95,818 results match your criteria randomised controlled


Cognitive insight, medication adherence and methamphetamine cessation in people enrolled in a pharmacotherapy trial for methamphetamine use.

J Subst Abuse Treat 2021 May 15;130:108473. Epub 2021 May 15.

National Drug and Alcohol Research Centre, University of New South Wales, Sydney, Australia.

Background: The current study examined correlates of cognitive insight in people enrolled in a methamphetamine pharmacotherapy trial; whether cognitive insight at the start of the trial predicted medication adherence and reductions in methamphetamine use during the trial; and, whether insight would remain stable over the trial or improve with reductions in methamphetamine use.

Methods: A subset of people enrolled in a 12-week randomised placebo-controlled pharmacotherapy trial for methamphetamine dependence completed the Beck Cognitive Insight Scale, comprising subscales for Self-Reflection and Self-Certainty, at baseline (n = 152) and at week 12 (n = 79). Medication adherence was expressed as the percentage of non-missed doses measured using eCAP™ technology. Read More

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Answer to "Clinical efficacy and safety of cefiderocol in the treatment of acute bacterial infections: A systematic review and meta-analysis of randomised controlled trials".

J Glob Antimicrob Resist 2021 Jun 9. Epub 2021 Jun 9.

Cellular and Molecular Pharmacology, Louvain Drug Research Institute, Université catholique de Louvain, Brussels, Belgium.

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Comparison of the analgesic effects of two quadratus lumborum blocks (QLBs), QLB type II vs. QLB type III, in Cesarean Delivery: A randomised study.

Int J Clin Pract 2021 Jun 12:e14513. Epub 2021 Jun 12.

Department of Anaesthesiology and Reanimation, Ondokuz Mayis University Faculty of Medicine, Samsun, Turkey.

Background: Quadratus lumborum blocks (QLB) are relatively novel regional anesthesia techniques, and the efficacy of all three types of QLB for postoperative analgesia in cesarean delivery (CD) has been demonstrated in separate studies. The aim of the present study is to compare the analgesic efficacy of the QLB-II and QLB-III blocks performed at the end of surgery in patients undergoing spinal anesthesia for CD.

Methods: We conducted a comparative, blinded, prospective, randomized, efficiency study. Read More

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Five year results of a prospective, randomised, contralateral eye trial of corneal crosslinking for keratoconus.

Clin Exp Ophthalmol 2021 Jun 11. Epub 2021 Jun 11.

Department of Ophthalmology, University of Auckland, Auckland, New Zealand.

Background: Few studies have evaluated corneal crosslinking in a prospective, randomised fashion. This study aimed to determine the efficacy and safety of corneal crosslinking to reduce the progression of keratoconus.

Methods: Prospective, unmasked, randomised, contralateral eye controlled trial at a tertiary eye centre. Read More

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'This could be my last chance': Therapeutic optimism in a randomised controlled trial for substance use disorders.

Sociol Health Illn 2021 Jun 12. Epub 2021 Jun 12.

British Columbia Centre on Substance Use, Vancouver, BC, Canada.

In randomised controlled trials (RCTs), 'therapeutic optimism' describes a participant's belief they will benefit from the study treatment, despite the express goal of RCTs to test unknown aspects of interventions. Harbouring such expectations may interfere with RCT participation experiences, particularly among marginalised populations, such as people with substance use disorders (PSUD) who may experience social and structural barriers to participation that also increase their vulnerability to therapeutic optimism. However, little research explores therapeutic optimism within substance use trials. Read More

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Surgically induced astigmatism following single site and twin site phacotrabeculectomy augmented with mitomycin C.

Eye (Lond) 2021 Jun 11. Epub 2021 Jun 11.

Glaucoma Clinic, Aravind Eye Hospital, Tirunelveli, India.

Purpose: To determine difference in surgically induced astigmatism (SIA), post-operative intraocular pressure (IOP) and axial length (AL) between single site and twin-site phacotrabeculectomy augmented with Mitomycin C (MMC).

Design: Prospective interventional randomised controlled study.

Methods: In a prospective interventional comparative study, eligible patients were scheduled for phacotrabeculectomy. Read More

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Transconjunctival versus transcutaneous local anaesthetic administration for lower eyelid surgery: a randomised controlled trial.

Eye (Lond) 2021 Jun 11. Epub 2021 Jun 11.

Department of Ophthalmology, Mater Misericordiae University Hospital, Dublin 7, Ireland.

Aim: To compare the associated discomfort and safety between transcutaneous (Tskin) and transconjunctival (Tconj) approaches of local anaesthetic (LA) administration in lower eyelid surgery.

Methods: A prospective randomised controlled trial comparing Tskin and Tconj LA in patients undergoing bilateral lower eyelid surgeries for horizontal laxity. Patients were randomised to receive LA via Tskin to one side and Tconj to the fellow side. Read More

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Feasibility of a home-based foot-ankle exercise programme for musculoskeletal dysfunctions in people with diabetes: randomised controlled FOotCAre (FOCA) Trial II.

Sci Rep 2021 Jun 11;11(1):12404. Epub 2021 Jun 11.

Department of Physical Therapy, Speech, and Occupational Therapy, Faculdade de Medicina, Universidade de São Paulo, Rua Cipotânea, 51, Cidade Universitária, São Paulo, SP, 05360-160, Brazil.

This study sought to assess the feasibility of design, adherence, satisfaction, safety and changes in outcomes followed by a home-based foot-ankle exercise guided by a booklet in individuals with diabetic peripheral neuropathy (DPN). 20 participants were allocated usual care [control group (CG)] or usual care plus home-based foot-ankle exercises [intervention group (IG)] for 8 weeks. For feasibility, we assessed contact, preliminary screening and recruitment rates, adherence, and using a 5-point Likert scale to satisfaction and safety of the booklet. Read More

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Diet and physical activity in pregnancy to prevent gestational diabetes: a protocol for an individual participant data (IPD) meta-analysis on the differential effects of interventions with economic evaluation.

BMJ Open 2021 Jun 11;11(6):e048119. Epub 2021 Jun 11.

WHO Collaborating Centre for Global Women's Health, Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK.

Introduction: Mothers with gestational diabetes mellitus (GDM) are at increased risk of pregnancy-related complications and developing type 2 diabetes after delivery. Diet and physical activity-based interventions may prevent GDM, but variations in populations, interventions and outcomes in primary trials have limited the translation of available evidence into practice. We plan to undertake an individual participant data (IPD) meta-analysis of randomised trials to assess the differential effects and cost-effectiveness of diet and physical activity-based interventions in preventing GDM and its complications. Read More

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Experiences and perceptions of trial participants and healthcare professionals in the UK Frozen Shoulder Trial (UK FROST): a nested qualitative study.

BMJ Open 2021 Jun 11;11(6):e040829. Epub 2021 Jun 11.

Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford, UK.

Objectives: To explore the experiences and perceptions of trial participants and healthcare professionals in the UK Frozen Shoulder Trial (UK FROST), a multicentre randomised controlled trial that compared manipulation under anaesthesia (MUA), arthroscopic capsular release (ACR) with a 12-week early structured physiotherapy programme (ESP) in people with unilateral frozen shoulder referred to secondary care.

Design: Nested qualitative study with semistructured interviews. We used constant comparison method to develop our themes. Read More

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Occupational therapy addressing the ability to perform activities of daily living among persons living with chronic conditions: a randomised controlled pilot study of ABLE 2.0.

Pilot Feasibility Stud 2021 Jun 11;7(1):122. Epub 2021 Jun 11.

The Parker Institute, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.

Background: The ABLE intervention was developed to enhance the ability to perform activities of daily living (ADL) tasks among persons living with chronic conditions. ABLE is a generic, home-based, individualised, 8-week occupational therapy intervention program, developed to be delivered in Danish municipalities. In a previous study, the feasibility of ABLE was evaluated in terms of content and delivery. Read More

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Integrating pharmacists into aged care facilities to improve the quality use of medicine (PiRACF Study): protocol for a cluster randomised controlled trial.

Trials 2021 Jun 11;22(1):390. Epub 2021 Jun 11.

Health Research Institute, Faculty of Health, University of Canberra, Bruce, ACT, Australia.

Background: Medication management in residential aged care facilities is an ongoing concern. Numerous studies have reported high rates of inappropriate prescribing and medication use in aged care facilities, which contribute to residents' adverse health outcomes. There is a need for new models of care that enhance inter-disciplinary collaboration between residential aged care facility staff and healthcare professionals, to improve medication management. Read More

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Perioperative liberal versus restrictive fluid strategies and postoperative outcomes: a systematic review and metanalysis on randomised-controlled trials in major abdominal elective surgery.

Crit Care 2021 06 11;25(1):205. Epub 2021 Jun 11.

Department of Anaesthesia and Intensive Care Medicine, Humanitas Clinical and Research Center - IRCCS, Via Alessandro Manzoni, 56, 20089, Rozzano, MI, Italy.

Background: Postoperative complications impact on early and long-term patients' outcome. Appropriate perioperative fluid management is pivotal in this context; however, the most effective perioperative fluid management is still unclear. The enhanced recovery after surgery pathways recommend a perioperative zero-balance, whereas recent findings suggest a more liberal approach could be beneficial. Read More

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A systematic review of non-drug interventions to prevent and treat anxiety in people with aphasia after stroke.

Disabil Rehabil 2021 Jun 11:1-10. Epub 2021 Jun 11.

Discipline of Clinical Psychology, Graduate School of Health, University of Technology Sydney, Ultimo, Australia.

Purpose: To investigate the effectiveness of non-drug interventions for people with aphasia in the prevention and/or treatment of anxiety post-stroke as either a primary or secondary outcome.

Materials And Methods: A systematic search of Medline, CINAHL, PsycINFO and Cochrane Library up to March 2021 was carried out. Studies of stroke populations were included if people with aphasia represented 25% or more of the enrolled participants. Read More

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Phosphodiesterase-5 inhibitors in Pregnancy: Systematic review and meta-analysis of maternal and perinatal safety and clinical outcomes.

Am J Obstet Gynecol 2021 Jun 8. Epub 2021 Jun 8.

Mater Research Institute - University of Queensland, Level 3 Aubigny Place, Raymond Terrace, South Brisbane, Queensland 4101, Australia; Faculty of Medicine, University of Medicine, Whitty Building, Annerley Road, South Brisbane, Queensland 4101, Australia; NHMRC Stillbirth Centre For Research Excellence, Mater Research Institute, South Brisbane, Queensland 4101, Australia. Electronic address:

Objective: Phosphodiesterase-5 inhibitors have recently been used for the treatment of severe early onset pre-eclampsia and fetal growth restriction. There are however concerns that they may increase the risk of neonatal morbidity and mortality. The aim of this systematic review was to assess the safety profile and clinical outcomes of phosphodiesterase-5 inhibitors use in pregnancy. Read More

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Low back pain.

Lancet 2021 Jun 8. Epub 2021 Jun 8.

Department of Anesthesiology and Critical Care Medicine, Johns Hopkins Medical Institutions, Baltimore, MD, USA; Neurology, Physical Medicine and Rehabilitation, Johns Hopkins Medical Institutions, Baltimore, MD, USA; Psychiatry and Behavioral Sciences, Johns Hopkins Medical Institutions, Baltimore, MD, USA; Department of Physical Medicine and Rehabilitation and Anesthesiology, Walter Reed National Military Medical Center, Bethesda, MD, USA.

Low back pain covers a spectrum of different types of pain (eg, nociceptive, neuropathic and nociplastic, or non-specific) that frequently overlap. The elements comprising the lumbar spine (eg, soft tissue, vertebrae, zygapophyseal and sacroiliac joints, intervertebral discs, and neurovascular structures) are prone to different stressors, and each of these, alone or in combination, can contribute to low back pain. Due to numerous factors related to low back pain, and the low specificity of imaging and diagnostic injections, diagnostic methods for this condition continue to be a subject of controversy. Read More

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Systematic review and network meta-analysis: efficacy of licensed drugs for abdominal bloating in irritable bowel syndrome with constipation.

Aliment Pharmacol Ther 2021 Jun 11. Epub 2021 Jun 11.

Leeds Gastroenterology Institute, St. James's University Hospital, Leeds, UK.

Background: Although bloating is a highly prevalent and troublesome symptom in irritable bowel syndrome with constipation (IBS-C), treatment is empirical with no specific guidelines for its management.

Aim: To conduct a pairwise and network meta-analysis, using a frequentist approach, of Food and Drug Administration-licensed drugs for IBS-C comparing their efficacy for abdominal bloating as a specific endpoint.

Methods: We searched the medical literature through December 2020 to identify randomised controlled trials (RCTs) in IBS-C, with abdominal bloating reported as a dichotomous assessment. Read More

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The effect of salutogenesis-based care on the sense of coherence in peritoneal dialysis patients.

J Clin Nurs 2021 Jun 10. Epub 2021 Jun 10.

Faculty of Health Sciences, Department of Mental Health and Disease Nursing, Erciyes University, Kayseri, Turkey.

Aims: This research is conducted to determine the effect of salutogenesis-based home care on the sense of coherence in patients with peritoneal dialysis.

Background: Recent studies on the salutogenesis model have shown that the model is effective in promoting and improving health. It was observed that studies based on the salutogenesis model were carried out in the form of a training programme, and there was no study that shows its effectiveness on patient care by integrating it into the nursing process. Read More

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Estimating the minimum important difference in the DEMQOL instrument in people with dementia.

Qual Life Res 2021 Jun 10. Epub 2021 Jun 10.

Centre for Applied Dementia Studies, University of Bradford, Bradford, UK.

Purpose: The Dementia-Related Quality of Life (DEMQOL) measure and the DEMQOL-Utility Score (DEMQOL-U) are validated tools for measuring quality of life (QOL) in people with dementia. What score changes translate to a clinically significant impact on patients' lives was unknown. This study establishes the minimal important differences (MID) for these two instruments. Read More

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Cruroplasty added to laparoscopic sleeve gastrectomy; does it decrease postoperative incidence of de-novo acid reflux?: A randomised controlled trial.

Ann Med Surg (Lond) 2021 Jun 21;66:102415. Epub 2021 May 21.

Department of General Surgery, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.

Background: Laparoscopic sleeve gastrectomy(LSG) is the most popular bariatric surgery worldwide. Postoperative de-novo acid reflux is one of the major common complications of the procedure. Different additive anti-reflux surgical techniques have been tried to decrease the complication although no favorable outcome is obtained. Read More

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A randomised controlled trial on effectiveness and feasibility of sport climbing in Parkinson's disease.

NPJ Parkinsons Dis 2021 Jun 10;7(1):49. Epub 2021 Jun 10.

Department of Neurology, Medical University of Vienna, Vienna, Austria.

Physical activity is of prime importance in non-pharmacological Parkinson's disease (PD) treatment. The current study examines the effectiveness and feasibility of sport climbing in PD patients in a single-centre, randomised controlled, semi-blind trial. A total of 48 PD patients without experience in climbing (average age 64 ± 8 years, Hoehn & Yahr stage 2-3) were assigned either to participate in a 12-week sport climbing course (SC) or to attend an unsupervised physical training group (UT). Read More

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Feasibility of shortening intravenous antibiotic therapy based on bacterial load- a proof of concept randomised controlled trial.

Eur Respir J 2021 Jun 10. Epub 2021 Jun 10.

MRC Centre for Inflammation Research, Queen's Medical Research Institute, Edinburgh, UK.

Introduction: There is lack of evidence to guide duration of intravenous antibiotics for bronchiectasis exacerbations.

Aims: To assess whether it is feasible based on bacterial load to shorten intravenous antibiotics during exacerbations and whether 14 days treatment is superior.

Method: We recruited participants requiring intravenous antibiotics for exacerbations. Read More

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Prediction of outcome from MRI and general movements assessment after hypoxic-ischaemic encephalopathy in low-income and middle-income countries: data from a randomised controlled trial.

Arch Dis Child Fetal Neonatal Ed 2021 Jun 10. Epub 2021 Jun 10.

Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology, Faculty of Medicine and Health Sciences, Trondheim, Norway.

Objective: To evaluate the accuracy of neonatal MRI and general movements assessment (GMA) in predicting neurodevelopmental outcomes in infants with hypoxic-ischaemic encephalopathy (HIE).

Design: Secondary analyses of a randomised controlled trial (RCT).

Setting: Tertiary neonatal intensive care unit in India. Read More

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Comparison of two dose escalation strategies of methotrexate in active rheumatoid arthritis: a multicentre, parallel group, randomised controlled trial.

Ann Rheum Dis 2021 Jun 10. Epub 2021 Jun 10.

Division of Clinical Immunology and Rheumatology, Department of Internal Medicine, Post Graduate Institute of Medical Education and Research, Chandigarh, India.

Objectives: There are no head-to-head trials of different dose escalation strategies of methotrexate (MTX) in RA. We compared the efficacy, safety and tolerability of 'usual' (5 mg every 4 weeks) versus 'fast' (5 mg every 2 weeks) escalation of oral MTX.

Methods: This multicentre, open-label (assessor blinded) RCT included patients 18-55 years of age having active RA with disease duration <5 years, and not on DMARDs. Read More

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How well do doctors understand a scientific article in English when it is not their first language? A randomised controlled trial.

BMJ Open 2021 Jun 10;11(6):e043444. Epub 2021 Jun 10.

The Journal of The Norwegian Medical Association, Oslo, Norway.

Introduction: English is the of science. How well doctors understand English is therefore crucial for their understanding of scientific articles. However, only 5% of the world's population have English as their first language. Read More

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Atherectomy Combined with Balloon Angioplasty versus Balloon Angioplasty Alone for de Novo Femoropopliteal Arterial Diseases: A Systematic Review and Meta-analysis of Randomised Controlled Trials.

Eur J Vasc Endovasc Surg 2021 Jun 7. Epub 2021 Jun 7.

Department of Vascular Surgery, Shanghai Ninth People's Hospital, Shanghai JiaoTong University, School of Medicine, Shanghai, China; Vascular Centre of Shanghai JiaoTong University, Shanghai, China. Electronic address:

Objective: The efficacy and cost effectiveness of atherectomy for femoropopliteal (FP) arterial diseases have not been determined yet. A systematic review and meta-analysis were performed to compare the efficacy and safety between atherectomy combined with balloon angioplasty (BA) and BA alone for patients with de novo FP steno-occlusive lesions.

Methods: The Cochrane Library, Medline, and Embase were used to search for studies evaluating outcomes of atherectomy combined with BA compared with BA alone in FP arterial diseases from inception to July 2020. Read More

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The effectiveness of volunteer befriending for improving the quality of life of patients with schizophrenia in Bosnia and Herzegovina - an exploratory randomised controlled trial.

Epidemiol Psychiatr Sci 2021 Jun 11;30:e48. Epub 2021 Jun 11.

Department of Psychiatry, Clinical Centre University of Sarajevo, Bosnia, Herzegovina.

Aims: Social isolation in people living with schizophrenia is associated with poor quality of life and increased symptom severity. Volunteer befriending interventions are a potential strategy for addressing social isolation, but evidence of their effectiveness is limited, particularly in low- and middle-income countries. We assessed the experiences of volunteer befriending and tested its effectiveness for improving the quality of life of patients with schizophrenia in Bosnia and Herzegovina. Read More

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Personalized medication adherence management in asthma and COPD: a review of effective interventions and development of a practical adherence toolkit.

J Allergy Clin Immunol Pract 2021 Jun 7. Epub 2021 Jun 7.

Groningen Research Institute for Asthma and COPD (GRIAC), Groningen, The Netherlands; Department of Clinical Pharmacy & Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands; Centre for Medicine Use and Safety, Monash Institute of Pharmaceutical Sciences, Monash University, Melbourne, VIC, Australia; Medication Adherence Expertise Center of the northern Netherlands (MAECON), Groningen, The Netherlands. Electronic address:

Background: Medication non-adherence management of patients with asthma/COPD remains challenging. Given the multitude of underlying causes, a personalized approach is required. The Test of Adherence to Inhalers (TAI) can identify reasons for non-adherence, but does not provide guidance on how to effectively act on results. Read More

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Metronomic capecitabine as adjuvant therapy in locoregionally advanced nasopharyngeal carcinoma: a multicentre, open-label, parallel-group, randomised, controlled, phase 3 trial.

Lancet 2021 Jun 4. Epub 2021 Jun 4.

Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China.

Background: Patients with locoregionally advanced nasopharyngeal carcinoma have a high risk of disease relapse, despite a high proportion of patients attaining complete clinical remission after receiving standard-of-care treatment (ie, definitive concurrent chemoradiotherapy with or without induction chemotherapy). Additional adjuvant therapies are needed to further reduce the risk of recurrence and death. However, the benefit of adjuvant chemotherapy for nasopharyngeal carcinoma remains controversial, highlighting the need for more effective adjuvant treatment options. Read More

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Evaluating motor performance with the Bruininks-Oseretsky Test of motor proficiency in impoverished Pakistani children.

J Pak Med Assoc 2021 Jun;71(6):1556-1560

Harvard T.H Chan School of Public Health, Boston, USA.

Objective: To evaluate the sensitivity of the modified Brief Form of Bruininks Oseretsky Test in identifying motor differences secondary to malnutrition and poverty.

Methods: This longitudinal cohort study was conducted at Nowshero Feroze, Sindh from 2013 to 2014 and comprised data drawn from children who participated in a randomised controlled trial, that assessed responsive stimulation and nutrition interventions in the first two years of life. Outcome measures included motor development assessed using Brief Form of Bruininks Oseretsky Test, child anthropometry and household economic and demographic information. Read More

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