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This review summarizes the effectiveness of scalable mind-body internet and mobile-based interventions (IMIs) on depression and anxiety symptoms in adults living with chronic physical conditions. Six databases (MEDLINE, PsycINFO, SCOPUS, EMBASE, CINAHL, and CENTRAL) were searched for randomized controlled trials published from database inception to March 2023. Mind-body IMIs included cognitive behavioral therapy, breathwork, meditation, mindfulness, yoga or Tai-chi. To focus on interventions with a greater potential for scale, the intervention delivery needed to be online with no or limited facilitation by study personnel. The primary outcome was mean change scores for anxiety and depression (Hedges' g). In subgroup analyses, random-effects models were used to calculate pooled effect size estimates based on personnel support level, intervention techniques, chronic physical condition, and survey type. Meta-regression was conducted on age and intervention length. Fifty-six studies met inclusion criteria (sample size 7691, mean age of participants 43 years, 58% female): 30% (n = 17) neurological conditions, 12% (n = 7) cardiovascular conditions, 11% cancer (n = 6), 43% other chronic physical conditions (n = 24), and 4% (n = 2) multiple chronic conditions. Mind-body IMIs demonstrated statistically significant pooled reductions in depression (SMD = -0.33 [-0.40, -0.26], p<0.001) and anxiety (SMD = -0.26 [-0.36, -0.17], p<0.001). Heterogeneity was moderate. Scalable mind-body IMIs hold promise as interventions for managing anxiety and depression symptoms in adults with chronic physical conditions without differences seen with age or intervention length. While modest, the effect sizes are comparable to those seen with pharmacological therapy. The field would benefit from detailed reporting of participant demographics including those related to technological proficiency, as well as further evaluation of non-CBT interventions. Registration: The study is registered with PROSPERO ID #CRD42022375606.
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INTRODUCTION: Mental illness is a leading cause of non-fatal disease burden worldwide. Natural health products (NHPs) are sought by patients with mental health conditions as a safer and more 'natural' option than conventional pharmacotherapy; however, the possible adverse events (AE) and interactions between NHPs and prescription medicines are not fully known. OBJECTIVES: The aim of this study was to determine (i) the prevalence of adult patients with mental health conditions taking prescription medications only, NHPs only, NHPs and prescription medications concurrently, or neither, (ii) which prescription medications and NHPs are most commonly used, (iii) AEs (serious and non-serious) experienced in the last 30 days for each product use group. METHODS: Mental health clinics in Alberta and Ontario, Canada, were included in an active surveillance study investigating NHP-drug interactions. On their first clinic visit, adult mental health patients were provided with a form inquiring about prescription drug use, NHP use, and any undesirable health events experienced in the last month. Healthcare professionals were also asked to report AEs. RESULTS: A total of 3079 patients were screened at 11 mental health clinics in Alberta and Ontario. In total, 620 AEs were reported in 447 patients (14.9%). The majority of adverse events were seen in patients using both NHPs and prescription medicines (58.8%), followed by patients taking only prescription medicines (37.1%), NHPs only (3.4%) and neither (0.67%). Combining NHPs and prescription medications increases the likelihood of experiencing AEs (OR 2.1; p < 0.001; 95% CI 1.7-2.6). CONCLUSIONS: Adult patients with mental health conditions who are taking both prescription medications and NHPs are more likely to report an adverse event than patients taking prescription drugs or NHPs alone. Polypharmacy increases the likelihood of an adverse event. Active surveillance is feasible and could contribute to enhanced pharmacovigilance.
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Produtos Biológicos , Medicamentos sob Prescrição , Adulto , Produtos Biológicos/efeitos adversos , Estudos Transversais , Interações Medicamentosas , Humanos , Saúde Mental , Ontário/epidemiologia , Medicamentos sob Prescrição/efeitos adversosRESUMO
Background and Objectives: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a chronic condition distinguished by disabling fatigue associated with post-exertional malaise, as well as changes to sleep, autonomic functioning, and cognition. Mind-body interventions (MBIs) utilize the ongoing interaction between the mind and body to improve health and wellbeing. Purpose: To systematically review studies using MBIs for the treatment of ME/CFS symptoms. Materials and Methods: MEDLINE, EMBASE, CINAHL, PsycINFO, and Cochrane CENTRAL were searched (inception to September 2020). Interventional studies on adults diagnosed with ME/CFS, using one of the MBIs in comparison with any placebo, standard of care treatment or waitlist control, and measuring outcomes relevant to the signs and symptoms of ME/CFS and quality of life were assessed for inclusion. Characteristics and findings of the included studies were summarized using a descriptive approach. Results: 12 out of 382 retrieved references were included. Seven studies were randomized controlled trials (RCTs) with one including three reports (1 RCT, 2 single-arms); others were single-arm trials. Interventions included mindfulness-based stress reduction, mindfulness-based cognitive therapy, relaxation, Qigong, cognitive-behavioral stress management, acceptance and commitment therapy and isometric yoga. The outcomes measured most often were fatigue severity, anxiety/depression, and quality of life. Fatigue severity and symptoms of anxiety/depression were improved in nine and eight studies respectively, and three studies found that MBIs improved quality of life. Conclusions: Fatigue severity, anxiety/depression and physical and mental functioning were shown to be improved in patients receiving MBIs. However, small sample sizes, heterogeneous diagnostic criteria, and a high risk of bias may challenge this result. Further research using standardized outcomes would help advance the field.
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Terapia Cognitivo-Comportamental , Síndrome de Fadiga Crônica , Adulto , Depressão , Terapia por Exercício , Síndrome de Fadiga Crônica/terapia , Humanos , Qualidade de VidaRESUMO
BACKGROUND: Pain is a common paediatric problem, and procedural pain, in particular, can be difficult to manage. Complementary therapies are often sought for pain management, including massage therapy (MT). We assessed the evidence for use of MT for acute procedural pain management in children. METHODS: We searched five main databases for (i) primary studies in English, (ii) included children 0 to 18 years of age, (iii) compared MT for procedural pain management to standard care alone or placebo, and (iv) measured pain as the primary or secondary outcome. The data were extracted by one author and verified by a second author. Randomized controlled trials were evaluated using the Cochrane Risk of Bias tool. RESULTS: Eleven paediatric trials of procedural pain in neonatal, burn, and oncology populations, a total of 771 participants, were identified. Eight reported statistically significant reductions in pain after MT compared to standard care. Pain was measured using validated pain scales, or physiologic indicators. The studies were heterogeneous in population, techniques, and outcome measures used. No adverse events associated with MT were identified. CONCLUSION: MT may be an effective nonpharmacologic adjunct for management of procedural pain in children.
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OBJECTIVE: The purpose of this study was to understand emerging roles of parents of hospitalized children with life threatening conditions and to explore how complementary therapies integrated into conventional pediatric care may shift and/or support these roles. DESIGN: This study is part of a larger research study that examined the introduction of a pediatric integrative medicine service at an acute care children's hospital in Canada. A qualitative descriptive study was conducted using one-on-one telephone interviews with a sample of parents of children included in the larger study. Children had access to complementary therapies including Reiki, massage therapy, and acupuncture. RESULTS: A total of 36 interviews were conducted between May 2014 and January 2016. This study found that parents of hospitalized children assume complex roles including that of caregiver, expert and patient (due to high levels of stress and anxiety). Moreover, the study reveals that the integration of complementary therapies with conventional care supports these parental roles. CONCLUSION: This study reveals that complementary therapies, introduced as a part of integrated approach to pediatric hospital care, and aimed primarily at managing distressing symptoms in patients, had simultaneously a positive contribution in providing parents with the means to navigate the complexities of parenting in the pediatric oncology and cardiology hospital wards and addressing some of their own needs.
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Cuidadores , Terapias Complementares , Criança , Criança Hospitalizada , Hospitais , Humanos , PaisRESUMO
Background: The prevalence and severity of pain, nausea/vomiting, and anxiety (PNVA) among hospitalized children is not well established. We describe the prevalence and severity of PNVA among hospitalized patients from oncology, general pediatrics, and cardiology services in a tertiary care center. Methods: Patients were recruited on admission and enrolled if their caregiver consented, spoke English, and were anticipated to stay 2-30 days. Symptoms were measured weekdays using age-validated tools. PNVA symptoms were described and compared. Results: We enrolled 496 (49.4%) patients of 1005 admitted. Patients were predominantly Caucasian (57.9%) on their first admission (53.6%). The average (SD) age was 8.6 years (5.9) in oncology, 4.2 (5.3) in general pediatrics and 2.6 (4.0) in cardiology. 325 (65.6%) patients reported anxiety, 275 (55.4%) reported nausea and 256 (52.0%) reported pain. Mean (SD) severity out of 10 was 3.7 (2.5) for anxiety, 3.2 (2.1) for nausea and 3.0 (1.5) for pain. Prevalence of PNVA was no different between clinical programs, but pain (p = 0.008) and nausea (p = 0.006) severity were. PNVA symptom co-occurrence was positively correlated (p < 0.001). Conclusions: Anxiety was the most common and severe symptom for hospitalized children. Patients in oncology demonstrated the least severe pain and nausea with no difference in anxiety between services.
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BACKGROUND: Health-related quality of life (HRQL) is increasingly recognized for its importance in health research. As there is increasing recognition of the inter-individual difference in response to therapeutic interventions, it may be helpful to apply individualized measures of HRQL. The MYMOP is a commonly used example of such measures, although several adaptations have been developed. OBJECTIVE: This review was conducted to identify adaptations of MYMOP, and evaluate the measurement properties of MYMOP and its adaptations. METHODS: Adaptations were identified using MYMOP website and personal communication, supplemented by a SCOPUS search in April 2017. Bibliographies of included studies were hand-searched. COSMIN criteria were used to evaluate the measurement properties. RESULTS: Sixteen studies were included in this review. Adaptations were developed to evaluate individualized therapies in cancer, psychiatry, and acupuncture. The included measures were MYMOP, measure yourself concern and wellbeing, psychological outcome profiles (PSYCHLOPS), and MYMOP-pictorial (MYMOP-P). The quality of the measurement properties varied; none of the included measures met all currently recommended quality criteria for measurement properties. CONCLUSION: Current literature provides evidence that MYMOP and its adaptations offer individualized assessment of patient-centered outcomes, and thereby provide a means to understand heterogeneity of treatment effects. However, current recommendations for psychometric testing suggest further validation of these measures would be beneficial.
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Psicometria/métodos , Qualidade de Vida/psicologia , Resultado do Tratamento , Humanos , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Chronic fatigue is increasingly common. Conventional medical care is limited in treating chronic fatigue, leading some patients to use traditional Chinese medicine therapies, including herbal medicine. OBJECTIVES: To assess the effectiveness of traditional Chinese medicine herbal products in treating idiopathic chronic fatigue and chronic fatigue syndrome. SEARCH METHODS: The following databases were searched for terms related to traditional Chinese medicine, chronic fatigue, and clinical trials: CCDAN Controlled Trials Register (July 2009), MEDLINE (1966-2008), EMBASE (1980-2008), AMED (1985-2008), CINAHL (1982-2008), PSYCHINFO (1985-2008), CENTRAL (Issue 2 2008), the Chalmers Research Group PedCAM Database (2004), VIP Information (1989-2008), CNKI (1976-2008), OCLC Proceedings First (1992-2008), Conference Papers Index (1982-2008), and Dissertation Abstracts (1980-2008). Reference lists of included studies and review articles were examined and experts in the field were contacted for knowledge of additional studies. SELECTION CRITERIA: Selection criteria included published or unpublished randomized controlled trials (RCTs) of participants diagnosed with idiopathic chronic fatigue or chronic fatigue syndrome comparing traditional Chinese medicinal herbs with placebo, conventional standard of care (SOC), or no treatment/wait lists. The outcome of interest was fatigue. DATA COLLECTION AND ANALYSIS: 13 databases were searched for RCTs investigating TCM herbal products for the treatment of chronic fatigue. Over 2400 references were located. Studies were screened and assessed for inclusion criteria by two authors. MAIN RESULTS: No studies that met all inclusion criteria were identified. AUTHORS' CONCLUSIONS: Although studies examining the use of TCM herbal products for chronic fatigue were located, methodologic limitations resulted in the exclusion of all studies. Of note, many of the studies labelled as RCTs and conducted in China did not utilize rigorous randomization procedures. Improvements in methodology in future studies is required for meaningful synthesis of data.
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Medicamentos de Ervas Chinesas/uso terapêutico , Síndrome de Fadiga Crônica/tratamento farmacológico , Fadiga/tratamento farmacológico , Doença Crônica , HumanosRESUMO
BACKGROUND: Newborn admission temperature is a strong predictor of outcomes across all gestations. Hypothermia immediately after birth remains a worldwide issue and, if prolonged, is associated with harm. Keeping preterm infants warm is difficult even when recommended routine thermal care guidelines are followed in the delivery room. OBJECTIVES: To assess the efficacy and safety of interventions designed for prevention of hypothermia in preterm and/or low birth weight infants applied within 10 minutes after birth in the delivery room, compared with routine thermal care or any other single/combination of intervention(s) also designed for prevention of hypothermia in preterm and/or low birth weight infants applied within 10 minutes after birth in the delivery room. SEARCH METHODS: We used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 5), MEDLINE via PubMed (1966 to 30 June 2016), Embase (1980 to 30 June 2016), and CINAHL (1982 to 30 June 2016). We also searched clinical trials databases, conference proceedings, and reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials. SELECTION CRITERIA: Trials using randomised or quasi-randomised allocations to test interventions designed to prevent hypothermia (apart from 'routine' thermal care) applied within 10 minutes after birth in the delivery room for infants at < 37 weeks' gestation and/or birth weight ≤ 2500 grams. DATA COLLECTION AND ANALYSIS: We used Cochrane Neonatal methods when performing data collection and analysis. MAIN RESULTS: Twenty-five studies across 15 comparison groups met the inclusion criteria, categorised as: barriers to heat loss (18 studies); external heat sources (three studies); and combinations of interventions (four studies).Barriers to heat loss Plastic wrap or bag versus routine carePlastic wraps improved core body temperature on admission to the neonatal intensive care unit (NICU) or up to two hours after birth (mean difference (MD) 0.58°C, 95% confidence interval (CI) 0.50 to 0.66; 13 studies; 1633 infants), and fewer infants had hypothermia on admission to the NICU or up to two hours after birth (typical risk ratio (RR) 0.67, 95% CI 0.62 to 0.72; typical risk reduction (RD) -0.25, 95% CI -0.29 to -0.20; number needed to treat for an additional beneficial outcome (NNTB) 4, 95% CI 4 to 5; 10 studies; 1417 infants). Risk of hyperthermia on admission to the NICU or up to two hours after birth was increased in infants in the wrapped group (typical RR 3.91, 95% CI 2.05 to 7.44; typical RD 0.04, 95% CI 0.02 to 0.06; number needed to treat for an additional harmful outcome (NNTH) 25, 95% CI 17 to 50; 12 studies; 1523 infants), but overall, fewer infants receiving plastic wrap were outside the normothermic range (typical RR 0.75, 95% CI 0.69 to 0.81; typical RD -0.20, 95% CI -0.26 to -0.15; NNTH 5, 95% CI 4 to 7; five studies; 1048 infants).Evidence was insufficient to suggest that plastic wraps or bags significantly reduce risk of death during hospital stay or other major morbidities, with the exception of reducing risk of pulmonary haemorrhage.Evidence of practices regarding permutations on this general approach is still emerging and has been based on the findings of only one or two small studies.External heat sourcesEvidence is emerging on the efficacy of external heat sources, including skin-to-skin care (SSC) versus routine care (one study; 31 infants) and thermal mattress versus routine care (two studies; 126 infants).SSC was shown to be effective in reducing risk of hypothermia when compared with conventional incubator care for infants with birth weight ≥ 1200 and ≤ 2199 grams (RR 0.09, 95% CI 0.01 to 0.64; RD -0.56, 95% CI -0.84 to -0.27; NNTB 2, 95% CI 1 to 4). Thermal (transwarmer) mattress significantly kept infants ≤ 1500 grams warmer (MD 0.65°C, 95% CI 0.36 to 0.94) and reduced the incidence of hypothermia on admission to the NICU, with no significant difference in hyperthermia risk.Combinations of interventionsTwo studies (77 infants) compared thermal mattresses versus plastic wraps or bags for infants at ≤ 28 weeks' gestation. Investigators reported no significant differences in core body temperature nor in the incidence of hypothermia, hyperthermia, or core body temperature outside the normothermic range on admission to the NICU.Two additional studies (119 infants) compared plastic bags and thermal mattresses versus plastic bags alone for infants at < 31 weeks' gestation. Meta-analysis of these two studies showed improvement in core body temperature on admission to the NICU or up to two hours after birth, but an increase in hyperthermia. Data show no significant difference in the risk of having a core body temperature outside the normothermic range on admission to the NICU nor in the risk of other reported morbidities. AUTHORS' CONCLUSIONS: Evidence of moderate quality shows that use of plastic wraps or bags compared with routine care led to higher temperatures on admission to NICUs with less hypothermia, particularly for extremely preterm infants. Thermal mattresses and SSC also reduced hypothermia risk when compared with routine care, but findings are based on two or fewer small studies. Caution must be taken to avoid iatrogenic hyperthermia, particularly when multiple interventions are used simultaneously. Limited evidence suggests benefit and no evidence of harm for most short-term morbidity outcomes known to be associated with hypothermia, including major brain injury, bronchopulmonary dysplasia, retinopathy of prematurity, necrotising enterocolitis, and nosocomial infection. Many observational studies have shown increased mortality among preterm hypothermic infants compared with those who maintain normothermia, yet evidence is insufficient to suggest that these interventions reduce risk of in-hospital mortality across all comparison groups. Hypothermia may be a marker for illness and poorer outcomes by association rather than by causality. Limitations of this review include small numbers of identified studies; small sample sizes; and variations in methods and definitions used for hypothermia, hyperthermia, normothermia, routine care, and morbidity, along with lack of power to detect effects on morbidity and mortality across most comparison groups. Future studies should: be adequately powered to detect rarer outcomes; apply standardised morbidity definitions; focus on longer-term outcomes, particularly neurodevelopmental outcomes.
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Hipotermia/prevenção & controle , Recém-Nascido de Baixo Peso , Doenças do Prematuro/prevenção & controle , Humanos , Recém-Nascido , Recém-Nascido Prematuro , Assistência Perinatal/métodos , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
PURPOSE: A growing number of cancer survivors suffer high levels of distress, depression and stress, as well as sleep disturbance, pain and fatigue. Two different mind-body interventions helpful for treating these problems are Mindfulness-Based Cancer Recovery (MBCR) and Tai Chi/Qigong (TCQ). However, while both interventions show efficacy compared to usual care, they have never been evaluated in the same study or directly compared. This study will be the first to incorporate innovative design features including patient choice while evaluating two interventions to treat distressed cancer survivors. It will also allow for secondary analyses of which program best targets specific symptoms in particular groups of survivors, based on preferences and baseline characteristics. METHODS AND SIGNIFICANCE: The design is a preference-based multi-site randomized comparative effectiveness trial. Participants (N=600) with a preference for either MBCR or TCQ will receive their preferred intervention; while those without a preference will be randomized into either intervention. Further, within the preference and non-preference groups, participants will be randomized into immediate intervention or wait-list control. Total mood disturbance on the Profile of mood states (POMS) post-intervention is the primary outcome. Other measures taken pre- and post-intervention and at 6-month follow-up include quality of life, psychological functioning, cancer-related symptoms and physical functioning. Exploratory analyses investigate biomarkers (cortisol, cytokines, blood pressure/Heart Rate Variability, telomere length, gene expression), which may uncover potentially important effects on key biological regulatory and antineoplastic functions. Health economic measures will determine potential savings to the health system.
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Atenção Plena/métodos , Neoplasias , Qigong , Qualidade de Vida , Estresse Psicológico , Tai Chi Chuan , Adaptação Psicológica , Adulto , Sobreviventes de Câncer/psicologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasias/psicologia , Neoplasias/terapia , Preferência do Paciente , Técnicas Psicológicas , Psicoterapia de Grupo/métodos , Qigong/métodos , Qigong/psicologia , Projetos de Pesquisa , Estresse Psicológico/fisiopatologia , Estresse Psicológico/terapia , Tai Chi Chuan/métodos , Tai Chi Chuan/psicologia , Resultado do TratamentoRESUMO
BACKGROUND: Some pediatric tertiary care centres in North America supplement conventional care with complementary therapies, together known as pediatric integrative medicine (PIM). Evidence to support the safety and efficacy of PIM is emerging, but the cost-effectiveness of an inpatient PIM service has yet to be assessed. METHODS/DESIGN: This study is a pragmatic cluster controlled clinical trial. Usual care will be compared to usual care augmented with PIM in three pediatric divisions; oncology, general medicine, and cardiology at one large urban tertiary care Canadian Children's Hospital. The primary outcome of the feasibility study is enrolment; the primary outcome of the main study is cost-effectiveness. Other secondary outcomes include the prevalence and severity of key symptoms (i.e. pain, nausea/vomiting and anxiety), efficacy of PIM interventions, patient safety, and parent satisfaction. DISCUSSION: This trial will be the first to evaluate the comparative effectiveness, both clinical and cost, of a PIM inpatient service. The evidence from this study will be useful to families, clinicians and decision makers, and will describe the clinical and economic value of PIM services for pediatric patients admitted to hospital.
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OBJECTIVE: To determine whether the application of occlusive wrap applied immediately after birth will reduce mortality in very preterm infants. STUDY DESIGN: This was a prospective randomized controlled trial of infants born 24 0/7 to 27 6/7 weeks' gestation who were assigned randomly to occlusive wrap or no wrap. The primary outcome was all cause mortality at discharge or 6 months' corrected age. Secondary outcomes included temperature, Apgar scores, pH, base deficit, blood pressure and glucose, respiratory distress syndrome, bronchopulmonary dysplasia, seizures, patent ductus arteriosus, necrotizing enterocolitis, gastrointestinal perforation, intraventricular hemorrhage, cystic periventricular leukomalacia, pulmonary hemorrhage, retinopathy of prematurity, sepsis, hearing screen, and pneumothorax. RESULTS: Eight hundred one infants were enrolled. There was no difference in baseline population characteristics. There were no significant differences in mortality (OR 1.0, 95% CI 0.7-1.5). Wrap infants had statistically significant greater baseline temperatures (36.3°C wrap vs 35.7°C no wrap, P < .0001) and poststabilization temperatures (36.6°C vs 36.2°C, P < .001) than nonwrap infants. For the secondary outcomes, there was a significant decrease in pulmonary hemorrhage (OR 0.6, 95% CI 0.3-0.9) in the wrap group and a significant lower mean one minute Apgar score (P = .007) in the wrap group. The study was stopped early because continued enrollment would not result in the attainment of a significant difference in the primary outcome. CONCLUSION: Application of occlusive wrap to very preterm infants immediately after birth results in greater mean body temperature but does not reduce mortality.
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Regulação da Temperatura Corporal , Doenças do Prematuro/mortalidade , Doenças do Prematuro/prevenção & controle , Curativos Oclusivos , Feminino , Humanos , Recém-Nascido , Recém-Nascido Prematuro , Masculino , Estudos ProspectivosAssuntos
Terapias Complementares/estatística & dados numéricos , Saúde Holística/estatística & dados numéricos , Medicina Integrativa/estatística & dados numéricos , Pediatria , Asma/terapia , Criança , Transtornos Globais do Desenvolvimento Infantil/terapia , Tratamento de Emergência , Gastroenteropatias/terapia , Humanos , Anamnese , Neoplasias/terapiaRESUMO
OBJECTIVES: To examine the quality of reporting of harms in systematic reviews, and to determine the need for a reporting guideline specific for reviews of harms. DESIGN: Systematic review. DATA SOURCES: Cochrane Database of Systematic Reviews (CDSR) and Database of Abstracts of Reviews of Effects (DARE). REVIEW METHODS: Databases were searched for systematic reviews having an adverse event as the main outcome, published from January 2008 to April 2011. Adverse events included an adverse reaction, harms, or complications associated with any healthcare intervention. Articles with a primary aim to investigate the complete safety profile of an intervention were also included. We developed a list of 37 items to measure the quality of reporting on harms in each review; data were collected as dichotomous outcomes ("yes" or "no" for each item). RESULTS: Of 4644 reviews identified, 309 were systematic reviews or meta-analyses primarily assessing harms (13 from CDSR; 296 from DARE). Despite a short time interval, the comparison between the years of 2008 and 2010-11 showed no difference on the quality of reporting over time (P=0.079). Titles in fewer than half the reviews (proportion of reviews 0.46 (95% confidence interval 0.40 to 0.52)) did not mention any harm related terms. Almost one third of DARE reviews (0.26 (0.22 to 0.31)) did not clearly define the adverse events reviewed, nor did they specify the study designs selected for inclusion in their methods section. Almost half of reviews (n=170) did not consider patient risk factors or length of follow-up when reviewing harms of an intervention. Of 67 reviews of complications related to surgery or other procedures, only four (0.05 (0.01 to 0.14)) reported professional qualifications of the individuals involved. The overall, unweighted, proportion of reviews with good reporting was 0.56 (0.55 to 0.57); corresponding proportions were 0.55 (0.53 to 0.57) in 2008, 0.55 (0.54 to 0.57) in 2009, and 0.57 (0.55 to 0.58) in 2010-11. CONCLUSION: Systematic reviews compound the poor reporting of harms data in primary studies by failing to report on harms or doing so inadequately. Improving reporting of adverse events in systematic reviews is an important step towards a balanced assessment of an intervention.
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Ensaios Clínicos Controlados Aleatórios como Assunto/efeitos adversos , Projetos de Pesquisa/normas , Literatura de Revisão como Assunto , Lista de Checagem , Humanos , Metanálise como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto/métodosRESUMO
BACKGROUND: The use of complementary and alternative medicine (CAM) has increased in recent years, with especially high prevalence in individuals with chronic illnesses. In the United States, the prevalence of CAM use in pediatric asthma patients is as high as 89%. OBJECTIVE: To investigate the epidemiology of pediatric CAM use in respiratory subspecialty clinics. METHODS: A survey was conducted at two hospital-based respiratory clinics in Edmonton (Alberta) and Ottawa (Ontario). Caregivers (most often parents) of children <18 years of age were asked questions regarding child and caregiver use of CAM, including products and practices used, beliefs about CAM, trust in information sources about CAM and characteristics of the respondents themselves. RESULTS: A total of 202 survey questionnaires were completed (151 from Edmonton and 51 from Ottawa). Pediatric CAM use in Edmonton was 68% compared with 45% in Ottawa, and was associated with caregiver CAM use, poorer health and health insurance coverage for CAM. The majority (67%) of children using CAM had taken prescription drugs concurrently and 58% of caregivers had discussed this with their doctor. DISCUSSION: Lifetime use of CAM at these pediatric clinics was higher than reported for children who do not have chronic diseases. CAM practices that are popular may be worthy of further research to evaluate their effectiveness and safety profile with regard to drug interactions. Health care providers should be encouraged to discuss CAM use at every visit, and explore their patient's health-related beliefs, behaviours and treatment preferences.
HISTORIQUE: L'utilisation de la médecine complémentaire et parallèle (MCP) a augmenté ces dernières années. Sa prévalence est particulièrement élevée chez les personnes atteintes d'une maladie chronique. Aux États-Unis, sa prévalence chez les patients asthmatiques d'âge pédiatrique atteint les 89 %. OBJECTIF: Examiner l'épidémiologie de l'utilisation de la MCP en pédiatrie dans des cliniques spécialisées en santé respiratoire. MÉTHODOLOGIE: Les chercheurs ont effectué un sondage dans deux cliniques de santé respiratoire en milieu hospitalier, à Edmonton (Alberta) et à Ottawa (Ontario). Les personnes qui s'occupaient d'enfants de 18 ans ou moins (en général, les parents) se sont fait poser des questions sur l'utilisation de la MCP par l'enfant et par elles, y compris les produits et pratiques utilisés, les croyances au sujet de la MCP, la confiance envers les sources d'information sur la MCP et leurs caractéristiques personnelles. RÉSULTATS: Au total, 202 sondages ont été remplis (151 à Edmonton et 51 à Ottawa). L'utilisation de la MCP en pédiatrie à Edmonton s'élevait à 68 %, et à 45 % à Ottawa. Elle s'associait à l'utilisation de MCP par la personne qui s'occupait de l'enfant, à une moins bonne santé et à une couverture d'assurance pour la MCP. La majorité des enfants (67 %) qui utilisaient la MCP prenaient simultanément des médicaments sur ordonnance, et 58 % des personnes qui s'occupaient d'eux en avaient parlé avec leur médecin. EXPOSÉ: À ces cliniques de pédiatrie, l'utilisation générale de MCP était plus élevée que celle déclarée chez les enfants qui n'ont pas de maladie chronique. Les pratiques de MCP qui sont populaires devraient peut-être faire l'objet de recherches supplémentaires pour en évaluer l'efficacité et le profil d'innocuité en matière d'interactions médicamenteuses. Il faut encourager les dispensateurs de soins à parler de MCP à chaque rendez-vous et à explorer les croyances de leurs patients liées à la santé, leurs comportements et leurs préférences thérapeutiques.
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Background. The use of complementary and alternative medicine (CAM) is high among children and youths with chronic illnesses, including cancer. The objective of this study was to assess prevalence and patterns of CAM use among pediatric oncology outpatients in two academic clinics in Canada. Procedure. A survey was developed to ask patients (or their parents/guardians) presenting to oncology clinics at the Stollery Children's Hospital in Edmonton and the Children's Hospital of Eastern Ontario (CHEO) in Ottawa about current or previous use of CAM products and practices. Results. Of the 137 families approached, 129 completed the survey. Overall CAM use was 60.5% and was not significantly different between the two hospitals. The most commonly reported reason for not using CAM was lack of knowledge about it. The most common CAM products ever used were multivitamins (86.5%), vitamin C (43.2%), cold remedies (28.4%), teething remedies (27.5%), and calcium (23.0%). The most common CAM practices ever used were faith healing (51.0%), massage (46.8%), chiropractic (27.7%), and relaxation (25.5%). Many patients (40.8%) used CAM products at the same time as prescription drugs. Conclusion. CAM use was high among patients at two academic pediatric oncology clinics. Although most respondents felt that their CAM use was helpful, many were not discussing it with their physicians.
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Background. Use of complementary and alternative medicine (CAM) by children with cancer is high; however, pediatric best cases are rare. Objectives. To investigate whether best cases exist in pediatric oncology using a three-phase approach and to compare our methods with other such programs. Methods. In phase I, Children's Oncology Group (COG) oncologists were approached via email and asked to recall patients who were (i) under 18 when diagnosed with cancer, (ii) diagnosed between 1990 and 2006, (iii) had unexpectedly positive clinical outcome, and (iv) reported using CAM during or after cancer treatment. Phase II involved partnering with CAM research networks; patients who were self-identified as best cases were asked to submit reports completed in conjunction with their oncologists. Phase III extended this partnership to 200 CAM associations and training organizations. Results. In phase I, ten cases from three COG sites were submitted, and most involved use of traditional Chinese medicine to improve quality of life. Phases II and III did not yield further cases. Conclusion. Identification of best cases has been suggested as an important step in guiding CAM research. The CARE Best Case Series Program had limited success in identifying pediatric cases despite the three approaches we used.
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OBJECTIVE: To conduct a scoping review of paediatric CAM utilisation literature, in order to establish the depth and breadth of the field and identify gaps in knowledge regarding the epidemiology of CAM use. METHODS: A CAM and paediatric search strategy was developed and run in three databases (Medline, Embase, Amed) in June 2006. It was revised and rerun in February 2010. Utilisation studies about paediatric CAM were selected if they had an English or French abstract. Data were extracted into an excel table by one individual. RESULTS: 152 paediatric CAM utilisation studies were identified as of February 2010, 136 were fulltext English. There was variation in how CAM was defined: vitamins were included in 35 studies, excluded in 12 studies and not mentioned in 40; while prayer was included in 64, excluded in 9, and not mentioned in 39. Over half of the studies identified were from North America. The majority of studies were conducted in conventional health settings. The four most commonly studied subpopulations were cancer, asthma, autistic spectrum disorder, and attention deficit hyperactivity disorder. Eighteen percent of studies did not report on the period of assessment used. Twenty-seven percent of studies inquired about adverse events and 32% inquired about costs and insurance coverage. CONCLUSION: There are substantial paediatric utilisation data available but some subpopulations remain poorly researched. The need for transparent utilisation data remains important in order to help prioritize safety and efficacy research.