scholarly journals Surveillance and Monitoring of Dialysis Access

2012 ◽  
Vol 2012 ◽  
pp. 1-9 ◽  
Author(s):  
Lalathaksha Kumbar ◽  
Jariatul Karim ◽  
Anatole Besarab
Keyword(s):  
Vascular Access ◽  
Hemodialysis Patient ◽  
Small Sample Size ◽  
Scientific Evidence ◽  
Randomized Study ◽  
Small Sample ◽  
Dialysis Access ◽  
Surveillance Strategy ◽  
Randomized Controlled ◽  
Monitoring And Surveillance

Vascular access is the lifeline of a hemodialysis patient. Currently arteriovenous fistula and graft are considered the permanent options for vascular access. Monitoring and surveillance of vascular access are an integral part of the care of hemodialysis patient. Although different techniques and methods are available for identifying access dysfunction, the scientific evidence for the optimal methodology is lacking. A small number of randomized controlled trials have been performed evaluating different surveillance techniques. We performed a study of the recent literature published in the PUBMED, to review the scientific evidence on different methodologies currently being used for surveillance and monitoring and their impact on the care of the dialysis access. The limited randomized studies especially involving fistulae and small sample size of the published studies with conflicting results highlight the need for a larger multicentered randomized study with hard clinical end points to evaluate the optimal surveillance strategy for both fistula and graft.

scholarly journals Deficiencies in Scientific Evidence for Medical Management of Gender Dysphoria

2019 ◽  
Vol 87 (1) ◽  
pp. 34-42 ◽  
Author(s):  
Paul W. Hruz
Keyword(s):  
Gender Identity ◽  
Gender Dysphoria ◽  
Small Sample Size ◽  
Scientific Evidence ◽  
Prospective Trial ◽  
Scientific Data ◽  
Small Sample ◽  
Sex Characteristics ◽  
Biological Sex

Individuals who experience a gender identity that is discordant with biological sex are increasingly presenting to physicians for assistance in alleviating associated psychological distress. In contrast to prior efforts to identify and primarily address underlying psychiatric contributors to gender dysphoria, interventions that include uncritical social affirmation, use of gonadotropin-releasing hormone agonists to suppress normally timed puberty, and administration of cross-sex steroid hormones to induce desired secondary sex characteristics are now advocated by an emerging cohort of transgender medicine specialists. For patients with persistent gender dysphoria, surgery is offered to alter the appearance of breasts and genital organs. Efforts to address ethical concerns regarding this contentious treatment paradigm are dependent upon reliable evidence on immediate and long-term risks and benefits. Although strong recommendations have been made for invasive and potentially irreversible interventions, high-quality scientific data on the effects of this approach are generally lacking. Limitations of the existing transgender literature include general lack of randomized prospective trial design, small sample size, recruitment bias, short study duration, high subject dropout rates, and reliance on “expert” opinion. Existing data reveal significant intervention-associated morbidity and raise serious concern that the primary goal of suicide prevention is not achieved. In addition to substantial moral questions, adherence to established principles of evidence-based medicine necessitates a high degree of caution in accepting gender-affirming medical interventions as a preferred treatment approach. Continued consideration and rigorous investigation of alternate approaches to alleviating suffering in people with gender dysphoria are warranted. Summary: This paper provides an overview of what is currently known about people who experience a gender identity that differs from their biological sex and the associated desire to engage the medical profession in alleviating associated discomfort and distress. The scientific evidence used to support current recommendations for affirming one’s preferred gender, halting normally timed puberty, administering cross-sex hormones, and surgically altering primary and secondary sexual traits are summarized and critically evaluated. Serious deficits in understanding the cause of this condition, the reasons for the marked increase in people presenting for medical care, together with immediate and long-term risks relative to benefit of medical intervention are exposed.

scholarly journals Acupuncture in Subacute Stroke: No Benefits Detected

2013 ◽  
Vol 93 (11) ◽  
pp. 1447-1455 ◽  
Author(s):  
Yi Zhu ◽  
Lixia Zhang ◽  
Gang Ouyang ◽  
Dianhuai Meng ◽  
Kailin Qian ◽  
...  
Keyword(s):  
Physical Therapy ◽  
Motor Function ◽  
Small Sample Size ◽  
Randomized Study ◽  
Theoretical Background ◽  
Scalp Acupuncture ◽  
Small Sample ◽  
Acupuncture Group ◽  
Rehabilitation Centers ◽  
Subacute Stroke

Background There is debate concerning the effect of acupuncture on rehabilitation following stroke, with key reviews unable to find evidence of benefit. This lack of evidence may be due to poor study design, small sample size, and insufficient theoretical background. Objective The present study was designed to determine whether acupuncture combined with conventional physical therapy improves motor function and activities of daily living in patients with subacute stroke compared with conventional physical therapy alone. Design A multicenter, single-blinded, randomized study was conducted. Setting Four rehabilitation centers in the Jiangsu province of China participated in this study. Patients One hundred eighty-eight patients with subacute stroke admitted to the hospital were randomized into an acupuncture group and a conventional rehabilitation group. Interventions A combination of body and scalp acupuncture was used for 3 months in the acupuncture group. All patients underwent conventional stroke rehabilitation. Measurements The Fugl-Meyer Assessment (FMA) and Barthel Index (BI) were performed at baseline and at 1, 3, and 6 months after inclusion in the study. Results No statistically significant differences were found at baseline between the groups. No statistically significant differences were found between the groups using the FMA motor scores and the BI scores at baseline or at 1, 3, or 6 months. Significant improvements were found in each group following treatment. Conclusions In patients with subacute stroke, the addition of body and scalp acupuncture to a regimen of conventional physical therapy does not result in further improvement in either motor function or ADL beyond the effect of conventional physical therapy alone.

scholarly journals Osteopathic Manual Treatment vs Kaltenborn-Evjenth Orthopedic Manual Therapy for Chronic Low Back Pain: A Proposal for a Protocol for Randomized Trials

2020 ◽  
Vol 1 (8) ◽  
pp. 383-388
Author(s):  
Pawel Lizis ◽  
Wojciech Kobza ◽  
Grzegorz Manko ◽  
Jaroslaw Jaszczur-Nowicki ◽  
Joanna Bukowska ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Manual Therapy ◽  
Randomized Trials ◽  
Rating Scale ◽  
Small Sample Size ◽  
Randomized Study ◽  
Small Sample ◽  
Random Allocation ◽  
Low Back

Introduction: Numerous modalities of conservative therapeutic interventions are available to achieve the best health benefits in people with Low Back Pain (LBP), e.g., kinesiotherapy, physical therapy, behavior therapy. People with LBP continue to experience pain and disability despite receiving the best evidence based therapy. Osteopathic Manual Therapy (OMT) and Kaltenborn-Evjenth Ortopedic Manual Therapy (KEOMT) are the other options, although their effectiveness remains controversial. The aim of this study is a proposal for a protocol for randomized trials to compare the effectiveness of OMT vs. KEOMT on pain and disability in people suffering from LBP. Methods and analysis: It's a randomized study with two-arms parallel, designed with concealed allocation, the assessor's blinding with intention to-treat analysis. It will include 34 people a group with severe disability ranged from 41 to 60% in Oswestry Disability Index (ODI). There will be two groups: a treatment group (OMT) and a comparison group (KEOMT). All the patients in both groups will receive 2 treatments a week for 5 weeks. Each session in both groups will not exceed 30 minutes. During each session OMT and KEOMT techniques will be repeated 3 times. A baseline assessment will be performed pre and post intervention, two days later. The following parameters will be assessed during the evaluations: Numeric Pain Rating Scale – NPRS, ODI. Ethics and dissemination: The trial was approved by the Scientific Research Ethics Committee of University of Warmia and Mazury, Olsztyn, Poland. Registration approval number: 9/2018. Trial registration: The study protocol was prospectively registered in the Chinese Clinical Trial Registry on December 28, 2019 (registration ID: ChiCTR1900028580). Strengths and Limitations of this Study The participants' random allocation to the experimental and the control groups. The same experienced physiotherapist, blind to the outcome measures, provides the interventions. The same assistant, blind to the group allocation, administrates the outcomes. The same number of the interventions, the compared contact time with the physiotherapist providing the interventions. A short follow-up period and/or a rather small sample size.

scholarly journals Current Treatment Options for Metastatic Hormone-Sensitive Prostate Cancer.

Cancers ◽  
2019 ◽  
Vol 11 (9) ◽  
pp. 1355 ◽  
Author(s):  
Cattrini ◽  
Castro ◽  
Lozano ◽  
Zanardi ◽  
Rubagotti ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Small Sample Size ◽  
Treatment Options ◽  
Current Treatment ◽  
Abiraterone Acetate ◽  
Small Sample ◽  
Phase 3 ◽  
Tumor Patient ◽  
Randomized Controlled ◽  
Hormone Sensitive

The possible treatments options for metastatic hormone-sensitive prostate cancer (mHSPC) have dramatically increased during the last years. The old backbone, which androgen-deprivation therapy (ADT) is the exclusive approach for hormone-naïve patients, has been disrupted. Despite the fact that several high-quality, randomized, controlled phase 3 trials have been conducted in this setting, no direct comparison is currently available among the different strategies. Inadequate power, absence of preplanning and small sample size frequently affect the subgroup analyses according to disease volume or patient’s risk. The choice between ADT alone and ADT combined with docetaxel, abiraterone acetate, enzalutamide, apalutamide or radiotherapy to the primary tumor remains challenging. Factors that are related to the tumor, patient or drug side effects, currently guide these clinical decisions. This comprehensive review aims to indirectly compare the phase 3 trials in the mHSPC setting, in order to extrapolate data useful for treatment selection, providing also perspectives on future biomarkers.

Are antifungal non-inferiority trials at risk of eroding effectiveness because of bio-creep? A secondary analysis of a systematic review

2021 ◽  
Author(s):  
Adam S. Komorowski ◽  
Anthony D. Bai ◽  
Anna Cvetkovic ◽  
Omar Mourad ◽  
Carson K.L. Lo ◽  
...  
Keyword(s):  
Systematic Review ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Small Sample ◽  
Risk Of Bias ◽  
Effective Control ◽  
Erosion Risk ◽  
Randomized Controlled ◽  
Over Time

Non-inferiority randomized controlled trial (RCT) effectiveness may erode when results favour the active control over time, and when a decreasingly effective control arm is used in serial trials. We analyzed 32 antifungal noninferiority RCTs (NI-RCTs) for these scenarios in this secondary analysis of a systematic review. Our exploratory analysis suggests that the erosion risk in the effectiveness of antifungal non-inferiority trials is uncommon. Findings are limited by small sample size, and overall risk of bias.

scholarly journals Effectiveness of Ondansetron versus Metoclopramide in Hyperemesis Gravidarum

2014 ◽  
Vol 9 (2) ◽  
pp. 27-32
Author(s):  
M Chhetry ◽  
A Thakur ◽  
P Basnet ◽  
R Joshi ◽  
H Sangraula ◽  
...  
Keyword(s):  
Hyperemesis Gravidarum ◽  
Small Sample Size ◽  
Supportive Therapy ◽  
Small Sample ◽  
Controlled Study ◽  
P Value ◽  
Weight Changes ◽  
Randomized Controlled ◽  
To Receive ◽  
Intravenous Medication

Aims: The aim was to evaluate the effectiveness of intravenous ondansetron as compared to intravenous metoclopramide in hyperemesis gravidarum. Methods: Sixty-eight patients with hyperemesis gravidarum were randomized to receive either intravenous ondansetron or intravenous metoclopramide according to randomization group, till they started tolerating orally along with supportive therapy and various treatment parameters were compared. Results: No statistically significant differences were found in the number of doses of intravenous medication used (three doses of ondansetron vs four doses of metoclopramide; p value 0.77), weight changes (ondansetron - 0 kg vs. metoclopramide – 1 kg; p value 0.11) during treatment, duration of intravenous fluids (ondansetron – 24 hours vs. metoclopramide- 24 hours; p value 0.48) in the two groups. The duration of hospital stay of the patients in the two groups was comparable (ondansetron - 3 days vs. metoclopramide - 3 days; p value 0.83).Conclusions: Metoclopramide and ondansetron appear to be equally effective to treat hyperemesis gravidarum. Although this was a prospective randomized controlled study, it had a small sample size and the results should be confirmed in a larger and powered study.DOI:http://dx.doi.org/10.3126/njog.v9i2.11753

scholarly journals Knee Arthroscopic Surgery in Middle-Aged Patients With Meniscal Symptoms: A 3-Year Follow-up of a Prospective, Randomized Study

2017 ◽  
Vol 45 (9) ◽  
pp. 2077-2084 ◽  
Author(s):  
Håkan Gauffin ◽  
Sofi Sonesson ◽  
Andreas Meunier ◽  
Henrik Magnusson ◽  
Joanna Kvist
Keyword(s):  
Small Sample Size ◽  
Controlled Trial ◽  
Randomized Study ◽  
Arthroscopic Surgery ◽  
Exercise Program ◽  
Small Sample ◽  
Middle Aged ◽  
Aged Patients ◽  
Intention To Treat

Background: The optimal treatment for middle-aged patients with knee pain and meniscal lesions has been extensively debated. Most previous studies have revealed only short-term beneficial results of knee arthroscopic surgery. The authors have previously shown a positive benefit of knee arthroscopic surgery and an exercise program after 1 year when compared with an exercise program alone. Purpose: To evaluate if knee arthroscopic surgery combined with an exercise program provided an additional long-term benefit after 3 years compared with an exercise program alone in middle-aged patients with meniscal symptoms. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Of 179 eligible patients, aged 45 to 64 years, 150 were randomized to (1) a 3-month exercise program (nonsurgery group) or (2) the same as group 1 plus knee arthroscopic surgery within 4 weeks (surgery group). The primary outcome was the change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) subscore of pain between baseline and the 3-year follow-up. Results from the 1-year follow-up have been published previously. Results: Both treatment groups improved significantly in the KOOS pain subscore at 3 years’ follow-up in the intention-to-treat and as-treated analyses ( P < .001). The between-group difference for the change in the KOOS pain subscore between baseline and the 3-year follow-up was no longer statistically significant, neither in the intention-to-treat analysis (7.6 points; 95% CI, –0.6 to 15.9; P = .068) nor in the as-treated analysis (5.3 points; 95% CI, –3.1 to 13.8; P = .216). The factorial analysis of the effect of the intervention and age, onset of pain, and mechanical symptoms indicated that older patients improved more, regardless of treatment, and surgery may be more beneficial for patients without mechanical symptoms (as-treated analysis). The effect of the predictive factors on the KOOS pain subscore was uncertain because of the small sample size in the subgroup analyses. Conclusion: The benefit of knee arthroscopic surgery, seen at 1 year in middle-aged patients with meniscal symptoms, was diminished at 3 years and was no longer statistically significant. Clinical Relevance: Knee arthroscopic surgery may be beneficial for middle-aged patients with meniscal symptoms in addition to an exercise program. Older age and absence of mechanical symptoms should not be contraindications to surgery. Registration: NCT01288768 ( ClinicalTrials.gov identifier)

scholarly journals A Pragmatic Pilot Cluster-Randomized Study of Tobacco Screening and Smoking Cessation Program for Community Pharmacies in Japan: FINE Program

2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Mitsuko Onda ◽  
Michiko Horiguchi ◽  
Masayuki Domichi ◽  
Naoki Sakane
Keyword(s):  
Smoking Cessation ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Randomized Study ◽  
Intervention Group ◽  
Small Sample ◽  
Smoking Cessation Program ◽  
Control Group ◽  
Community Pharmacies ◽  
Cluster Randomized

Objectives. To investigate the effectiveness of a smoking cessation program (FINE program) in community pharmacies. Methods. A cluster-randomized controlled trial was conducted in 11 community pharmacies in Japan. The participants were randomly assigned to a pharmacist-led structured smoking cessation program (intervention group) or pharmacist-led usual care (control group). The intervention group was followed up over the telephone on the third day of smoking cessation, and ongoing follow-up and advice were provided according to the original smoking cessation guidebook developed for the current study based on a behavioral change approach. The control group received brief advice and ready-made pamphlets on smoking cessation from pharmacists upon their visit to these community pharmacies. The primary outcome was continued smoking cessation as determined by self-reporting and carbon monoxide monitoring with a microsmokerlyzer after 3 months. Results. Five hundred and seventy-two smokers who met the eligibility criteria visited the pharmacies included in the study. Of these individuals, 24 patients agreed to participate in the study. The quit rates were 45.5% and 18.2% in the intervention and control groups, respectively ( P = 0.380 , effect   size = 0.60 ). Conclusion. Based on the effect size values, the FINE program may be effective to some extent, but the difference was not significant. We speculate that this is related to the small sample size due to difficulty in recruiting. Further studies with an effective recruitment method and larger sample sizes are needed to accurately verify the effectiveness of this program.

scholarly journals Problem-based learning in medical degree teaching: a scoping review

2021 ◽  
Author(s):  
Joan Carles Trullas ◽  
Carles Blay ◽  
Elisabet Sarri ◽  
Ramon Pujol
Keyword(s):  
Scoping Review ◽  
Postgraduate Medical Education ◽  
Small Sample Size ◽  
Meta Analysis ◽  
Scientific Evidence ◽  
Problem Based Learning ◽  
Knowledge Retention ◽  
Small Sample ◽  
Continuous Training ◽  
Randomized Design

Abstract Problem-based learning (PBL) is a pedagogical approach that shifts the role of the teacher to the student (student-centred) and is based on self-directed learning. Although PBL has been adopted in undergraduate and postgraduate medical education, the effectiveness of the method is still under discussion. We employed a scoping review to appraise available international evidence concerning to the effectiveness and usefulness of PBL methodology in undergraduate medical teaching programs. We applied the Arksey and O’Malley framework to undertake a scoping review. A search of literature published in English and Spanish identified one hundred and twenty four publications eligible for this review. Despite the fact that this review includes many studies, their design is heterogeneous and only a few provide a high scientific evidence methodology (randomized design and/or systematic review with meta-analysis). Furthermore, most are single-center experiences with small sample size and there are no large multi-center studies. PBL methodology obtains a high level of satisfaction, especially among students. It is more effective than other more traditional (or lecture-based methods) at improving social and communication skills, problem-solving and self-learning skills. Knowledge retention and academic performance are no worse (and in many studies are better) than with traditional methods. PBL is not universally widespread, probably because it requires greater human resources and continuous training for its implementation. More comparative and randomized studies and/or other systematic reviews and meta-analysis are required to determine which educational strategies are the most suitable for training the doctors of the future.

Abstract WP301: Timing of Occurrence of MRI DWI Abnormalities in Patients with Spontaneous Intracerebral Hemorrhages: A Subgroup Analysis from The SHRINC Trial

Stroke ◽  
2013 ◽  
Vol 44 (suppl_1) ◽  
Author(s):  
Jorge Kawano-Castillo ◽  
Navdeep Sangha ◽  
Ellie Eun Ju Choi ◽  
Rebecca Martinez ◽  
Teslyn Kauffman ◽  
...  
Keyword(s):  
Intracerebral Hemorrhage ◽  
Small Sample Size ◽  
Randomized Study ◽  
Small Sample ◽  
Chronic Patients ◽  
Treatment Allocation ◽  
Intracerebral Hemorrhages ◽  
Baseline Characteristics ◽  
Underlying Mechanisms ◽  
Prospective Database

BACKGROUND MRI DWI abnormalities have been reported in 22-35% of patients with intracerebral hemorrhage (ICH). The mechanism underlying these changes is unknown. The timing of development of DWI changes has not been well described. We evaluated the time at which DWI changes occurred in a prospective database of patients with spontaneous ICH in the Safety of Pioglitazone for Hematoma Resolution In Intracerebral Hemorrhage trial (SHRINC). We also sought to examine if clinical features might predict the time at which DWI changes occurred. METHODS SHRINC is an ongoing prospective, randomized study evaluating the safety of pioglitazone versus placebo in patients with ICH. Patients undergo serial MRI on Day (D)1, D2, D7/14, D28, and D42. We captured the occurrence of DWI lesions on MRI and categorized patients into 4 groups according to the time of onset of DWI lesions: observed on admission (hyperacute), D2 (acute), D7 or 14 (subacute) or >28 days (chronic). Patients were excluded if they did not have an MRI for comparison on the selected days. Baseline characteristics were collected prospectively on admission and compared between groups. RESULTS: Thirty patients had complete imaging; 17 (56.67%) had DWI abnormalities in total. Characteristics are included in Table 1. Seven patients (23.33%) had DWI abnormalities remote from the ICH. There were no differences in the baseline characteristics between the groups except INR was significantly lower in the hyperacute group compared to the chronic group (p<0.05). CONCLUSION: Our data demonstrate that DWI lesions are more frequently seen at the time of initial ICH. The occurrence of DWI lesions at later time points suggests there may be different mechanisms accounting for these changes. Our study is limited by the small sample size and blinded nature of treatment allocation. Further study is needed to understand the underlying mechanisms of these DWI changes and their clinical relevance.

Sign in / Sign up

Export Citation Format

Share Document