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1.
Medicine (Baltimore) ; 99(7): e19136, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-32049833

RESUMO

BACKGROUND: Virtual reality (VR)-based rehabilitation is a promising approach for improving recovery in many conditions to optimize functional results, enhancing the clinical and social benefits of surgery. OBJECTIVE: To assess the efficacy of an early rehabilitation performed by the VR-based rehabilitation versus the traditional rehabilitation provided by physical therapists after primary total knee arthroplasty (TKA). METHODS: In this randomized controlled clinical trial, 85 subjects met the inclusion criteria and were randomized 3 to 4 days after TKA to an inpatient VR-based rehabilitation and a traditional rehabilitation. Participants in both groups received 60 minutes/day sessions until discharge (around 10 days after surgery). The primary outcome was the pain intensity. The secondary outcomes were: the disability knee, the health related quality of life, the global perceived effect, the functional independent measure, the drugs assumption, the isometric strength of quadriceps and hamstrings, the flexion range of motion, and the ability to perform proprioception exercises. Outcomes were assessed at baseline (3-4 days after TKA) and at discharge. RESULTS: VR-based or traditional rehabilitation, with 13% of dropout rate, shown no statistically significant pain reduction between groups (P = .2660) as well as in all other outcomes, whereas a statistically significant improvement was present in the global proprioception (P = .0020), in favor of the VR-based rehabilitation group. CONCLUSIONS: VR-based rehabilitation is not superior to traditional rehabilitation in terms of pain relief, drugs assumptions and other functional outcomes but seems to improve the global proprioception for patients received TKA. LEVEL OF EVIDENCE: Therapy, level 1b. CONSORT-compliant. TRIAL REGISTRATION: http://www.clinicaltrials.gov, ClinicalTrials.gov, NCT02413996.

2.
Medicine (Baltimore) ; 98(39): e17105, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31574809

RESUMO

We aimed to determine the accuracy and failure of OAK device, an automated screening, for the assessment of fall risk in a prospective cohort of healthy adults aged over 65 years. The algorithm for fall risk assessment of the centers for disease control and prevention (CDC) was used as reference standard. Of the 183 individuals recruited, the CDC algorithm classified 80 as being at moderate/high risk and 103 at low risk of falling. OAK device failure incidence was 4.9% (confidence interval [CI] upper limit 7.7%), below the preset threshold for futility-early termination of the study (i.e., not above 15%). The OAK device showed a sensitivity of 84% and a specificity of 67% (receiver operating characteristic [ROC] area 82%; 95% confidence interval [CI] 76-88%), not reaching the preplanned target sensitivity (not lower than 85%). Diagnostic accuracy was not far from the sensitivity levels similar to those obtained with other fall risk assessment. However, some limitations can be considered.ClinicalTrials.gov identifier: NCT02655796.


Assuntos
Acidentes por Quedas , Teste de Esforço/métodos , Programas de Rastreamento/métodos , Medição de Risco/métodos , Idoso , Desenho de Equipamento , Falha de Equipamento , Teste de Esforço/instrumentação , Feminino , Humanos , Masculino , Programas de Rastreamento/instrumentação , Estudos Prospectivos , Curva ROC , Sensibilidade e Especificidade
3.
Medicine (Baltimore) ; 98(33): e16762, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31415375

RESUMO

BACKGROUND: Neck Pain (NP) has been ranked as one of the top chronic pain conditions in terms of prevalence and years lived with disability in the latest Global Burden of Disease. NP has remarkable socio-economic consequences however, research efforts are limited. Discrepancies among guidelines recommendations on management of chronic neck pain exist. The purpose of this study protocol is to provide the methods for a review with network meta-analysis to identify the most effective interventions for chronic neck pain. METHODS: The following databases will be searched from their inception to February 2019: Cochrane Controlled Trials Register (CENTRAL), PubMed, CINAHL, Scopus, ISI Web of Science and PEDro.Randomized controlled trials (RCTs) on pharmacological and not pharmacological interventions will be included and their risk of bias will be evaluated using the Cochrane Risk of bias tool. Primary outcomes will be reduction in pain and disability. A network meta-analysis will be carried out and pairwise meta-analysis will be conducted using Stata 15 software. Grading of recommendations assessment, development, and evaluation (GRADE) will be applied to assess quality of the body of the evidence. RESULTS: The results of this review will be submitted to a peer-review journal for publication. CONCLUSION: This network meta-analysis will provide a comprehensive review on the most effective treatments for the management of chronic neck pain providing key evidence-based information to patients, clinicians and other relevant stakeholders. Registration: PROSPERO (registration number CRD42019124501).


Assuntos
Dor Crônica/terapia , Cervicalgia/terapia , Dor Crônica/economia , Humanos , Cervicalgia/economia , Meta-Análise em Rede , Manejo da Dor
4.
Syst Rev ; 8(1): 196, 2019 08 08.
Artigo em Inglês | MEDLINE | ID: mdl-31395091

RESUMO

BACKGROUND: Non-specific low back pain (LBP) is the leading cause of disability worldwide. Acute LBP usually has a good prognosis, with rapid improvement within the first 6 weeks. However, the majority of patients develop chronic LBP and suffer from recurrences. For clinical management, a plethora of treatments is currently available but evidence of the most effective options is lacking. The objective of this study will be to identify the most effective interventions to relieve pain and reduce disability in acute and sub-acute non-specific LBP. METHODS/DESIGN: We will search electronic databases (MEDLINE, Embase, CENTRAL) from inception onwards. The eligible population will be individuals with non-specific LBP older than 18 years, both males and females, who experience pain less than 6 weeks (acute) or between 6 and 12 weeks (subacute). Eligible interventions and comparators will include all conservative rehabilitation or pharmacological treatments provided by any health professional; the only eligible study design will be a randomized controlled trial. The primary outcomes will be pain intensity and back-specific functional status. Secondary outcomes will be any adverse events. Studies published in languages other than English will also potentially be included. Two reviewers will independently screen the titles and abstracts retrieved from a literature search, as well as potentially relevant full-text articles. General characteristics, potential effect modifiers, and outcome data will be extracted from the included studies, and the risk of bias will be appraised. Conflicts at all levels of screening and abstraction will be resolved through team discussions. After describing the results of the review, if appropriate, a random effects meta-analysis and network meta-analysis will be conducted in a frequentist setting, assuming equal heterogeneity across all treatment comparisons and accounting for correlations induced by multi-arm studies using a multivariate normal model. DISCUSSION: Our systematic review will address the uncertainties in the use of pharmacological or non-pharmacological treatments, and their relative efficacy, for acute and subacute LBP. These findings will be useful for patients, healthcare providers, and policymakers. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42018102527.

5.
Health Qual Life Outcomes ; 17(1): 127, 2019 Jul 22.
Artigo em Inglês | MEDLINE | ID: mdl-31331343

RESUMO

BACKGROUND: An observed statistically significant difference between two interventions does not necessarily imply that this difference is clinically important for patients and clinicians. We aimed to assess if treatment effects of randomized controlled trials (RCTs) for low back pain (LBP) are statistically significant and clinically relevant, and if RCTs were powered to achieve clinically relevant differences on continuous outcomes. METHODS: We searched for all RCTs included in Cochrane Systematic Reviews focusing on the efficacy of rehabilitation interventions for LBP and published until April 2017. RCTs having sample size calculation and a planned minimal important difference were considered. In the primary analysis, we calculated the proportion of RCTs classified as "statistically significant and clinically relevant", "statistically significant but not clinically relevant", "not statistically significant but clinically relevant", and "not statistically significant and not clinically relevant". Then, we investigated how many times the mismatch between statistical significance and clinical relevance was due to inadequate power. RESULTS: From 20 eligible SRs including 101 RCTs, we identified 42 RCTs encompassing 81 intervention comparisons. Overall, 60% (25 RCTs) were statistically significant while only 36% (15 RCTs) were both statistically and clinically significant. Most trials (38%) did not discuss the clinical relevance of treatment effects when results did not reached statistical significance. Among trials with non-statistically significant findings, 60% did not reach the planned sample size, therefore being at risk to not detect an effect that is actually there (type II error). CONCLUSION: Only a minority of positive RCT findings was both statistically significant and clinically relevant. Scarce diligence or frank omissions of important tactic elements of RCTs, such as clinical relevance, and power, decrease the reliability of study findings to current practice.


Assuntos
Dor Lombar/reabilitação , Ensaios Clínicos Controlados Aleatórios como Assunto , Humanos , Qualidade de Vida , Reprodutibilidade dos Testes
6.
J Clin Epidemiol ; 112: 28-35, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30981833

RESUMO

OBJECTIVE: To assess the inter-rater reliability (IRR) and usability of the risk of bias in nonrandomized studies of interventions tool (ROBINS-I). STUDY DESIGN AND SETTING: We designed a cross-sectional study. Five raters independently applied ROBINS-I to the nonrandomized cohort studies in three systematic reviews on vaccines, opiate abuse, and rehabilitation. We calculated Fleiss' Kappa for multiple raters as a measure of IRR and discussed the application of ROBINS-I to identify difficulties and possible reasons for disagreement. RESULTS: Thirty one studies were included (195 evaluations). IRRs were slight for overall judgment (IRR 0.06, 95% CI 0.001 to 0.12) and individual domains (from 0.04, 95% CI -0.04 to 0.12 for the domain "selection of reported results" to 0.18, 95% CI 0.10 to 0.26 for the domain "deviation from intended interventions"). Mean time to apply the tool was 27.8 minutes (SD 12.6) per study. The main difficulties were due to poor reporting of primary studies, misunderstanding of the question, translation of questions into a final judgment, and incomplete guidance. CONCLUSION: We found ROBINS-I difficult and demanding, even for raters with substantial expertise in systematic reviews. Calibration exercises and intensive training before its application are needed to improve reliability.

7.
Syst Rev ; 7(1): 110, 2018 07 28.
Artigo em Inglês | MEDLINE | ID: mdl-30055658

RESUMO

BACKGROUND: The evaluation of imprecision is a key dimension of the grading of the confidence in the estimate. Grading of Recommendations Assessment, Development and Evaluation (GRADE) gives recommendations on how to downgrade evidence for imprecision, but authors vary in their use. Trial Sequential Analysis (TSA) has been advocated for a more reliable assessment of imprecision. We aimed to evaluate reporting of and adherence to GRADE and to compare the assessment of imprecision of intervention effects assessed by GRADE and TSA in Cochrane systematic reviews. METHODS: In this cross-sectional study, we included 100 Cochrane reviews irrespective of type of intervention with a key dichotomous outcome meta-analyzed and assessed by GRADE. The methods and results sections of each review were assessed for adequacy of imprecision evaluation. We re-analyzed imprecision following the GRADE Handbook and the TSA Manual. RESULTS: Overall, only 13.0% of reviews stated the criteria they applied to assess imprecision. The most common dimensions were the 95% width of the confidence intervals and the optimal information size. Review authors downgraded 48.0% of key outcomes due to imprecision. When imprecision was re-analyzed following the GRADE Handbook, 64% of outcomes were downgraded. Agreement between review authors' assessment and assessment by the authors of this study was moderate (kappa 0.43, 95% confidence interval [CI] 0.23 to 0.58). TSA downgraded 69.0% outcomes due to imprecision. Agreement between review authors' GRADE assessment and TSA, irrespective of downgrading levels, was moderate (kappa 0.43, 95% CI 0.21 to 0.57). Agreement between our GRADE assessment following the Handbook and TSA was substantial (kappa 0.66, 95% CI 0.49 to 0.79). CONCLUSIONS: In a sample of Cochrane reviews, methods for assessing imprecision were rarely reported. GRADE according to Handbook guidelines and TSA led to more severe judgment of imprecision rather than GRADE adopted by reviews' authors. Cochrane initiatives to improve adherence to GRADE Handbook are warranted. TSA may transparently assist in such development.


Assuntos
Epidemiologia/normas , Metanálise como Assunto , Literatura de Revisão como Assunto , Viés de Seleção , Estudos Transversais , Humanos
8.
Health Qual Life Outcomes ; 16(1): 91, 2018 May 15.
Artigo em Inglês | MEDLINE | ID: mdl-29764423

RESUMO

BACKGROUND: The results of meta-analyses are all too often elusive, making it difficult to interpret their relevance for clinical practice. Reporting them in minimal important difference (MID) units could improve the interpretation of evidence in meta-analyses. The aim of this study was to compare, via calculation of MID units, outcomes after multidisciplinary biopsychosocial rehabilitation (MBR) versus usual care for pain relief in chronic low back pain (LBP). METHODS: We re-analyzed the data of a published Cochrane review on MBR. To attribute a MID to each pain instrument, we first searched the literature for MIDs. The MID was imputed for instruments without an established MID. We compared outcomes after MBR versus usual care for chronic LBP in the short (< 3 months), mid (> 3 and < 12 months), and long (≥12 months) term. The results of the meta-analyses are reported in MID units and interpreted as follows: if the overall effect size was greater than 1, many patients gained clinically important benefits, if it lay between 0.5 and 1.0, an appreciable number benefited, and if it fell below 0.5 few did. RESULTS: Improvement in back pain was observed in an appreciable number of patients in the short- and medium-term after MBR: the MID was lower but still close to 1 (0.75 and 0.86 MID units, respectively). MBR probably had little or no benefit for the majority of patients in the long-term, where the MID approached 0 (0.27 MID units, confidence interval 0.07-0.48). CONCLUSIONS: Meta-analyses expressed in MID units may offer better insight into the clinical relevance of MBR: the intervention is highly recommended for reducing pain in the short- and medium-term but cannot be recommended for long-term pain reduction since the benefit decays rapidly.


Assuntos
Dor Crônica/reabilitação , Dor Lombar/reabilitação , Dor Crônica/psicologia , Humanos , Dor Lombar/psicologia , Masculino , Qualidade de Vida , Fatores de Tempo
9.
BMC Health Serv Res ; 17(1): 656, 2017 Sep 15.
Artigo em Inglês | MEDLINE | ID: mdl-28915808

RESUMO

BACKGROUND: Although several risk assessment tools are in use, uncertainties on their accuracy in detecting fall risk already exist. Choosing the most accurate tool for hospital inpatient is still a challenge for the organizations. We aimed to retrospectively assess the appropriateness of a fall risk prevention program with the STRATIFY assessment tool in detecting acute-care inpatient fall risk. METHODS: Number of falls and near falls, occurred from January 2014 to March 2015, was collected through the incident reporting web-system implemented in the hospital's intranet. We reported whether the fall risk was assessed with the STRATIFY assessment tool and, if so, which was the judgement. Primary outcome was the proportion of inpatients identified as high risk of fall among inpatients who fell (True Positive Rate), and the proportion of inpatients identified as low-risk that experienced a fall howsoever (False Negative Rate). Characteristics of population and fall events were described among subgroups of low risk and high risk inpatients. RESULTS: We collected 365 incident reports from 40 hospital units, 349 (95.6%) were real falls and 16 (4.4%) were near falls. The fall risk assessment score at patient's admission had been reported in 289 (79%) of the overall incident reports. Thus, 74 (20.3%) fallers were actually not assessed with the STRATIFY, even though the majority of them presented risk recommended to be assessed. The True Positive Rate was 35.6% (n = 101, 95% CI 30% - 41.1%). The False Negative Rate was 64.4% (n = 183, 95% CI 58.9%-70%) of fallers, nevertheless they incurred in a fall. The STRATIFY mean score was 1.3 ± 1.4; the median was 1 (IQQ 0-2). CONCLUSIONS: The prevention program using only the STRATIFY tool was found to be not adequate to screen our inpatients population. The incorrect identification of patients' needs leads to allocate resources to erroneous priorities and to untargeted interventions, decreasing healthcare performance and quality.


Assuntos
Acidentes por Quedas/prevenção & controle , Gestão de Riscos/métodos , Acidentes por Quedas/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Feminino , Hospitalização/estatística & dados numéricos , Hospitais/estatística & dados numéricos , Humanos , Pacientes Internados/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Avaliação de Programas e Projetos de Saúde , Estudos Retrospectivos , Medição de Risco/métodos , Fatores de Risco
10.
BMC Musculoskelet Disord ; 18(1): 299, 2017 Jul 14.
Artigo em Inglês | MEDLINE | ID: mdl-28709418

RESUMO

BACKGROUND: Single-leg squat (SLS) is a functional test visually rated by clinicians for assessing lower limb function as a preventive injury strategy. SLS clinical rating is a qualitative evaluation and it does not count objective outcomes as kinematics data and surface electromyography (sEMG) assessment. Based on the SLS rating, the aims of this study were (i) to determine the clinical rating agreement among six raters and (ii) to assess kinematic and sEMG predictors of good SLS performance in physically and non-physically active individuals. METHODS: Seventy-two healthy adults, divided in physically active and non-physically active groups, performed three SLSs on their dominant leg. Clinical ratings, kinematic data and sEMG were acquired. By using a validated clinical scale, six expert clinicians rated each SLS watching a video at three different time points. Intra and inter-rater agreement of clinical ratings were undertaken and a binary logistic regression analysis was used to determine kinematic and sEMG as predictors of SLS performance. RESULTS: The weighted kappa coefficient for intra-rater reliability within each rater ranged between moderate and almost perfect agreement (0.55-0.85) whereas the weighted kappa coefficient for inter-rater reliability among raters was fair (0.34, time point 0; 0.31, time point 1; 0.30, time point 2). SLS analyses of physically active compared to non-physically active group showed a statistically significant difference in knee flexion and hip flexion (p = 0.041 and p = 0.023 respectively) and no difference in clinical ratings (p = 0.081). Greater knee flexion can predict the good SLS performance taking into account the belonging group (p = 0.019). CONCLUSIONS: Physically active individuals seemed to be at less risk to perform a non-good SLS and they had greater knee and hip flexions kinematics than non-physically active individuals. Knee flexion can predict the SLS performance quality therefore a greater knee flexion might also be considered a protective element from injuries. TRIAL REGISTRATION: ClinicalTrials.gov identifier (trial has been registred retrospectively: NCT03203083. Date registration: June 21, 2017.


Assuntos
Exercício/fisiologia , Extremidade Inferior/fisiologia , Músculo Esquelético/fisiologia , Amplitude de Movimento Articular/fisiologia , Comportamento Sedentário , Adolescente , Adulto , Estudos de Coortes , Estudos Transversais , Feminino , Humanos , Masculino , Adulto Jovem
11.
Musculoskelet Sci Pract ; 30: 1-9, 2017 08.
Artigo em Inglês | MEDLINE | ID: mdl-28448859

RESUMO

BACKGROUND: The methodological quality of controlled clinical trials (CCTs) of physiotherapeutic treatment modalities for myofascial trigger points (MTrP) has not been investigated yet. OBJECTIVES: To detect the methodological quality of CCTs for physiotherapy treatments of MTrPs and demonstrating the possible increase over time. DESIGN: Systematic review. METHODS: A systematic search was conducted in two databases, Physiotherapy Evidence Database (PEDro) and Medicine Medical Literature Analysis and Retrieval System online (MEDLINE), using the same keywords and selection procedure corresponding to pre-defined inclusion criteria. The methodological quality, assessed by the 11-item PEDro scale, served as outcome measure. The CCTs had to compare at least two interventions, where one intervention had to lay within the scope of physiotherapy. Participants had to be diagnosed with myofascial pain syndrome or trigger points (active or latent). RESULTS: A total of n = 230 studies was analysed. The cervico-thoracic region was the most frequently treated body part (n = 143). Electrophysical agent applications was the most frequent intervention. The average methodological quality reached 5.5 on the PEDro scale. A total of n = 6 studies scored the value of 9. The average PEDro score increased by 0.7 points per decade between 1978 and 2015. CONCLUSIONS: The average PEDro score of CCTs for MTrP treatments does not reach the cut-off of 6 proposed for moderate to high methodological quality. Nevertheless, a promising trend towards an increase of the average methodological quality of CCTs for MTrPs was recorded. More high-quality CCT studies with thorough research procedures are recommended to enhance methodological quality.


Assuntos
Ensaios Clínicos como Assunto/normas , Fenômenos Eletrofisiológicos/fisiologia , Síndromes da Dor Miofascial/diagnóstico , Síndromes da Dor Miofascial/terapia , Modalidades de Fisioterapia/tendências , Pontos-Gatilho/fisiologia , Previsões , Humanos
12.
Physiother Can ; 68(3): 267-274, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27909376

RESUMO

Purpose: To assess reporting completeness of the most frequent outcome measures used in randomized controlled trials (RCTs) of rehabilitation interventions for mechanical low back pain. Methods: We performed a cross-sectional study of RCTs included in all Cochrane systematic reviews (SRs) published up to May 2013. Two authors independently evaluated the type and frequency of each outcome measure reported, the methods used to measure outcomes, the completeness of outcome reporting using a eight-item checklist, and the proportion of outcomes fully replicable by an independent assessor. Results: Our literature search identified 11 SRs, including 185 RCTs. Thirty-six different outcomes were investigated across all RCTs. The 2 most commonly reported outcomes were pain (n=165 RCTs; 89.2%) and disability (n=118 RCTs; 63.8%), which were assessed by 66 and 44 measurement tools, respectively. Pain and disability outcomes were found replicable in only 10.3% (n=17) and 10.2% (n=12) of the RCTs, respectively. Only 40 RCTs (21.6%) distinguished between primary and secondary outcomes. Conclusions: A large number of outcome measures and a myriad of measurement instruments were used across all RCTs. The reporting was largely incomplete, suggesting an opportunity for a standardized approach to reporting in rehabilitation science.

13.
Physiother Can ; 68(1): 61-3, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27504049

RESUMO

PURPOSE: To evaluate the number of published randomized controlled trials (RCTs) focusing on mechanical low back pain (MLBP) rehabilitation, the secular (i.e., long-term) trend, and the distribution of interventions studied. METHODS: All included RCTs were extracted from all Cochrane systematic reviews focusing on rehabilitation therapies for MLBP, and two independent reviewers screened and analyzed the information on interventions. RESULTS: After removal of duplicates, the data set consisted of 196 RCTs published between 1961 and 2010. The number of RCTs published increased consistently over time: 2 trials (1% of the total) were published in 1961-1970, 10 (5%) in 1971-1980, 41 (21%) in 1981-1990, 68 (35%) in 1991-2000, and 75 (38%) in 2001-2010. The intervention of interest in the majority of RCTs was exercise therapy (115/399; 29%), followed by spinal manipulation therapies (60/399; 15%). CONCLUSION: The number of RCTs focusing on MLBP has risen over time; of all interventions studied, exercise therapy has attracted the most research interest.

14.
Spine (Phila Pa 1976) ; 41(5): 412-8, 2016 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-26926164

RESUMO

STUDY DESIGN: Methodological review of randomized controlled trials (RCTs). OBJECTIVE: To assess the quality of reporting of rehabilitation interventions for mechanical low back pain (LBP) in published RCTs. SUMMARY OF BACKGROUND DATA: Reporting of interventions in RCTs often focused on the outcome value and failed to describe interventions adequately. METHODS: We systematically searched for all RCTs in Cochrane systematic reviews on LBP published in the Cochrane Database of Systematic Reviews until December 2013. The description of rehabilitation interventions of each RCT was evaluated independently by 2 of the investigators, using an ad hoc checklist of 7 items. The primary outcome was the number of items reported in sufficient details to be replicable in a new RCT or in everyday practice. RESULTS: We found 11 systematic reviews, including 220 eligible RCTs, on LBP. Of those, 185 RCTs were included. The median publication year was 1998 (I-III quartiles, 1990 to 2004). The most reported items were the characteristics of participants (91.3%; 95% confidence interval [CI], 87.3-95.4), the intervention providers (81.1%; 95% CI, 75.4-86.7), and the intervention schedule (69.7%; 95% CI, 63-76). Based on the description of the intervention, less than one fifth would be replicable clinically. The proportion of trials providing all essential information about the participants and interventions increased from 14% (n = 7) in 1971 to 1980 to 20% (n = 75) in 2001 to 2010. CONCLUSION: Despite the remarkable amount of energy spent producing RCTs in LBP rehabilitation, the majority of RCTs failed to report sufficient information that would allow the intervention to be replicated in clinical practice. Improving the quality of intervention description is urgently needed to better transfer research into rehabilitation practices. LEVEL OF EVIDENCE: 1.


Assuntos
Dor Lombar/diagnóstico , Dor Lombar/reabilitação , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Relatório de Pesquisa , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Reprodutibilidade dos Testes , Resultado do Tratamento
15.
Arch Phys Med Rehabil ; 97(7): 1195-201, 2016 07.
Artigo em Inglês | MEDLINE | ID: mdl-26971671

RESUMO

OBJECTIVE: To systematically assess the reporting of sample size calculation in randomized controlled trials (RCTs) on rehabilitation interventions for mechanical low back pain. DATA SOURCES: The Cochrane Database of Systematic Reviews was searched through February 2015. STUDY SELECTION: We conducted an electronic database search for RCTs published from January 1, 1968 to February 28, 2015 and included in the Cochrane Systematic Reviews. DATA EXTRACTION: Two investigators independently used an ad hoc 6-item checklist derived from the Consolidated Standards of Reporting Trials (CONSORT) 2010 statement recommendations to extract data on sample size calculation. The primary outcome was the proportion of RCTs that reported sample size calculation; the secondary outcome was the completeness of sample size analysis reporting. We also evaluated improvement in reporting of sample size calculation over time. DATA SYNTHESIS: Sample size calculation was reported in 80 (36.0%) of the 222 eligible RCTs included in 14 Cochrane Systematic Reviews. Only 13 (16.3%) of these RCT reports gave a complete description, and about half reported ≥4 of the 6 elements of sample size calculation (median, 4; interquartile range, 3-5). Completeness of reporting of sample size calculation improved from 1968 to 2013; since 2005, the number of RCTs reporting sample size calculation has increased compared with the number of RCTs not reporting it. CONCLUSIONS: Despite improvement, reporting of sample size calculation and power analysis remains inadequate, limiting the reader's ability to assess the quality and accuracy of rehabilitation studies.


Assuntos
Dor Lombar/reabilitação , Modalidades de Fisioterapia , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Tamanho da Amostra , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Projetos de Pesquisa
16.
Cochrane Database Syst Rev ; (10): CD004433, 2015 Oct 08.
Artigo em Inglês | MEDLINE | ID: mdl-26446577

RESUMO

BACKGROUND: In people who have had a stroke, upper limb paresis affects many activities of daily life. Reducing disability is therefore a major aim of rehabilitative interventions. Despite preserving or recovering movement ability after stroke, sometimes people do not fully realise this ability in their everyday activities. Constraint-induced movement therapy (CIMT) is an approach to stroke rehabilitation that involves the forced use and massed practice of the affected arm by restraining the unaffected arm. This has been proposed as a useful tool for recovering abilities in everyday activities. OBJECTIVES: To assess the efficacy of CIMT, modified CIMT (mCIMT), or forced use (FU) for arm management in people with hemiparesis after stroke. SEARCH METHODS: We searched the Cochrane Stroke Group trials register (last searched June 2015), the Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library Issue 1, 2015), MEDLINE (1966 to January 2015), EMBASE (1980 to January 2015), CINAHL (1982 to January 2015), and the Physiotherapy Evidence Database (PEDro; January 2015). SELECTION CRITERIA: Randomised control trials (RCTs) and quasi-RCTs comparing CIMT, mCIMT or FU with other rehabilitative techniques, or none. DATA COLLECTION AND ANALYSIS: One author identified trials from the results of the electronic searches according to the inclusion and exclusion criteria, three review authors independently assessed methodological quality and risk of bias, and extracted data. The primary outcome was disability. MAIN RESULTS: We included 42 studies involving 1453 participants. The trials included participants who had some residual motor power of the paretic arm, the potential for further motor recovery and with limited pain or spasticity, but tended to use the limb little, if at all. The majority of studies were underpowered (median number of included participants was 29) and we cannot rule out small-trial bias. Eleven trials (344 participants) assessed disability immediately after the intervention, indicating a non-significant standard mean difference (SMD) 0.24 (95% confidence interval (CI) -0.05 to 0.52) favouring CIMT compared with conventional treatment. For the most frequently reported outcome, arm motor function (28 studies involving 858 participants), the SMD was 0.34 (95% CI 0.12 to 0.55) showing a significant effect (P value 0.004) in favour of CIMT. Three studies involving 125 participants explored disability after a few months of follow-up and found no significant difference, SMD -0.20 (95% CI -0.57 to 0.16) in favour of conventional treatment. AUTHORS' CONCLUSIONS: CIMT is a multi-faceted intervention where restriction of the less affected limb is accompanied by increased exercise tailored to the person's capacity. We found that CIMT was associated with limited improvements in motor impairment and motor function, but that these benefits did not convincingly reduce disability. This differs from the result of our previous meta-analysis where there was a suggestion that CIMT might be superior to traditional rehabilitation. Information about the long-term effects of CIMT is scarce. Further trials studying the relationship between participant characteristics and improved outcomes are required.


Assuntos
Técnicas de Exercício e de Movimento/métodos , Imobilização/métodos , Paresia/reabilitação , Reabilitação do Acidente Vascular Cerebral , Extremidade Superior , Humanos , Paresia/etiologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Acidente Vascular Cerebral/complicações , Fatores de Tempo
17.
Trials ; 15: 512, 2014 Dec 26.
Artigo em Inglês | MEDLINE | ID: mdl-25542215

RESUMO

BACKGROUND: Trial sequential analysis (TSA) may establish when firm evidence about the efficacy of interventions is reached in a cumulative meta-analysis, combining a required information size with adjusted thresholds for conservative statistical significance. Our aim was to demonstrate TSA results on randomized controlled trials (RCTs) included in a Cochrane systematic review on the effectiveness of constraint-induced movement therapy (CIMT) for stroke patients. METHODS: We extracted data on the functional independence measure (FIM) and the action research arm test (ARAT) from RCTs that compared CIMT versus other rehabilitative techniques. Mean differences (MD) were analyzed using a random-effects model. We calculated the information size and the cumulative Z-statistic, applying the O'Brien-Fleming monitoring boundaries. RESULTS: We included data from 14 RCTs. In the conventional meta-analysis (seven trials, 233 patients), the effect of CIMT on FIM was reported as significant (MD 2.88, 95% CI 0.08 to 5.68; P = 0.04). The diversity-adjusted required information size was 142 patients, and the cumulative Z-score did not cross the trial sequential monitoring boundary for benefit (adjusted 95% CI -0.02 to 5.78). The effect of CIMT on ARAT (nine trials, 199 patients) was reported as significant (MD 7.78, 95% CI 1.19 to 14.37; P = 0.02). However, the diversity-adjusted required information size was 252 patients, and the Z-score did not cross the trial sequential monitoring boundary for benefit (adjusted 95% CI -0.06 to 15.62). CONCLUSIONS: Although conventional meta-analyses of CIMT reached statistical significance, their overall results remain inconclusive and might be spurious. Researchers should not be overconfident on CIMT efficacy based on the results of meta-analyses and derived recommendations.


Assuntos
Medicina Baseada em Evidências , Terapia por Exercício/métodos , Reabilitação do Acidente Vascular Cerebral , Distribuição de Qui-Quadrado , Interpretação Estatística de Dados , Avaliação da Deficiência , Medicina Baseada em Evidências/estatística & dados numéricos , Terapia por Exercício/estatística & dados numéricos , Humanos , Atividade Motora , Valor Preditivo dos Testes , Ensaios Clínicos Controlados Aleatórios como Assunto , Recuperação de Função Fisiológica , Reprodutibilidade dos Testes , Projetos de Pesquisa , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/fisiopatologia , Fatores de Tempo , Resultado do Tratamento
18.
Phys Ther ; 93(11): 1456-66, 2013 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-23744458

RESUMO

BACKGROUND: Systematic reviews (SRs) have become increasingly important for informing clinical practice; however, little is known about the reporting characteristics and the quality of the SRs relevant to the practice of rehabilitation health professionals. OBJECTIVE: The purpose of this study was to examine the reporting quality of a representative sample of published SRs on rehabilitation, focusing on the descriptive, reporting, and bias-related characteristics. METHODS: A cross-sectional study was conducted by searching MEDLINE for aggregative and configurative SRs indexed in 2011 that focused on rehabilitation as restorative of functional limitations. Two reviewers independently screened and selected the SRs and extracted data using a 38-item data collection form derived from Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). The data were analyzed descriptively. RESULTS: Eighty-eight SRs published in 59 journals were sampled. The median compliance with the PRISMA items was 17 (63%) out of 27 items (interquartile ratio=13-22 [48%-82%]). Two thirds of the SRs (n=66) focused on interventions for which efficacy is best addressed through a randomized controlled trial (RCT) design, and almost all of these SRs included RCTs (63/66 [95%]). More than two thirds of the SRs assessed the quality of primary studies (74/88 [84%]). Twenty-eight reviews (28/88 [32%]) meta-analyzed the results for at least one outcome. One half of the SRs reported positive statistically significant findings (46%), whereas a detrimental result was present only in one review. CONCLUSIONS: This sample of SRs in the rehabilitation field showed heterogeneous characteristics and a moderate quality of reporting. Poor control of potential source of bias might be improved if more widely agreed-upon evidence-based reporting guidelines will be actively endorsed and adhered to by authors and journals.


Assuntos
Fidelidade a Diretrizes , Reabilitação , Projetos de Pesquisa/normas , Literatura de Revisão como Assunto , Estudos Transversais , Apoio Financeiro , Guias como Assunto , Humanos , Editoração/normas
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