-
Iranian Red Crescent Medical Journal Dec 2015This study aimed to explore the effect of the International Organization for Standardization (ISO) ISO 9001 standard and the European foundation for quality management... (Review)
Review
CONTEXT
This study aimed to explore the effect of the International Organization for Standardization (ISO) ISO 9001 standard and the European foundation for quality management (EFQM) model on improving hospital performance.
EVIDENCE ACQUISITION
PubMed, Embase and the Cochrane Library databases were searched. In addition, Elsevier and Springer were searched as main publishers in the field of health sciences. We included empirical studies with any design that had used ISO 9001 or the EFQM model to improve the quality of healthcare. Data were collected and tabulated into a data extraction sheet that was specifically designed for this study. The collected data included authors' names, country, year of publication, intervention, improvement aims, setting, length of program, study design, and outcomes.
RESULTS
Seven out of the 121 studies that were retrieved met the inclusion criteria. Three studies assessed the EFQM model and four studies assessed the ISO 9001 standard. Use of the EFQM model increased the degree of patient satisfaction and the number of hospital admissions and reduced the average length of stay, the delay on the surgical waiting list, and the number of emergency re-admissions. ISO 9001 also increased the degree of patient satisfaction and patient safety, increased cost-effectiveness, improved the hospital admissions process, and reduced the percentage of unscheduled returns to the hospital.
CONCLUSIONS
Generally, there is a lack of robust and high quality empirical evidence regarding the effects of ISO 9001 and the EFQM model on the quality care provided by and the performance of hospitals. However, the limited evidence shows that ISO 9001 and the EFQM model might improve hospital performance.
PubMed: 26756012
DOI: 10.5812/ircmj.23010 -
JPMA. the Journal of the Pakistan... Aug 2023To map literature on research ethics committees, institutional review boards and ethics review framework in Pakistan to identify key insights during public health...
OBJECTIVE
To map literature on research ethics committees, institutional review boards and ethics review framework in Pakistan to identify key insights during public health emergencies and normal times.
METHOD
The systematic scoping review was conducted in April 2022, and comprised literature search on PubMed, World Health Organisation Global Index Medicus and Summons databases for articles published between January 2005 and February 2022. Information extracted included authors' names, year of publication, title, study methodology, and key insights under the heads of challenges and solutions. Due to data heterogeneity, key themes were identified and analysed.
RESULTS
Of the 2,190 studies initially identified, 21(0.95%) were subjected to full-text review, and, from among them, 9(45%) were analysed in detail. There were 4 key insights identified: research ethics committees and institutional review boards in Pakistan remain unregulated as they are currently not registered or accredited by a competent national-level authority; most members of such committees are not formally trained to implement the mandate; internal and external pressures hinder independent decision-making of such committees; and other issues hindering the functionality and performance of research ethics committees and institutional review boards.
CONCLUSIONS
Despite existing publications calling for urgent policy and regulatory reforms, there is a dearth of literature and minimal policy actions underlying the fact that ethics review remains a neglected area in Pakistan.
Topics: Humans; Pakistan; Ethics Committees, Research; Learning; Databases, Factual
PubMed: 37697760
DOI: 10.47391/JPMA.8033 -
Frontiers in Oncology 2023The uncommon -altered primary central nervous system (CNS) tumors were recently added to the World Health Organization 2021 classification under the name Astroblastoma,...
The uncommon -altered primary central nervous system (CNS) tumors were recently added to the World Health Organization 2021 classification under the name Astroblastoma, -altered. Another term used to describe them, "High-grade neuroepithelial tumor with alteration" (HGNET-MN1), makes reference to their distinct epigenetic profile but is currently not a recommended name. Thought to occur most commonly in children and predominantly in females, -altered CNS tumors are associated with typical but not pathognomonic histological patterns and are characterized by a distinct DNA methylation profile and recurrent fusions implicating the (meningioma 1) gene. Diagnosis based on histological features alone is challenging: most cases with morphological features of astroblastoma (but not all) show these molecular features, whereas not all tumors with fusions show astroblastoma morphology. There is large variability in reported outcomes and detailed clinical and therapeutic information is frequently missing. Some patients experience multiple recurrences despite multimodality treatment, whereas others experience no recurrence after surgical resection alone, suggesting large clinical and biological heterogeneity despite unifying epigenetic features and recurrent fusions. In this report, we present the demographics, tumor characteristics, treatment, and outcome (including patient-reported outcomes) of three adults with -altered primary CNS tumors diagnosed genome-wide DNA methylation and RNA sequencing. All three patients were females and two of them were diagnosed as young adults. By reporting our neuropathological and clinical findings and comparing them with previously published cases we provide insight into the clinical heterogeneity of this tumor. Additionally, we propose a model for prospective, comprehensive, and systematic collection of clinical data in addition to neuropathological data, including standardized patient-reported outcomes.
PubMed: 36741001
DOI: 10.3389/fonc.2023.1099618 -
Journal of Fungi (Basel, Switzerland) Mar 2022Objective: To systematically review literature enabling the comparison of the efficacy of pharmaceutical treatments for tinea pedis in adults. Design: Systematic review... (Review)
Review
Objective: To systematically review literature enabling the comparison of the efficacy of pharmaceutical treatments for tinea pedis in adults. Design: Systematic review of randomised controlled trials (RCTs) with mycological cure as the primary outcome. Secondary outcomes did include the clinical assessment of resolving infection or symptoms, duration of treatment, adverse events, adherence, and recurrence. Eligibility Criteria: Study participants suffering from only tinea pedis that were treated with a pharmaceutical treatment. The study must have been conducted using an RCT study design and recording age of the participant > 16 years of age. Results: A total of seven studies met the inclusion criteria, involving 1042 participants. The likelihood of resolution in study participants treated with terbinafine was RR 3.9 (95% CI: 2.0−7.8) times those with a placebo. Similarly, the allylamine butenafine was effective by RR 5.3 (95% CI: 1.4−19.6) compared to a placebo. Butenafine was similarly efficacious to terbinafine RR 1.3 (95% CI: 0.4−4.4). Terbinafine was marginally more efficacious than itraconazole, RR 1.3 (95% CI: 1.1−1.5). Summary/Conclusion: Topical terbinafine and butenafine treatments of tinea pedis were more efficacious than placebo. Tableted terbinafine and itraconazole administered orally were efficacious in the drug treatment of tinea pedis fungal infection. We are concerned about how few studies were available that reported the baseline characteristics for each treatment arm and that did not suffer greater than 20% loss to follow-up. We would like to see improved reporting of clinical trials in academic literature. Registration name: Treatment’s for athlete’s foot—systematic review with meta-analysis [CRD42020162078].
PubMed: 35448582
DOI: 10.3390/jof8040351 -
PLoS Neglected Tropical Diseases Feb 2016Neglected Tropical Diseases (NTDs) not only cause health and life expectancy loss, but can also lead to economic consequences including reduced ability to work. This... (Review)
Review
BACKGROUND
Neglected Tropical Diseases (NTDs) not only cause health and life expectancy loss, but can also lead to economic consequences including reduced ability to work. This article describes a systematic literature review of the effect on the economic productivity of individuals affected by one of the five worldwide most prevalent NTDs: lymphatic filariasis, onchocerciasis, schistosomiasis, soil-transmitted helminths (ascariasis, trichuriasis, and hookworm infection) and trachoma. These diseases are eligible to preventive chemotherapy (PCT).
METHODOLOGY/PRINCIPAL FINDINGS
Eleven bibliographic databases were searched using different names of all NTDs and various keywords relating to productivity. Additional references were identified through reference lists from relevant papers. Of the 5316 unique publications found in the database searches, thirteen papers were identified for lymphatic filariasis, ten for onchocerciasis, eleven for schistosomiasis, six for soil-transmitted helminths and three for trachoma. Besides the scarcity in publications reporting the degree of productivity loss, this review revealed large variation in the estimated productivity loss related to these NTDs.
CONCLUSIONS
It is clear that productivity is affected by NTDs, although the actual impact depends on the type and severity of the NTD as well as on the context where the disease occurs. The largest impact on productivity loss of individuals affected by one of these diseases seems to be due to blindness from onchocerciasis and severe schistosomiasis manifestations; productivity loss due to trachoma-related blindness has never been studied directly. However, productivity loss at an individual level might differ from productivity loss at a population level because of differences in the prevalence of NTDs. Variation in estimated productivity loss between and within diseases is caused by differences in research methods and setting. Publications should provide enough information to enable readers to assess the quality and relevance of the study for their purposes.
Topics: Animals; Chemoprevention; Humans; Neglected Diseases; Tropical Medicine; Work
PubMed: 26890487
DOI: 10.1371/journal.pntd.0004397 -
Health Research Policy and Systems Oct 2020Knowledge translation (KT) platforms are organisations, initiatives and networks that focus on supporting evidence-informed policy-making at least in part about the...
Lessons learned from descriptions and evaluations of knowledge translation platforms supporting evidence-informed policy-making in low- and middle-income countries: a systematic review.
BACKGROUND
Knowledge translation (KT) platforms are organisations, initiatives and networks that focus on supporting evidence-informed policy-making at least in part about the health-system arrangements that determine whether the right programmes, services and products get to those who need them. Many descriptions and evaluations of KT platforms in low- and middle-income countries have been produced but, to date, they have not been systematically reviewed.
METHODS
We identified potentially relevant studies through a search of five electronic databases and a variety of approaches to identify grey literature. We used four criteria to select eligible empirical studies. We extracted data about seven characteristics of included studies and about key findings. We used explicit criteria to assess study quality. In synthesising the findings, we gave greater attention to themes that emerged from multiple studies, higher-quality studies and different contexts.
RESULTS
Country was the most common jurisdictional focus of KT platforms, EVIPNet the most common name and high turnover among staff a common infrastructural feature. Evidence briefs and deliberative dialogues were the activities/outputs that were the most extensively studied and viewed as helpful, while rapid evidence services were the next most studied but only in a single jurisdiction. None of the summative evaluations used a pre-post design or a control group and, with the exception of the evaluations of the influence of briefs and dialogues on intentions to act, none of the evaluations achieved a high quality score.
CONCLUSIONS
A large and growing volume of research evidence suggests that KT platforms offer promise in supporting evidence-informed policy-making in low- and middle-income countries. KT platforms should consider as next steps expanding their current, relatively limited portfolio of activities and outputs, building bridges to complementary groups, and planning for evaluations that examine 'what works' for 'what types of issues' in 'what types of contexts'.
Topics: Developing Countries; Government Programs; Health Policy; Humans; Policy Making; Translational Research, Biomedical
PubMed: 33129335
DOI: 10.1186/s12961-020-00626-5 -
PloS One 2017Only 45% of people currently living with HIV infection in sub-Saharan Africa are aware of their HIV status. Unmet testing needs may be addressed by utilizing the... (Review)
Review
INTRODUCTION
Only 45% of people currently living with HIV infection in sub-Saharan Africa are aware of their HIV status. Unmet testing needs may be addressed by utilizing the Emergency Department (ED) as an innovative testing venue in low and middle-income countries (LMICs). The purpose of this review is to examine the burden of HIV infection described in EDs in LMICs, with a focus on summarizing the implementation of various ED-based HIV testing strategies.
METHODOLOGY AND RESULTS
We performed a systematic review of Pubmed, Embase, Scopus, Web of Science and the Cochrane Library on June 12, 2016. A three-concept search was employed with emergency medicine (e.g., Emergency department, emergency medical services), HIV/AIDS (e.g., human immunodeficiency virus, acquired immunodeficiency syndrome), and LMIC terms (e.g., developing country, under developed countries, specific country names). The search returned 2026 unique articles. Of these, thirteen met inclusion criteria and were included in the final review. There was a large variation in the reported prevalence of HIV infection in the ED population ranging from to 2.14% in India to 43.3% in Uganda. The proportion HIV positive patients with previously undiagnosed infection ranged from 90% to 65.22%.
CONCLUSION
In the United States ED-based HIV testing strategies have been front and center at curbing the HIV epidemic. The limited number of ED-based studies we observed in this study may represent the paucity of HIV testing in this venue in LMICs. All of the studies in this review demonstrated a high prevalence of HIV infection in the ED and an extraordinarily high percentage of previously undiagnosed HIV infection. Although the numbers of published reports are few, these diverse studies imply that in HIV endemic low resource settings EDs carry a large burden of undiagnosed HIV infections and may offer a unique testing venue.
Topics: AIDS Serodiagnosis; Emergency Service, Hospital; Female; HIV Infections; HIV Seroprevalence; Health Care Rationing; Humans; India; Male; Uganda
PubMed: 29095899
DOI: 10.1371/journal.pone.0187443 -
BMC Palliative Care Nov 2020Worldwide, many patients with cancer, are infrequently referred to palliative care or are referred late. Oncologists and haematologists may act as gatekeepers, and their...
BACKGROUND
Worldwide, many patients with cancer, are infrequently referred to palliative care or are referred late. Oncologists and haematologists may act as gatekeepers, and their views may facilitate or hinder referrals to palliative care. This review aimed to identify, explore and synthesise their views on referrals systematically.
METHODS
Databases of MEDLINE, CINAHL, PsycINFO, EMBASE, Scopus, Web of Science and Cochrane were searched for articles from 01/01/1990 to 31/12/2019. All studies were scored for their methodological rigour using Hawker's tool. Findings were synthesised using Popay's narrative synthesis method and interpreted using a critical realist lens and social exchange theory.
RESULTS
Out of 9336 initial database citations, 23 studies were included for synthesis. Five themes were developed during synthesis. 1. Presuppositions of oncologists and haematologists about palliative care referral: Role conflict, abandonment, rupture of therapeutic alliance and loss of hope were some of the presuppositions that hindered palliative care referral. Negative emotions and perception of self-efficacy to manage palliative care need also hindered referral. 2. Power relationships and trust issues: Oncologists and haematologists preferred to gatekeep the referral process and wished to control and coordinate the care process. They had diminished trust in the competency of palliative care providers. 3. Making a palliative care referral: A daunting task: The stigma associated with palliative care, navigating illness and treatment associated factors, addressing patient and family attitudes, and overcoming organisational challenges made referral a daunting task. Lack of referral criteria and limited palliative care resources made the referral process challenging. 4. Cost-benefit of palliative care referral: Pain and symptom management and psychosocial support were the perceived benefits, whereas inconsistencies in communication and curtailment of care were some of the costs associated with palliative care referral. 5. Strategies to facilitate palliative care referral: Developing an integrated model of care, renaming and augmenting palliative care resources were some of the strategies that could facilitate a referral.
CONCLUSION
Presuppositions, power relationships, trust issues and the challenges associated with the task of referrals hindered palliative care referral. Oncologists and haematologists appraised the cost-benefit of making a palliative care referral. They felt that an integrated model of care, changing the name of palliative care and augmenting palliative care resources might facilitate a referral.
Topics: Attitude of Health Personnel; Hematology; Humans; Medical Oncology; Palliative Care; Physicians; Referral and Consultation; Trust
PubMed: 33228651
DOI: 10.1186/s12904-020-00671-5 -
The Cochrane Database of Systematic... Feb 2015Mosquitoes become infected with Plasmodium when they ingest gametocyte-stage parasites from an infected person's blood. Plasmodium falciparum gametocytes are sensitive... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Mosquitoes become infected with Plasmodium when they ingest gametocyte-stage parasites from an infected person's blood. Plasmodium falciparum gametocytes are sensitive to 8-aminoquinolines (8AQ), and consequently these drugs could prevent parasite transmission from infected people to mosquitoes and reduce the incidence of malaria. However, when used in this way, these drugs will not directly benefit the individual.In 2010, the World Health Organization (WHO) recommended a single dose of primaquine (PQ) at 0.75 mg/kg alongside treatment for P. falciparum malaria to reduce transmission in areas approaching malaria elimination. In 2013, the WHO revised this to 0.25 mg/kg to reduce risk of harms in people with G6PD deficiency.
OBJECTIVES
To assess the effects of PQ (or an alternative 8AQ) given alongside treatment for P. falciparum malaria on malaria transmission and on the occurrence of adverse events.
SEARCH METHODS
We searched the following databases up to 5 January 2015: the Cochrane Infectious Diseases Group Specialized Register; the Cochrane Central Register of Controlled Trials (CENTRAL), published in The Cochrane Library (Issue 1, 2015); MEDLINE (1966 to 5 January 2015); EMBASE (1980 to 5 January 2015); LILACS (1982 to 5 January 2015); metaRegister of Controlled Trials (mRCT); and the WHO trials search portal using 'malaria*', 'falciparum', 'primaquine', 8-aminoquinoline and eight individual 8AQ drug names as search terms. In addition, we searched conference proceedings and reference lists of included studies, and contacted researchers and organizations.
SELECTION CRITERIA
Randomized controlled trials (RCTs) or quasi-RCTs in children or adults, comparing PQ (or alternative 8AQ) as a single dose or short course alongside treatment for P. falciparum malaria, with the same malaria treatment given without PQ/8AQ.
DATA COLLECTION AND ANALYSIS
Two review authors independently screened all abstracts, applied inclusion criteria and extracted data. We sought evidence of an impact on transmission (community incidence), infectiousness (mosquitoes infected from humans) and potential infectiousness (gametocyte measures). We calculated the area under the curve (AUC) for gametocyte density over time for comparisons for which data were available. We sought data on haematological and other adverse effects, asexual parasite clearance time and recrudescence. We stratified the analysis by artemisinin and non-artemisinin treatments; and by PQ dose (low < 0.4 mg/kg; medium ≥ 0.4 to < 0.6 mg/kg; high ≥ 0.6 mg/kg). We used the GRADE approach to assess evidence quality.
MAIN RESULTS
We included 17 RCTs and one quasi-RCT. Eight trials tested for G6PD status: six then excluded participants with G6PD deficiency, one included only those with G6PD deficiency, and one included all irrespective of status. The remaining 10 trials either did not report on whether they tested (eight trials), or reported that they did not test (two trials).Nine trials included study arms with artemisinin-based treatments and eleven included study arms with non-artemisinin-based treatments.Only one trial evaluated PQ given as a single dose of less than 0.4 mg/kg. PQ with artemisinin-based treatments: No trials evaluated effects on malaria transmission directly (incidence, prevalence or entomological inoculation rate) and none evaluated infectiousness to mosquitoes. For potential infectiousness, the proportion of people with detectable gametocytaemia on day eight was reduced by around two-thirds with the high dose PQ category (RR 0.29, 95% confidence interval (CI) 0.22 to 0.37; seven trials, 1380 participants, high quality evidence) and the medium dose PQ category (RR 0.30, 95% CI 0.16 to 0.56; one trial, 219 participants, moderate quality evidence). For the low dose category, the effect size was smaller and the 95% CIs include the possibility of no effect (dose: 0.1 mg/kg: RR 0.67, 95% CI 0.44 to 1.02; one trial, 223 participants, low quality evidence). Reductions in log(10)AUC estimates for gametocytaemia on days 1 to 43 with medium and high doses ranged from 24.3% to 87.5%. For haemolysis, one trial reported percent change in mean haemoglobin against baseline and did not detect a difference between the two arms (very low quality evidence). PQ with non-artemisinin treatments: No trials assessed effects on malaria transmission directly. Two small trials from the same laboratory in China evaluated infectiousness to mosquitoes, and reported that infectivity was eliminated on day 8 in 15/15 patients receiving high dose PQ compared to 1/15 in the control group (low quality evidence). For potential infectiousness, the proportion of people with detectable gametocytaemia on day 8 was reduced by three-fifths with high dose PQ category (RR 0.39, 95% CI 0.25 to 0.62; four trials, 186 participants, high quality evidence), and by around two-fifths with medium dose category (RR 0.60, 95% CI 0.49 to 0.75; one trial, 216 participants, high quality evidence), with no trial in the low dose PQ category reporting this outcome. Reduction in log(10)AUC for gametocytaemia days 1 to 43 were 24.3% and 27.1% for two arms in one trial giving medium dose PQ. No trials systematically sought evidence of haemolysis.Two trials evaluated the 8AQ bulaquine, and suggest the effects may be greater than PQ, but the small number of participants (N = 112) preclude a definite conclusion.
AUTHORS' CONCLUSIONS
In individual patients, PQ added to malaria treatments reduces gametocyte prevalence, but this is based on trials using doses of more than 0.4 mg/kg. Whether this translates into preventing people transmitting malaria to mosquitoes has rarely been tested in controlled trials, but there appeared to be a strong reduction in infectiousness in the two small studies that evaluated this. No included trials evaluated whether this policy has an impact on community malaria transmission.For the currently recommended low dose regimen, there is currently little direct evidence to be confident that the effect of reduction in gametocyte prevalence is preserved, or that it is safe in people with G6PD deficiency.
Topics: Antimalarials; Artemisinins; Artesunate; Chloroquine; Drug Combinations; Glucosephosphate Dehydrogenase Deficiency; Humans; Malaria, Falciparum; Mefloquine; Plasmodium falciparum; Primaquine; Pyrimethamine; Quinine; Randomized Controlled Trials as Topic; Sulfadoxine
PubMed: 25693791
DOI: 10.1002/14651858.CD008152.pub4 -
Indian Journal of Pharmacology 2021Registration of study protocols brings about transparency and traceability and the amount of publication bias can be estimated. In this study, we have collected and... (Meta-Analysis)
Meta-Analysis
INTRODUCTION
Registration of study protocols brings about transparency and traceability and the amount of publication bias can be estimated. In this study, we have collected and presented data regarding clinical study registries, preclinical, in vitro and in silico study registries across the globe.
MATERIALS AND METHODS
We searched via Google Search Engine with appropriate keywords e.g. name of country (n = 198), name of continent (n = 7), registry, study registry, animal, in silico, virtual, simulation, preclinical, animal, clinical trial. The overall pooled prevalence of clinical study registries and WHO primary registries in per continent was calculated using Medcalc software.
RESULTS
The overall pooled prevalence of clinical study registries were 13% in each continent. The prevalence of WHO primary study registries were 8.9% of the countries per continent. Overall, there are 17 primary registries associated with WHO ICTRP as primary registries, 2 partner registries and 6 registries are affiliated to ICMJE. However, the amount of preclinical animal study registry was quite less (n = 4). Regarding in vitro studies, only country specific in vitro fertilization registries were available, however, in other research domains, registries were absent. Only one simulation study registry was available.
CONCLUSION
At priori study registration is essential to deal with selective reporting. Comparison between study protocol and final report allows us to know the protocol deviations and allows us to evaluate risk of bias and internal validity of the research findings. Although trialists are responsible for the completeness of records, yet the registries must have some measures for their periodic update and quality control of the data.
Topics: Animals; Clinical Protocols; Clinical Trials as Topic; Drug Evaluation, Preclinical; Humans; Registries; World Health Organization
PubMed: 34100401
DOI: 10.4103/ijp.ijp_1090_20