Computerized decision support systems (CDSSs) are computer programs that provide doctors with person-specific, actionable recommendations, or management options that are intelligently filtered or ...presented at appropriate times to enhance health care. CDSSs might be integrated with patient electronic health records (EHRs) and evidence-based knowledge.
The Computerized DEcision Support in ONCOlogy (ONCO-CODES) trial is a pragmatic, parallel group, randomized controlled study with 1:1 allocation ratio. The trial is designed to evaluate the effectiveness on clinical practice and quality of care of a multi-specialty collection of patient-specific reminders generated by a CDSS in the IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) hospital. We hypothesize that the intervention can increase clinician adherence to guidelines and, eventually, improve the quality of care offered to cancer patients. The primary outcome is the rate at which the issues reported by the reminders are resolved, aggregating specialty and primary care reminders. We will include all the patients admitted to hospital services. All analyses will follow the intention-to-treat principle.
The results of our study will contribute to the current understanding of the effectiveness of CDSSs in cancer hospitals, thereby informing healthcare policy about the potential role of CDSS use. Furthermore, the study will inform whether CDSS may facilitate the integration of primary care in cancer settings, known to be usually limited. The increasing use of and familiarity with advanced technology among new generations of physicians may support integrated approaches to be tested in pragmatic studies determining the optimal interface between primary and oncology care.
ClinicalTrials.gov, NCT02645357.
Little is known about publication agreements between industry and academic investigators in trial protocols and the consistency of these agreements with corresponding statements in publications. We ...aimed to investigate (i) the existence and types of publication agreements in trial protocols, (ii) the completeness and consistency of the reporting of these agreements in subsequent publications, and (iii) the frequency of co-authorship by industry employees.
We used a retrospective cohort of randomized clinical trials (RCTs) based on archived protocols approved by six research ethics committees between 13 January 2000 and 25 November 2003. Only RCTs with industry involvement were eligible. We investigated the documentation of publication agreements in RCT protocols and statements in corresponding journal publications. Of 647 eligible RCT protocols, 456 (70.5%) mentioned an agreement regarding publication of results. Of these 456, 393 (86.2%) documented an industry partner's right to disapprove or at least review proposed manuscripts; 39 (8.6%) agreements were without constraints of publication. The remaining 24 (5.3%) protocols referred to separate agreement documents not accessible to us. Of those 432 protocols with an accessible publication agreement, 268 (62.0%) trials were published. Most agreements documented in the protocol were not reported in the subsequent publication (197/268 73.5%). Of 71 agreements reported in publications, 52 (73.2%) were concordant with those documented in the protocol. In 14 of 37 (37.8%) publications in which statements suggested unrestricted publication rights, at least one co-author was an industry employee. In 25 protocol-publication pairs, author statements in publications suggested no constraints, but 18 corresponding protocols documented restricting agreements.
Publication agreements constraining academic authors' independence are common. Journal articles seldom report on publication agreements, and, if they do, statements can be discrepant with the trial protocol.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Non-specific low back pain (LBP) is the leading cause of disability worldwide. Acute LBP usually has a good prognosis, with rapid improvement within the first 6 weeks. However, the majority of ...patients develop chronic LBP and suffer from recurrences. For clinical management, a plethora of treatments is currently available but evidence of the most effective options is lacking. The objective of this study will be to identify the most effective interventions to relieve pain and reduce disability in acute and sub-acute non-specific LBP.
We will search electronic databases (MEDLINE, Embase, CENTRAL) from inception onwards. The eligible population will be individuals with non-specific LBP older than 18 years, both males and females, who experience pain less than 6 weeks (acute) or between 6 and 12 weeks (subacute). Eligible interventions and comparators will include all conservative rehabilitation or pharmacological treatments provided by any health professional; the only eligible study design will be a randomized controlled trial. The primary outcomes will be pain intensity and back-specific functional status. Secondary outcomes will be any adverse events. Studies published in languages other than English will also potentially be included. Two reviewers will independently screen the titles and abstracts retrieved from a literature search, as well as potentially relevant full-text articles. General characteristics, potential effect modifiers, and outcome data will be extracted from the included studies, and the risk of bias will be appraised. Conflicts at all levels of screening and abstraction will be resolved through team discussions. After describing the results of the review, if appropriate, a random effects meta-analysis and network meta-analysis will be conducted in a frequentist setting, assuming equal heterogeneity across all treatment comparisons and accounting for correlations induced by multi-arm studies using a multivariate normal model.
Our systematic review will address the uncertainties in the use of pharmacological or non-pharmacological treatments, and their relative efficacy, for acute and subacute LBP. These findings will be useful for patients, healthcare providers, and policymakers.
PROSPERO CRD42018102527.
The aim of this study was to describe the clinical use of bevacizumab in Lombardy (9.5 million inhabitants), Italy, during 2006–2007 in patients with metastatic colorectal cancer (mCRC) to evaluate ...compliance with the Italian Medicine Agency (AIFA) indications, the incidence of adverse events, and the survival rate.
We performed computerized record linkage among three different Lombardy health care databases: File F registry, Regional discharge database, and Registry Office records. Patients were classified into approved and off‐label uses according to the AIFA indications.
Treatment with bevacizumab was administered to 780 patients, of whom 81.7% (n = 637) had mCRC. Among these, 37.8% (n = 241) of patients received the drug in observance of AIFA indications. Overall, ∼10% of patients had serious treatment‐related toxicities (fistula, 3.5%; venous thromboembolism, 2.8%; hemorrhage, 1.9%; intestinal perforation and arterial thromboembolism, <1%). The 1‐year survival rate was 74.3% and the 2‐year survival rate was 39.2%. The median survival time was 20.5 months, and there were no meaningful differences between gender and age groups.
There was a gap between the bevacizumab approved indication and clinical practice pattern: overall, less than one half of the patients received bevacizumab in observance with the regulatory indication. The main reason for nonadherence to the indication was use as a second‐line or advanced line of therapy. The incidence of serious adverse events and the survival rates of mCRC patients were similar to those reported in clinical trials.
摘要
本研究的目的是，通过回顾2006‐2007年贝伐珠单抗在意大利 Lombardy 地区（950万居民）用于转移性结直肠癌（ mCRC ）患者的临床应用数据，评估其在意大利药品局（ AIFA ）所规定适应症的符合性、不良事件的发生率以及生存率。
回顾性分析 Lombardy 地区三个不同的医疗保健数据库的计算机链接记录，包括 File F 登记库、当地出院病人数据库以及登记办公室记录数据库。根据 AIFA 规定的适应症将患者分为两类，即适应症内使用与适应症外使用。
共有 780 例患者接受了贝伐珠单抗治疗，其中81.7%（ n=637）为 mCRC 。在这些患者中，有37.8%（n =241）用药符合 AIFA 规定的适应症。约10%的患者出现严重治疗相关毒性（瘘管 3.5%；静脉血栓栓塞2.8%；出血1.9%；肠穿孔与动脉血栓栓塞<1%）。1年生存率与2年生存率分别为74.3%和39.2%。中位生存期为20.5个月，不同性别与年龄组间无显著差异。
已批准的贝伐珠单抗适应症与临床实践间存在差异：总体而言，只有不到一半的患者使用贝伐珠单抗是符合规定适应症的。不符合适应症的主要原因是将贝伐珠单抗用作二线或更后线的治疗。 mCRC 患者中严重不良事件的发生率及生存率与已报道的临床研究结果相近。
Compliance with the Italian Medicine Agency indications for bevacizumab was examined in Lombardy (9.5 million inhabitants), Italy, during 2006–2007 in patients with metastatic colorectal cancer using computerized databases. Less than one half of the patients received bevacizumab in observance with the regulatory indication. Incidence of major adverse events and median survival were comparable to those reported in clinical trials.
Systematic reviews (SRs) have become increasingly important for informing clinical practice; however, little is known about the reporting characteristics and the quality of the SRs relevant to the ...practice of rehabilitation health professionals.
The purpose of this study was to examine the reporting quality of a representative sample of published SRs on rehabilitation, focusing on the descriptive, reporting, and bias-related characteristics.
A cross-sectional study was conducted by searching MEDLINE for aggregative and configurative SRs indexed in 2011 that focused on rehabilitation as restorative of functional limitations. Two reviewers independently screened and selected the SRs and extracted data using a 38-item data collection form derived from Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). The data were analyzed descriptively.
Eighty-eight SRs published in 59 journals were sampled. The median compliance with the PRISMA items was 17 (63%) out of 27 items (interquartile ratio=13-22 48%-82%). Two thirds of the SRs (n=66) focused on interventions for which efficacy is best addressed through a randomized controlled trial (RCT) design, and almost all of these SRs included RCTs (63/66 95%). More than two thirds of the SRs assessed the quality of primary studies (74/88 84%). Twenty-eight reviews (28/88 32%) meta-analyzed the results for at least one outcome. One half of the SRs reported positive statistically significant findings (46%), whereas a detrimental result was present only in one review.
This sample of SRs in the rehabilitation field showed heterogeneous characteristics and a moderate quality of reporting. Poor control of potential source of bias might be improved if more widely agreed-upon evidence-based reporting guidelines will be actively endorsed and adhered to by authors and journals.
Celotno besedilo
Dostopno za:
DOBA, FSPLJ, IZUM, KILJ, NUK, OILJ, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK, VSZLJ
Background
In people who have had a stroke, upper limb paresis affects many activities of daily life. Reducing disability is therefore a major aim of rehabilitative interventions. Despite preserving ...or recovering movement ability after stroke, sometimes people do not fully realise this ability in their everyday activities. Constraint‐induced movement therapy (CIMT) is an approach to stroke rehabilitation that involves the forced use and massed practice of the affected arm by restraining the unaffected arm. This has been proposed as a useful tool for recovering abilities in everyday activities.
Objectives
To assess the efficacy of CIMT, modified CIMT (mCIMT), or forced use (FU) for arm management in people with hemiparesis after stroke.
Search methods
We searched the Cochrane Stroke Group trials register (last searched June 2015), the Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library Issue 1, 2015), MEDLINE (1966 to January 2015), EMBASE (1980 to January 2015), CINAHL (1982 to January 2015), and the Physiotherapy Evidence Database (PEDro; January 2015).
Selection criteria
Randomised control trials (RCTs) and quasi‐RCTs comparing CIMT, mCIMT or FU with other rehabilitative techniques, or none.
Data collection and analysis
One author identified trials from the results of the electronic searches according to the inclusion and exclusion criteria, three review authors independently assessed methodological quality and risk of bias, and extracted data. The primary outcome was disability.
Main results
We included 42 studies involving 1453 participants. The trials included participants who had some residual motor power of the paretic arm, the potential for further motor recovery and with limited pain or spasticity, but tended to use the limb little, if at all. The majority of studies were underpowered (median number of included participants was 29) and we cannot rule out small‐trial bias. Eleven trials (344 participants) assessed disability immediately after the intervention, indicating a non‐significant standard mean difference (SMD) 0.24 (95% confidence interval (CI) ‐0.05 to 0.52) favouring CIMT compared with conventional treatment. For the most frequently reported outcome, arm motor function (28 studies involving 858 participants), the SMD was 0.34 (95% CI 0.12 to 0.55) showing a significant effect (P value 0.004) in favour of CIMT. Three studies involving 125 participants explored disability after a few months of follow‐up and found no significant difference, SMD ‐0.20 (95% CI ‐0.57 to 0.16) in favour of conventional treatment.
Authors' conclusions
CIMT is a multi‐faceted intervention where restriction of the less affected limb is accompanied by increased exercise tailored to the person’s capacity. We found that CIMT was associated with limited improvements in motor impairment and motor function, but that these benefits did not convincingly reduce disability. This differs from the result of our previous meta‐analysis where there was a suggestion that CIMT might be superior to traditional rehabilitation. Information about the long‐term effects of CIMT is scarce. Further trials studying the relationship between participant characteristics and improved outcomes are required.
Access to essential cancer medicines is a major determinant of childhood cancer outcomes globally. The degree to which pediatric oncologists deem medicines listed on WHO's Model List of Essential ...Medicines for Children (EMLc) essential is unknown, as is the extent to which such medicines are accessible on the front lines of clinical care.
An electronic survey developed was distributed through the International Society of Pediatric Oncology mailing list to members from 87 countries. Respondents were asked to select 10 cancer medicines that would provide the greatest benefit to patients in their context; subsequent questions explored medicine availability and cost. Descriptive and bivariate statistics compared access to medicines between low- and lower-middle-income countries (LMICs), upper-middle-income countries (UMICs), and high-income countries (HICs).
Among 159 respondents from 44 countries, 43 (27%) were from LMICs, 79 (50%) from UMICs, and 37 (23%) from HICs. The top five medicines were methotrexate (75%), vincristine (74%), doxorubicin (74%), cyclophosphamide (69%), and cytarabine (65%). Of the priority medicines identified, 87% (27 of 31) are represented on the 2021 EMLc and 77% (24 of 31) were common to the lists generated by LMIC, UMIC, and HIC respondents. The proportion of respondents indicating universal availability for each of the top medicines ranged from 9% to 46% for LMIC, 25% to 89% for UMIC, and 67% to 100% for HIC. Risk of catastrophic expenditure was more common in LMIC (8%-20%), compared with UMIC (0%-28%) and HIC (0%).
Most medicines that oncologists deem essential for childhood cancer treatment are currently included on the EMLc. Barriers remain in access to these medicines, characterized by gaps in availability and risks of catastrophic expenditure for families that are most pronounced in low-income settings but evident across all income contexts.
Established in 2015, the Multi-Stakeholder Engagement (MuSE) Consortium is an international network of over 120 individuals interested in stakeholder engagement in research and guidelines. The MuSE ...group is developing guidance for stakeholder engagement in the development of health and healthcare guideline development. The development of this guidance has included multiple meetings with stakeholders, including patients, payers/purchasers of health services, peer review editors, policymakers, program managers, providers, principal investigators, product makers, the public, and purchasers of health services and has identified a number of key issues. These include: (1) Definitions, roles, and settings (2) Stakeholder identification and selection (3) Levels of engagement, (4) Evaluation of engagement, (5) Documentation and transparency, and (6) Conflict of interest management. In this paper, we discuss these issues and our plan to develop guidance to facilitate stakeholder engagement in all stages of the development of health and healthcare guideline development.
The WHO essential medicines list (EML) guides selection of drugs for national formularies. Here, we evaluate which medicines are considered highest priority by Indian oncologists and the extent to ...which they are available in routine practice.
This is a secondary analysis of an electronic survey developed by the WHO EML Cancer Medicine Working Group. The survey was distributed globally using a hierarchical snowball method to physicians who prescribe systemic anticancer therapy. The survey captured the 10 medicines oncologists considered highest priority for population health and their availability in routine practice.
The global study cohort included 948 respondents from 82 countries; 98 were from India and 67 were from other low- and middle-income countries. Compared with other low- and middle-income countries, the Indian cohort was more likely to be medical oncologist (70%
31%,
< .001) and work exclusively in the private health system (52%
17%,
< .001). 14/20 most commonly selected medicines were conventional cytotoxic drugs. Universal access to these medicines was reported by a minority of oncologists; risks of significant out-of-pocket expenditures for each medicine were reported by 19%-58% of oncologists. Risk of catastrophic expenditure was reported by 58%-67% of oncologists for rituximab and trastuzumab. Risks of financial toxicity were substantially higher within the private health system compared with the public system.
Most high-priority cancer medicines identified by Indian oncologists are generic chemotherapy agents that provide substantial improvements in survival and are already included in WHO EML. Access to these treatments remains limited by major financial burdens experienced by patients. This is particularly acute within the private health system. Strategies are urgently needed to ensure that high-quality cancer care is affordable and accessible to all patients in India.
E‐learning for health professionals Vaona, Alberto; Banzi, Rita; Kwag, Koren H ...
Cochrane database of systematic reviews,
01/2018, Letnik:
2018, Številka:
8
Journal Article
Recenzirano
Odprti dostop
Background
The use of e‐learning, defined as any educational intervention mediated electronically via the Internet, has steadily increased among health professionals worldwide. Several studies have ...attempted to measure the effects of e‐learning in medical practice, which has often been associated with large positive effects when compared to no intervention and with small positive effects when compared with traditional learning (without access to e‐learning). However, results are not conclusive.
Objectives
To assess the effects of e‐learning programmes versus traditional learning in licensed health professionals for improving patient outcomes or health professionals' behaviours, skills and knowledge.
Search methods
We searched CENTRAL, MEDLINE, Embase, five other databases and three trial registers up to July 2016, without any restrictions based on language or status of publication. We examined the reference lists of the included studies and other relevant reviews. If necessary, we contacted the study authors to collect additional information on studies.
Selection criteria
Randomised trials assessing the effectiveness of e‐learning versus traditional learning for health professionals. We excluded non‐randomised trials and trials involving undergraduate health professionals.
Data collection and analysis
Two authors independently selected studies, extracted data and assessed risk of bias. We graded the certainty of evidence for each outcome using the GRADE approach and standardised the outcome effects using relative risks (risk ratio (RR) or odds ratio (OR)) or standardised mean difference (SMD) when possible.
Main results
We included 16 randomised trials involving 5679 licensed health professionals (4759 mixed health professionals, 587 nurses, 300 doctors and 33 childcare health consultants).
When compared with traditional learning at 12‐month follow‐up, low‐certainty evidence suggests that e‐learning may make little or no difference for the following patient outcomes: the proportion of patients with low‐density lipoprotein (LDL) cholesterol of less than 100 mg/dL (adjusted difference 4.0%, 95% confidence interval (CI) −0.3 to 7.9, N = 6399 patients, 1 study) and the proportion with glycated haemoglobin level of less than 8% (adjusted difference 4.6%, 95% CI −1.5 to 9.8, 3114 patients, 1 study). At 3‐ to 12‐month follow‐up, low‐certainty evidence indicates that e‐learning may make little or no difference on the following behaviours in health professionals: screening for dyslipidaemia (OR 0.90, 95% CI 0.77 to 1.06, 6027 patients, 2 studies) and treatment for dyslipidaemia (OR 1.15, 95% CI 0.89 to 1.48, 5491 patients, 2 studies). It is uncertain whether e‐learning improves or reduces health professionals' skills (2912 health professionals; 6 studies; very low‐certainty evidence), and it may make little or no difference in health professionals' knowledge (3236 participants; 11 studies; low‐certainty evidence).
Due to the paucity of studies and data, we were unable to explore differences in effects across different subgroups. Owing to poor reporting, we were unable to collect sufficient information to complete a meaningful 'Risk of bias' assessment for most of the quality criteria. We evaluated the risk of bias as unclear for most studies, but we classified the largest trial as being at low risk of bias. Missing data represented a potential source of bias in several studies.
Authors' conclusions
When compared to traditional learning, e‐learning may make little or no difference in patient outcomes or health professionals' behaviours, skills or knowledge. Even if e‐learning could be more successful than traditional learning in particular medical education settings, general claims of it as inherently more effective than traditional learning may be misleading.
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