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1.
Cureus ; 14(11): e31633, 2022 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-36540505

RESUMO

Objective Patients with chronic respiratory diseases (CRD) like asthma and chronic obstructive pulmonary disease (COPD) experience significant morbidity and mortality. The patient's quality of life deteriorates with the progression of the disease. Pharmacological treatment focuses on reducing the symptoms. The psychological impact of the disease on the patient's quality of life is not assessed by all healthcare providers. There is limited knowledge about the patient's demographic and clinical factors affecting the quality of life in CRD patients and aspects hindering or influencing the management of disease in this population. Hence we aimed to conduct a qualitative study on patients with asthma or COPD to get a view of their knowledge about the disease, the problems they encounter in their day-to-day life and the treatment. Methods Semi-structured, face-to-face interviews were conducted by the investigator in the hospital during the patient's follow-up visits. The questions focused on the patient's awareness of the disease, living with chronic respiratory disease, understanding of disease and treatment, and compliance with inhaled therapy. The interviews were audio recorded and transcribed verbatim. Content analysis of the data was done manually. Codes and themes were derived manually. Themes were formed from the codes and sub-themes. Results Five themes were generated from the data obtained: (1) misconceptions regarding the contagious nature of the disease; (2) psychological stress due to feelings of worthlessness, helplessness due to inability to work and poor understanding among family members; (3) inappropriate lifestyle modifications like avoiding fruits and vegetables due to the fear of acute attacks; (4) poor adherence to inhalers due to work timing and difficulty travelling; and (5) lack of reinforcement by the healthcare providers on inhaler technique and adherence were identified as causes of poor inhaler technique and inappropriate knowledge about drugs. Conclusion Subjective reporting by patients in this study was helpful in understanding issues concerning disease management in CRD patients. Apart from assessing the patients' symptoms and prescribing drugs, healthcare providers should take time to impart knowledge about the disease to patients. Though patient education and psychological intervention are challenging to implement daily, they are supplemental to the pharmacologic management of the disease.

2.
Sleep Vigil ; 6(1): 61-84, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35496325

RESUMO

Yoga nidra, also known as 'yogic sleep', is a simplified form of an ancient tantric relaxation technique. The most general description of the practice is that it combines guided mental imagery with a specific yoga posture called Shavasana (or "corpse pose"). The goal of yoga nidra is to promote a profound state of relaxation, which differs from sleep inasmuch as there is still an awareness of one's surroundings. While several components of the practice have been known since ancient times, it was not until the 1960s that an updated and systematized system of practice was introduced to the public through the writings of Swami Satyananda Saraswati. Unlike other schools of yoga, which emphasize concentration or contemplation, yoga nidra's goal is complete relaxation. As such, its advocates claim that it is suitable for all individuals, from beginners to advanced practitioners of yoga. The calm inner stillness induced by yoga nidra is claimed by practitioners to be an effective stress management tool as well as a means for attaining greater receptivity to personal resolutions. These resolutions can range from the goal of achieving self-transformation, enhancing creativity, or improving one's learning ability. Additionally, yoga nidra is claimed to promote beneficial changes in physiological and mental health. The following narrative review summarizes the basic steps used to achieve the final state of yoga nidra relaxation as well as some recent experimental findings regarding its physiological and psychological effects. Standard research databases were searched for relevant articles. Clinical studies have shown that yoga nidra meditation is associated with positive physiological changes, including improvements in several hematological variables, red blood cell counts, blood glucose levels, and hormonal status. Two neuroimaging studies have shown that yoga nidra produces changes in endogenous dopamine release and cerebral blood flow, a further confirmation that its effects on the CNS are objectively measurable. The practice has also been shown to reduce psychometrically measured indices of mild depression and anxiety, although these benefits were not shown in an experimental study to extend to severe depression or severe anxiety.

3.
Hum Vaccin Immunother ; 18(1): 2034456, 2022 12 31.
Artigo em Inglês | MEDLINE | ID: mdl-35321625

RESUMO

India approved COVID-19 vaccine called Covaxin, developed by the Indian Council of Medical Research and Bharat Biotech Ltd. The primary objective of the study was to estimate the effectiveness of Covaxin in preventing breakthrough SARS-CoV-2 infection in healthcare workers (HCWs). A test-negative matched case-control study was conducted among HCWs of tertiary care hospital in Eastern India. Any HCW who tested positive for COVID-19 using RT-PCR during April and May 2021 was taken as the case. The HCWs who tested negative for COVID-19 by RT-PCR were considered as controls after matching with the date of testing and profession of the cases. Vaccination data were collected from the institution's vaccine database and recall. In case of discrepancy, it was confirmed from the CoWIN portal (cowin.gov.in). The sample size was 670 participants (335 pairs). Conditional logistic regression models were used to calculate the adjusted odds ratio for breakthrough SARS-CoV-2 infection. Vaccine effectiveness was calculated using the following formula: VE = (1-aOR) × 100%. Sensitivity analysis was done for effectiveness of Covaxin, excluding Covishield vaccination. The mean age of participants was 29.1 years (SD = 7.1), and the majority were males (55.2%). Among the study participants, 60% were completely vaccinated, 18.51% were partially vaccinated, and 21.49% were unvaccinated. After adjusting for age, gender, type of household and past history of COVID-19 disease in conditional logistic models, the vaccine effectiveness was 22% (aOR 0.78, 95% CI: 0.52-1.17; p = .233). Sensitivity analysis with Covaxin showed an effectiveness of 29% (aOR 0.71, 95% CI: 0.47-1.08; p = .114) for preventing breakthrough SARS-CoV-2 infection.


Assuntos
COVID-19 , Adulto , COVID-19/epidemiologia , COVID-19/prevenção & controle , Vacinas contra COVID-19 , Estudos de Casos e Controles , ChAdOx1 nCoV-19 , Feminino , Pessoal de Saúde , Humanos , Índia/epidemiologia , Masculino , SARS-CoV-2
4.
J Family Med Prim Care ; 10(8): 2974-2979, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-34660434

RESUMO

STATEMENT OF THE PROBLEM: Healthcare workers (HCW) are the most vulnerable group for contracting SARS-CoV-2. Assessment of seroprevalence of SARS-CoV-2 antibodies among HCW, thus can provide important data on pathogen exposure, infectivity, and adherence to personal protective equipment (PPE). The present study aimed at assessing SARS-CoV-2 seroprevalence among HCW and exploring associations with demographics, category of exposure to COVID-19 patients, preventive measures taken and relation with COVID-19 symptoms. METHOD OF STUDY: HCWs with a minimum gap 2 weeks from last duty were eligible to participate in the study. The enrolled HCW were categorized into high-risk and low-risk category based on work in COVID-19 areas. HCWs SARS-CoV-2 specific IgG and IgM antibodies were detected using rapid immunochromatography test. RESULTS: Out of 821 randomly selected HCWs, either IgM or IgG antibody was detected in 32 HCWs (32/821, 3.9%). Only IgM antibodies were detected in 14 (1.7%), only IgG was detected in 9 (1.0%), and both IgM and IgG antibodies were present in 9 HCWs. Seropositivity was significantly higher in high-risk category (5.7% vs. 2.2.%), HCWs who ever had COVID-19 related symptoms in last 3 months (5.6% vs. 2.8%), and those who had earlier tested positive for SARS-CoV-2 with real-time reverse transcriptase PCR (36.6% vs. 3.5%). Seroprevalence was highest (6.9%) among housekeeping and sanitation staff. CONCLUSIONS: Overall, low seroprevalence of SARS-CoV-2 antibodies in our HCWs is an indicator of effective infection control practice. HCW posted in dedicated COVID ward need more stringent implementation of infection prevention measures.

5.
JMIR Form Res ; 5(10): e28519, 2021 Oct 21.
Artigo em Inglês | MEDLINE | ID: mdl-34596569

RESUMO

BACKGROUND: The contact tracing and subsequent quarantining of health care workers (HCWs) are essential to minimizing the further transmission of SARS-CoV-2 infection and mitigating the shortage of HCWs during the COVID-19 pandemic situation. OBJECTIVE: This study aimed to assess the yield of contact tracing for COVID-19 cases and the risk stratification of HCWs who are exposed to these cases. METHODS: This was an analysis of routine data that were collected for the contact tracing of COVID-19 cases at the All India Institute of Medical Sciences, Bhubaneswar, in Odisha, India. Data from March 19 to August 31, 2020, were considered for this study. COVID-19 cases were admitted patients, outpatients, or HCWs in the hospital. HCWs who were exposed to COVID-19 cases were categorized, per the risk stratification guidelines, as high-risk contacts or low-risk contacts. RESULTS: During contact tracing, 3411 HCWs were identified as those who were exposed to 360 COVID-19 cases. Of these 360 cases, 269 (74.7%) were either admitted patients or outpatients, and 91 (25.3%) were HCWs. After the risk stratification of the 3411 HCWs, 890 (26.1%) were categorized as high-risk contacts, and 2521 (73.9%) were categorized as low-risk contacts. The COVID-19 test positivity rates of high-risk contacts and low-risk contacts were 3.8% (34/890) and 1.9% (48/2521), respectively. The average number of high-risk contacts was significantly higher when the COVID-19 case was an admitted patient (number of contacts: mean 6.6) rather than when the COVID-19 case was an HCW (number of contacts: mean 4.0) or outpatient (number of contacts: mean 0.2; P=.009). Similarly, the average number of high-risk contacts was higher when the COVID-19 case was admitted in a non-COVID-19 area (number of contacts: mean 15.8) rather than when such cases were admitted in a COVID-19 area (number of contacts: mean 0.27; P<.001). There was a significant decline in the mean number of high-risk contacts over the study period (P=.003). CONCLUSIONS: Contact tracing and risk stratification were effective and helped to reduce the number of HCWs requiring quarantine. There was also a decline in the number of high-risk contacts during the study period. This indicates the role of the implementation of hospital-based, COVID-19-related infection control strategies. The contact tracing and risk stratification approaches that were designed in this study can also be implemented in other health care settings.

6.
PLoS One ; 16(2): e0247163, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33592050

RESUMO

BACKGROUND: Ivermectin is one among several potential drugs explored for its therapeutic and preventive role in SARS-CoV-2 infection. The study was aimed to explore the association between ivermectin prophylaxis and the development of SARS-CoV-2 infection among healthcare workers. METHODS: A hospital-based matched case-control study was conducted among healthcare workers of AIIMS Bhubaneswar, India, from September to October 2020. Profession, gender, age and date of diagnosis were matched for 186 case-control pairs. Cases and controls were healthcare workers who tested positive and negative, respectively, for COVID-19 by RT-PCR. Exposure was defined as the intake of ivermectin and/or hydroxychloroquine and/or vitamin-C and/or other prophylaxis for COVID-19. Data collection and entry was done in Epicollect5, and analysis was performed using STATA version 13. Conditional logistic regression models were used to describe the associated factors for SARS-CoV-2 infection. RESULTS: Ivermectin prophylaxis was taken by 76 controls and 41 cases. Two-dose ivermectin prophylaxis (AOR 0.27, 95% CI, 0.15-0.51) was associated with a 73% reduction of SARS-CoV-2 infection among healthcare workers for the following month. Those involved in physical activity (AOR 3.06 95% CI, 1.18-7.93) for more than an hour/day were more likely to contract SARS-CoV-2 infection. Type of household, COVID duty, single-dose ivermectin prophylaxis, vitamin-C prophylaxis and hydroxychloroquine prophylaxis were not associated with SARS-CoV-2 infection. CONCLUSION: Two-dose ivermectin prophylaxis at a dose of 300 µg/kg with a gap of 72 hours was associated with a 73% reduction of SARS-CoV-2 infection among healthcare workers for the following month. Chemoprophylaxis has relevance in the containment of pandemic.


Assuntos
COVID-19/prevenção & controle , Pessoal de Saúde/estatística & dados numéricos , Ivermectina/uso terapêutico , Adulto , Ácido Ascórbico/administração & dosagem , Ácido Ascórbico/uso terapêutico , COVID-19/epidemiologia , Estudos de Casos e Controles , Quimioprevenção/métodos , Combinação de Medicamentos , Feminino , Humanos , Índia , Ivermectina/administração & dosagem , Masculino , Pessoa de Meia-Idade
7.
Adv Respir Med ; 87(4): 217-225, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31476009

RESUMO

INTRODUCTION: Dry powder inhalers (DPI) have been in use in the treatment of chronic respiratory diseases for decades. DPIs require proper inhaler technique to ensure appropriate dose delivery to the lungs which in turn provides disease control and hence reduces the economic burden due to frequent acute attacks and hospital visits. Inadequate inhaler technique remains an everlasting problem among patients with chronic respiratory disease. Hence the aim is to assess the inhaler technique in patients using DPI and to determine the factors associated with inhaler technique. MATERIAL AND METHODS: A cross-sectional study was conducted and 385 patients with asthma or chronic obstructive pulmonary disease (COPD) were recruited. Patient-related and disease-related factors were noted. Severity of the disease were assessed using asthma control test/COPD assessment test questionnaire and spirometer. The investigator assessed the inhaler technique of the patient against standard checklist. RESULTS: Nearly 46.2% of the patients performed incorrect inhaler technique. Multivariate analysis showed factors like young age [Odd's ratio (OR) 4.13, CI 1.31-17.8], well controlled disease (OR 2, CI 1.1-3.65), and the patients who learnt the technique from a medical personnel (OR 3.67, CI 1.46-9.24) had better inhaler technique. CONCLUSION: This study shows that the proper use of inhaler is still an unattained goal and significance of correct use has to be reiterated.


Assuntos
Broncodilatadores/uso terapêutico , Inaladores de Pó Seco/métodos , Educação de Pacientes como Assunto/métodos , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Administração por Inalação , Adulto , Asma/tratamento farmacológico , Estudos Transversais , Feminino , Humanos , Masculino , Adesão à Medicação , Pessoa de Meia-Idade
8.
Natl Med J India ; 32(4): 207-212, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-32769240

RESUMO

Background: Medication errors have an adverse impact on the healthcare system by increasing patient morbidity and mortality. They are preventable, and educational or technology-based interventions are needed to reduce their prevalence and improve medication safety. We aimed to study the impact of a sensitization programme and a blame-free reporting tool for doctors and nurses on the prevalence and reporting of medication errors in the intensive care units (ICUs) of a tertiary care teaching hospital. Methods: This prospective interventional study was conducted in the ICUs of cardiology, medicine, paediatrics and neonatology. Baseline medication errors were detected by prescription order review and direct observation of administration of medication for 30 days. A sensitization programme was conducted for doctors and nurses in these ICUs, the results were discussed, and a blame-free medication error reporting tool was introduced. Medication charts were modified to remove the transcription process in the cardiology and paediatrics ICUs. The follow-up study was conducted for 30 days in each ICU to monitor the impact of the sensitization programme. Results: The prevalence of medication errors was found to be 334.1/1000 patient observation days. Prescription errors were the most common types of errors at 129.1/1000 patient observation days. The interventions significantly reduced the error rate in all four ICUs. The overall number of prescriptions with errors was reduced from 9.1% (177/1944) to 3.5% (48/1373) and no medication error was reported using the tool. Conclusion: The sensitization programme on medication errors for doctors and nurses may be effective in improving medication safety. The impact was more pronounced in prescription errors. Reporting of medication errors did not improve in this study despite the introduction of a blame-free reporting tool.


Assuntos
Prescrições de Medicamentos/estatística & dados numéricos , Unidades de Terapia Intensiva/estatística & dados numéricos , Erros de Medicação/prevenção & controle , Erros de Medicação/estatística & dados numéricos , Atitude do Pessoal de Saúde , Educação Médica Continuada , Pessoal de Saúde/educação , Hospitais de Ensino , Humanos , Índia , Prevalência , Estudos Prospectivos , Atenção Terciária à Saúde
9.
Ayu ; 40(4): 262-272, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-33935445

RESUMO

BACKGROUND: There are several reports worldwide on adulteration of herbal medicines (HMs) with allopathic drugs. In India, only a few studies have reported adulteration of HMs with antidiabetics and there are no systematic studies. AIMS: To develop a rapid and validated method for detection of allopathic antidiabetic adulterants and to explore the extent of adulteration in HMs sold in South India. MATERIALS AND METHODS: Standards and solvents were purchased from Sigma-Aldrich. Different brands of antidiabetic HM samples with manufacturing licenses were procured from dispensaries. Spiked drug free psyllium husk as solid and flask seed oil as liquid herbal matrices were used for method development. The spiked matrices with different concentrations were extracted with methanol and subjected to centrifugation. The supernatant was collected and analyzed by liquid chromatography-tandem mass spectrometry (LC-MS/MS). Isocratic elution was carried on a C18 column with 0.1% (v/v) formic acid:methanol (3:7, v/v) as a mobile phase. All drugs were monitored for two ion products in positive electrospray ionization mode using multiple reaction monitoring scans. RESULTS: The retention time was 9 min. Limit of detection is 10 Pictograms (pg) for all analytes except for metformin, which was 370 pg. Recoveries of analytes range from 96% to 117%. Forty different brands of antidiabetic HMs were analyzed. Adulterant peaks were not observed in the mass chromatograms of HMs. CONCLUSIONS: A single-run method was developed by LC-MS/MS for the detection of proposed antidiabetics in HMs from licensed manufacturing units and online sold HMs across herbal dispensaries in Puducherry union territory, India. None of the HMs was found to be adulterated with proposed allopathic antidiabetic adulterants.

10.
BMC Health Serv Res ; 18(1): 526, 2018 07 05.
Artigo em Inglês | MEDLINE | ID: mdl-29976180

RESUMO

BACKGROUND: Irrational use of medicines is widespread in the South-East Asia Region (SEAR), where policy implementation to encourage quality use of medicines (QUM) is often low. The aim was to determine whether public-sector QUM is better in SEAR countries implementing essential medicines (EM) policies than in those not implementing them. METHODS: Data on six QUM indicators and 25 EM policies were extracted from situational analysis reports of 20 country (2-week) visits made during 2010-2015. The average difference (as percent) for the QUM indicators between countries implementing versus not implementing specific policies was calculated. Policies associated with better (> 1%) QUM were included in regression of a composite QUM score versus total number of policies implemented. RESULTS: Twenty-two policies were associated with better (> 1%) QUM. Twelve policies were associated with 3.6-9.5% significantly better use (p < 0.05), namely: standard treatment guidelines; formulary; a government unit to promote QUM; continuing health worker education on prescribing by government; limiting over-the-counter (OTC) availability of systemic antibiotics; disallowing public-sector prescriber revenue from medicines sales; not charging fees at the point of care; monitoring advertisements of OTC medicines; public education on QUM; and a good drug supply system. There was significant correlation between the number of policies implemented out of 22 and the composite QUM score (r = 0.71, r2 = 0.50, p < 0.05). CONCLUSIONS: Country situational analyses allowed rapid data collection that showed EM policies are associated with better QUM. SEAR countries should implement all such policies.


Assuntos
Medicamentos Essenciais/uso terapêutico , Política de Saúde , Setor Público , Sudeste Asiático , Confiabilidade dos Dados , Coleta de Dados , Honorários e Preços , Humanos , Qualidade da Assistência à Saúde
12.
Asian Pac J Cancer Prev ; 17(5): 2611-7, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27268639

RESUMO

BACKGROUND: Medication errors are common but most often preventable events in any health care setup. Studies on medication errors involving chemotherapeutic drugs are limited. OBJECTIVE: We studied three aspects of medication errors - prescription, transcription and administration errors in 500 cancer patients who received ambulatory cancer chemotherapy at a resource limited setting government hospital attached cancer centre in South India. The frequency of medication errors, their types and the possible reasons for their occurrence were analysed. DESIGN AND METHODS: Cross-sectional study using direct observation and chart review in anmbulatory day care unit of a Regional Cancer Centre in South India. Prescription charts of 500 patients during a three month time period were studied and errors analysed. Transcription errors were estimated from the nurses records for these 500 patients who were prescribed anticancer medications or premedication to be administered in the day care centre, direct observations were made during drug administration and administration errors analysed. Medical oncologists prescribing anticancer medications and nurses administering medications also participated. RESULTS: A total of 500 patient observations were made and 41.6% medication errors were detected. Among the total observed errors, 114 (54.8%) were prescription errors, 51(24.5%) were transcribing errors and 43 (20.7%) were administration errors. The majority of the prescription errors were due to missing information (45.5%) and administration errors were mainly due to errors in drug reconstitution (55.8%). There were no life threatening events during the observation period since most of the errors were either intercepted before reaching the patient or were trivial. CONCLUSIONS: A high rate of potentially harmful medication errors were intercepted at the ambulatory day care unit of our regional cancer centre. Suggestions have been made to reduce errors in the future by adoption of computerised prescriptions and periodic sensitisation of the responsible health personnel.


Assuntos
Prescrições de Medicamentos/normas , Escrita Manual , Prontuários Médicos/normas , Erros de Medicação/estatística & dados numéricos , Pacientes Ambulatoriais/estatística & dados numéricos , Medicamentos sob Prescrição/administração & dosagem , Estudos Transversais , Hospital Dia , Prescrições de Medicamentos/estatística & dados numéricos , Humanos , Índia , Prontuários Médicos/estatística & dados numéricos , Erros de Medicação/classificação
14.
J Pharmacol Pharmacother ; 6(2): 83-7, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-25969654

RESUMO

OBJECTIVE: To estimate the frequency and type of prescription errors in patients receiving cancer chemotherapy. SETTINGS AND DESIGN: We conducted a cross-sectional study at the day care unit of the Regional Cancer Centre (RCC) of a tertiary care hospital in South India. MATERIALS AND METHODS: All prescriptions written during July to September 2013 for patients attending the out-patient department of the RCC to be treated at the day care center were included in this study. The prescriptions were analyzed for omission of standard information, usage of brand names, abbreviations and legibility. The errors were further classified into potentially harmful ones and not harmful based on the likelihood of resulting in harm to the patient. Descriptive analysis was performed to estimate the frequency of prescription errors and expressed as total number of errors and percentage. RESULTS: A total of 4253 prescribing errors were found in 1500 prescriptions (283.5%), of which 47.1% were due to omissions like name, age and diagnosis and 22.5% were due to usage of brand names. Abbreviations of pre-medications and anticancer drugs accounted for 29.2% of the errors. Potentially harmful errors that were likely to result in serious consequences to the patient were estimated to be 11.7%. CONCLUSIONS: Most of the errors intercepted in our study are due to a high patient load and inattention of the prescribers to omissions in prescription. Redesigning prescription forms and sensitizing prescribers to the importance of writing prescriptions without errors may help in reducing errors to a large extent.

15.
Glob Pediatr Health ; 2: 2333794X14566625, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-27335932

RESUMO

This study was designed to compare the performance of a new weight estimation strategy (Mercy Method) with 12 existing weight estimation methods (APLS, Best Guess, Broselow, Leffler, Luscombe-Owens, Nelson, Shann, Theron, Traub-Johnson, Traub-Kichen) in children from India. Otherwise healthy children, 2 months to 16 years, were enrolled and weight, height, humeral length (HL), and mid-upper arm circumference (MUAC) were obtained by trained raters. Weight estimation was performed as described for each method. Predicted weights were regressed against actual weights and the slope, intercept, and Pearson correlation coefficient estimated. Agreement between estimated weight and actual weight was determined using Bland-Altman plots with log-transformation. Predictive performance of each method was assessed using mean error (ME), mean percentage error (MPE), and root mean square error (RMSE). Three hundred seventy-five children (7.5 ± 4.3 years, 22.1 ± 12.3 kg, 116.2 ± 26.3 cm) participated in this study. The Mercy Method (MM) offered the best correlation between actual and estimated weight when compared with the other methods (r (2) = .967 vs .517-.844). The MM also demonstrated the lowest ME, MPE, and RMSE. Finally, the MM estimated weight within 20% of actual for nearly all children (96%) as opposed to the other methods for which these values ranged from 14% to 63%. The MM performed extremely well in Indian children with performance characteristics comparable to those observed for US children in whom the method was developed. It appears that the MM can be used in Indian children without modification, extending the utility of this weight estimation strategy beyond Western populations.

16.
J Pharmacol Pharmacother ; 5(2): 81-2, 2014 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-24799809
17.
J Pharmacol Pharmacother ; 5(1): 1-3, 2014 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-24554901
20.
Pediatrics ; 129 Suppl 3: S161-84, 2012 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-22661763

RESUMO

BACKGROUND: An important step toward improvement of the conduct of pediatric clinical research is the standardization of the ages of children to be included in pediatric trials and the optimal age-subgroups to be analyzed. METHODS: We set out to evaluate empirically the age ranges of children, and age-subgroup analyses thereof, reported in recent pediatric randomized clinical trials (RCTs) and meta-analyses. First, we screened 24 RCTs published in Pediatrics during the first 6 months of 2011; second, we screened 188 pediatric RCTs published in 2007 in the Cochrane Central Register of Controlled Trials; third, we screened 48 pediatric meta-analyses published in the Cochrane Database of Systematic Reviews in 2011. We extracted information on age ranges and age-subgroups considered and age-subgroup differences reported. RESULTS: The age range of children in RCTs published in Pediatrics varied from 0.1 to 17.5 years (median age: 5; interquartile range: 1.8-10.2) and only 25% of those presented age-subgroup analyses. Large variability was also detected for age ranges in 188 RCTs from the Cochrane Central Register of Controlled Trials, and only 28 of those analyzed age-subgroups. Moreover, only 11 of 48 meta-analyses had age-subgroup analyses, and in 6 of those, only different studies were included. Furthermore, most of these observed differences were not beyond chance. CONCLUSIONS: We observed large variability in the age ranges and age-subgroups of children included in recent pediatric trials and meta-analyses. Despite the limited available data, some age-subgroup differences were noted. The rationale for the selection of particular age-subgroups deserves further study.


Assuntos
Metanálise como Assunto , Seleção de Pacientes , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Fatores Etários , Criança , Humanos , Projetos de Pesquisa/normas
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