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1.
Lancet ; 395(10226): 828-838, 2020 03 07.
Artigo em Inglês | MEDLINE | ID: mdl-32145797

RESUMO

Placebo comparisons are increasingly being considered for randomised trials assessing the efficacy of surgical interventions. The aim of this Review is to provide a summary of knowledge on placebo controls in surgical trials. A placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges. This Review outlines what a placebo control entails and present understanding of this tool in the context of surgery. We consider when placebo controls in surgery are acceptable (and when they are desirable) in terms of ethical arguments and regulatory requirements, how a placebo control should be designed, how to identify and mitigate risk for participants in these trials, and how such trials should be done and interpreted. Use of placebo controls is justified in randomised controlled trials of surgical interventions provided there is a strong scientific and ethical rationale. Surgical placebos might be most appropriate when there is poor evidence for the efficacy of the procedure and a justified concern that results of a trial would be associated with high risk of bias, particularly because of the placebo effect. Feasibility work is recommended to optimise the design and implementation of randomised controlled trials. This Review forms an outline for best practice and provides guidance, in the form of the Applying Surgical Placebo in Randomised Evaluations (known as ASPIRE) checklist, for those considering the use of a placebo control in a surgical randomised controlled trial.


Assuntos
Placebos , Ensaios Clínicos Controlados Aleatórios como Assunto , Procedimentos Cirúrgicos Operatórios , Guias como Assunto , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto/ética , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Projetos de Pesquisa
4.
Nat Rev Neurol ; 16(3): 171-182, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-32094485

RESUMO

Early evaluation of treatment response and prediction of disease evolution are key issues in the management of people with multiple sclerosis (MS). In the past 20 years, MRI has become the most useful paraclinical tool in both situations and is used clinically to assess the inflammatory component of the disease, particularly the presence and evolution of focal lesions - the pathological hallmark of MS. However, diffuse neurodegenerative processes that are at least partly independent of inflammatory mechanisms can develop early in people with MS and are closely related to disability. The effects of these neurodegenerative processes at a macroscopic level can be quantified by estimation of brain and spinal cord atrophy with MRI. MRI measurements of atrophy in MS have also been proposed as a complementary approach to lesion assessment to facilitate the prediction of clinical outcomes and to assess treatment responses. In this Consensus statement, the Magnetic Resonance Imaging in MS (MAGNIMS) study group critically review the application of brain and spinal cord atrophy in clinical practice in the management of MS, considering the role of atrophy measures in prognosis and treatment monitoring and the barriers to clinical use of these measures. On the basis of this review, the group makes consensus statements and recommendations for future research.


Assuntos
Encéfalo/patologia , Consenso , Imagem por Ressonância Magnética/normas , Esclerose Múltipla/diagnóstico por imagem , Guias de Prática Clínica como Assunto/normas , Índice de Gravidade de Doença , Medula Espinal/diagnóstico por imagem , Atrofia/diagnóstico por imagem , Atrofia/patologia , Encéfalo/diagnóstico por imagem , Humanos , Imagem por Ressonância Magnética/métodos , Esclerose Múltipla/patologia , Prognóstico , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Medula Espinal/patologia
5.
Br J Sports Med ; 54(1): 51-57, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31511232

RESUMO

BACKGROUND: In randomised controlled trials (RCTs) of interventions that aim to prevent sports injuries, the intention-to-treat principle is a recommended analysis method and one emphasised in the Consolidated Standards of Reporting Trials (CONSORT) statement that guides quality reporting of such trials. However, an important element of injury prevention trials-compliance with the intervention-is not always well-reported. The purpose of the present educational review was to describe the compliance during follow-up in eight large-scale sports injury trials and address compliance issues that surfaced. Then, we discuss how readers and researchers might consider interpreting results from intention-to-treat analyses depending on the observed compliance with the intervention. METHODS: Data from seven different randomised trials and one experimental study were included in the present educational review. In the trials that used training programme as an intervention, we defined full compliance as having completed the programme within ±10% of the prescribed running distance (ProjectRun21 (PR21), RUNCLEVER, Start 2 Run) or time-spent-running in minutes (Groningen Novice Running (GRONORUN)) for each planned training session. In the trials using running shoes as the intervention, full compliance was defined as wearing the prescribed running shoe in all running sessions the participants completed during follow-up. RESULTS: In the trials that used a running programme intervention, the number of participants who had been fully compliant was 0 of 839 (0%) at 24-week follow-up in RUNCLEVER, 0 of 612 (0%) at 14-week follow-up in PR21, 12 of 56 (21%) at 4-week follow-up in Start 2 Run and 8 of 532 (1%) at 8-week follow-up in GRONORUN. In the trials using a shoe-related intervention, the numbers of participants who had been fully compliant at the end of follow-up were 207 of 304 (68%) in the 21 week trial, and 322 of 423 (76%), 521 of 577 (90%), 753 of 874 (86%) after 24-week follow-up in the other three trials, respectively. CONCLUSION: The proportion of runners compliant at the end of follow-up ranged from 0% to 21% in the trials using running programme as intervention and from 68% to 90% in the trials using running shoes as intervention. We encourage sports injury researchers to carefully assess and report the compliance with intervention in their articles, use appropriate analytical approaches and take compliance into account when drawing study conclusions. In studies with low compliance, G-estimation may be a useful analytical tool provided certain assumptions are met.


Assuntos
Traumatismos em Atletas/prevenção & controle , Cooperação do Paciente , Condicionamento Físico Humano/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Interpretação Estatística de Dados , Humanos , Análise de Intenção de Tratamento , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Corrida/lesões , Sapatos
6.
New Dir Child Adolesc Dev ; 2019(167): 17-37, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31507056

RESUMO

This chapter highlights the key assumptions underlying Randomized Control Trials (RCTs) and illustrates them with regard to the practice of RCTs in the realm of child and adolescent development. Given the prominence of RCTs in policy research, we analyze the possible ways in which these assumptions might not be met by single randomized experiments, thereby making it difficult to draw valid causal inference from single studies. We frame this discussion within the categories of internal validity, statistical conclusion validity, construct validity, and external validity and address the debate about the "gold standard" status accorded to RCTs.


Assuntos
Desenvolvimento do Adolescente , Desenvolvimento Infantil , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Projetos de Pesquisa/normas , Adolescente , Criança , Humanos , Reprodutibilidade dos Testes
7.
BMC Palliat Care ; 18(1): 69, 2019 Aug 08.
Artigo em Inglês | MEDLINE | ID: mdl-31395039

RESUMO

BACKGROUND: Pain is one of the most common symptoms that has a severe impact on quality of life and is associated with numerous psychosocial issues in cancer patients. Palliative care, which is a recent development in China, mainly focuses on symptom control and provides psychosocial support in order to improve quality of life for terminally ill patients. This meta-analysis aimed to evaluate the effects of palliative care on cancer pain in China. METHODS: The four most comprehensive Chinese academic databases-CNKI, Wanfang, Vip and CBM-were searched from their inception until July 2019. Medline/PubMed, Web of Science, EBSCO and internet search (Google and Google Scholar) were also searched. Randomized controlled studies assessing the effects of palliative care on cancer pain were analyzed. The pooled random-effect estimates of standardized mean difference (SMD) and 95% confidence intervals (CI) were calculated. Subgroup analysis was conducted by moderating factors for heterogeneity. RESULTS: The present meta-analysis included 18 studies with a total of 1370 patients. The random-effect model showed a significant effect size of palliative care on cancer pain (SMD = 1.475, p < 0.001; 95% CI = 1.071-1.878). Age, pharmacological/non-pharmacological strategies and publication date could account for the heterogeneity through subgroup analysis to some extent. CONCLUSIONS: Palliative care was largely effective for relieving pain among Chinese adults with cancer, indicating that an adequate system should be urgently established to provide palliative care for cancer patients in Chinese medical settings. However, given the extent of heterogeneity, our findings should be interpreted cautiously.


Assuntos
Neoplasias/tratamento farmacológico , Manejo da Dor/normas , Cuidados Paliativos/normas , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Adulto , China , Humanos , Neoplasias/complicações , Neoplasias/fisiopatologia , Manejo da Dor/métodos , Manejo da Dor/psicologia , Cuidados Paliativos/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/normas
8.
J Orthop Surg Res ; 14(1): 248, 2019 Aug 06.
Artigo em Inglês | MEDLINE | ID: mdl-31387611

RESUMO

BACKGROUND: Tennis elbow or lateral epicondylitis is a common source of pain among craftsmen. Although it cannot be completely resolved, extracorporeal shock wave therapy (ESWT) and ultrasonics (US) have been found to be effective for tennis elbow as highlighted in previously published randomized controlled trials (RCTs) and reviews. However, the efficacy of these two therapies in treating tennis elbow is unknown. This meta-analysis compares the effectiveness of ESWT and US in relieving pain and restoring the functions of tennis elbow following tendinopathy. METHODS: RCTs published in the PubMed, Embase, Cochrane Library, and SpringerLink databases comparing ESWT and US in treating tennis elbow were identified by a software and manual search. The risk of bias and clinical relevance of the included studies were assessed. Publication bias was explored using funnel plot and statistical tests (Egger's test and Begg's test). The major outcomes of the studies were analyzed using the Review Manager 5.3. RESULTS: Five RCTs comprising five patients were included in the present meta-analysis. The results revealed a significantly lower VAS score of pain in the ESWT group (1 month: MD = 4.47, p = 0.0001; 3 months: MD = 20.32, p < 0.00001; and 6 months: MD = 4.32, p < 0.0001) compared to US. Besides, the grip strength was markedly higher 3 months after the intervention in ESWT (MD = 8.87, p < 0.00001) than in the US group. Although no significant difference was observed in the scores of the elbow function after 3 months of treatment (SMD = 1.51, p = 0.13), the subjective scores of elbow functions were found to be better in the ESWT group (SMD = 3.34; p = 0.0008) compared to the US group. CONCLUSIONS: Although there was no significant difference in the elbow function evaluation scores between ESWT and US, the superiority of the ESWT group in the VAS of pain (both at 1 month, 3 months, and 6 months follow-ups) raised grip strength in ESWT group and the scores for subjective evaluation of efficacy indicated that ESWT offers more effective therapy for lateral epicondylitis than US therapy.


Assuntos
Tratamento por Ondas de Choque Extracorpóreas/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Cotovelo de Tenista/terapia , Ondas Ultrassônicas , Tratamento por Ondas de Choque Extracorpóreas/normas , Seguimentos , Humanos , Manejo da Dor/métodos , Manejo da Dor/normas , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Cotovelo de Tenista/diagnóstico , Resultado do Tratamento , Terapia por Ultrassom/métodos , Terapia por Ultrassom/normas
9.
J Shoulder Elbow Surg ; 28(12): 2409-2417, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31420227

RESUMO

BACKGROUND: Considered the gold standard of study designs, randomized controlled trials' (RCTs) results shape clinical practice, effect policy, and influence reimbursement. The fragility index (FI) can be used to quantitate the relative robustness of RCT results, with higher scores indicating more stout results. Unfortunately, most RCTs in surgery have fragile results. The aim of this study was to report on the FI in addition to a qualitative assessment of recent RCTs within the field of shoulder and elbow surgery. METHODS: A systematic review was performed identifying recently published shoulder/elbow RCTs that included 1:1 allocated parallel study arms, dichotomous primary outcome variables, and statistical significance. The FI was calculated by sequentially modifying outcome groups by exchanging a nonevent in one group to an event until the P value for the outcome comparison, as calculated by the Fisher exact test, was increased above the .05 threshold. RESULTS: Thirty RCTs were included. The median FI was 4. Sixty percent trials had a FI of 2 or less. Fifty-three percent studies reported that participants were lost to follow-up. In 87.5% of these studies, the losses to follow-up exceeded their respective FIs. Only 53% of studies defined a primary outcome variable and 60% studies performed a prestudy power analysis. CONCLUSIONS: The median FI reported in the recent shoulder/elbow literature is 4; however, a high proportion of included RCTs display significant methodological concerns. The FI is a useful adjunct to analyze RCT results, but careful analysis of trial methods should be employed in each circumstance before drawing conclusions.


Assuntos
Cotovelo/cirurgia , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Projetos de Pesquisa , Ombro/cirurgia , Articulação do Cotovelo , Determinação de Ponto Final , Humanos , Perda de Seguimento
11.
BMC Musculoskelet Disord ; 20(1): 388, 2019 Aug 28.
Artigo em Inglês | MEDLINE | ID: mdl-31455297

RESUMO

BACKGROUND: Ankle fractures cause considerable pain, loss of function and healthcare resource use. High quality randomised controlled trials are required to evaluate the optimal management protocols for ankle fracture. However, there is debate regarding the most appropriate outcome measure to use when assessing patients with ankle fractures. The aim of this systematic review is to identify and summarise primary outcome measure use in clinical trials of non-pharmacological interventions for adults with an ankle fracture. METHODS: We performed comprehensive searches of the Medline, Embase, CINAHL, AMED and Cochrane CENTRAL databases, as well as ISRCTN and ClinicalTrials.gov online clinical trial registries on 19/06/2019 with no date limits applied. The titles and abstracts were initially screened to identify randomised or quasi-randomised clinical trials of non-pharmacological interventions for ankle fracture in adults. Two authors independently screened the full text of any articles which could potentially be eligible. Descriptive statistics we used to summarise the outcome measures collected in these articles including an assessment of trends over time. Secondary analysis included a descriptive summary of the multi-item patient reported outcome measures used in this study type. RESULTS: The searches returned a total of 3380 records. Following application of the eligibility criteria, 121 records were eligible for inclusion in this review. The most frequently collected primary outcome measures in this type of publication was the Olerud Molander Ankle Score, followed by radiographic and range of movement assessments. There was a total of 28 different outcome measures collected and five different multi-item, patient reported outcome measures collected as the primary outcome measure. There was a sequential increase in the number of this type of study published per decade since the 1980's. CONCLUSION: This review demonstrates the wide range of measurement methods used to assess outcome in adults with an ankle fracture. Future research should focus on establishing the validity and reliability of the outcome measures used in this patient population. Formulation of a consensus based core outcome set for adults with an ankle fracture would be advantageous for ensuring homogeneity across studies in order to meta-analyse trial results.


Assuntos
Fraturas do Tornozelo/terapia , /métodos , Adulto , Consenso , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Reprodutibilidade dos Testes
12.
Br J Surg ; 106(11): 1464-1471, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31393612

RESUMO

BACKGROUND: Research waste is a major challenge for evidence-based medicine. It implicates misused resources and increased risks for research participants. The aim of this study was to quantify constituent components of waste in surgical RCTs and explore targets for improvement. METHODS: ClinicalTrials.gov was searched for RCTs registered between January 2011 and December 2012 using the keyword 'surgery'. The primary outcome was research waste, defined as non-publication, inadequate reporting or presence of an avoidable design limitation. Serial systematic searches of PubMed and Scopus databases were performed to determine publication status. Adequacy of reporting was assessed using the CONSORT checklist. Avoidable design limitations were evaluated according to the presence of bias and/or the absence of a cited systematic review of the literature. RESULTS: Of 5617 registered RCTs, 304 met all eligibility criteria. Overall, 259 of 304 (85·2 per cent) demonstrated at least one feature of waste. Of these, 221 (72·7 per cent) were published in a peer-reviewed journal and 219 were accessible for full-text review. Only 73 of 131 (55·7 per cent) RCTs with a pharmacological intervention and 24 of 88 (27 per cent) with a non-pharmacological intervention were reported adequately, and 159 of 219 (72·6 per cent) demonstrated an avoidable design limitation. Multicentre (odds ratio 0·31, 95 per cent c.i. 0·11 to 0·88) and externally funded (OR 0·35, 0·15 to 0·82) RCTs were less associated with research waste. CONCLUSION: This study identified a considerable burden of research waste in surgical RCTs. Future initiatives should target improvements in single-centre, poorly supported RCTs.


Assuntos
Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Estudos Transversais , Humanos , Publicações/estatística & dados numéricos , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Projetos de Pesquisa/normas , Projetos de Pesquisa/estatística & dados numéricos , Procedimentos Cirúrgicos Operatórios/estatística & dados numéricos
14.
Medicine (Baltimore) ; 98(25): e16043, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31232938

RESUMO

BACKGROUND: Multiple sclerosis (MS) is a chronic immune mediated disease which affects the central nervous system (CNS), having a substantial financial, functional, and quality of life (QOL) impact on these people. The vitamin A supplementation has been studied as a therapeutic possibility for in MS. Therefore, the objective of this protocol is to build an outline for a future systematic review, which will provide up-to-date available evidence about the clinical impact of nutritional supplementation of vitamin A in the outcomes related to the symptoms in patients with this pathology. METHODS: The search will be performed in the following databases: PubMed, Embase, Scopus, cinahl, Scielo, Web of Science, the Cochrane Library and Science Direct, randomized clinical trials published until May 2019 that evaluate the relationship of the supplementation of vitamin A and health-related outcomes in patients with MS will be included. Preferred Reporting Items for Systematic review and Meta-Analysis Protocols (PRISMA-P) will be used to outline the protocol, and PRISMA to the systematic review. Undergraduate handbook of quality of evidence and strength of recommendations for decision making in health (GRADE) will be used to assess the quality of evidence and the strength of the recommendation, and the JADAD scale to assess the internal validity of selected studies. For the extraction of all the data found a database in Microsoft Excel will be created. For the summary of the findings the Cochrane Collaboration Handbook recommendations will be used, and for the meta-analysis standard statistical techniques the RevMan software will be used. RESULTS: In this study, we hope to find a considerable number of articles presenting evidence about the effectiveness of vitamin A supplementation in patients with MS. CONCLUSION: Currently, many lines of evidence have been produced when it comes to the use of food supplements. This systematic review proposal might provide recent, important, and trusted information for better treatment of patients. RECORD OF SYSTEMATIC REVIEW: This review was recorded in the International Register of Prospective Systematic Reviews (PROSPERO) on the January 30, 2019 (registration: CRD42019121757). Available at: http://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42019121757.


Assuntos
Suplementos Nutricionais/normas , Metanálise como Assunto , Esclerose Múltipla/dietoterapia , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Literatura de Revisão como Assunto , Humanos , Terapia Nutricional/métodos , /normas , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Vitamina A/uso terapêutico , Vitaminas/uso terapêutico
16.
Clin Drug Investig ; 39(10): 917-926, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31250403

RESUMO

BACKGROUND AND OBJECTIVES: Subject dropout rates in placebo-controlled randomized clinical trials (RCTs) of antipsychotics are high. The missing values due to dropout represent a potential source of bias in clinical trials. We aimed to identify the potential factors affecting subject dropout in atypical antipsychotics RCTs by conducting a meta-analysis. METHODS: Placebo-controlled RCTs for atypical antipsychotics using positive and negative syndrome scale (PANSS) as a psychiatric assessment scale were selected by database search. The potential factors affecting subject dropout, such as publication year, study design, and operational factors, were analyzed by meta-regression. RESULTS: Forty-seven placebo controlled RCTs of atypical antipsychotics of which results were published between 1993 and 2018 were identified through the database search. In the multivariate meta-regression analysis, earlier publication year, older age of subjects, and longer study duration were significantly associated with high subject dropout rates in placebo-controlled clinical trials of atypical antipsychotics. CONCLUSION: Subject dropout rates in clinical trials of atypical antipsychotics published between 1993 and 2018 year decreased over time. Study duration should be taken into consideration when designing future studies, where short study periods yet appropriate for evaluating the efficacy of new atypical antipsychotics are preferable. Additionally, previous medications and the degree of subject satisfaction with antipsychotics might affect subject dropout rate.


Assuntos
Antipsicóticos/uso terapêutico , Transtornos Mentais/tratamento farmacológico , Pacientes Desistentes do Tratamento , Escalas de Graduação Psiquiátrica/normas , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Humanos , Transtornos Mentais/diagnóstico , Transtornos Mentais/psicologia , Pacientes Desistentes do Tratamento/psicologia , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos
17.
Trials ; 20(1): 329, 2019 Jun 06.
Artigo em Inglês | MEDLINE | ID: mdl-31171041

RESUMO

BACKGROUND: Randomised controlled trials (RCTs) are widely used for establishing evidence of the effectiveness of interventions, yet public health interventions are often complex, posing specific challenges for RCTs. Although there is increasing recognition that qualitative methods can and should be integrated into RCTs, few frameworks and practical guidance highlight which qualitative methods should be integrated and for what purposes. As a result, qualitative methods are often poorly or haphazardly integrated into existing trials, and researchers rely heavily on interviews and focus group discussions. To improve current practice, we propose a framework for innovative qualitative research methods that can help address the challenges of RCTs for complex public health interventions. METHODS: We used a stepped approach to develop a practical framework for researchers. This consisted of (1) a systematic review of the innovative qualitative methods mentioned in the health literature, (2) in-depth interviews with 23 academics from different methodological backgrounds working on RCTs of public health interventions in 11 different countries, and (3) a framework development and group consensus-building process. RESULTS: The findings are presented in accordance with the CONSORT (Consolidated Standards of Reporting Trials) Statement categories for ease of use. We identify the main challenges of RCTs for public health interventions alongside each of the CONSORT categories, and potential innovative qualitative methods that overcome each challenge are listed as part of a Framework for the Integration of Innovative Qualitative Methods into RCTs of Complex Health Interventions. Innovative qualitative methods described in the interviews include rapid ethnographic appraisals, document analysis, diary methods, interactive voice responses and short message service, community mapping, spiral walks, pair interviews and visual participatory analysis. CONCLUSIONS: The findings of this study point to the usefulness of observational and participatory methods for trials of complex public health interventions, offering a novel contribution to the broader literature about the need for mixed methods approaches. Integrating a diverse toolkit of qualitative methods can enable appropriate adjustments to the intervention or process (or both) of data collection during RCTs, which in turn can create more sustainable and effective interventions. However, such integration will require a cultural shift towards the adoption of method-neutral research approaches, transdisciplinary collaborations, and publishing regimes.


Assuntos
Saúde Pública , Pesquisa Qualitativa , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Projetos de Pesquisa , Consenso , Difusão de Inovações , Grupos Focais , Humanos , Entrevistas como Assunto , Saúde Pública/normas , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Projetos de Pesquisa/normas
18.
J Prosthodont ; 28(6): 656-658, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31081575

RESUMO

PURPOSE: Bias can occur in various phases of an investigation, and its control is an important measure of the validity of results for randomized controlled trials (RCTs). The purpose of this study is to determine if bias control in prosthodontic RCTs published from 2008 to 2017 improved over those published from 1988 to 1997. MATERIALS AND METHODS: MEDLINE was searched for RCTs in The International Journal of Prosthodontics, The Journal of Prosthetic Dentistry, and The Journal of Prosthodontics published from 2008 to 2017. Citations retrieved were included if the trial involved human subjects, included at least 2 treatment groups, and group assignment was by random allocation. Pilot and follow-up studies were excluded. Included RCTs were evaluated on the basis of how control of potential sources of bias in trial methodology were reported. Three areas-control of bias at entry, control of bias in assessment of outcome, and control of bias after entry-were scored 1 or 0, based on whether method of randomization was explicitly reported, blinding was done, and all subjects were accounted for at the end of the study. Thus, the maximum quality score was 3 (good bias control) and the minimum 0 (poor bias control). Frequencies were calculated for each dimension of trial methodology, and overall scores were reported. Results were compared to those of RCTs published from 1988 to 1997 reported in a previous study. RESULTS: Ninety-six RCTs published from 2008 to 2017 met the inclusion criteria and were reviewed. Method of randomization was explicit in 68% of RCTs, 50% reported blinding, and 85% accounted for all subjects; 32% scored the maximum 3 points for good bias control. In comparison, 62 RCTs published from 1988 to 1997 had frequencies of 47%, 40%, and 76% in the 3 areas examined, respectively; only 16% had maximum scores for good bias control. CONCLUSION: Control of bias and overall quality scores have improved for RCTs published in the 3 studied prosthodontic journals.


Assuntos
Publicações Periódicas como Assunto , Prostodontia , Ensaios Clínicos Controlados Aleatórios como Assunto , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto/normas
20.
Osteoporos Int ; 30(9): 1723-1732, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31041475

RESUMO

The present systematic review aimed to evaluate bone mineral density (BMD) change and complication rates of elcatonin on treating postmenopausal osteoporosis. The result confirmed efficacy of elcatonin and safety in combination therapies of elcatonin (C-E). INTRODUCTION: Postmenopausal osteoporosis is an important issue in global aging trends. One treatment of osteoporosis is elcatonin, a kind of calcitonin. However, it has been challenged for long time because of safety. Many trials investigated on this topic, but they were designed differently. Those designs can be categorized in monotherapy of elcatonin (M-E) and C-E. Unfortunately, no synthesized evidence dealt this topic. METHODS: This study systematically identified target trials from six important databases and only included randomized controlled trial for synthesis. Two investigators assessed quality of eligible trials using the Cochrane Risk of Bias Tool, and they independently extracted data. Network meta-analysis performed Peto odds ratio (POR, used for dealing with zero cell) or weighted mean difference (WMD, for continuous data) with 95% confidence intervals (CI) and consistency H. RESULTS: Sixteen trials recruiting 2754 women with postmenopausal osteoporosis were included in our study. Elcatonin therapies and non-elcatonin medications had comparable fracture rates and bone mineral density change. Yet, C-E (WMD, - 18.93; 95% CI, - 23.97 to - 13.89) and M-E (WMD, - 13.72; 95% CI, - 19.51 to - 7.94) had significantly lower pain score than non-elcatonin medications. However, M-E (POR = 8.413, 95% CI, 2.031 to 34.859) and non-elcatonin medication (Peto OR, 7.450; 95% CI, 1.479 to 37.530) had significantly higher complication rates than placebo. No evidence detected inconsistency and small study effect in this network model. CONCLUSIONS: Based on current evidence, C-E may be considered for treating postmenopausal osteoporosis because it benefits on pain relief and complications. Moreover, it shows comparable fracture rate and bone mineral density change as compared with anti-osteoporosis and calcium supplements. Nevertheless, further trials are needed to investigate formula and dosages of elcatonin.


Assuntos
Conservadores da Densidade Óssea/uso terapêutico , Calcitonina/análogos & derivados , Hormônios e Agentes Reguladores de Cálcio/uso terapêutico , Osteoporose Pós-Menopausa/tratamento farmacológico , Densidade Óssea/efeitos dos fármacos , Conservadores da Densidade Óssea/efeitos adversos , Calcitonina/efeitos adversos , Calcitonina/uso terapêutico , Hormônios e Agentes Reguladores de Cálcio/efeitos adversos , Quimioterapia Combinada , Feminino , Humanos , Osteoporose Pós-Menopausa/complicações , Osteoporose Pós-Menopausa/fisiopatologia , Fraturas por Osteoporose/prevenção & controle , Dor/etiologia , Dor/prevenção & controle , Medição da Dor , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/normas
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