scholarly journals Systematic Review of Non-Conventional Dosing of Oral Anticancer Therapies in Malignant Haematology

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 5915-5915
Author(s):  
Faouzi Djebbari ◽  
Nicola Stoner ◽  
Verna Lavender
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Cancer Therapy ◽  
Cohort Studies ◽  
Case Reports ◽  
Survival Outcomes ◽  
Anti Cancer ◽  
Dosing Strategies ◽  
Comprehensive Search

Abstract Introduction Survival outcomes for patients with lymphoid, myeloid and plasma cell malignancies, have improved with the use of oral small molecule inhibitory agents. Oral anti-cancer therapies are often administered continuously and can have significant side-effects, which can adversely impact adherence, quality of life (QoL) and survival outcomes. In order to improve tolerability, non-standard dosing strategies are increasingly adopted in clinical practice; although, with limited guidance. A systematic review was conducted to identify evidence of, and outcomes from, non-conventional dosing of oral anti-cancer therapy in malignant haematology. Methods A comprehensive search of all oral anti-cancer therapy listed in the British National Formulary for use to treat haematological malignancies was undertaken using the following databases: MEDLINE®, EMBASE®, and Cochrane Library©, and Cumulative Index to Nursing and Allied Health Literature (CINAHL©). The search was expanded using prospective citation chaining in the Web of Science and retrospective snowballing of reference lists of included studies to ensure a sensitive, comprehensive search. Studies were selected based on predefined inclusion/exclusion criteria, and were critically appraised. Extracted data were tabulated to summarise key findings, which were analysed by type of non-dosing strategy: dose interruption; dose reduction; and other dosing strategies. Results Eleven studies were included and reviewed: two late phase clinical trials, four cohort studies, and five case reports. Findings from each included study (aim, design, treatment schdeule, reported efficacy/toxicty/QoL outcomes) are presented in the accompanying Table 1. These studies evaluated non-standard dosing of dasatinib, imatinib, lenalidomide and thalidomide. Four studies were conducted in Italy, four in the US, and one in Brazil, South Korea and UK. Dose reductions were the most commonly reported strategy (five studies). Two studies reported dose interruptions and four reported other dosing strategies. The quality of the studies ranged from moderate to high (e.g. clinical trials) to moderate to low (e.g. case reports). Russo et al (2015) conducted a single arm, open-label trial, in which the use of one month on/one month off schedule of imatinib was investigated in 96 CML patients aged ≥65 years. Although this trial did not report toxicity or QoL outcomes, there were no transformations (progressions) of CML to an accelerated or blast phase of disease using this alternative schedule. Therefore, results do not draw definitive conclusions that intermittent treatment can be offered to optimal and stable responders. However, they indicate a role for alternative treatment schedules tailored to individual patients, particularly those experiencing significant toxicities. Mangiacavalli et al (2012) investigated efficacy and adverse effects of a one-week interruption of thalidomide following daily administration for three weeks, compared to continuous therapy. Limited patient numbers (13 vs. 10) prevented this trial from obtaining definitive data regarding efficacy, but there was a trend for worse overall survival (OS, p< 0.001) and progression free survival (PFS, p=0.02) in the intermittent arm compared to the continuous one, with no difference in peripheral neuropathy. Dose reduction was reported in two imatinib retrospective cohort studies and three case reports (2 dasatinib, 1 imatinib). Results were inconclusive, primarily due to limitations in the design of the studies, small sample sizes and lack of detail in reporting toxicities and QoL outcomes. Lenalidomide was investigated in two small prospective cohort studies using alternate-day dosing in myelodysplastic syndrome and multiple myeloma. Toxicity outcomes were only reported in the myeloma study and QoL outcomes were reported in neither study. Conclusions This review identified limited evidence to support non-standard dosing strategies in malignant haematology. Imatinib dose interruption in optimally responsive CML patients warrants further investigation in large-scale, prospective, ideally blinded trials. Table 1. Table 1. Disclosures Djebbari: Pfizer: Other: conference registration; Takeda: Honoraria, Other: travel support; Celgene: Honoraria, Other: travel support, Research Funding.

scholarly journals The Use of tPA in the Treatment of Frostbite: A Systematic Review

Hand ◽  
2018 ◽  
Vol 14 (1) ◽  
pp. 13-18 ◽  
Author(s):  
Richard L. Hutchison ◽  
Hannah M. Miller ◽  
Spencer K. Michalke
Keyword(s):  
Systematic Review ◽  
Cohort Studies ◽  
Case Reports ◽  
Case Series ◽  
Scientific Quality ◽  
Complication Rates ◽  
Outcomes Measures ◽  
Study Results

Background: The use of tissue plasminogen activator (tPA) for the treatment of frostbite has been reported and advocated, but its efficacy has not been well established. We conducted a systematic review to guide physicians on the role of tPA in the treatment of frostbite. Our hypothesis was that the use of tPA improves clinical outcomes, as measured by amputation rate. Methods: We searched MEDLINE (PubMed) and EMBASE for primary research articles on the use of tPA for the treatment of extremity frostbite. Information related to study design, outcomes, and complications was extracted. A total of 204 citations were screened, and then 35 abstracts and 24 reports were reviewed. Fifteen studies met the standard for final review. Results: One randomized, prospective study; 3 cohort studies; 8 case series; and 3 case reports were found. A total of 208 patients were treated. Differences in protocols, inclusion criteria, and outcomes measures prevented combining the study results. In all the studies, the authors reported that the use of tPA was or may have been useful in reducing amputation rates or increasing tissue salvage. Complication rates ranged from 0% to 100%, with a combined rate of 13%. The quality of the evidence was low. Conclusions: Due to the low scientific quality of the studies, the efficacy of tPA in reducing amputation rates cannot currently be established. Randomized, prospective trials or well-controlled cohort studies are needed to better assess the role of tPA. Consideration should be given to limiting its use to research protocols.

O-178 Reproductive and endocrine outcomes after fresh and frozen-thawed ovarian tissue transplantation based on age and anti-cancer therapy: A systematic review and individual patient data meta-analysis

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
H Khattak ◽  
R Malhas ◽  
L Craciunas ◽  
Y Afifi ◽  
S Fishel ◽  
...  
Keyword(s):  
Systematic Review ◽  
Cancer Therapy ◽  
Case Reports ◽  
Ovarian Tissue ◽  
Meta Analysis ◽  
Pregnancy Rates ◽  
Tissue Transplantation ◽  
Ovarian Tissue Transplantation ◽  
Level Data ◽  
Anti Cancer

Abstract Study question Do reproductive and endocrine outcomes from fresh and frozen-thawed ovarian transplants differ based on age and anti-cancer therapy before cryopreservation? Summary answer There was a significant difference in reproductive outcomes of women who have their tissue cryopreserved before or at the age of 35 years. What is known already Ovarian tissue cryopreservation (OTC) and transplantation is emerging as a new fertility preservation method. Despite being available for two decades, there is a marked variation in the delivery of this procedure worldwide. Most of the data are based on case reports from specialised centres with expertise in providing this procedure, but there are many unreported cases. Through this review, we aim to collate reproductive and endocrine outcomes from ovarian tissue transplantation. In particular the outcomes in women based on age at cryopreservation and whether they had anti-cancer therapy before cryopreservation were explored. Study design, size, duration This study was a systematic review and individual participant level meta-analysis to synthesize the existing evidence on the use of fresh and cryopreserved ovarian tissue transplantation. The review protocol was registered with PROSPERO (CRD42018115233) in November 2018 and the review was concluded in December 2020, including 87 studies (768 women).  Participants/materials, setting, methods Literature search was performed using MEDLINE, EMBASE, CINAHL and Cochrane Central Register of Controlled Trials from inception to October 2020. After screening 20,566 abstracts, 87 studies (768 women) were included in the review. Patient-level data was extracted for 388 women and study-level data for 380 women. Authors were also contacted for data if relevant outcomes were not reported in published manuscripts. Meta-analysis was performed using inverse-variance weighting to calculate summary estimates using a fixed-effects model.  Main results and the role of chance Age at cryopreservation was provided for 319 out of 388 (82%) women at participant level data. Of these, 283 (88.7%) had ovarian tissue retrieved at ≤ 35 years of age. A subgroup of four studies that reported data on participants age at cryopreservation and transplantation were included in meta-analysis. Pregnancy rates were higher in participants at ≤ 35 years of age at cryopreservation, with results being statistically significant (OR, 0.35; 95% CI: 0.13 to 0.92; z = 2.13; P 0.03, I2= 0%). Return of hormonal function shown as a decrease in FSH (IU/L) was also lower in this group (MD, 4.38; 95% CI: -4.29 to 13.05; z = 0.99; P 0.32, I2= 0%. Whether a participant had received chemotherapy before cryopreservation was explicitly reported in 122 out of 388 (31%) participants and 56 of them (46%) had received anti-cancer treatment before OTC. Thirty-five pregnancies and twenty-four live births were reported in these women. A further meta-analysis from 5 studies showed that although the results were not statistically significant for return of endocrine function, a decrease in FSH, an increase in oestrogen and increased pregnancy rates were noted in participants who did not receive anti-cancer therapy before cryopreservation. Limitations, reasons for caution Although we gathered 768 cases of ovarian transplants published in the literature, most were case reports and therefore not included in the meta-analysis. Of the studies included in the meta-analysis, information such as age and anti-cancer therapy were not always provided for individual participants but as an aggregate. Wider implications of the findings There was no difference in reproductive and endocrine outcomes for anti-cancer therapy before OTC. Previous chemotherapy alone should therefore not be a deterrent in offering young girls and women OTC. Furthermore, the ideal age to achieve higher pregnancy and live birth rates from OTC is less than 35 years.  Trial registration number PROSPERO (CRD42018115233)

Effects of electromyographic biofeedback interventions for shoulder pain and function: Systematic review and meta-analysis

2021 ◽  
pp. 026921552199095
Author(s):  
Danilo Harudy Kamonseki ◽  
Letícia Bojikian Calixtre ◽  
Rodrigo Py Gonçalves Barreto ◽  
Paula Rezende Camargo
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Confidence Interval ◽  
Shoulder Pain ◽  
Meta Analysis ◽  
Quality Of Evidence ◽  
Electromyographic Biofeedback ◽  
Mean Differences ◽  
And Function

Objective: To systematically review the effectiveness of electromyographic biofeedback interventions to improve pain and function of patients with shoulder pain. Design: Systematic review of controlled clinical trials. Literature search: Databases (Medline, EMBASE, CINAHL, PEDro, CENTRAL, Web of Science, and SCOPUS) were searched in December 2020. Study selection criteria: Randomized clinical trials that investigated the effects of electromyographic biofeedback for individuals with shoulder pain. Patient-reported pain and functional outcomes were collected and synthesized. Data synthesis: The level of evidence was synthesized using GRADE and Standardized Mean Differences and 95% confidence interval were calculated using a random-effects inverse variance model for meta-analysis. Results: Five studies were included with a total sample of 272 individuals with shoulder pain. Very-low quality of evidence indicated that electromyographic biofeedback was not superior to control for reducing shoulder pain (standardized mean differences = −0.21, 95% confidence interval: −0.67 to 0.24, P = 0.36). Very-low quality of evidence indicated that electromyographic biofeedback interventions were not superior to control for improving shoulder function (standardized mean differences = −0.11, 95% confidence interval: −0.41 to 0.19, P = 0.48). Conclusion: Electromyographic biofeedback may be not effective for improving shoulder pain and function. However, the limited number of included studies and very low quality of evidence does not support a definitive recommendation about the effectiveness of electromyographic biofeedback to treat individuals with shoulder pain.

scholarly journals Measurement properties of patient-reported outcome measures (PROMs) in hyperhidrosis: a systematic review

2021 ◽  
Author(s):  
Michaela Gabes ◽  
Helge Knüttel ◽  
Gesina Kann ◽  
Christina Tischer ◽  
Christian J. Apfelbacher
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Measurement Properties ◽  
High Quality ◽  
High Quality Evidence ◽  
Patient Reported ◽  
Quality Evidence

Abstract Purpose To critically appraise, compare and summarize the quality of all existing PROMs that have been validated in hyperhidrosis to at least some extend by applying the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology. Thereby, we aim to give a recommendation for the use of PROMs in future clinical trials in hyperhidrosis. Methods We considered studies evaluating, describing or comparing measurement properties of PROMs as eligible. A systematic literature search in three big databases (MEDLINE, EMBASE and Web of Science) was performed. We assessed the methodological quality of each included study using the COSMIN Risk of Bias checklist. Furthermore, we applied predefined quality criteria for good measurement properties and finally, graded the quality of the evidence. Results Twenty-four articles reporting on 13 patient-reported outcome measures were included. Three instruments can be further recommended for use. They showed evidence for sufficient content validity and moderate- to high-quality evidence for sufficient internal consistency. The methodological assessment showed existing evidence gaps for eight other PROMs, which therefore require further validation studies to make an adequate decision on their recommendation. The Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) and the short-form health survey with 36 items (SF-36) were the only questionnaires not recommended for use in patients with hyperhidrosis due to moderate- to high-quality evidence for insufficient measurement properties. Conclusion Three PROMs, the Hyperhidrosis Quality of Life Index (HidroQoL), the Hyperhidrosis Questionnaire (HQ) and the Sweating Cognitions Inventory (SCI), can be recommended for use in future clinical trials in hyperhidrosis. Results obtained with these three instruments can be seen as trustworthy. Nevertheless, further validation of all three PROMs is desirable. Systematic review registration PROSPERO CRD42020170247

scholarly journals Impact of Use of Gastric-Acid Suppressants and Oral Anti-Cancer Agents on Survival Outcomes: A Systematic Review and Meta-Analysis

Cancers ◽  
2020 ◽  
Vol 12 (4) ◽  
pp. 998 ◽  
Author(s):  
Alice Indini ◽  
Fausto Petrelli ◽  
Gianluca Tomasello ◽  
Erika Rijavec ◽  
Antonio Facciorusso ◽  
...  
Keyword(s):  
Systematic Review ◽  
Gastric Acid ◽  
Solid Tumors ◽  
Fixed Effects ◽  
Negative Impact ◽  
Meta Analysis ◽  
Soft Tissue Sarcomas ◽  
Oral Chemotherapy ◽  
Survival Outcomes ◽  
Anti Cancer

We performed a systematic review and meta-analysis to evaluate the role of gastric acid suppressant use on outcomes of tyrosine kinase inhibitors (TKIs) and oral chemotherapy. We identified all research evaluating the effect of GAS (gastric acid suppressants) use on patients receiving oral chemotherapy or TKIs for solid tumors. The pooled hazard ratios (HRs) and 95% confidence interval (95%CI) for overall survival (OS) and progression-free survival (PFS) were calculated with a fixed-effects or a random effects model. The study population included n = 16 retrospective studies and 372,418 patients. The series concerned gastrointestinal tract tumors (n = 5 studies), renal cell carcinomas (RCC, n = 3 studies), non-small cell lung cancers (NSCLC, n = 5 studies), and soft tissue sarcomas or mixed histologies solid tumors in n = 3 studies. The pooled HRs for OS and PFS were 1.31 (95%CI: 1.20–1.43; p < 0.01) and 1.3 (95%CI 1.07–1.57; p < 0.01) for GAS and no GAS users, respectively. Only studies of EGFR (epidermal growth factor receptor) mutated NSCLC patients receiving TKIs and those with colorectal cancer receiving oral chemotherapy showed a significant correlation between GAS and poor survival. Our study supports the evidence of a possible negative impact of concomitant GAS therapy on survival outcomes of patients receiving oral anti-cancer drugs.

Quality of Trials in a Systematic Review of Powered Toothbrushes: Suggestions for Future Clinical Trials

2006 ◽  
Vol 77 (12) ◽  
pp. 1944-1953 ◽  
Author(s):  
Peter G. Robinson ◽  
A. Damien Walmsley ◽  
Michael Heanue ◽  
Scott Deacon ◽  
Christopher Deery ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials

Surgical treatment of rectovaginal fistulas (systematic literature review)

2021 ◽  
pp. 30-48
Author(s):  
Andrei Anatolevich Mudrov ◽  
Aleksandr Yur’evich Titov ◽  
Mariyam Magomedovna Omarova ◽  
Sergei Alekseevich Frolov ◽  
Ivan Vasilevich Kostarev ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Literature Review ◽  
Systematic Literature Review ◽  
Meta Analysis ◽  
High Recurrence Rate ◽  
Surgical Interventions ◽  
Rectovaginal Fistulas ◽  
Surgical Treatments

Despite the large number of available surgical interventions aimed at the treatment of rectovaginal fistulas, the results of their use remain extremely disappointing, associated with the high recurrence rate of the disease reaching 80 %, as well as the lack of a single tactic to minimize the risk of anal incontinence and the need for colostomy. Objective: to conduct a systematic literature review in order to summarize information related to the rectovaginal fistulas surgery. The systematic review includes the results of an analysis of 97 clinical trials selected from 756 publications found in databases. Inclusion criteria: a full-text article, the presence of at least 5 patients in the study, as well as data on the outcome of surgery. Clinical trials with different surgical treatments were identified and classified into the following categories: elimination of the rectovaginal septal defect with a displaced flap (rectal and vaginal); Martius surgery; gracilis muscle transposition; transperineal procedure; abdominal procedure including endoscopic and laparoscopic methods; use of biological or biocompatible materials. Treatment outcomes vary significantly from 0 % to > 80 %. None of the studies were randomized. Due to the low quality of the identified studies, comparison of results and meta-analysis conduction were not possible. Conclusion: as a result of the systematic review, data for the analysis and development of any strategic and tactical algorithms for the treatment of RVF were not obtained. The most important questions still remain open: what and when surgical method to choose, is it necessary to form a disconnecting stoma?

EHR-based machine learning modeling for preterm birth prediction: A systematic review (Preprint)

2021 ◽  
Author(s):  
Zahra Sharifiheris ◽  
Juho Laitala ◽  
Antti Airola ◽  
Amir M Rahmani ◽  
Miriam Bender
Keyword(s):  
Machine Learning ◽  
Systematic Review ◽  
Preterm Birth ◽  
Model Performance ◽  
Bibliographic Databases ◽  
Complementary Approach ◽  
Prisma Statement ◽  
Comprehensive Search ◽  
First Time

BACKGROUND Preterm birth (PTB) as a common pregnancy complication is responsible for 35% of the 3.1 million pregnancy-related deaths each year and significantly impacts around 15 million children annually across the world. Conventional approaches to predict PTB may neither be applicable for first-time mothers nor possess reliable predictive power. Recently, machine learning (ML) models have shown the potential as an appropriate complementary approach for PTB prediction. OBJECTIVE In this article we systematically reviewed the literature concerned with PTB prediction using ML modeling. METHODS This systematic review was conducted in accordance with the PRISMA statement. A comprehensive search was performed in seven bibliographic databases up until 15 May 2021. The quality of studies was assessed, and the descriptive information including socio-demographic characteristics, ML modeling processes, and model performance were extracted and reported. RESULTS A total of 732 papers were screened through title and abstract. Of these, 23 studies were screened by full text resulting in 13 papers that met the inclusion criteria. CONCLUSIONS We identified various ML models used for different EHR data resulting in a desirable performance for PTB prediction. However, evaluation metrics, software/package used, data size and type, and selected features, and importantly data management method often varied from study to study threatening the reliability and generalizability of the model. CLINICALTRIAL n.a.

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