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BACKGROUND: The global research response to the COVID-19 pandemic was impressive, but also led to an infodemic and considerable research waste. Registered, but unpublished trials added to this noise. We aimed to determine the proportion of registered randomised trials of common COVID-19 treatments that were published and to describe the characteristics of these trials to examine the association between trial characteristics, publication status and research waste. METHODS: This meta-epidemiological cohort study used a sample of randomised trials of corticosteroids, hydroxychloroquine or vitamin D as treatments for COVID-19, registered between 1 November 2019 and 31 December 2021 and available via the WHO ICTRP portal. We searched for the trials' published results up to 20 October 2022. We extracted the trial characteristics, analysing with descriptive statistics. We performed univariate logistic regression to examine the association between trials' characteristics and publication status, followed by multiple logistic regression using significant characteristics to assess the association between trial characteristics and publication status. RESULTS: We identified 357 eligible trials on ICTRP. Of these, 107 (30%) had published or made their results available publicly by 20 October 2022, while 250 (70%) had not been published or shared their results publicly. Multiple logistic regression analysis showed that a larger target sample size was a significant positive predictor of publication with target sample sizes above 300 almost tripling the odds of publication (aOR: 2.75, 95% CI: 1.35 to 5.62). CONCLUSIONS: Less than one third of registered trials made their results public and our findings identified that many trialists had not updated their trial registry entry with the trial status, results or both. Failure to share trial results publicly is a disservice to patients, clinicians and policy makers and adds to research waste.
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COVID-19 , Vitamina D , Humanos , Corticoesteroides , Estudios de Cohortes , Tratamiento Farmacológico de COVID-19 , Hidroxicloroquina , Pandemias , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND: Children often require pain management following surgery to avoid suffering. Effective pain management has consequences for healing time and quality of life. Ibuprofen, a frequently used non-steroidal anti-inflammatory drug (NSAID) administered to children, is used to treat pain and inflammation in the postoperative period. OBJECTIVES: 1) To assess the efficacy and safety of ibuprofen (any dose) for acute postoperative pain management in children compared with placebo or other active comparators. 2) To compare ibuprofen administered at different doses, routes (e.g. oral, intravenous, etc.), or strategies (e.g. as needed versus as scheduled). SEARCH METHODS: We used standard Cochrane search methods. We searched CENTRAL, MEDLINE, Embase, CINAHL and trials registries in August 2023. SELECTION CRITERIA: We included randomised controlled trials (RCTs) in children aged 17 years and younger, treated for acute postoperative or postprocedural pain, that compared ibuprofen to placebo or any active comparator. We included RCTs that compared different administration routes, doses of ibuprofen and schedules. DATA COLLECTION AND ANALYSIS: We adhered to standard Cochrane methods for data collection and analysis. Our primary outcomes were pain relief reported by the child, pain intensity reported by the child, adverse events, and serious adverse events. We present results using risk ratios (RR) and standardised mean differences (SMD), with the associated confidence intervals (CI). We used GRADE to assess the certainty of the evidence. MAIN RESULTS: We included 43 RCTs that enroled 4265 children (3935 children included in this review). We rated the overall risk of bias at the study level as high or unclear for 37 studies that had one or several unclear or high risk of bias judgements across the domains. We judged six studies as having a low risk of bias across all domains. Ibuprofen versus placebo (35 RCTs) No studies reported pain relief reported by the child or a third party, or serious adverse events. Ibuprofen probably reduces child-reported pain intensity less than two hours postintervention compared to placebo (SMD -1.12, 95% CI -1.39 to -0.86; 3 studies, 259 children; moderate-certainty evidence). Ibuprofen may reduce child-reported pain intensity, two hours to less than 24 hours postintervention (SMD -1.01, 95% CI -1.24 to -0.78; 5 studies, 345 children; low-certainty evidence). Ibuprofen may result in little to no difference in adverse events compared to placebo (RR 0.79, 95% CI 0.51 to 1.23; 5 studies, 384 children; low-certainty evidence). Ibuprofen versus paracetamol (21 RCTs) No studies reported pain relief reported by the child or a third party, or serious adverse events. Ibuprofen likely reduces child-reported pain intensity less than two hours postintervention compared to paracetamol (SMD -0.42, 95% CI -0.82 to -0.02; 2 studies, 100 children; moderate-certainty evidence). Ibuprofen may slightly reduce child-reported pain intensity two hours to 24 hours postintervention (SMD -0.21, 95% CI -0.40 to -0.02; 6 studies, 422 children; low-certainty evidence). Ibuprofen may result in little to no difference in adverse events (0 events in each group; 1 study, 44 children; low-certainty evidence). Ibuprofen versus morphine (1 RCT) No studies reported pain relief or pain intensity reported by the child or a third party, or serious adverse events. Ibuprofen likely results in a reduction in adverse events compared to morphine (RR 0.58, 95% CI 0.40 to 0.83; risk difference (RD) -0.25, 95% CI -0.40 to -0.09; number needed to treat for an additional beneficial outcome (NNTB) 4; 1 study, 154 children; moderate-certainty evidence). Ibuprofen versus ketorolac (1 RCT) No studies reported pain relief or pain intensity reported by the child, or serious adverse events. Ibuprofen may result in a reduction in adverse events compared to ketorolac (RR 0.51, 95% CI 0.27 to 0.96; RD -0.29, 95% CI -0.53 to -0.04; NNTB 4; 1 study, 59 children; low-certainty evidence). AUTHORS' CONCLUSIONS: Despite identifying 43 RCTs, we remain uncertain about the effect of ibuprofen compared to placebo or active comparators for some critical outcomes and in the comparisons between different doses, schedules and routes for ibuprofen administration. This is largely due to poor reporting on important outcomes such as serious adverse events, and poor study conduct or reporting that reduced our confidence in the results, along with small underpowered studies. Compared to placebo, ibuprofen likely results in pain reduction less than two hours postintervention, however, the efficacy might be lower at two hours to 24 hours. Compared to paracetamol, ibuprofen likely results in pain reduction up to 24 hours postintervention. We could not explore if there was a different effect in different kinds of surgeries or procedures. Ibuprofen likely results in a reduction in adverse events compared to morphine, and in little to no difference in bleeding when compared to paracetamol. We remain mostly uncertain about the safety of ibuprofen compared to other drugs.
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Ibuprofeno , Dolor Postoperatorio , Humanos , Acetaminofén , Ibuprofeno/uso terapéutico , Ketorolaco , Morfina , Dolor Postoperatorio/tratamiento farmacológico , NiñoRESUMEN
BACKGROUND: For the professions of audiology and speech-language therapy (A/SLT), there continues be a dire need for more equitable services. Therefore there is a need to develop emerging practices which have a specific focus on equity as a driving force in shifting practices. This scoping review aimed to synthesise the characteristics of emerging practices in A/SLT clinical practice in relation to equity with an emphasis on communication professions. METHODS: This scoping review followed the Joanna Briggs Institute guidelines and aimed to map the emerging practices in A/SLT to identify the ways in which the professions are developing equitable practices. Papers were included if they addressed equity, focused on clinical practice and were situated within A/SLT literature. There were no time or language restrictions. The review included all sources of evidence across PubMed, Scopus, EbscoHost, The Cochrane Library and Dissertation Abstracts International, Education Resource Information Centre from their inception. The review uses PRISMA Extension for scoping reviews and PRISMA-Equity Extension reporting guidelines. RESULTS: The 20 included studies ranged from 1997-2020, spanning over 20 years. There were a variety of papers including empirical studies, commentaries, reviews and research. The results demonstrated that the professions were increasingly considering addressing equity through their practice. However, there was a prominent focus around culturally and linguistically diverse populations, with limited engagement around other intersections of marginalisation. The results also showed that while the majority of contributions to theorising equity are from the Global North with a small cluster from the Global South offering critical contributions considering social categories such as race and class. Collectively the contributions from the Global South remain a very small minority of the professional discourse which have a focus on equity. CONCLUSION: Over the last eight years, the A/SLT professions are increasingly developing emerging practices to advance equity by engaging with marginalised communities. However, the professions have a long way to go to achieve equitable practice. The decolonial lens acknowledges the impact and influence of colonisation and coloniality in shaping inequity. Using this lens, we argue for the need to consider communication as a key aspect of health necessary to achieve health equity.
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Audiología , Terapia del Lenguaje , Humanos , Terapia del Lenguaje/educación , Práctica Profesional , Habla , Logopedia/educaciónRESUMEN
BACKGROUND: Many children undergo various surgeries, which often lead to acute postoperative pain. This pain influences recovery and quality of life. Non-steroidal anti-inflammatory drugs (NSAIDs), specifically cyclo-oxygenase (COX) inhibitors such as diclofenac, can be used to treat pain and reduce inflammation. There is uncertainty regarding diclofenac's benefits and harms compared to placebo or other drugs for postoperative pain. OBJECTIVES: To assess the efficacy and safety of diclofenac (any dose) for acute postoperative pain management in children compared with placebo, other active comparators, or diclofenac administered by different routes (e.g. oral, rectal, etc.) or strategies (e.g. 'as needed' versus 'as scheduled'). SEARCH METHODS: We used standard, extensive Cochrane search methods. We searched CENTRAL, MEDLINE, and trial registries on 11 April 2022. SELECTION CRITERIA: We included randomised controlled trials (RCTs) in children under 18 years of age undergoing surgery that compared diclofenac (delivered in any dose and route) to placebo or any active pharmacological intervention. We included RCTs comparing different administration routes of diclofenac and different strategies. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. Our primary outcomes were: pain relief (PR) reported by the child, defined as the proportion of children reporting 50% or better postoperative pain relief; pain intensity (PI) reported by the child; adverse events (AEs); and serious adverse events (SAEs). We presented results using risk ratios (RR), mean differences (MD), and standardised mean differences (SMD), with the associated confidence intervals (CI). MAIN RESULTS: We included 32 RCTs with 2250 children. All surgeries were done using general anaesthesia. Most studies (27) included children above age three. Only two studies had an overall low risk of bias; 30 had an unclear or high risk of bias in one or several domains. Diclofenac versus placebo (three studies) None of the included studies reported on PR or PI. We are very uncertain about the benefits and harms of diclofenac versus placebo on nausea/vomiting (RR 0.83, 95% CI 0.38 to 1.80; 2 studies, 100 children) and any reported bleeding (RR 3.00, 95% CI 0.34 to 26.45; 2 studies, 100 children), both very low-certainty evidence. None of the included studies reported SAEs. Diclofenac versus opioids (seven studies) We are very uncertain if diclofenac reduces PI at 2 to 24 hours postoperatively compared to opioids (median pain intensity 0.3 (interquartile range (IQR) 0.0 to 2.5) for diclofenac versus median 0.7 (IQR 0.1 to 2.4) in the opioid group; 1 study, 50 children; very low-certainty evidence). None of the included studies reported on PR or PI for other time points. Diclofenac probably results in less nausea/vomiting compared to opioids (41.0% in opioids, 31.0% in diclofenac; RR 0.75, 95% CI 0.58 to 0.96; 7 studies, 463 participants), and probably increases any reported bleeding (5.4% in opioids, 16.5% in diclofenac; RR 3.06, 95% CI 1.31 to 7.13; 2 studies, 222 participants), both moderate-certainty evidence. None of the included studies reported SAEs. Diclofenac versus paracetamol (10 studies) None of the included studies assessed child-reported PR. Compared to paracetamol, we are very uncertain if diclofenac: reduces PI at 0 to 2 hours postoperatively (SMD -0.45, 95% CI -0.74 to -0.15; 2 studies, 180 children); reduces PI at 2 to 24 hours postoperatively (SMD -0.64, 95% CI -0.89 to -0.39; 3 studies, 300 children); reduces nausea/vomiting (RR 0.47, 95% CI 0.25 to 0.87; 5 studies, 348 children); reduces bleeding events (RR 0.57, 95% CI 0.12 to 2.62; 5 studies, 332 participants); or reduces SAEs (RR 0.50, 95% CI 0.05 to 5.22; 1 study, 60 children). The evidence certainty was very low for all outcomes. Diclofenac versus bupivacaine (five studies) None of the included studies reported on PR or PI. Compared to bupivacaine, we are very uncertain about the effect of diclofenac on nausea/vomiting (RR 1.28, 95% CI 0.58 to 2.78; 3 studies, 128 children) and SAEs (RR 4.52, 95% CI 0.23 to 88.38; 1 study, 38 children), both very low-certainty evidence. Diclofenac versus active pharmacological comparator (10 studies) We are very uncertain about the benefits and harms of diclofenac versus any other active pharmacological comparator (dexamethasone, pranoprofen, fluorometholone, oxybuprocaine, flurbiprofen, lignocaine), and for different routes and delivery of diclofenac, due to few and small studies, no reporting of key outcomes, and very low-certainty evidence for the reported outcomes. We are unable to draw any meaningful conclusions from the numerical results. AUTHORS' CONCLUSIONS: We remain uncertain about the efficacy of diclofenac compared to placebo, active comparators, or by different routes of administration, for postoperative pain management in children. This is largely due to authors not reporting on clinically important outcomes; unclear reporting of the trials; or poor trial conduct reducing our confidence in the results. We remain uncertain about diclofenac's safety compared to placebo or active comparators, except for the comparison of diclofenac with opioids: diclofenac probably results in less nausea and vomiting compared with opioids, but more bleeding events. For healthcare providers managing postoperative pain, diclofenac is a COX inhibitor option, along with other pharmacological and non-pharmacological approaches. Healthcare providers should weigh the benefits and risks based on what is known of their respective pharmacological effects, rather than known efficacy. For surgical interventions in which bleeding or nausea and vomiting are a concern postoperatively, the risks of adverse events using opioids or diclofenac for managing pain should be considered.
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Acetaminofén , Diclofenaco , Humanos , Niño , Adolescente , Diclofenaco/uso terapéutico , Acetaminofén/uso terapéutico , Dolor Postoperatorio/tratamiento farmacológico , Náusea/inducido químicamente , Vómitos/inducido químicamente , Analgésicos Opioides/uso terapéutico , BupivacaínaRESUMEN
BACKGROUND: Noncommunicable diseases are major contributors to morbidity and mortality worldwide. Modifying the risk factors for these conditions, such as physical inactivity, is thus essential. Addressing the context or circumstances in which physical activity occurs may promote physical activity at a population level. We assessed the effects of infrastructure, policy or regulatory interventions for increasing physical activity. METHODS: We searched PubMed, Embase and clinicaltrials.gov to identify randomised controlled trials (RCTs), controlled before-after (CBAs) studies, and interrupted time series (ITS) studies assessing population-level infrastructure or policy and regulatory interventions to increase physical activity. We were interested in the effects of these interventions on physical activity, body weight and related measures, blood pressure, and CVD and type 2 diabetes morbidity and mortality, and on other secondary outcomes. Screening and data extraction was done in duplicate, with risk of bias was using an adapted Cochrane risk of bias tool. Due to high levels of heterogeneity, we synthesised the evidence based on effect direction. RESULTS: We included 33 studies, mostly conducted in high-income countries. Of these, 13 assessed infrastructure changes to green or other spaces to promote physical activity and 18 infrastructure changes to promote active transport. The effects of identified interventions on physical activity, body weight and blood pressure varied across studies (very low certainty evidence); thus, we remain very uncertain about the effects of these interventions. Two studies assessed the effects of policy and regulatory interventions; one provided free access to physical activity facilities and showed that it may have beneficial effects on physical activity (low certainty evidence). The other provided free bus travel for youth, with intervention effects varying across studies (very low certainty evidence). CONCLUSIONS: Evidence from 33 studies assessing infrastructure, policy and regulatory interventions for increasing physical activity showed varying results. The certainty of the evidence was mostly very low, due to study designs included and inconsistent findings between studies. Despite this drawback, the evidence indicates that providing access to physical activity facilities may be beneficial; however this finding is based on only one study. Implementation of these interventions requires full consideration of contextual factors, especially in low resource settings. TRIAL REGISTRATION: PROSPERO 2018 CRD42018093429.
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Enfermedades Cardiovasculares , Diabetes Mellitus Tipo 2 , Ejercicio Físico , Adolescente , Humanos , Peso Corporal , Enfermedades Cardiovasculares/prevención & control , Diabetes Mellitus Tipo 2/prevención & control , PolíticasRESUMEN
OBJECTIVES: To assess the effects of device-based circumcisions compared with standard surgical techniques in adolescent and adult males (10 years old and above). METHODS: We performed a comprehensive search with no restrictions to the language of publication or publication status. We included randomised controlled trials (RCTs) of device-based circumcisions compared to standard surgical dissection-based circumcision conducted by health professionals in a medical setting. We reported study results as risk ratios (RRs) or mean differences (MDs) using 95% confidence intervals (CIs) and a random-effects model. We used the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach to evaluate the overall certainty of the evidence for each outcome. RESULTS: A total of 18 trials met the inclusion criteria. These trials did not report severe adverse events (AEs; 11 trials, 3472 participants). There may be a slight increase in moderate AEs for devices compared to surgical techniques (RR 1.31, 95% CI 0.55-3.10; I2 = 68%; 10 trials, 3370 participants; low-certainty evidence); this corresponds to eight more (ranging from 15 fewer to 84 more) moderate AEs per 1000 participants. We are uncertain about the difference in mild AEs between groups when devices are used compared to surgical techniques (RR 1.09, 95% CI 0.44-2.72; I2 = 91%; 10 trials, 3370 participants; very low-certainty evidence). CONCLUSIONS: We found no serious AEs using a circumcision device compared to surgical techniques. Still, they may slightly increase moderate AEs, and it is unclear whether there is a difference in mild AEs. High-quality trials evaluating this intervention are needed to provide further certainty regarding the rates of AEs. Clinicians, patients, and policymakers can use these results combined with their contextual factors to inform the best approach that suits their healthcare settings.
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Circuncisión Masculina , Adolescente , Adulto , Niño , Circuncisión Masculina/efectos adversos , Humanos , MasculinoRESUMEN
BACKGROUND: Medical circumcisions are among the most common surgical procedures performed in males. The usual indications are phimosis (inability to completely retract the foreskin and expose the glans due to a congenital or acquired constriction of the prepuce), paraphimosis (when the foreskin is not pulled back over the glans after retraction resulting in a tight constricting band which causes swelling of the distal penis and acute discomfort), balanoposthitis (erythema and edema of the prepuce and glans) and balanitis (inflammation is confined to the glans; the foreskin is usually non-retractile). Circumcision devices have been developed to shorten the operative time, simplify techniques, and improve safety and cosmetic outcomes. The devices generally aim to crush the foreskin while simultaneously creating hemostasis, the foreskin is then excised or allowed to slough off. Their use is supposedly safer and easier to replicate than the standard dissection techniques. There are at least 20 devices for male circumcision on the market, yet their effectiveness has not been reviewed to date. OBJECTIVES: To assess the effects of device-based circumcisions compared with standard surgical techniques in adolescent and adult males (10 years old and above). SEARCH METHODS: We performed a comprehensive search with no restrictions to the language of publication or publication status. We searched the Cochrane Library, MEDLINE (PubMed), Embase, Web of Science, trials registries, grey literature sources and conference proceedings up to 16 April 2020. SELECTION CRITERIA: We included randomized controlled trials of device-based circumcisions (crush or ligature circumcision devices) compared to standard surgical dissection-based circumcision conducted by health professionals in a medical setting. DATA COLLECTION AND ANALYSIS: At least two review authors independently assessed study eligibility and extracted data from the included studies. We classified adverse events into serious, moderate or mild. We reported study results as risk ratios (RR) or mean differences (MD) using 95% confidence intervals (CI) and a random-effects model. We used the GRADE approach to evaluate the overall certainty of the evidence for each outcome. MAIN RESULTS: Eighteen trials met the inclusion criteria. Trials were conducted in China, South Africa, Kenya and Zambia, Mozambique, Rwanda, Uganda and Zimbabwe. Primary outcomes Serious adverse events: there were no serious adverse events in either treatment arm (11 trials, 3472 participants). Moderate adverse events: there may be a slight increase in moderate adverse events when devices are used compared to standard surgical techniques (RR 1.31, 95% CI 0.55 to 3.10; I²= 68%; 10 trials, 3370 participants; low-certainty evidence); this corresponds to 8 more (ranging from 15 fewer to 84 more) moderate adverse events per 1000 participants. We downgraded the certainty of the evidence for study limitations and imprecision. Secondary outcomes Mild adverse events: we are uncertain about the difference in mild adverse events between groups when devices are used compared to standard surgical techniques (RR 1.09, 95% CI 0.44 to 2.72; I² = 91%; 10 trials, 3370 participants; very low-certainty evidence). We downgraded the certainty of the evidence for study limitations, imprecision and unexplained inconsistency. Operative time: operative time is probably about 17 minutes shorter when using a device rather than standard surgical techniques, which constitutes a clinically meaningful decrease in a procedure (MD -17.26 minutes, 95% CI -19.96 to -14.57; I² = 99%; 14 trials, 4812 participants; moderate-certainty evidence). We downgraded the certainty of the evidence for serious study limitations. The standard surgical technique generally takes about 24 minutes. There may be less postoperative pain during the first 24 hours when circumcision devices are used compared to standard surgical techniques (measured using a visual analog scale [VAS]; MD 1.30 cm lower, 95% CI 2.37 lower to 0.22 lower; I² = 99%; 9 trials, 3022 participants; low-certainty evidence). We downgraded the certainty of the evidence for study limitations and unexplained heterogeneity. There may be little or no difference in postoperative pain experienced during the first seven days when compared with standard surgical techniques (measured using a VAS; MD 0.11 cm higher, 95% CI 0.89 lower to 1.11 higher; I² = 94%; 4 trials, 1430 participants; low-certainty evidence). We downgraded the certainty of the evidence for study limitations and unexplained inconsistency. A higher score on the VAS indicates greater pain. Participants may slightly prefer circumcision devices compared to standard surgical techniques (RR 1.19, 95% CI 1.04 to 1.37; I² = 97%; 15 trials, 4501 participants; low-certainty evidence). We downgraded the certainty of the evidence for study limitations and unexplained inconsistency. We recorded satisfaction as a dichotomous outcome. Higher rates reflected greater satisfaction. AUTHORS' CONCLUSIONS: We found that there were no serious adverse events reported when using a circumcision device compared to standard surgical techniques, but they may slightly increase moderate adverse effects, and it is unclear whether there is a difference in mild adverse effects. Use of circumcision devices probably reduces the time of the procedure by about 17 minutes, a clinically meaningful time saving. For patients, use of the circumcision device may result in lower pain scores during the first 24 hours and patients may be slightly more satisfied with it compared with standard surgical techniques. Clinicians, patients and policymakers can use these results in conjunction with their own contextual factors to inform the approach that best suits their healthcare settings. High-quality trials evaluating this intervention are needed to provide further certainty regarding the rates of adverse effects and postoperative pain of using devices compared to standard approaches.
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Circuncisión Masculina/instrumentación , Circuncisión Masculina/métodos , Adolescente , Adulto , Sesgo , Niño , Circuncisión Masculina/efectos adversos , Humanos , Masculino , Persona de Mediana Edad , Tempo Operativo , Dolor Postoperatorio/epidemiología , Prioridad del Paciente/estadística & datos numéricos , Ensayos Clínicos Controlados Aleatorios como Asunto , Adulto JovenRESUMEN
BACKGROUND: Hypertension is a major public health challenge affecting more than one billion people worldwide; it disproportionately affects populations in low- and middle-income countries (LMICs), where health systems are generally weak. The increasing prevalence of hypertension is associated with population growth, ageing, genetic factors, and behavioural risk factors, such as excessive salt and fat consumption, physical inactivity, being overweight and obese, harmful alcohol consumption, and poor management of stress. Over the long term, hypertension leads to risk for cardiovascular events, such as heart disease, stroke, kidney failure, disability, and premature mortality. Cardiovascular events can be preventable when high-risk populations are targeted, for example, through population-wide screening strategies. When available resources are limited, taking a total risk approach whereby several risk factors of hypertension are taken into consideration (e.g. age, gender, lifestyle factors, diabetes, blood cholesterol) can enable more accurate targeting of high-risk groups. Targeting of high-risk groups can help reduce costs in that resources are not spent on the entire population. Early detection in the form of screening for hypertension (and associated risk factors) can help identify high-risk groups, which can result in timely treatment and management of risk factors. Ultimately, early detection can help reduce morbidity and mortality linked to it and can help contain health-related costs, for example, those associated with hospitalisation due to severe illness and poorly managed risk factors and comorbidities. OBJECTIVES: To assess the effectiveness of different screening strategies for hypertension (mass, targeted, or opportunistic) to reduce morbidity and mortality associated with hypertension. SEARCH METHODS: An Information Specialist searched the Cochrane Register of Studies (CRS-Web), the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Latin American Caribbean Health Sciences Literature (LILACS) Bireme, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) without language, publication year, or publication status restrictions. The searches were conducted from inception until 9 April 2020. SELECTION CRITERIA: Randomised controlled trials (RCTs) and non-RCTs (NRCTs), that is, controlled before and after (CBA), interrupted time series (ITS), and prospective analytic cohort studies of healthy adolescents, adults, and elderly people participating in mass, targeted, or opportunistic screening of hypertension. DATA COLLECTION AND ANALYSIS: Screening of all retrieved studies was done in Covidence. A team of reviewers, in pairs, independently assessed titles and abstracts of identified studies and acquired full texts for studies that were potentially eligible. Studies were deemed to be eligible for full-text screening if two review authors agreed, or if consensus was reached through discussion with a third review author. It was planned that at least two review authors would independently extract data from included studies, assess risk of bias using pre-specified Cochrane criteria, and conduct a meta-analysis of sufficiently similar studies or present a narrative synthesis of the results. MAIN RESULTS: We screened 9335 titles and abstracts. We identified 54 potentially eligible studies for full-text screening. However, no studies met the eligibility criteria. AUTHORS' CONCLUSIONS: There is an implicit assumption that early detection of hypertension through screening can reduce the burden of morbidity and mortality, but this assumption has not been tested in rigorous research studies. High-quality evidence from RCTs or programmatic evidence from NRCTs on the effectiveness and costs or harms of different screening strategies for hypertension (mass, targeted, or opportunistic) to reduce hypertension-related morbidity and mortality is lacking.
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Hipertensión/diagnóstico , Diagnóstico Precoz , Humanos , Tamizaje MasivoRESUMEN
BACKGROUND: A well-functioning routine health information system (RHIS) can provide the information needed for health system management, for governance, accountability, planning, policy making, surveillance and quality improvement, but poor information support has been identified as a major obstacle for improving health system management. OBJECTIVES: To assess the effects of interventions to improve routine health information systems in terms of RHIS performance, and also, in terms of improved health system management performance, and improved patient and population health outcomes. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, MEDLINE Ovid and Embase Ovid in May 2019. We searched Global Health, Ovid and PsycInfo in April 2016. In January 2020 we searched for grey literature in the Grey Literature Report and in OpenGrey, and for ongoing trials using the International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov. In October 2019 we also did a cited reference search using Web of Science, and a 'similar articles' search in PubMed. SELECTION CRITERIA: Randomised and non-randomised trials, controlled before-after studies and time-series studies comparing routine health information system interventions, with controls, in primary, hospital or community health care settings. Participants included clinical staff and management, district management and community health workers using routine information systems. DATA COLLECTION AND ANALYSIS: Two authors independently reviewed records to identify studies for inclusion, extracted data from the included studies and assessed the risk of bias. Interventions and outcomes were too varied across studies to allow for pooled risk analysis. We present a 'Summary of findings' table for each intervention comparisons broadly categorised into Technical and Organisational (or a combination), and report outcomes on data quality and service quality. We used the GRADE approach to assess the certainty of the evidence. MAIN RESULTS: We included six studies: four cluster randomised trials and two controlled before-after studies, from Africa and South America. Three studies evaluated technical interventions, one study evaluated an organisational intervention, and two studies evaluated a combination of technical and organisational interventions. Four studies reported on data quality and six studies reported on service quality. In terms of data quality, a web-based electronic TB laboratory information system probably reduces the length of time to reporting of TB test results, and probably reduces the overall rate of recording errors of TB test results, compared to a paper-based system (moderate certainty evidence). We are uncertain about the effect of the electronic laboratory information system on the recording rate of serious (misidentification) errors for TB test results compared to a paper-based system (very low certainty evidence). Misidentification errors are inaccuracies in transferring test results between an electronic register and patients' clinical charts. We are also uncertain about the effect of the intervention on service quality (timeliness of starting or changing a patient's TB treatment) (very low certainty evidence). A hand-held electronic device probably improves the length of time to report TB test results, and probably reduces the total frequency of recording errors in TB test results between the laboratory notebook and the electronic information record system, compared to a paper-based system (moderate-certainty evidence). We are, however, uncertain about the effect of the intervention on the frequency of serious (misidentification) errors in recording between the laboratory notebook and the electronic information record, compared to a paper-based system (very low certainty evidence). We are uncertain about the effect of a hospital electronic health information system on service quality (length of time outpatients spend at hospital, length of hospital stay, and hospital revenue collection), compared to a paper-based system (very low certainty evidence). High-intensity brief text messaging (SMS) may make little or no difference to data quality (in terms of completeness of documentation of pregnancy outcomes), compared to low-intensity brief text messaging (low-certainty evidence). We are uncertain about the effect of electronic drug stock notification (with either data management support or product transfer support) on service quality (in terms of transporting stock and stock levels), compared to paper-based stock notification (very low certainty evidence). We are uncertain about the effect of health information strengthening (where it is part of comprehensive service quality improvement intervention) on service quality (health worker motivation, receipt of training by health workers, health information index scores, quality of clinical observation of children and adults) (very low certainty evidence). AUTHORS' CONCLUSIONS: The review indicates mixed effects of mainly technical interventions to improve data quality, with gaps in evidence on interventions aimed at enhancing data-informed health system management. There is a gap in interventions studying information support beyond clinical management, such as for human resources, finances, drug supply and governance. We need to have a better understanding of the causal mechanisms by which information support may affect change in management decision-making, to inform robust intervention design and evaluation methods.
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Atención a la Salud/organización & administración , Sistemas de Información en Salud/normas , Política Organizacional , Mejoramiento de la Calidad , Sesgo , Sistemas de Información en Laboratorio Clínico/organización & administración , Sistemas de Información en Laboratorio Clínico/normas , Computadoras de Mano , Recolección de Datos/normas , Toma de Decisiones , Atención a la Salud/normas , Servicios de Información sobre Medicamentos/normas , Sistemas de Información en Hospital/normas , Pruebas de Sensibilidad Microbiana , Innovación Organizacional , Preparaciones Farmacéuticas/provisión & distribución , Ensayos Clínicos Controlados Aleatorios como Asunto , Envío de Mensajes de Texto/normas , Tuberculosis/diagnóstico , Tuberculosis/tratamiento farmacológicoRESUMEN
BACKGROUND: Data harmonisation (DH) has emerged amongst health managers, information technology specialists and researchers as an important intervention for routine health information systems (RHISs). It is important to understand what DH is, how it is defined and conceptualised, and how it can lead to better health management decision-making. This scoping review identifies a range of definitions for DH, its characteristics (in terms of key components and processes), and common explanations of the relationship between DH and health management decision-making. METHODS: This scoping review identified relevant studies from 2000 onwards (date filter), written in English and published in PubMed, Web of Science and CINAHL. Two reviewers independently screened records for potential inclusion for the abstract and full-text screening stages. One reviewer did the data extraction, analysis and synthesis, with built-in reliability checks from the rest of the team. We developed a narrative synthesis of definitions and explanations of the relationship between DH and health management decision-making. RESULTS: We sampled 61 of 181 included to synthesis definitions and concepts of DH in detail. We identified six common terms for data harmonisation: record linkage, data linkage, data warehousing, data sharing, data interoperability and health information exchange. We also identified nine key components of data harmonisation: DH involves (a) a process of multiple steps; (b) integrating, harmonising and bringing together different databases (c) two or more databases; (d) electronic data; (e) pooling data using unique patient identifiers; and (f) different types of data; (g) data found within and across different departments and institutions at facility, district, regional and national levels; (h) different types of technical activities; (i) has a specific scope. The relationship between DH and health management decision-making is not well-described in the literature. Several studies mentioned health providers' concerns about data completeness, data quality, terminology and coding of data elements as barriers to data utilisation for clinical decision-making. CONCLUSION: To our knowledge, this scoping review was the first to synthesise definitions and concepts of DH and address the causal relationship between DH and health management decision-making. Future research is required to assess the effectiveness of data harmonisation on health management decision-making.
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Intercambio de Información en Salud , Sistemas de Información en Salud , Atención a la Salud , Humanos , Almacenamiento y Recuperación de la Información , Reproducibilidad de los ResultadosRESUMEN
Background: Computer-aided detection (CAD) may be a useful screening tool for tuberculosis (TB). However, there are limited data about its utility in active case finding (ACF) in a community-based setting, and particularly in an HIV-endemic setting where performance may be compromised. Methods: We performed a systematic review and evaluated articles published between January 2012 and February 2023 that included CAD as a screening tool to detect pulmonary TB against a microbiological reference standard (sputum culture and/or nucleic acid amplification test [NAAT]). We collected and summarized data on study characteristics and diagnostic accuracy measures. Two reviewers independently extracted data and assessed methodological quality against Quality Assessment of Diagnostic Accuracy Studies-2 criteria. Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Diagnostic Test Accuracy Studies (PRISMA-DTA) guidelines were followed. Results: Of 1748 articles reviewed, 5 met with the eligibility criteria and were included in this review. A meta-analysis revealed pooled sensitivity of 0.87 (95% CI, 0.78-0.96) and specificity of 0.74 (95% CI, 0.55-0.93), just below the World Health Organization (WHO)-recommended target product profile (TPP) for a screening test (sensitivity ≥0.90 and specificity ≥0.70). We found a high risk of bias and applicability concerns across all studies. Subgroup analyses, including the impact of HIV and previous TB, were not possible due to the nature of the reporting within the included studies. Conclusions: This review provides evidence, specifically in the context of ACF, for CAD as a potentially useful and cost-effective screening tool for TB in a resource-poor HIV-endemic African setting. However, given methodological concerns, caution is required with regards to applicability and generalizability.
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Rationale: Diagnosing bacterial infection as the etiology in acute exacerbations of chronic obstructive pulmonary disease (AECOPDs) remains challenging. Sputum discoloration is easily measured and often used as a marker of bacterial infection in AECOPD, although high-quality evidence for this practice is lacking. Objectives: To determine the diagnostic accuracy of sputum color as a marker for bacteria in AECOPD. Methods: Articles were searched for in electronic databases, and the gray literature were reviewed. Quality assessment of included articles was performed using the revised Quality Assessment of Diagnostic Accuracy Studies tool. A meta-analysis was conducted using a bivariate logistic regression model with random effects. Analysis was conducted on individual sputum samples rather than on individual participants so that each sample represented a unique index test. Results: Of the 1,600 candidate studies, 13 eligible studies satisfied the inclusion criteria. These included prospective cohort studies (n = 3), cross-sectional studies (n = 3), and secondary analyses of randomized controlled trials (n = 7). The included studies were all from Europe and North America. Most studies scored high risk of bias in at least one domain. In total, this systematic review and meta-analysis included 5,770 sputum samples. The estimated pooled sensitivity and specificity were 81% (95% confidence interval [CI], 70-88%) and 50% (95% CI, 35-65%), respectively, and these results were not significantly altered in a series of sensitivity analyses. Conclusions: Sputum color has limited value as a stand-alone test in diagnosing bacterial infection as the etiology in AECOPD because of its moderate sensitivity and poor specificity.
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Enfermedad Pulmonar Obstructiva Crónica , Esputo , Humanos , Estudios Transversales , Estudios Prospectivos , Tos , Bacterias , Progresión de la EnfermedadRESUMEN
Retrospective studies on artificial intelligence (AI) in screening for diabetic retinopathy (DR) have shown promising results in addressing the mismatch between the capacity to implement DR screening and increasing DR incidence. This review sought to evaluate the diagnostic test accuracy (DTA) of AI in screening for referable diabetic retinopathy (RDR) in real-world settings. We searched CENTRAL, PubMed, CINAHL, Scopus, and Web of Science on 9 February 2023. We included prospective DTA studies assessing AI against trained human graders (HGs) in screening for RDR in patients with diabetes. Two reviewers independently extracted data and assessed methodological quality against QUADAS-2 criteria. We used the hierarchical summary receiver operating characteristics (HSROC) model to pool estimates of sensitivity and specificity and, forest plots and SROC plots to visually examine heterogeneity in accuracy estimates. From our initial search results of 3899 studies, we included 15 studies comprising 17 datasets. Meta-analyses revealed a sensitivity of 95.33% (95%CI: 90.60-100%) and specificity of 92.01% (95%CI: 87.61-96.42%) for patient-level analysis (10 datasets, N = 45,785) while, for the eye-level analysis, sensitivity was 91.24% (95%CI: 79.15-100%) and specificity, 93.90% (95%CI: 90.63-97.16%) (7 datasets, N = 15,390). Subgroup analyses did not provide variations in the diagnostic accuracy of country classification and DR classification criteria. However, a moderate increase was observed in diagnostic accuracy in the primary-level healthcare settings: sensitivity of 99.35% (95%CI: 96.85-100%), specificity of 93.72% (95%CI: 88.83-98.61%) and, a minimal decrease in the tertiary-level healthcare settings: sensitivity of 94.71% (95%CI: 89.00-100%), specificity of 90.88% (95%CI: 83.22-98.53%). Sensitivity analyses did not show any variations in studies that included diabetic macular edema in the RDR definition, nor studies with ≥3 HGs. This review provides evidence, for the first time from prospective studies, for the effectiveness of AI in screening for RDR in real-world settings. The results may serve to strengthen existing guidelines to improve current practices.
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A rapid systematic review, based on Cochrane rapid review methodology was conducted to assess the effectiveness of two 10µg doses of BNT162b2 vaccine in preventing morbidity and mortality associated with COVID-19 in children aged 5 to 11 years. We searched the Cochrane Library COVID-19 study register, the COVID-NMA living review database and the McMaster University Living Evidence Synthesis for pre-appraised trials and observational studies up to 7 December 2022. Records were screened independently in duplicate. Where appraisal was not available, these were done in duplicate. Meta-analysis was conducted using RevMan 5.3 presenting risk ratios/odds ratios/inverse vaccine efficacy with 95% confidence intervals (CI). GRADE for assessing the overall certainty of the evidence was done in Gradepro. We screened 403 records and assessed 52 full-text articles for eligibility. One randomised controlled trial (RCT) and 24 observational studies were included. The RCT reported that BNT162b2 was likely safe and 91% efficacious, RR 0.09 (95% CI 0.03 to 0.32) against incident COVID-19 infection (moderate certainty evidence). In absolute terms, this is 19 fewer cases per 1,000 vaccines delivered (ranging from 15 to 21 fewer cases). Observational studies reported vaccine effectiveness (VE) against incident COVID-19 infection of 65% (OR 0.35, 95% CI 0.26 to 0.47) and 76% against hospitalisation (OR 0.24, 95% CI 0.13 to 0.42) (moderate certainty evidence). The absolute effect is 167 fewer cases per 1,000 vaccines given (ranging from 130 fewer to 196 fewer cases) and 4 fewer hospitalisations per 10,000 children (from 3 fewer to 5 fewer hospitalisations). Adverse events following vaccination with BNT162b2 were mild or moderate and transient. The evidence demonstrated a reduction in incident COVID-19 cases and small absolute reduction in hospitalisation if a two-dose BNT162b2 vaccine regimen is offered to children aged 5 to 11 years, compared to placebo. PROSPERO registration: CRD42021286710.
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BACKGROUND: Human communication is essential for socialising, learning and working. Disabilities and social disadvantage have serious negative consequences on communication which can impact development from early life into adulthood. While speech-language therapists and audiologists (SLT/As) have an important role to play in addressing communication disability and disadvantage, services continue to be inaccessible, unaffordable and unattainable for the majority population. In order to support this large population, it is necessary to reimagine SLT/A practices in line with equity and social inclusion. Recently in the literature, there have been increasing calls for professions to reduce inequities in practice as indicated by the sustainable development goals, human rights and social inclusion approaches increasing in prominence. For the scoping review, equity is understood using the colonial matrix of power to understand how intersections of race, gender, class, disability, geography, heteronormativity and language create the context for inequity. As such, the aim of the scoping review is to address the following question: what are the emerging professional practices in SLT/A focused on reducing inequities? METHODS: Following the Joanna Briggs Institute guidelines, this scoping review will focus on systematically mapping the documented emerging clinical practices in SLT/A in the literature to identify how the professions are developing equitable practices. The search will include electronic databases and grey literature including PubMed, Scopus, EbscoHost, The Cochrane Library and Dissertation Abstracts International, Education Resource Information Centre from their inception onwards. Published and unpublished literature including all evidence sources will be considered. There should be a clear focus on clinical practice addressing equity in SLT/A. There will be no language limitations for the study. The authors will endeavour translate to have abstracts of articles translated. There will be no time restrictions on date of publication of the literature. DISCUSSION: We aim to review the current literature on emerging professional practices in relation to equity in SLT/A to identify emerging trends in clinical practice. It is our goal to provide a synthesis of emerging directions for practice, particularly to inform future practices in the Global South. SYSTEMATIC REVIEW REGISTRATION: Open Science Framework ( osf.io/3a29w ).
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Audiología , Adulto , Técnicos Medios en Salud , Humanos , Terapia del Lenguaje , Práctica Profesional , Literatura de Revisión como Asunto , HablaRESUMEN
Background: COVID-19 has proven to be challenging to manage for many reasons, including its high infection rate. One of the potential ways to limit its spread is by limiting international travel. The objective of this systematic review was to identify, critically appraise and summarise evidence on international air travel-related control measures for COVID-19. Methods: This review is based on the Cochrane review: International travel-related control measures to contain the COVID-19 pandemic and followed the same methods. In brief, we searched for clinical and modelling studies in general health and COVID-19-specific bibliographic databases. The primary outcome categories were (i) cases avoided, (ii) a shift in epidemic development and, (iii) cases detected. Results: From 6,202 citations identified by the search strategy, we included 22 new studies (modelling = 9, observational = 13) in addition to the 62 studies identified in the Cochrane review. Studies suggest that quarantine or microbial detection or a combination may avoid further cases. Similarly, these interventions may produce a positive shift in epidemic development and case detection may improve. Most studies were evaluated as having a moderate to critical risk of bias. The studies did not change the main conclusions of the Cochrane review nor the quality of the evidence (very low certainty); however, they added to the evidence base for most outcomes. Conclusions: Weak evidence supports the use of international air travel-related control measures to limit the spread of COVID-19 via air travel. More real-world studies are required to support these conclusions.
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AIMS: Peripartum cardiomyopathy (PPCM) remains a major contributor to maternal morbidity and mortality worldwide. The disease is associated with various complications occurring mainly early during its course. Reported adverse outcomes include decompensated heart failure, thromboembolic complications, arrhythmias and death. We sought to systematically and comprehensively review published literature on the management and outcome of women with PPCM across different geographical regions and to identify possible predictors of adverse outcomes. METHODS AND RESULTS: We performed a comprehensive search of relevant literature (2000 to June 2021) across a number of electronic databases. Cohort, case-control and cross-sectional studies, as well as control arms of randomized controlled trials reporting on 6- and/or 12-month outcomes of PPCM were considered eligible (PROSPERO registration: CRD42021255654). Forty-seven studies (4875 patients across 60 countries) met the inclusion criteria. Haemodynamic and echocardiographic parameters were similar across all continents. All-cause mortality was 8.0% (95% confidence interval [CI] 5.5-10.8, I2 = 79.1%) at 6 months and 9.8% (95% CI 6.2-14.0, I2 = 80.5%) at 12 months. All-cause mortality was highest in Africa and Asia/Pacific. Overall, 44.1% (95% CI 36.1-52.2, I2 = 91.7%) of patients recovered their left ventricular (LV) function within 6 months and 58.7% (95% CI 48.1-68.9, I2 = 75.8%) within 12 months. Europe and North America reported the highest prevalence of LV recovery. Frequent prescription of beta-blocker, angiotensin-converting enzyme inhibitor/angiotensin receptor blocker and bromocriptine/cabergoline were associated with significantly lower all-cause mortality and better LV recovery. CONCLUSION: We identified significant global differences in 6- and 12-month outcomes in women with PPCM. Frequent prescription of guideline-directed heart failure therapy was associated with better LV recovery and lower all-cause mortality. Timely initiation and up-titration of heart failure therapy should therefore be strongly encouraged to improve outcome in PPCM.
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Cardiomiopatías , Insuficiencia Cardíaca , Complicaciones Cardiovasculares del Embarazo , Trastornos Puerperales , Antagonistas de Receptores de Angiotensina , Inhibidores de la Enzima Convertidora de Angiotensina , Bromocriptina , Cabergolina , Cardiomiopatías/tratamiento farmacológico , Cardiomiopatías/epidemiología , Cardiotónicos , Estudios Transversales , Femenino , Insuficiencia Cardíaca/complicaciones , Insuficiencia Cardíaca/epidemiología , Insuficiencia Cardíaca/terapia , Humanos , Periodo Periparto , Embarazo , Complicaciones Cardiovasculares del Embarazo/epidemiología , Complicaciones Cardiovasculares del Embarazo/terapia , Trastornos Puerperales/epidemiología , Trastornos Puerperales/terapiaRESUMEN
BACKGROUND: The Pan African Clinical Trials Registry (PACTR) is a WHO International Clinical Trials Registry Platform primary register, which caters for clinical trials conducted in Africa. PACTR is the first and, at present, the only member of the Network of WHO Primary Registers in Africa. The aim is to describe and report on the trends of trial records registered in PACTR. METHODS: PACTR was established in 2007 as the AIDS, Tuberculosis, and Malaria Clinical Trials Registry. The scope of the registry was then expanded in 2009 to include all diseases. This is a cross-sectional study of trials registered in PACTR from inception to 18 August 2021. A descriptive analysis of the use and trends of the following data fields: study intervention, disease condition, sex of the participants, sample size, ethics, funding and availability of results was conducted using Microsoft Excel. RESULTS: The number of trials registered has increased year on year, reaching 606 trials registered in 2020. The total number of trials registered at the time of the analysis was 2998. More than half of the trials in the registry (1655 of 2998, ie, 55%) were prospectively registered. Ethical approval was received by 90% (2691 of 2998) of the registered trials. Factorial assignment as an intervention model was in 20% (589 of 2998) of the trials registered. There were 36% (1083 of 2998) completed trials, of which 3% (94 of 1083) had results available in the registry. The most dominant funding source indicated was self-funding in 23% (693 of 2998) of the registered trials, and 55% (1639 of 2998) had no funding. CONCLUSION: Registration on PACTR continues to grow; however, our analysis shows that researchers' capacity-building is needed to understand the importance of the registry and how this information informs healthcare decisions. Promoting prospective trial registration remains critical to avoid selective reporting bias to inform research gaps.
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Ensayos Clínicos como Asunto , Sistema de Registros , Estudios Transversales , HumanosRESUMEN
BACKGROUND: Integrase strand transfer inhibitors (InSTIs) decrease HIV plasma viral load faster than other antiretroviral classes. More rapid viral load decline has been associated with higher risk of immune reconstitution inflammatory syndrome (IRIS). There are conflicting reports on the association between InSTI and IRIS. We performed a systematic review and meta-analysis to compare the risk of IRIS among treatment-naive HIV-positive patients starting InSTI versus non-InSTI regimens. METHODS: We searched PubMed, Scopus, Web of Science, Africa-Wide, and Cochrane databases from earliest available date to 26 November 2021, for randomized controlled trials (RCTs) having intervention arms with InSTI versus control arms without InSTI in patients initiating first-line antiretroviral therapy. The primary outcome was relative risk (RR) of IRIS, whereas the secondary outcome was RR of paradoxical tuberculosis-associated IRIS (TB-IRIS). Data were combined by random-effects meta-analysis according to the Mantel-Haenszel method. The protocol for this study is registered with PROSPERO, CRD42020213976. RESULTS: We included 14 RCTs comprising 8696 participants from 6 continents for the primary outcome of IRIS and a subset of 674 participants (from 3 RCTs) for the secondary outcome of paradoxical TB-IRIS. Risk of IRIS was similar between InSTI and non-InSTI regimens (RR, 0.93; 95% confidence interval: 0.75 to 1.14). There was a trend towards a lower risk of paradoxical TB-IRIS with InSTI versus efavirenz regimens that was not statistically significant (RR, 0.64; 95% confidence interval: 0.34 to 1.19). CONCLUSIONS: In this meta-analysis among treatment-naive patients commencing first-line antiretroviral therapy, InSTI regimens were not associated with higher risk of IRIS.