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  1. Sasongko TH, Nagalla S
    Cochrane Database Syst Rev, 2021 Dec 21;12(12):CD009191.
    PMID: 34932828 DOI: 10.1002/14651858.CD009191.pub4
    BACKGROUND: Sickle cell disease is a group of disorders characterized by deformation of erythrocytes. Renal damage is a frequent complication in sickle cell disease as a result of long-standing anemia and disturbed circulation through the renal medullary capillaries. Due to the improvement in life expectancy of people with sickle cell disease, there has been a corresponding significant increase in the incidence of renal complications. Microalbuminuria and proteinuria are noted to be a strong predictor of subsequent renal failure. There is extensive experience and evidence with angiotensin-converting enzyme (ACE) inhibitors over many years in a variety of clinical situations for patients who do not have sickle cell disease, but their effect in people with this disease is unknown. It is common practice to administer ACE inhibitors for sickle nephropathy due to their renoprotective properties; however, little is known about their effectiveness and safety in this setting. This is an update of a Cochrane Review first published in 2013 and 2015.

    OBJECTIVES: To determine the effectiveness of ACE inhibitor administration in people with sickle cell disease for decreasing intraglomerular pressure, microalbuminuria and proteinuria and to to assess the safety of ACE inhibitors as pertains to their adverse effects.

    SEARCH METHODS: The authors searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Hameoglobinopathies Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. Date of the most recent search: 18 October 2021. We also searched clinical trial registries. Date of the most recent search: 22 August 2021.

    SELECTION CRITERIA: Randomized or quasi-randomized controlled trials of ACE inhibitors designed to reduce microalbuminuria and proteinuria in people with sickle cell disease compared to either placebo or standard treatment regimen.

    DATA COLLECTION AND ANALYSIS: Three authors independently applied the inclusion criteria in order to select studies for inclusion in the review. Two authors assessed the risk of bias of studies and extracted data and the third author verified these assessments.

    MAIN RESULTS: Seven studies were identified through the searches. Six studies were excluded. The included study randomized 22 participants (7 males and 15 females) having proteinuria or microalbuminuria with sickle cell disease and treated the participants for six months (median length of follow up of three months) with captopril or placebo. Overall, the certainty of the evidence provided in this review was very low, since most risk of bias domains were judged to have either an unclear or a high risk of bias. Because of this, we are uncertain whether captopril makes any difference, in total urinary albumin excretion (at six months) as compared to the placebo group, although it yielded a mean difference of -49.00 (95% confidence interval (CI) -124.10 to 26.10) or in the absolute change score, although it yielded a mean difference of -63.00 (95% CI -93.78 to -32.22). At six months albumin excretion in the captopril group was noted to decrease from baseline by a mean (standard deviation) of 45 (23) mg/day and the placebo group was noted to increase by 18 (45) mg/day. Serum creatinine and potassium levels were reported constant throughout the study (very low-certainty evidence). The potential for inducing hypotension should be highlighted; the study reported a decrease of 8 mmHg in systolic pressure and 5 mmHg in diastolic and mean blood pressure (very low-certainty evidence).

    AUTHORS' CONCLUSIONS: Overall, we judged the certainty of the evidence to be very low. The included study selectively reported its results, was not powered to detect a group difference, should it exist, and otherwise did not offer enough information to allow us to judge the bias inherent in the study. Indirectness (in relation to the limited age and type of population included) and imprecision (wide confidence intervals around the effect estimate) were observed. More long-term studies involving multiple centers and larger cohorts using a randomized-controlled design are warranted, especially among the pediatric age group. Detailed reporting of each outcome measure is necessary to allow a clear cut interpretation in a systematic review. One of the difficulties encountered in this review was the lack of detailed data reported in the included study. Overall, we judged the certainty of this evidence to be very low.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  2. Pratoomsoot C, Sruamsiri R, Dilokthornsakul P, Chaiyakunapruk N
    PLoS One, 2015;10(1):e108681.
    PMID: 25633206 DOI: 10.1371/journal.pone.0108681
    Many randomised controlled trials (RCTs) of herbal interventions have been conducted in the ASEAN Communities. Good quality reporting of RCTs is essential for assessing clinical significance. Given the importance ASEAN placed on herbal medicines, the reporting quality of RCTs of herbal interventions among the ASEAN Communities deserved a special attention.
    Matched MeSH terms: Randomized Controlled Trials as Topic*
  3. Lai NM, Leom DYX, Chow WL, Chen KH, Lin PH, Chaiyakunapruk N, et al.
    Neonatology, 2020;117(4):428-435.
    PMID: 32209794 DOI: 10.1159/000506703
    BACKGROUND: Research findings based on patient-important outcomes (PIOs) provide more useful conclusions than those that are based on surrogate outcomes. It is unclear to what extent PIOs are represented in neonatal randomized controlled trials (RCTs).

    OBJECTIVES: We determined the proportion of PIOs in neonatal RCTs included in Cochrane Neonatal reviews.

    METHODS: We extracted up to 5 outcomes from each RCT included in Cochrane Neonatal reviews published until January 2018, with independent determination of PIOs among authors followed by a discussion leading to a consensus. We defined PIOs as outcomes that matter to patient care, such as clinical events or physiological or laboratory parameters that are widely used to guide management.

    RESULTS: Among 6,832 outcomes extracted from 1,874 RCTs included in 276 reviews, 5,349 (78.3%) were considered PIOs; 461 studies (24.5%) included 5 or more PIOs, 1,278 (68.2%) included 1-4 PIOs, while 135 (7.2%) had no PIO included. PIOs were observed more often among dichotomous than among continuous outcomes (94.9 vs. 61.5%; RR: 1.54; 95% CI: 1.50-1.58), and more among subjective than among objective outcomes (95.9 vs. 76.8%; RR: 1.25; 95% CI: 1.22-1.28). Newer studies were more likely to have a greater number of PIOs (adjusted OR: 1.033 [95% CI: 1.025-1.041] with each publication year).

    CONCLUSIONS: The large and increasing representation of PIOs over the years suggests an improving awareness by neonatal trialists of the need to incorporate important outcomes in order to justify the utilization of resources. Further research should explore the reasons for non-inclusion or non-reporting of PIOs in a small proportion of RCTs.

    Matched MeSH terms: Randomized Controlled Trials as Topic*
  4. Nagendrababu V, Duncan HF, Bjørndal L, Kvist T, Priya E, Jayaraman J, et al.
    Int Endod J, 2020 Jun;53(6):774-803.
    PMID: 32266988 DOI: 10.1111/iej.13304
    Well-designed and properly conducted randomized clinical trials provide a true estimate of the effects of interventions and are acknowledged as the gold standard in terms of clinical study design. However, the quality of randomized clinical trials published in the field of Endodontics is suboptimal. The Preferred Reporting Items for RAndomized Trials in Endodontics (PRIRATE) 2020 guidelines were developed exclusively for Endodontics by integrating and adapting the CONsolidated Standards of Reporting Trials (CONSORT) statement and Clinical and Laboratory Images in Publications (CLIP) principles, through an accepted and well-documented consensus process. Full implementation of the PRIRATE 2020 guidelines will minimize potential sources of bias and thus enhance the standard of manuscripts submitted for publication, which will ultimately improve the reporting of randomized clinical trials in Endodontics. The aim of this document is to provide an explanation for each item in the PRIRATE 2020 checklist and flowchart with examples from the literature in order to help authors understand their rationale and significance. A link to this PRIRATE 2020 explanation and elaboration document is available on the Preferred Reporting Items for study Designs in Endodontology (PRIDE) website at http://www.pride-endodonticguidelines.org/prirate/.
    Matched MeSH terms: Randomized Controlled Trials as Topic*
  5. Ahmed A, Tanveer M, Dujaili JA, Chuah LH, Hashmi FK, Awaisu A
    AIDS Patient Care STDS, 2023 Jan;37(1):31-52.
    PMID: 36626156 DOI: 10.1089/apc.2022.0192
    People living with human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS; PLWHA) frequently encounter antiretroviral (ARV) therapy-related problems. Clinical pharmacists with specialized training in ARV stewardship play an important role in managing these problems. However, there is a paucity of evidence to clarify the impact of clinical pharmacists' interventions on managing ARV therapy-related problems in PLWHA. Therefore, we aim to systematically review the literature to determine the nature and impact of pharmacists' interventions on managing medication-related problems in PLWHA. The review protocol was registered on International Prospective Register of Systematic Reviews (PROSPERO; CRD42020173078). Relevant records were identified from six electronic bibliographic databases (PubMed, Embase, EBSCOhost, ProQuest, Scopus, and the Cochrane Central Register) from their inception until September 2022. We included all randomized and nonrandomized interventional studies that were published in English. After the abstract and full-text screening, data were extracted from the selected studies, and the quality of the studies was assessed. The electronic database search and citation tracking identified two thousand and three citations. The review included 21 of these studies, involving 2998 PLWHA, published between 2014 and 2022. Pharmacists' interventions, working alone or in a multi-disciplinary team, comprised ARV medication review, management of adverse drug reactions (ADRs), therapeutic drug monitoring, prevention of drug interactions, and provision of drug information to PLWHA or the health care team. The pharmacist-involved interventions significantly reduced incorrect/incomplete ARV regimens, drug interactions, incorrect dosages, duplicate therapy, polypharmacy, administration errors, missing medication, wrong formulation, ADRs, and prescribing errors. Most studies reported that physicians usually accept more than 90% of the pharmacists' recommendations. ARV medication-related problems remain highly prevalent in PLWHA. Pharmacist-led interventions and stewardship significantly reduce ARV therapy-related problems in PLWHA and are widely accepted by physicians. Dedicated pharmacists with specialized training and credentialing in infectious diseases or HIV/AIDS have a great potential to improve health outcomes in PLWHA.
    Matched MeSH terms: Randomized Controlled Trials as Topic; Non-Randomized Controlled Trials as Topic
  6. Nagendrababu V, Duncan HF, Pulikkotil SJ, Dummer PMH
    Int Endod J, 2021 Mar;54(3):354-365.
    PMID: 33089501 DOI: 10.1111/iej.13434
    Randomized clinical trials are positioned at the highest level of primary clinical evidence, as they are designed to be unbiased with a reduced risk of systematic error. The Consolidated Standards of Reporting Trials (CONSORT) statement was first developed in 1996 to improve the reporting quality of randomized clinical trials with updates being published subsequently. Recently, the Preferred Reporting Items for RAndomized Trials in Endodontics (PRIRATE) 2020 guidelines were developed exclusively for the field of Endodontics to address the suboptimal quality of randomized clinical trials submitted to Endodontic journals, which result in many being rejected. A principal flaw in submissions is the fact that many authors are unclear on the keys terms that should be used when developing manuscripts for publication. Clearly, authors should be aware of the most common terms used when conducting and reporting randomized clinical trials. Hence, the aim of the current paper is to present a comprehensive glossary of the terminology used in randomized clinical trials in order to assist authors when designing, executing and writing-up randomized clinical trials.
    Matched MeSH terms: Randomized Controlled Trials as Topic
  7. Al-Rudayni AHM, Gopinath D, Maharajan MK, Veettil SK, Menon RK
    PMID: 34299869 DOI: 10.3390/ijerph18147418
    Oral mucositis is a debilitating complication of chemotherapy, characterized by erythema, ulcers and oedema of the oral mucosa. This review aimed to evaluate the efficacy of Photobiomodulation in the treatment of oral mucositis using meta-analysis and trial sequential analysis, and also to assess the quality of the results by Grading of Recommendations, Assessment, Development and Evaluation (GRADE). A comprehensive search of three databases, including Embase, Medline and Central, was performed to identify randomized controlled trials studying the efficacy of Photobiomodulation in the treatment of cancer chemotherapy-induced oral mucositis. The primary outcome was reduction in the severity of oral mucositis. Secondary outcomes were pain relief, duration of oral mucositis and adverse effects. The meta-analysis was performed using the random-effects model, and random errors of the meta-analyses were detected by trial sequential analysis. A total of 6 randomized controlled trials with 398 participants were included in our analysis. Photobiomodulation significantly reduced the severity of oral mucositis when compared to sham radiation (RR 0.43, 95% CI 0.20 to 0.93; p < 0.05). Sensitivity analysis by excluding trials with high risk of bias reiterated the robustness of our results (RR 0.28, 95% CI 0.16 to 0.48). Trial sequential analysis illustrated that the evidence from the meta-analysis was conclusive. The result of the meta-analyses with trial sequential analysis illustrated that Photobiomodulation is an effective therapeutic intervention for the treatment of oral mucositis, and the evidence gathered can be considered conclusive with a moderate level of certainty according to GRADE. Further trials are recommended to standardize the laser parameters required for the optimal effect.
    Matched MeSH terms: Randomized Controlled Trials as Topic
  8. Western JS, Dicksit DD
    J Conserv Dent, 2016 Jul-Aug;19(4):343-6.
    PMID: 27563183 DOI: 10.4103/0972-0707.186457
    AIM OF THIS STUDY: The aim was to evaluate the efficiency of different sterilization methods on extracted human teeth (EHT) by a systematic review of in vitro randomized controlled trials.
    METHODOLOGY: An extensive electronic database literature search concerning the sterilization of EHT was conducted. The search terms used were "human teeth, sterilization, disinfection, randomized controlled trials, and infection control." Randomized controlled trials which aim at comparing the efficiency of different methods of sterilization of EHT were all included in this systematic review.
    RESULTS: Out of 1618 articles obtained, eight articles were selected for this systematic review. The sterilization methods reviewed were autoclaving, 10% formalin, 5.25% sodium hypochlorite, 3% hydrogen peroxide, 2% glutaraldehyde, 0.1% thymol, and boiling to 100°C. Data were extracted from the selected individual studies and their findings were summarized.
    CONCLUSION: Autoclaving and 10% formalin can be considered as 100% efficient and reliable methods. While the use of 5.25% sodium hypochlorite, 3% hydrogen peroxide, 2% glutaraldehyde, 0.1% thymol, and boiling to 100°C was inefficient and unreliable methods of sterilization of EHT.
    KEYWORDS: Autoclaving; extracted human teeth; formalin; sterilization methods; systematic review
    Matched MeSH terms: Randomized Controlled Trials as Topic
  9. Duncan HF, Nagendrababu V, Bjørndal L, Kvist T, Dummer PMH
    Int Endod J, 2020 Jun;53(6):731-732.
    PMID: 32396666 DOI: 10.1111/iej.13297
    Matched MeSH terms: Randomized Controlled Trials as Topic
  10. Nagendrababu V, Dummer PMH
    Int Endod J, 2020 Jul;53(7):885-886.
    PMID: 32533798 DOI: 10.1111/iej.13309
    Matched MeSH terms: Randomized Controlled Trials as Topic
  11. Ali AS, Hasan SS, Kow CS, Merchant HA
    Clin Nutr ESPEN, 2021 10;45:26-32.
    PMID: 34620326 DOI: 10.1016/j.clnesp.2021.08.019
    BACKGROUND: Lactoferrin (Lf) is one of the key immunomodulatory substances found naturally in various body fluids, such as saliva, tears, and breast milk, and forms a vital part of the innate defense against invading pathogens. Various studies have demonstrated antibacterial, antifungal, and antiviral properties of Lf and its protective role against respiratory tract infections (RTIs). The present meta-analysis aims to elucidate the association of Lf administration in reducing the risk of RTIs by systematically reviewing the data from randomized controlled trials (RCTs).

    METHODS: We systematically searched PubMed, Cochrane Library, Medline & CINAHL, Turning Research into Practice (TRIP), ProQuest Theses & Dissertations Databases, and China National Knowledge Infrastructure (CNKI) from inception till March 15, 2021. The primary outcome measure was a reduction in respiratory illness; decrease in frequency, symptoms, and duration. Random-effects model was used to estimate the odds ratio (OR) and 95% confidence interval (CI). We used Cochrane's RoB-2 to appraise the risk of bias of included RCTs.

    RESULTS: A total of nine RCTs were eligible for this review, of which six were included in the meta-analysis. Overall, two studies demonstrated a high risk of bias. The meta-analysis revealed a significantly reduced odds of developing respiratory infections with the use of Lf relative to the control (pooled odds ratio = 0.57; 95% confidence interval 0.44 to 0.74, n = 1,194), with sufficient evidence against the hypothesis of 'no significant difference' at the current sample size.

    CONCLUSIONS: The administration of Lf shows promising efficacy in reducing the risk of RTIs. Current evidence also favours Lf fortification of infant formula. Lf may also have a beneficial role in managing symptoms and recovery of patients suffering from RTIs and may have potential for use as an adjunct in COVID-19, however this warrants further evidence from a large well-designed RCT.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  12. Khan KS, Chien PFW
    Int J Gynaecol Obstet, 2022 11;159(2):613.
    PMID: 36030408 DOI: 10.1002/ijgo.14394
    Matched MeSH terms: Randomized Controlled Trials as Topic
  13. Khamis KM, Kadir Shahar H, Abdul Manaf R, Hamdan HM
    PLoS One, 2022;17(11):e0277888.
    PMID: 36441678 DOI: 10.1371/journal.pone.0277888
    BACKGROUND: Treatment failure and disease relapse among tuberculosis (TB) patients are commonly caused by non-adherence. It can lead to prolonged infection, increased transmission, drug resistance, and loss of life. Even though the causative microorganism of TB has been identified for more than a century, the disease is still a substantial public health problem worldwide. This research aims to devise, implement, and assess an educational intervention to improve adherence to TB treatment.

    METHODS AND FINDINGS: A randomised clinical trial involving 146 Sudanese TB patients will be conducted at the Abu Anga hospital in Khartoum. The participants will be randomly assigned to the intervention and control groups. A 2-hour session will be offered to the intervention group in a one-day TB educational intervention course. The same educational materials will also be provided to the control group after the randomised controlled trial (RCT). Data will be collected at baseline, one month, and four months after the intervention. The primary outcome of interest is TB treatment adherence, while secondary outcomes include quality of life score, tuberculosis knowledge, and health belief domains. Generalised estimating equations (GEE) in SPSS software version 25.0 will be utilised to evaluate the changes over time.

    CONCLUSIONS: This trial will provide information that could be used in improving TB control strategies to achieve better results in the adherence of healthcare services to the norms of the National Program and patient adherence to the disease treatment and cure.

    TRIAL REGISTRATION: This study is registered at TCTR: (TCTR20210607006).

    Matched MeSH terms: Randomized Controlled Trials as Topic
  14. Reynor A, McArdle N, Shenoy B, Dhaliwal SS, Rea SC, Walsh J, et al.
    Sleep, 2022 Apr 11;45(4).
    PMID: 34739082 DOI: 10.1093/sleep/zsab264
    STUDY OBJECTIVES: Randomized controlled trials (RCTs) have shown no reduction in adverse cardiovascular (CV) events in patients randomized to continuous positive airway pressure (CPAP) therapy for obstructive sleep apnea (OSA). This study examined whether randomized study populations were representative of OSA patients attending a sleep clinic.

    METHODS: Sleep clinic patients were 3,965 consecutive adults diagnosed with OSA by in-laboratory polysomnography from 2006 to 2010 at a tertiary hospital sleep clinic. Characteristics of these patients were compared with participants of five recent RCTs examining the effect of CPAP on adverse CV events in OSA. The percentage of patients with severe (apnea-hypopnea index, [AHI] ≥ 30 events/h) or any OSA (AHI ≥ 5 events/h) who met the eligibility criteria of each RCT was determined, and those criteria that excluded the most patients identified.

    RESULTS: Compared to RCT participants, sleep clinic OSA patients were younger, sleepier, more likely to be female and less likely to have established CV disease. The percentage of patients with severe or any OSA who met the RCT eligibility criteria ranged from 1.2% to 20.9% and 0.8% to 21.9%, respectively. The eligibility criteria that excluded most patients were preexisting CV disease, symptoms of excessive sleepiness, nocturnal hypoxemia and co-morbidities.

    CONCLUSIONS: A minority of sleep clinic patients diagnosed with OSA meet the eligibility criteria of RCTs of CPAP on adverse CV events in OSA. OSA populations in these RCTs differ considerably from typical sleep clinic OSA patients. This suggests that the findings of such OSA treatment-related RCTs are not generalizable to sleep clinic OSA patients.Randomized Intervention with Continuous Positive Airway Pressure in CAD and OSA (RICCADSA) trial, https://clinicaltrials.gov/ct2/show/NCT00519597, ClinicalTrials.gov number, NCT00519597.Usefulness of Nasal Continuous Positive Airway Pressure (CPAP) Treatment in Patients with a First Ever Stroke and Sleep Apnea Syndrome, https://clinicaltrials.gov/ct2/show/NCT00202501, ClinicalTrials.gov number, NCT00202501.Effect of Continuous Positive Airway Pressure (CPAP) on Hypertension and Cardiovascular Morbidity-Mortality in Patients with Sleep Apnea and no Daytime Sleepiness, https://clinicaltrials.gov/ct2/show/NCT00127348, ClinicalTrials.gov number, NCT00127348.Continuous Positive Airway Pressure (CPAP) in Patients with Acute Coronary Syndrome and Obstructive Sleep Apnea (OSA) (ISAACC), https://clinicaltrials.gov/ct2/show/NCT01335087, ClinicalTrials.gov number, NCT01335087.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  15. Vasantha Kumar P, Subramaniam P, Che Din N
    Asian J Psychiatr, 2021 Jun;60:102646.
    PMID: 33873045 DOI: 10.1016/j.ajp.2021.102646
    BACKGROUND: The effects of aging and its associated cognitive decline is particularly acute in Asia given the exponential growth of older adults as a proportion of the population as a whole. Many structured cognitive interventions have been proposed to prevent the cognitive decline typically seen in older age, but their utility as a viable means of achieving these goals is questionable.

    OBJECTIVES: To summarize and synthesize evidence on the utility and methodological quality of cognitive-based interventions on cognitive performance and associated secondary outcomes among healthy older adults in Asia, as well as novel, culture-specific components of cognitive interventions across the region.

    DATA SOURCES: The PubMed/Medline, Web of Science, Scopus, and ScienceDirect databases were searched through May 2020.

    ELIGIBILITY: Studies including individuals aged 60 years and above, who had no previous history of physical and/or mental illness. Few restrictions placed on intervention design, duration and mode of delivery, provided that participants were randomized to study conditions, and intervention included components addressing at least one cognitive domain.

    RESULTS: A total of 17 studies from six countries met the eligibility criteria and were included in the final review. Evidence from those studies indicated that cognitive interventions may be most effective when the design and aims were directed towards improvement in specific cognitive domains, but evidence regarding long-term effectiveness in preventing progression to clinical-level cognitive deficits is still unclear. Several studies highlighted culture-specific activities as components of their interventions, though these will need to be further outlined and standardized clearly in future research.

    Matched MeSH terms: Randomized Controlled Trials as Topic
  16. Shamsudin N, Fleischer AB
    J Drugs Dermatol, 2010 Oct;9(10):1221-6.
    PMID: 20941946
    BACKGROUND: A topical comparison in a randomized controlled trial (RCT) should correctly be termed a vehicle rather than a placebo as the vehicle in a dermatologic drug product enhances delivery and efficacy of the active compound.
    OBJECTIVES: To conduct a systematic review of RCTs involving topical drugs published in the Archives of Dermatology, Journal of the American Academy of Dermatology and British Journal of Dermatology for correct classification of studies as vehicle versus placebo-controlled.
    METHODS: RCTs involving topical drugs published in the Archives of Dermatology, Journal of the American Academy of Dermatology and British Journal of Dermatology from January 1999 to November 2008 were identified through PubMed, supplemented by citation lists from the individual journals' web pages. Only original studies that involved using a topical control or used the term topical "vehicle" or "placebo" were selected. The studies were examined for correct classification as vehicle-controlled, the year of publication, country of origin, sample size, funding source and nature of study center.
    RESULTS: Out of 132, 64 (49%) correctly classified their studies as vehicle-controlled. Pharmaceutical-funded studies (55%, P=0.01) were significantly associated with the use of correct classification.
    LIMITATIONS: As only three peer-reviewed dermatology journals were studied, findings may not be generalized to other dermatology journals and other types of publications.
    CONCLUSION: This systematic review highlights a common pitfall in the reporting of studies of topical dermatology drugs.
    Matched MeSH terms: Randomized Controlled Trials as Topic*
  17. Ng CA, Ho JJ, Lee ZH
    PLoS One, 2019;14(4):e0215869.
    PMID: 31022227 DOI: 10.1371/journal.pone.0215869
    BACKGROUND: The benefits of six months exclusive breastfeeding are well established for both mother and infant. One of the 10 steps of the Baby Friendly Hospital Initiative is rooming-in (mother and baby together in the same room throughout hospitalisation). A Cochrane review found only one randomised controlled trial (RCT) examining the effects of continuous rooming-in versus nursery care on breastfeeding duration, and concluded there was insufficient evidence to support or refute either practice. We aimed to examine the effect of continuous or intermittent rooming-in on breastfeeding duration.

    METHODS AND FINDINGS: We included all prospective controlled studies (randomised and non-randomised) comparing rooming-in to nursery care that reported full or partial breastfeeding up to six months. We used the 2016 search results of the Cochrane review and updated the search to August 2018 using OVID MEDLINE. Duplicate data extraction and assessment of risk of bias were performed. Meta-analyses were performed using REVMAN 5. The GRADE approach was used to assess quality of evidence. Seven studies were included, five had 24-hour-per-day, one daytime only and one 8-hours-per-day rooming-in. Four studies had at least one additional co-intervention: Differences in delivery room management, and educational packages. All studies contributing to meta-analyses had 24-hour rooming-in. There was no difference in the proportion of infants on full breastfeeding at 3 months (RR 1.14; 95% CI 0.84 to 1.54; very-low-quality evidence), 4 months (RR 0.99; 95% CI 0.73 to 1.33; very-low-quality evidence) and 6 months (RR 0.95; 95% CI 0.57 to 1.58; low-quality evidence). The proportion of infants on partial breastfeeding at 3-4 months was higher with rooming-in (RR 1.31; 95% CI 1.06 to 1.61; very-low-quality evidence).

    CONCLUSION: The addition of non-randomised prospective controlled studies to existing evidence did not add further information on the effects of rooming-in on breastfeeding duration but resulted in lower quality of evidence. Uncertainty about the effects of rooming-in on breastfeeding duration remains.

    Matched MeSH terms: Randomized Controlled Trials as Topic*
  18. Lai NM, Ong JMJ, Chen KH, Chaiyakunapruk N, Ovelman C, Soll R
    Neonatology, 2019;116(2):123-131.
    PMID: 31108494 DOI: 10.1159/000497423
    BACKGROUND: The introduction of Neonatology as a subspecialty in 1960 has stimulated an enormous amount of neonatal research. A large proportion of neonatal randomized-controlled trials (RCTs) have been included in the Cochrane reviews, within which methodological quality or risk-of-bias (ROB) assessment is an integral feature.

    OBJECTIVES: We described the ROB profile of neonatal RCTs published since the 1950s.

    METHODS: We analyzed individual studies within the Cochrane Neonatal reviews published up to December 2016. We extracted the reviewers' judgments on the ROB domains including random sequence generation, allocation concealment, blinding, incomplete outcome data, and selective reporting. We evaluated blinding of personnel in trials in which blinding was considered feasible.

    RESULTS: We assessed 1980 RCTs published between 1952 and 2016 from 294 Cochrane Neonatal systematic reviews, with full ROB assessments performed in 848 trials (42.8%). Among the ROB domains, the highest proportion of trials (73%) were judged as satisfactory ("low risk") in handling incomplete outcome data, while fewest trials achieved blinding of outcome assessor (38.4%). In the last 6 decades, a progressive increase has been observed in the proportion of trials that were rated as low risk in random sequence generation, allocation concealment, and selective reporting. However, blinding was achieved in less than half of the trials with no clear improvement across decades (23-44% since the 1980s).

    CONCLUSIONS: Despite steady improvement in the overall quality of neonatal RCTs over the last 6 decades, blinding remained unsatisfactory in the majority of the trials.

    Matched MeSH terms: Randomized Controlled Trials as Topic*
  19. Nagendrababu V, Duncan HF, Bjørndal L, Kvist T, Priya E, Jayaraman J, et al.
    Int Endod J, 2020 Jun;53(6):764-773.
    PMID: 32196696 DOI: 10.1111/iej.13294
    In evidence-based health care, randomized clinical trials provide the most accurate and reliable information on the effectiveness of an intervention. This project aimed to develop reporting guidelines, exclusively for randomized clinical trials in the dental specialty of Endodontology, using a well-documented, validated consensus-based methodology. The guidelines have been named Preferred Reporting Items for RAndomized Trials in Endodontics (PRIRATE) 2020. A total of eight individuals (PD, VN, HD, LB, TK, JJ, EP and SP), including the project leaders (PD and VN) formed a steering committee. The committee developed a checklist based on the items in the Consolidated Standards of Reporting Trials (CONSORT) guidelines and Clinical and Laboratory Images in Publications (CLIP) principles. A PRIRATE Delphi Group (PDG) and PRIRATE Face-to-Face Meeting group (PFMG) were also formed. Thirty PDG members participated in the online Delphi process and achieved consensus on the checklist items and flowchart that make up the PRIRATE guidelines. The guidelines were discussed at a meeting of the PFMG at the 19th European Society of Endodontology (ESE) Biennial congress, held on 13 September 2019 in Vienna, Austria. A total of 21 individuals from across the globe and four steering committee members (PD, VN, HD and LB) attended the meeting. As a consequence of the discussions, the guidelines were modified and then piloted by several authors whilst writing a manuscript. The PRIRATE 2020 guidelines contain a checklist consisting of 11 sections and 58 individual items as well as a flowchart, considered essential for authors to include when writing manuscripts for randomized clinical trials in Endodontics.
    Matched MeSH terms: Randomized Controlled Trials as Topic*
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