55 papers were identified and all of these have been referenced. We have presented the inconsistencies and uncertainties in the evidence available from the limited information available from cohort studies. Prescription of HRT in cancer survivors of many hormone dependent non-gynaecological cancers needs careful consideration of histology of the cancer and consideration about liaison with the concerned oncology team.

Thrombopoietin Receptor Agonists as Second-Line Treatment in Children With Ongoing Immune Thrombocytopenia

What Is the Issue? Immune thrombocytopenia (ITP) is an autoimmune disorder characterized by low platelets and an increase in bleeding risk; in the pediatric population, the reported incidence rate varies between 2 and 5 per 100,000 children per year. Spontaneous remission may be observed in up to 70% of patients, while 20% of patients may experience severe bleeding symptoms. In children whose ITP does not respond to first-line corticosteroids, IV immunoglobulin (IVIG), or anti-D immunoglobulin, guidelines recommend the use of thrombopoietin receptor agonists (TPO-RAs), i.e., eltrombopag or romiplostim (avatrombopag did not have a marketing authorization and Notice of Compliance at the time that the review was initiated). Rituximab is considered a subsequent-line of therapy. Splenectomy is not usually considered an appropriate treatment option in children. The goal of therapy in pediatric patients with ITP is to reduce bleeding and improve quality of life. Platelet response is considered a valid and appropriate surrogate end point in studies and routine assessment in clinical practice. Children whose ITP does not respond to available first-line drugs may require subsequent treatment with off-label drugs because they do not have access to TPO-RAs. What Did We Do? We searched key resources, including journal citation databases, and conducted a focused internet search for relevant evidence. A systematic review of the literature identified 5 studies (4 randomized controlled trials [RCTs] and 1 observational study), which were synthesized narratively. The review addressed the following policy questions: In children with ongoing, active ITP, what is the overall body of evidence supporting the use of TPO-RAs and rituximab after failure of first-line therapies? Based on the level and quality of clinical evidence, should TPO-RAs be reimbursed for use earlier in the treatment sequencing for children with ongoing, active ITP, instead of being reimbursed only after a course of rituximab? What Did We Find? Evidence from 2 RCTs (n = 159) suggests that eltrombopag likely increases and maintains platelet response over time, in addition to decreasing the use of rescue medication and clinically significant bleeding compared to placebo, which were considered clinically meaningful outcomes for pediatric patients with ITP. There was a low risk of bias in the studies, but uncertainty was introduced due to the small sample sizes. Evidence from 1 RCT (n = 62) suggests that romiplostim may also increase and maintain platelet response, as well as reduce clinically significant bleeding compared to placebo. However, there was some concern due to a high risk of bias in the studies and uncertainty due to the small sample size, which suggests a need for caution in the interpretation of the findings. The effectiveness of rituximab was inconclusive due to the lack of evidence, as no comparative RCTs could be identified, while the observational study included presented only descriptive comparisons. No evidence was identified in support of trying rituximab before accessing TPO-RAs. What Does This Mean? Given that ITP is rare in children, there is a gap in available relevant evidence, and robust evidence from large RCTs in this patient population are unlikely to be conducted. Jurisdictions may consider requesting an implementation advice panel for use of eltrombopag and romiplostim after failure of first-line therapies in children with ongoing, active ITP.

What matters most to pediatric rheumatologists in deciding whether to discontinue biologics in a child with juvenile idiopathic arthritis? A best-worst scaling survey.

Care for JIA patients has been transformed in the biologics era; however, biologics carry important (although rare) risks and are costly. Flares after biological withdrawal are seen frequently, yet there is little clinical guidance to identify which patients in clinical remission can safely have their biologic discontinued (by stopping or tapering). We examined what characteristics of the child or their context are important to pediatric rheumatologists when making the decision to discuss withdrawal of biologics. We conducted a survey including a best-worst scaling (BWS) exercise in pediatric rheumatologists who are part of the UCAN CAN-DU network to assess the relative importance of 14 previously identified characteristics. A balanced incomplete block design was used to generate choice tasks. Respondents evaluated 14 choice sets of 5 characteristics of a child with JIA and identified for each set which was the most and least important in the decision to offer withdrawal. Results were analyzed using conditional logit regression. Fifty-one (out of 79) pediatric rheumatologists participated (response rate 65%). The threemost important characteristics were how challenging it was to achieve remission, history of established joint damage, and time spent in remission. The threeleast important characteristics were history of temporomandibular joint involvement, accessibility of biologics, and the patient's age. These findings give quantitative insight about factors important to pediatric rheumatologists' decision-making about biologic withdrawal. In addition to high quality clinical evidence, further research is needed to understand the perspective of patients and families to inform shared decision-making about biologic withdrawal for JIA patients with clinically inactive disease. Key Points ● What is already known on this topic-there is limited clinical guidance for pediatric rheumatologists in making decisions about biologic withdrawal for patients with juvenile idiopathic arthritis who are in clinical remission. ● What this study adds-this study quantitatively examined what characteristic of the child in clinical remission, or of their context, are most important to pediatric rheumatologists in deciding whether to offer withdrawal of biologics. ● How this study might affect research, practice or policy-understanding of these characteristics can provide useful information to other pediatric rheumatologists in making their decisions, and may guide areas to focus on for future research.

Quality of clinical evidence and political justifications of ivermectin mass distribution of COVID-19 kits in eight Latin American countries

BackgroundSeveral countries in Latin America conducted mass distribution of COVID-19 kits intended to treat mild COVID-19, thereby preventing excess hospitalisations. Many of the kits contained ivermectin, an antiparasitic medicine that...

Assessment of Autologous Blood marker localIzation and intraoperative coLonoscopy localIzation in laparoscopic colorecTal cancer surgery (ABILITY): a randomized controlled trial

BackgroundLaparoscopic colorectal surgery has been proved to have similar oncological outcomes with open surgery. Due to the lack of tactile perception, surgeons may have misjudgments in laparoscopic colorectal surgery. Therefore, the accurate localization of a tumor before surgery is important, especially in the early stages of cancer. Autologous blood was thought a feasible and safe tattooing agent for preoperative endoscopic localization but its benefits remain controversial. We therefore proposed this randomized trial to the accuracy and safety of autogenous blood localization in small, serosa-negative lesion which will be resected by laparoscopic colectomy.MethodsThe current study is a single-center, open-label, non-inferiority, randomized controlled trial. Eligible participants would be aged 18–80 years and diagnosed with large lateral spreading tumors that could not be treated endoscopically, malignant polyps treated endoscopically that required additional colorectal resection, and serosa-negative malignant colorectal tumors (≤ cT3). A total of 220 patients would be randomly assigned (1:1) to autologous blood group or intraoperative colonoscopy group. The primary outcome is the localization accuracy. The secondary endpoint is adverse events related to endoscopic tattooing.DiscussionThis trial will investigate whether autologous blood marker achieves similar localization accuracy and safety in laparoscopic colorectal surgery compared to intraoperative colonoscopy. If our research hypothesis is statistically proved, the rational introduction of autologous blood tattooing in preoperative colonoscopy can help improve identification of the location of tumors for laparoscopic colorectal cancer surgery, performing an optimal resection, and minimizing unnecessary resections of normal tissues, thereby improving the patient’s quality of life. Our research data will also provide high quality clinical evidence and data support for the conduction of multicenter phase III clinical trials.Trial registrationThis study is registered with ClinicalTrials.gov, NCT05597384. Registered 28 October 2022

A review of clinical efficacy data supporting emergency use authorization for COVID-19 therapeutics and lessons for future pandemics.

Emergency Use Authorization (EUA) allows the US Food and Drug Administration (FDA) to expedite the availability of therapeutics in the context of a public health emergency. To date, an evidentiary standard for clinical efficacy to support an EUA has not yet been established. This review examines the clinical data submitted in support of EUA for antiviral and anti‐inflammatory therapeutics for coronavirus disease 2019 (COVID‐19) through December of 2021 and the resilience of the authorization as new clinical data arose subsequent to the authorization. In the vast majority of cases, EUA was supported by at least one well‐powered randomized controlled trial (RCT) where statistically significant efficacy was demonstrated. This included branded medications already approved for use outside of the context of COVID‐19. When used, the standard of a single RCT seemed to provide adequate evidence of clinical efficacy, such that subsequent clinical studies generally supported or expanded the EUA of the therapeutic in question. The lone generic agent that was granted EUA (chloroquine/hydroxychloroquine) was not supported by a well‐controlled RCT, and the EUA was withdrawn within 3 months time. This highlighted not only the ambiguity of the EUA standard, but also the need to provide avenues through which high quality clinical evidence for the efficacy of a generic medication could be obtained. Therefore, maintaining the clinical trial networks assembled during the COVID‐19 pandemic could be a critical component of our preparation for future pandemics. Consideration could also be given to establishing a single successful RCT as regulatory guidance for obtaining an EUA.

Food Emulsifiers and Metabolic Syndrome: The Role of the Gut Microbiota.

The use of emulsifiers in processed foods and the rapid epidemic development of metabolic syndrome in Western countries over the past 20 years have generated growing interest. Evidence for the role of emulsifiers in metabolic syndrome through gut microbiota has not been clearly established, thus making it challenging for clinical nutritionists and dietitians to make evidence-based associations between the nature and the quantity of emulsifiers and metabolic disorders. This narrative review summarizes the highest quality clinical evidence currently available about the impact of food emulsifiers on gut microbiota composition and functions and the potential development of metabolic syndrome. The state-of-the-art of the different common emulsifiers is performed, highlighting where they are present in daily foods and their roles. Recent findings of in vitro, in vivo, and human studies assessing the effect of different emulsifiers on gut microbiota have been recently published. There is some progress in understanding how some food emulsifiers could contribute to developing metabolic diseases through gut microbiota alterations while others could have prebiotic effects. However, there are still many unanswered questions regarding daily consumption amounts and the synergic effects between emulsifiers’ intake and responses by the microbial signatures of each individual.

Changing trends in clinical research literature on PubMed database from 1991 to 2020

BackgroundClinical research publications have become the dominant source and basis of clinical evidence-based decision-making. Exploring the type and quantity of clinical research publications in the PubMed database is useful for clarifying the changing trends of clinical research development in recent years. Therefore, a longitudinal analysis of the type and quantity of clinical research publications in the PubMed database over three decades was conducted.MethodsThe PubMed database was searched to retrieve clinical research according to the type and year of publication from January 1, 1991 to December 31, 2020. The research types were classified as primary and secondary literature.ResultsA total of 1,078,404 primary literatures were retrieved and the constituent proportions were ranked from high to low as case report/series (27.54%), randomized clinical trials (RCTs) (23.62%), cohort studies (21.05%), cross-sectional studies (17.49%), case control studies (9.15%), non-RCTs (1.01%), and pragmatic clinical trials (PCTs) (0.15%). Correspondingly, 1,302,173 secondary literatures were retrieved and ranked as narrative review (70.88%), systematic review (15.02%), systematic review and meta-analyses (13.89%), traditional meta-analyses (4.48%), expert consensus (2.31%), guidelines (1.49%), scoping reviews (0.68%), net meta-analyses (0.40%), and umbrella reviews (0.04%). The average annual growth rate for the primary literature was 10.28%, and ranked from high to low as PCTs (83.68%), cohort studies (17.74%), cross-sectional studies (17.61%), non-RCTs (12.11%), case control studies (8.86%), RCTs (7.68%), case report/series (7.51%); while that for the secondary literature was 10.57%, and ranked from high to low as net meta-analyses (48.97%), umbrella reviews (47.09%), scoping reviews (41.92%), systematic reviews and meta-analyses (33.44%), systematic reviews (33.05%), traditional meta-analyses (12.49%), expert consensuses (9.22%), narrative review (8.72%), and guidelines (2.82%). ConclusionBoth the composition and number of clinical studies changed significantly from 1991 to 2020. Based on the trend, the case report/series, case control study, and narrative review are on the decline, while cohort study, cross-sectional study, systematic reviews, and systematic review and meta-analysis literature have increased. To improve the quality of clinical evidence, we recommend RCT and cohort study give priority to access to allocated research resources in future.

Evaluating the quality of clinical evidence in gastrointestinal cancers PubMed searches: How relevant are the results?

11037 Background: Bibliographic repositories have become increasingly important as clinical evidence is more accessible on the internet. Often, oncologists rely on published literature to guide patient care. However, with the proliferation of journals and increasing number of peer reviewed papers, current search strategies have the potential to retrieve large numbers of irrelevant or misleading articles. Moreover, access to current best evidence may require paid subscriptions. Here, we assessed the quality of retrieved medical literature pertaining to treatment of gastrointestinal cancers using the PubMed database. Methods: We interrogated 6 focused-therapy questions in 3 categories: medical oncology (MedOnc), surgical oncology (SurgOnc), and alternative medicine (AltMed). We extracted journal metrics of the first two pages (40 results) from each search. We defined the composite outcome “relevant result” as the product of removing results from 1) predatory journals (Beall’s list), 2) non-English language, and 3) no free access publications. As a sensitivity analysis, we defined 2007 as a cutoff for “relevant” publications and Impact Factor (IF) > 3 or H-index > 50. Results: Two hundred and forty results were retrieved (80 per search type). Forty-eight percent of the journals were European (n = 115), 40% US-based (n = 96), and 94% were in English (n = 225). Most journals (n = 170; 70.8%) had an IF between 1-10, followed by ̃21% with an IF > 10 (n = 51); yet ̃45% (n = 107) were in the Clarivate Analytics top quartile. Sixty percent (n = 139) of articles were free to access. The articles had a median H-index of 117 [IR 59, 168]. When modelling the multivariate association with “relevant result”, year of publication after 2007 had an OR = 1.07 (95% CI = 1.01-1.14; p< 0.02) and availability through GOLD Open Access by Clarivate Analytics had an OR = 1.09 (95% CI = 1.03-1.15; p< 0.0008). MedOnc retrieved more papers published in journals with IF > 10 (n = 31; 38.8%) than SurgOnc searches (n = 12; 15%; p< 0.001). Only the AltMed searches included non-peer reviewed publications (n = 4; 5%) and 4 results were from “predatory journals”, all in MedOnc. Conclusions: Articles had a 7% higher chance of being considered a “relevant result” if they were published after 2007 and a 9% higher chance if available under GOLD Open Access. Publications identified as “relevant results” with an IF or H-index above the established cutoffs, had a 6% higher chance to be in the top 40 PubMed search results. In the sensitivity analysis the results remain virtually unchanged. Importantly, nearly 40% of papers indexed in PubMed do not have free full-text articles, making them unavailable to oncologists without access to a medical library or paid subscription. These results highlight the imperative to deliver relevant, freely accessible information that can impact the care of the cancer patients.

Is There a Place for Medicinal Cannabis in Treating Patients with Sleep Disorders? What We Know so Far.

The legalization of cannabis for medicinal, and in some countries, recreational, purposes in addition to growth in the cannabis industry has meant that cannabis use and interest in the area has increased rapidly over the past 20 years. Treatment of poor sleep and sleep disorders are two of the most common reasons for the current use of medicinal cannabis. However, evidence for the role of medical cannabis in the treatment of sleep disorders has not been clearly established, thus making it challenging for clinicians to make evidence-based decisions regarding efficacy and safety. This narrative review summarizes the highest quality clinical evidence currently available in relation to the use of medicinal cannabis for the treatment of sleep disorders including insomnia, obstructive sleep apnea, restless legs syndrome, rapid eye movement sleep behavior disorder, nightmare disorder and narcolepsy. A summary of the effect of cannabis on sleep quality and architecture is also presented. Currently, there is insufficient evidence to support the routine use of medicinal cannabis as an effective and safe treatment option for any sleep disorder. Nevertheless, emerging evidence is promising and warrants further investigation using standardized cannabinoid products and validated quantitative measurement techniques.

Arthroereisis: Treatment of Pes Planus.

Arthroereisis is a surgical procedure primarily used to treat flexible pes planus (flatfoot) in pediatric and young adult patients. The principal goal of subtalar arthroereisis is to relieve pain and restore function. This is primarily done by restoring the medial foot arch without fusing the subtalar joint and without requiring a long recovery period needed after osteotomies. Although the procedure can be performed in isolation to treat flexible flatfoot, it can also be performed as an ancillary in the treatment of tarsal coalition, posterior tibial tendon dysfunction, and accessory navicular syndrome. Various implants and multiple surgical techniques exist for arthroereisis, such as the sinus tarsi implant and calcaneo-stop. The type of device and the surgical approach to proceed with are based on the surgeon’s discretion rather than an evidence-based protocol. Multiple complications can arise from subtalar arthroereisis, most commonly sinus tarsi pain. Currently, there is a dearth of quality clinical data and evidence on the long-term outcomes and complications of arthroereisis. This lack of literature for a commonly performed procedure validates the need for future studies to better guide a standard protocol, reach consensus on well-defined indications and contraindications, provide expected complications, and improve the practice of evidence-based medicine.

Flexor Digitorum Longus Transfer for Posterior Tibial Tendon Dysfunction is the Standard of Care: Does the Evidence Support It?

Category:Basic Sciences/Biologics; Hindfoot; OtherIntroduction/Purpose:Flexor digitorum longus (FDL) transfer, in conjunction with osseous procedures, is used routinely for the treatment of posterior tibial tendon dysfunction (PTTD). It is well established however that the relative power of the FDL tendon is significantly inferior than that of the native posterior tibial tendon. The purpose of this study is to systematically evaluate the evidence that supports or refutes the use of an FDL transfer in the surgical treatment of PTTD.Methods:A systematic review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta- Analysis. Using the terms 'flexor digitorum longus OR FDL AND posterior tibial tendon dysfunction OR PTTD OR adult acquired flatfoot OR AAFD' we searched the PubMed/Medline database. Both clinical and biomechanical studies were eligible for inclusion.Results:Forty-one studies met the inclusion criteria, including 31 clinical studies and 10 biomechanical in vitro studies. All 31 clinical studies consisted of Level IV evidence, and support the use of an FDL transfer. There was significant heterogeneity of the clinical evidence due to the variety of concomitant procedures. Of the 10 biomechanical in vitro studies, 2 support the use of an FDL transfer, although these did not assess the procedure in isolation. 8 biomechanical in vitro studies specifically assessing the effect on of an FDL transfer contradict its use for PTTD.Conclusion:There is poor quality clinical evidence to support the use of an FDL transfer for PTTD and the biomechanical literature refutes the use of the procedure. It remains unknown if the clinical improvement reported in the literature can be attributed to the FDL transfer or the concomitant osseous procedures. Additional studies are needed to assess the validity of the FDL transfer and whether alternatives are available to preserve the PTT muscle.

The Assessment of the Innovativeness of a New Medicine in Italy.

Objectives: Starting from April 2017, the Italian Medicine Agency (AIFA) has approved new criteria for defining any new medicinal product with an innovative indication. The purpose of the study is to analyze the activity of innovativeness evaluation according to the new approach, to estimate the weight of each criterion considered for innovativeness definition, and to evaluate how the new approach works in terms of consistency and reproducibility.Methods: A retrospective analysis was performed on the final reports evaluating the drug innovativeness assessment published on the AIFA's website between April 2017 and January 2021. Descriptive statistics, chi-square test, whether the conditions were respected, or Fisher's exact test was used to explore the association between characteristics of drugs and the innovativeness status and the association between the three criteria. Profiles of the decision process and their relationship with innovativeness response were described. In order to evaluate the weight of each criterion in predicting the innovativeness status, a Classification Tree (CT) algorithm was applied.Results: Overall, of the 109 published drugs reports, 37 (33.9%) were recognized as fully innovative, 29 (26.6%) were considered conditionally innovative, while for 43 (39.4%) reports innovativeness was not recognized. Considering the three criteria of the decision process, the added therapeutic value was the only criterion statistically associated with a drug's degree of innovation (p < 0.001). The therapeutic need and the quality of clinical evidence were statistically associated (p = 0.008) even if only a mild association was observed. The added therapeutic value was the most important variable in predicting the innovativeness status according to the classification tree (CT) model applied, achieving an accuracy of 89.4%. No difference was found between orphans and non-orphan drugs or oncological and non-oncological drugs.Discussion: The added therapeutic value is the most important criterion of the multidimensional approach for the innovativeness status definition of a new medical product. A mild association was found between the therapeutic need and the quality of evidence. Overall, similar decision profiles bring the same evaluation of innovativeness status, indicating a good consistency and reproducibility between decisions.

Participation of Black and Hispanic women in clinical trial evidence for NCCN preferred systemic therapies in advanced ovarian cancer

<h3>Objectives:</h3> Minority participation in clinical trials is important for expanding opportunities in access to cancer therapies and may aid in understanding racial disparities in oncology care. Prior studies have identified underrepresentation in gynecologic oncology phase I recruitment and large group trials in the United States, but minority participation specific to trials that drive current treatment recommendations remains unclear. We sought to evaluate minority participation as described in publications of curated, high quality clinical evidence for ovarian cancer therapies as identified by the National Comprehensive Cancer Network (NCCN). <h3>Methods:</h3> NCCN Clinical Practice Guidelines for Ovarian Cancer, Version 1.2020, was accessed in order to identify evidence provided for ‘preferred' primary and recurrent systemic therapies and dosing regimens in advanced epithelial ovarian cancer using explicitly listed citations. Race and ethnicity data of trial enrollment provided in publications listed as references was manually abstracted. <h3>Results:</h3> We identified 26 prospective trials including 13,887 participants, published across 5 journals: <i>New England Journal of Medicine, Lancet, Lancet Oncology, Gynecologic Oncology,</i> and <i>Journal of the National Cancer Institute.</i> All were phase II or III trials and 96% of trials were published in or more recently than 2003. Of these trials, race or ethnicity was reported in only 9 publications (35%). Of these 9 publications, there was marked language variation between trials in reporting race and ethnicity. There were 7 trials that included a description of participants as Black or African American. Of the 4,701 women who participated in these trials, 206 were Black or African American, representing approximately 4% of trial participants. There were 4 trials that included a description of participants as Hispanic. Of the 3,436 women who participated in these trials, 152 were Hispanic, representing approximately 4% of trial participants. <h3>Conclusions:</h3> Of the clinical trial evidence for preferred systemic therapies identified in the NCCN clinical practice guidelines for advanced ovarian cancer, minority participation was reported in less than half of publications and description of race and ethnicity varied between trials. Of trials that reported minority participation, Black and hispanic women represented <5% of trial participants, respectively.

Strength of clinical evidence leading to approval of novel cancer medicines in Europe: A systematic review and data synthesis.

We aimed to evaluate the quality of clinical evidence that substantiated approval of cancer medicines by the European Medicines Agency (EMA) in the last decade. We performed a systematic review and data synthesis of EMA documents in agreement with PRISMA guidelines. We included the European Public Assessment Reports, Summaries of Product Characteristics, and published randomized controlled trials (RCTs) on anti‐cancer drugs approved by EMA from 2010 to 2019, and excluded drugs not indicated for targeting solid or hematological tumors and non‐innovative treatments. We synthesized frequencies of approvals differentiating between unblinded and blinded RCTs with and without overall survival (OS) as a predefined primary outcome measure. We assessed the frequency of post‐approval RCTs for indications without at least one RCT at the time of approval. Of 199 approvals, 159 (80%) were supported by at least one RCT, 63 (32%) by at least one RCT having OS as the primary or co‐primary endpoint, 74 (37%) by at least one blinded RCT, and 30 (15%) by at least one blinded RCT having OS as the primary or co‐primary endpoint. Whereas 40 approvals (20%) were not supported by any RCT and, of those, 9 (22%) were followed by a post‐approval RCT. While the majority of approvals of cancer medicines approved by EMA was supported by at least one RCT, we noted substantial methodological heterogeneity of the studies. Clinical trial registration: PROSPERO registration number CRD42020206669.

Decision making in the management of adults with malignant colorectal polyps: An exploration of the experiences of patients and clinicians.

A diagnosis of colorectal polyp cancer presents a treatment dilemma. The decision between segmental resection versus endoscopic surveillance is difficult due to a lack of good quality clinical evidence for either option. The aim of this study was to understand the decision making experiences of both clinicians and patients when faced with such a diagnosis. Qualitative, semi-structured interviews were undertaken with 10 clinicians involved in the care of patients diagnosed with polyp cancer and five patients who had experience of a diagnosis of polyp cancer. All clinicians and patients were from four hospital trusts across the north of England. Interviews were audio-recorded, transcribed verbatim and analysed using the principles of interpretative phenomenological analysis. Analysis of the interview transcripts evidenced that clinicians and patients were supportive of a shared approach to treatment decision making in the context of a diagnosis of colorectal polyp cancer. Uncertainty, influences and information were among the themes identified to be preventing this happening at present. This study identified themes which were common to both groups. These were complexity of the risk information, lack of patient information resources, and system factors and time. This research study has evidenced several factors such as uncertainty, complexity of risk information and influences on decisions which are preventing patients being involved in treatment decisions following a diagnosis of colorectal polyp cancer. Recommendations for improvements in practice, including a framework to assist treatment decision making in the future, are highlighted.

Compilation of registered clinical trials for the treatment of COVID-19 infection

The Wuhan city, the capital of Hubei province in China became the focal point for origin of virulent disease which later named as COVID-19. This paper aims to analyze the on-going clinical trials for drugs/interventions used for treatment of COVID-19 infection in open domain. The data on ongoing clinical trials on COVID-19 was retrieved from database clinicaltrials.gov. The data extracted includes national clinical trial registry number, title of study, recruitment status, results availability, intervention, outcome measure, sponsorship, study types, study design, start and completion dates, and location. All the extracted data was analyzed. As on 10th August 2020, a total of 2935 trials were registered in different countries. Of which 1115 trials are being conducted in Europe and 640 in United States of America (USA). Majority of COVID-19 clinical trials (95%) were enrolling all age groups including children and older adults. Similarly, majority of trials were including both genders (97%). Among all these clinical trials ongoing on COVID-19, 1645 were interventional, 1266 were observational studies. In interventional study 876 trials used drug intervention. Among all these trials 390 different drug interventions are being tried. Among these hydroxychloroquine, antiretrovirals and angiotensin converting enzyme (ACE) inhibitors were top three drug groups. The conduct of clinical trials in time of pandemic have so many tenacious issues that need to be addressed. It is very important to utilize the resources efficiently such as following a standard protocol then one can easily pool the data of various trials conducted at various places. Given the smaller sample sizes, long completion period, high risk of bias and imprecise information, it will take quite a long time to obtain high quality clinical evidence for the treatment of COVID-19 infection.

Cannabis sativa subsp. sativa's pharmacological properties and health effects: A scoping review of current evidence.

IntroductionHemp (Cannabis sativa subsp. sativa), commonly used for industrial purposes, is now being consumed by the public for various health promoting effects. As popularity of hemp research and claims of beneficial effects rises, a systematic collection of current scientific evidence on hemp’s health effects and pharmacological properties is needed to guide future research, clinical, and policy decision making.ObjectiveTo provide an overview and identify the present landscape of hemp research topics, trends, and gaps.MethodsA systematic search and analysis strategy according to the preferred reporting items for systematic review and meta-analysis-ScR (PRISMA-ScR) checklist on electronic databases including MEDLINE, OVID (OVFT, APC Journal Club, EBM Reviews), Cochrane Library Central and Clinicaltrials.gov was conducted to include and analyse hemp research articles from 2009 to 2019.Results65 primary articles (18 clinical, 47 pre-clinical) were reviewed. Several randomised controlled trials showed hempseed pills (in Traditional Chinese Medicine formulation MaZiRenWan) improving spontaneous bowel movement in functional constipation. There was also evidence suggesting benefits in cannabis dependence, epilepsy, and anxiety disorders. Pre-clinically, hemp derivatives showed potential anti-oxidative, anti-hypertensive, anti-inflammatory, anti-diabetic, anti-neuroinflammatory, anti-arthritic, anti-acne, and anti-microbial activities. Renal protective effects and estrogenic properties were also exhibited in vitro.ConclusionCurrent evidence on hemp-specific interventions are still preliminary, with limited high quality clinical evidence for any specific therapeutic indication. This is mainly due to the wide variation in test item formulation, as the multiple variants of this plant differ in their phytochemical and bioactive compounds. Future empirical research should focus on standardising the hemp plant for pharmaceutical use, and uniformity in experimental designs to strengthen the premise of using hemp in medicine.

Prostate Cancer: People Transforming A Diagnosis, A Diagnosis Transforming People

Prostatic specific antigen (PSA) screening has been controversial since its inception. Controversy has persisted despite more and higher quality clinical evidence. Attention to lead and length time biases, overdiagnosis, overtreatment, medicalisation, iatrogenesis and financial conflict of interest has had limited impact. I undertook a social history of the prostate cancer diagnosis to reassess the causes of controversy and suggest different clinical and policy responses. For much of the twentieth century, clinicians were uninterested in early detection and radical treatment, believing that cancers revealed after obstruction-relieving surgery or autopsy could be ignored. In 1985, the FDA approved PSA diagnostic tests, which rapidly catalysed two self-reinforcing cycles of action and perception. One occurred when the increased diagnoses made the disease more prevalent and feared, and efforts at prevention and treatment seem more efficacious, leading to more screening, and so on. The other cycle occurred among men with screening detected cancer who initially eschewed radical treatments or imagined doing so, whose lives were often consumed with fear and surveillance, increasing demand for radical cures. This history underscores the need for novel clinical and policy responses to the looping effects—self-reinforcing cycles of action and perception—which can radically transform so much of what we believe and do about disease.

Invited review: Probiotic yogurt quality criteria, regulatory framework, clinical evidence, and analytical aspects

Yogurt is a milk-based product manufactured by lactic acid fermentation enabled by symbiotic yogurt cultures. Yogurt is largely considered to be a health product, and it is employed to deliver probiotics and prebiotics to the consumer. However, not all yogurts are probiotic, neither are they all functional products. There is increasing demand for health-promoting beverages, which is prompting the dairy industry to develop functional probiotic yogurts to meet the demand. However, there seems to be a scarcity of reviews providing critical information on regulatory frameworks in regions of the world, clinical trial outcomes, and methodological approaches for enumerating multiprobiotic strains in yogurt. This review, relating to functional probiotic yogurt, covers the newest information on the topic for the period mostly between 2014 and 2019. Conformance to regulations is paramount and hence, global regulatory frameworks for probiotic yogurt and prebiotic and nonprebiotic ingredients included in yogurt are reviewed. The paper emphasizes the need for convincing clinical trial outcomes that provide the dairy industry with an opportunity to market products with substantiated beneficial claims. The paper also discusses probiotic strains in functional yogurt, which is required to have population levels above the recommended therapeutic minimum during shelf life. The multiprobiotic species added to yogurt may present challenges relating to methodological and analytical approaches needed to determine viability of each strain contained in such yogurt. Hence, the review also presents the pros and cons of the culture-dependent and culture-independent approaches for the enumeration of probiotic cells in yogurt. The review is arguably valuable to the dairy industry, functional food developers, related scientists, and researchers, as well as policy makers.