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BMJ Open Nov 2017To systematically review the quality of reporting of pilot and feasibility of cluster randomised trials (CRTs). In particular, to assess (1) the number of pilot CRTs... (Review)
Review
OBJECTIVES
To systematically review the quality of reporting of pilot and feasibility of cluster randomised trials (CRTs). In particular, to assess (1) the number of pilot CRTs conducted between 1 January 2011 and 31 December 2014, (2) whether objectives and methods are appropriate and (3) reporting quality.
METHODS
We searched PubMed (2011-2014) for CRTs with 'pilot' or 'feasibility' in the title or abstract; that were assessing some element of feasibility and showing evidence the study was in preparation for a main effectiveness/efficacy trial. Quality assessment criteria were based on the Consolidated Standards of Reporting Trials (CONSORT) extensions for pilot trials and CRTs.
RESULTS
Eighteen pilot CRTs were identified. Forty-four per cent did not have feasibility as their primary objective, and many (50%) performed formal hypothesis testing for effectiveness/efficacy despite being underpowered. Most (83%) included 'pilot' or 'feasibility' in the title, and discussed implications for progression from the pilot to the future definitive trial (89%), but fewer reported reasons for the randomised pilot trial (39%), sample size rationale (44%) or progression criteria (17%). Most defined the cluster (100%), and number of clusters randomised (94%), but few reported how the cluster design affected sample size (17%), whether consent was sought from clusters (11%), or who enrolled clusters (17%).
CONCLUSIONS
That only 18 pilot CRTs were identified necessitates increased awareness of the importance of conducting and publishing pilot CRTs and improved reporting. Pilot CRTs should primarily be assessing feasibility, avoiding formal hypothesis testing for effectiveness/efficacy and reporting reasons for the pilot, sample size rationale and progression criteria, as well as enrolment of clusters, and how the cluster design affects design aspects. We recommend adherence to the CONSORT extensions for pilot trials and CRTs.
Topics: Bias; Cluster Analysis; Feasibility Studies; Humans; Models, Statistical; Pilot Projects; Randomized Controlled Trials as Topic; Research Report; Sample Size
PubMed: 29122791
DOI: 10.1136/bmjopen-2017-016970 -
The Cochrane Database of Systematic... Dec 2014Manual rotation is commonly performed to increase the chances of normal vaginal delivery and is perceived to be safe. Manual rotation has the potential to prevent... (Review)
Review
BACKGROUND
Manual rotation is commonly performed to increase the chances of normal vaginal delivery and is perceived to be safe. Manual rotation has the potential to prevent operative delivery and caesarean section, and reduce obstetric and neonatal complications.
OBJECTIVES
To assess the effect of prophylactic manual rotation for women with malposition in labour on mode of delivery, and maternal and neonatal outcomes.
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 October 2014), the Australian and New Zealand Clinical Trials Registry (ANZCTR), ClinicalTrials.gov, Current Controlled Trials and the WHO International Clinical Trials Registry Platform (ICTRP) (all searched 23 February 2014), previous reviews and, references of retrieved studies.
SELECTION CRITERIA
Randomised, quasi-randomised or cluster-randomised clinical trials comparing prophylactic manual rotation in labour for fetal malposition versus expectant management, augmentation of labour or operative delivery. We defined prophylactic manual rotation as rotation performed without immediate assisted delivery.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed study eligibility and quality, and extracted data.
MAIN RESULTS
We included only one small pilot study (involving 30 women). The study, which we considered to be at low risk of bias, was conducted in a tertiary referral hospital in Australia, and involved women with cephalic, singleton pregnancies. The primary outcome was operative delivery (instrumental delivery or caesarean section).In the manual rotation group, 13/15 women went on to have an instrumental delivery or caesarean section, whereas in the control group, 12/15 women had an operative delivery. The estimated risk ratio was 1.08 (95% confidence interval 0.79 to 1.49). There were no maternal or fetal mortalities in either groupThere were no clear differences for any of the secondary maternal or neonatal outcomes reported (e.g. perineal trauma, analgesia use duration of labour).In terms of adverse events, there were no reported cases of umbilical cord prolapse or cervical laceration and a single case of a non-reassuring or pathological cardiotocograph during the procedure.
AUTHORS' CONCLUSIONS
Currently, there is insufficient evidence to determine the efficacy of prophylactic manual rotation early in the second stage of labour for prevention of operative delivery. One additional study is ongoing. Further appropriately designed trials are required to determine the efficacy of manual rotation.
Topics: Adult; Analgesia, Obstetrical; Cesarean Section; Extraction, Obstetrical; Female; Humans; Labor Presentation; Obstetric Labor Complications; Perineum; Pilot Projects; Pregnancy; Version, Fetal
PubMed: 25532081
DOI: 10.1002/14651858.CD009298.pub2 -
The Cochrane Database of Systematic... Apr 2021Bronchiectasis is characterised by excessive sputum production, chronic cough, and acute exacerbations and is associated with symptoms of dyspnoea and fatigue, which... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Bronchiectasis is characterised by excessive sputum production, chronic cough, and acute exacerbations and is associated with symptoms of dyspnoea and fatigue, which reduce exercise tolerance and impair quality of life. Exercise training in isolation or in conjunction with other interventions is beneficial for people with other respiratory diseases, but its effects in bronchiectasis have not been well established.
OBJECTIVES
To determine effects of exercise training compared to usual care on exercise tolerance (primary outcome), quality of life (primary outcome), incidence of acute exacerbation and hospitalisation, respiratory and mental health symptoms, physical function, mortality, and adverse events in people with stable or acute exacerbation of bronchiectasis.
SEARCH METHODS
We identified trials from the Cochrane Airways Specialised Register, ClinicalTrials.gov, and the World Health Organization trials portal, from their inception to October 2020. We reviewed respiratory conference abstracts and reference lists of all primary studies and review articles for additional references.
SELECTION CRITERIA
We included randomised controlled trials in which exercise training of at least four weeks' duration (or eight sessions) was compared to usual care for people with stable bronchiectasis or experiencing an acute exacerbation. Co-interventions with exercise training including education, respiratory muscle training, and airway clearance therapy were permitted if also applied as part of usual care.
DATA COLLECTION AND ANALYSIS
Two review authors independently screened and selected trials for inclusion, extracted outcome data, and assessed risk of bias. We contacted study authors for missing data. We calculated mean differences (MDs) using a random-effects model. We used the GRADE approach to assess the certainty of evidence.
MAIN RESULTS
We included six studies, two of which were published as abstracts, with a total of 275 participants. Five studies were undertaken with people with clinically stable bronchiectasis, and one pilot study was undertaken post acute exacerbation. All studies included co-interventions such as instructions for airway clearance therapy and/or breathing strategies, provision of an educational booklet, and delivery of educational sessions. The duration of training ranged from six to eight weeks, with a mix of supervised and unsupervised sessions conducted in the outpatient or home setting. No studies of children were included in the review; however we identified two studies as currently ongoing. No data were available regarding physical activity levels or adverse events. For people with stable bronchiectasis, evidence suggests that exercise training compared to usual care improves functional exercise tolerance as measured by the incremental shuttle walk distance, with a mean difference (MD) between groups of 87 metres (95% confidence interval (CI) 43 to 132 metres; 4 studies, 161 participants; low-certainty evidence). Evidence also suggests that exercise training improves six-minute walk distance (6MWD) (MD between groups of 42 metres, 95% CI 22 to 62; 1 study, 76 participants; low-certainty evidence). The magnitude of these observed mean changes appears clinically relevant as they exceed minimal clinically important difference (MCID) thresholds for people with chronic lung disease. Evidence suggests that quality of life improves following exercise training according to St George's Respiratory Questionnaire (SGRQ) total score (MD -9.62 points, 95% CI -15.67 to -3.56 points; 3 studies, 160 participants; low-certainty evidence), which exceeds the MCID of 4 points for this outcome. A reduction in dyspnoea (MD 1.0 points, 95% CI 0.47 to 1.53; 1 study, 76 participants) and fatigue (MD 1.51 points, 95% CI 0.80 to 2.22 points; 1 study, 76 participants) was observed following exercise training according to these domains of the Chronic Respiratory Disease Questionnaire. However, there was no change in cough-related quality of life as measured by the Leicester Cough Questionnaire (LCQ) (MD -0.09 points, 95% CI -0.98 to 0.80 points; 2 studies, 103 participants; moderate-certainty evidence), nor in anxiety or depression. Two studies reported longer-term outcomes up to 12 months after intervention completion; however exercise training did not appear to improve exercise capacity or quality of life more than usual care. Exercise training reduced the number of acute exacerbations of bronchiectasis over 12 months in people with stable bronchiectasis (odds ratio 0.26, 95% CI 0.08 to 0.81; 1 study, 55 participants). After an acute exacerbation of bronchiectasis, data from a single study (N = 27) suggest that exercise training compared to usual care confers little to no effect on exercise capacity (MD 11 metres, 95% CI -27 to 49 metres; low-certainty evidence), SGRQ total score (MD 6.34 points, 95%CI -17.08 to 29.76 points), or LCQ score (MD -0.08 points, 95% CI -0.94 to 0.78 points; low-certainty evidence) and does not reduce the time to first exacerbation (hazard ratio 0.83, 95% CI 0.31 to 2.22).
AUTHORS' CONCLUSIONS
This review provides low-certainty evidence suggesting improvement in functional exercise capacity and quality of life immediately following exercise training in people with stable bronchiectasis; however the effects of exercise training on cough-related quality of life and psychological symptoms appear to be minimal. Due to inadequate reporting of methods, small study numbers, and variation between study findings, evidence is of very low to moderate certainty. Limited evidence is available to show longer-term effects of exercise training on these outcomes.
Topics: Adult; Bias; Breathing Exercises; Bronchiectasis; Cough; Disease Progression; Dyspnea; Exercise; Exercise Tolerance; Hospitalization; Humans; Mental Health; Physical Endurance; Physical Functional Performance; Quality of Life; Respiration Disorders; Walk Test
PubMed: 33822364
DOI: 10.1002/14651858.CD013110.pub2 -
BMC Public Health Aug 2018Worldwide more than ten million people are detained at any given time. Between 5 and 60% of people experiencing incarceration report receipt of a tattoo in prison -... (Review)
Review
BACKGROUND
Worldwide more than ten million people are detained at any given time. Between 5 and 60% of people experiencing incarceration report receipt of a tattoo in prison - mostly clandestine, which is associated with risks of blood-borne infections (BBIs). Although safer tattooing techniques are effective in preventing BBI transmission and available to the general population, there is limited knowledge about the impact of safer tattooing strategies in prisons in terms of health outcomes, changes in knowledge and behaviors, and best practice models for implementation. The objective of this research was to identify and review safer tattooing interventions.
METHODS
We conducted a systematic review of the literature. Studies of all design types were included if they were published until 27 June 2018, the population was incarcerated adults, they reported quantitative outcomes, and were published in English, French, or Spanish.
RESULTS
Of 55 papers retrieved from the initial search, no peer-reviewed article was identified. One paper from the grey literature described a multi-site pilot project in Canada. Its evaluation suggested that the project was effective in enhancing knowledge of incarcerated people and prison staff on standard precautions, had the potential to reduce harm, provided vocational opportunities, and was feasible although enhancements were needed to improve implementation issues and efficiency.
CONCLUSIONS
Although access to preventive services, including to safer tattooing interventions, is a human right and recommended by United Nations agencies as part of a comprehensive package of harm reduction interventions in prisons, this review identified only a few promising strategies for safer tattooing interventions in carceral settings. We call upon governments, criminal justice authorities, non-governmental organizations, and academic institutions to implement safer tattooing projects that adhere to the following guiding principles: i) integration of methodologically-rigorous implementation research; ii) involvement of key stakeholders (incarcerated people, prison authorities, research partners) in the project design, implementation, and research; iii) integration into a comprehensive package of BBI prevention, treatment, and care, using a stepwise approach that considers local resources and acceptability; and iv) publication and dissemination of findings, and scaling up efforts.
PROSPERO REGISTRATION
CRD42017072502 .
Topics: Humans; Prisons; Safety Management; Tattooing
PubMed: 30111364
DOI: 10.1186/s12889-018-5867-x -
International Journal of Surgery... Nov 2023Hepatocellular carcinoma (HCC) is the third-most lethal malignant tumor worldwide. The rapid development of immunotherapy utilizing immune checkpoint inhibitors for... (Meta-Analysis)
Meta-Analysis
Clinico-characteristics of patients which correlated with preferable treatment outcomes in immunotherapy for advanced hepatocellular carcinoma: a systematic review and meta-analysis.
BACKGROUND AND AIMS
Hepatocellular carcinoma (HCC) is the third-most lethal malignant tumor worldwide. The rapid development of immunotherapy utilizing immune checkpoint inhibitors for advanced HCC patients has been witnessed in recent years, along with numerous randomized clinical trials demonstrating the survival benefits for these individuals. This systematic review and meta-analysis aimed to identify specific clinico-pathological characteristics of advanced HCC patients that may lead to preferable responses to immunotherapy in terms of overall survival (OS), progression-free survival (PFS), and objective response rate (ORR).
METHODS
The included clinical trials were retrieved from PubMed, Embase, the Cochrane library, and the Web of Science databases published in English between 1 January 2002 and 20 October 2022. A systematic review and meta-analysis for first-line and second-line phase II/III studies were conducted on immunotherapy for patients with advanced HCC by using OS as the primary outcome measure, and PFS and ORR as the secondary outcome measures to obtain clinico-pathological characteristics of patients which might be preferable responses to programmed death-1 (PD-1) and programmed cell death-Ligand 1 (PD-L1) inhibitors. Toxicity and specific treatment-related adverse events (TRAEs) were also determined.
RESULTS
After screening 1392 relevant studies, 12 studies were included in this systematic review and meta-analysis to include 5948 patients. Based on the analysis of interaction, the difference in OS after first-line immunotherapy between the subgroups of viral hepatitis [hazard ratio (HR)=0.73 vs 0.87, P for interaction=0.02] and macrovascular invasion and/or extrahepatic spread (HR=0.73 vs 0.89, P for interaction=0.02) were significant. The difference in PFS between the subgroups of viral hepatitis was highly significant (pooled HR=0.55 vs 0.81, P for interaction=0.007). After second-line immunotherapy, the difference in ORR between the subgroups of Barcelona Clinic Liver Cancer was significant (pooled ES=0.12 vs 0.23, P for interaction=0.04). Compared with PD-L1 inhibitors, PD-1 inhibitors may have a higher probability to cause TRAEs. Diarrhea, increased aspartate aminotransferase, and hypertension were the top three TRAEs.
CONCLUSIONS
This systematic review and meta-analysis represents the first pilot study aimed at identifying crucial clinico-pathological characteristics of patients with advanced HCC that may predict favorable treatment outcomes in terms of OS, PFS, and ORR to immunotherapy. Findings suggest that patients with viral hepatitis positivity (especially hepatitis B virus) and macrovascular invasion and/or extrahepatic spread may benefit more in OS when treated with PD-1/PD-L1 immune checkpoint inhibitors.
Topics: Humans; Carcinoma, Hepatocellular; B7-H1 Antigen; Immune Checkpoint Inhibitors; Pilot Projects; Programmed Cell Death 1 Receptor; Liver Neoplasms; Treatment Outcome; Immunotherapy; Hepatitis, Viral, Human; Lung Neoplasms
PubMed: 37598406
DOI: 10.1097/JS9.0000000000000652 -
Systematic Reviews Dec 2023The living systematic review (LSR) approach is based on ongoing surveillance of the literature and continual updating. Most currently available guidance documents...
BACKGROUND AND OBJECTIVE
The living systematic review (LSR) approach is based on ongoing surveillance of the literature and continual updating. Most currently available guidance documents address the conduct, reporting, publishing, and appraisal of systematic reviews (SRs), but are not suitable for LSRs per se and miss additional LSR-specific considerations. In this scoping review, we aim to systematically collate methodological guidance literature on how to conduct, report, publish, and appraise the quality of LSRs and identify current gaps in guidance.
METHODS
A standard scoping review methodology was used. We searched MEDLINE (Ovid), EMBASE (Ovid), and The Cochrane Library on August 28, 2021. As for searching gray literature, we looked for existing guidelines and handbooks on LSRs from organizations that conduct evidence syntheses. The screening was conducted by two authors independently in Rayyan, and data extraction was done in duplicate using a pilot-tested data extraction form in Excel. Data was extracted according to four pre-defined categories for (i) conducting, (ii) reporting, (iii) publishing, and (iv) appraising LSRs. We mapped the findings by visualizing overview tables created in Microsoft Word.
RESULTS
Of the 21 included papers, methodological guidance was found in 17 papers for conducting, in six papers for reporting, in 15 papers for publishing, and in two papers for appraising LSRs. Some of the identified key items for (i) conducting LSRs were identifying the rationale, screening tools, or re-revaluating inclusion criteria. Identified items of (ii) the original PRISMA checklist included reporting the registration and protocol, title, or synthesis methods. For (iii) publishing, there was guidance available on publication type and frequency or update trigger, and for (iv) appraising, guidance on the appropriate use of bias assessment or reporting funding of included studies was found. Our search revealed major evidence gaps, particularly for guidance on certain PRISMA items such as reporting results, discussion, support and funding, and availability of data and material of a LSR.
CONCLUSION
Important evidence gaps were identified for guidance on how to report in LSRs and appraise their quality. Our findings were applied to inform and prepare a PRISMA 2020 extension for LSR.
Topics: Humans; Publishing; Bias; Checklist; Research Report; MEDLINE
PubMed: 38098023
DOI: 10.1186/s13643-023-02396-x -
International Journal of Environmental... Jan 2021While hypertension remains the leading modifiable risk factor for cardiovascular morbidity and mortality, the pathogenesis of essential hypertension remains only... (Review)
Review
While hypertension remains the leading modifiable risk factor for cardiovascular morbidity and mortality, the pathogenesis of essential hypertension remains only partially understood. Recently, microbial dysbiosis has been associated with multiple chronic diseases closely related to hypertension. In addition, multiple small-scale animal and human studies have provided promising results for the association between gut microbial dysbiosis and hypertension. Animal models and a small human pilot study, have demonstrated that high salt intake, a risk factor for both hypertension and cardiovascular disease, depletes certain species while oral treatment of prevented salt-sensitive hypertension. To date, four large cohort studies have reported modest associations between gut microbiota features and hypertension. In this systematic literature review, we examine the previously reported links between the gut microbiota and hypertension and what is known about the functional mechanisms behind this association.
Topics: Animals; Blood Pressure; Dysbiosis; Gastrointestinal Microbiome; Humans; Hypertension; Pilot Projects
PubMed: 33561095
DOI: 10.3390/ijerph18031248 -
Clinical and Experimental Dental... Dec 2023The aim of the systematic review was to compare studies on implant-supported two-unit cantilever crowns with two adjacent implant-supported crowns in the anterior...
OBJECTIVES
The aim of the systematic review was to compare studies on implant-supported two-unit cantilever crowns with two adjacent implant-supported crowns in the anterior region. The second aim was to assess in a 10-year prospective comparative pilot study, hard and soft peri-implant tissue changes in patients with a missing central and adjacent lateral upper incisor, treated with either an implant-supported two-unit cantilever crown or two single implant-supported crowns.
MATERIALS AND METHODS
Medline, Embase, and the Cochrane Central Register of Controlled Trials were searched (last search March 1, 2023). Inclusion criteria were studies reporting outcomes of two missing adjacent teeth in the esthetic region and treated with a single implant-supported two-unit cantilever fixed dental prosthesis, or with two solitary implant-supported crowns. Outcome measures assessed included implant survival (primary), changes in marginal bone and gingiva level, restoration survival, subjective and objective esthetic scores, papilla volume, mid-facial marginal mucosa level, probing depth, bleeding on probing, and biological and technical complications with ≥1-year follow-up. In addition, in a 10-year pilot study, the same outcome measures were assessed of five patients with a single implant-supported two-unit cantilever crown and compared with five patients with two adjacent single implant-supported crowns in the esthetic zone.
RESULTS
Nine articles with 11 study groups were found eligible for data extraction. Meta-analyses of implant survival rates were 96.9% (mean follow-up 3.4 ± 1.4 years) for the implant-cantilever treatment and 97.6% (mean follow-up 3.0 ± 1.8 years) for the adjacent implants treatment (p = .79). In the 10-year comparative pilot study, no clinically relevant changes in hard and soft peri-implant tissue levels occurred in both groups. Patient satisfaction was also high in both groups.
CONCLUSION
Single implant-supported two-unit crowns can be a viable alternative to the placement of two adjacent single implant crowns in the esthetic zone.
Topics: Humans; Dental Implants; Treatment Outcome; Pilot Projects; Dental Implants, Single-Tooth; Prospective Studies; Esthetics, Dental
PubMed: 37592440
DOI: 10.1002/cre2.773