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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.
Front Neurol ; 9: 254, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29740386

RESUMO

Background: A variety of interventions has been proposed for symptomatology relief in primary headaches. Among these, manual trigger points (TrPs) treatment gains popularity, but its effects have not been investigated yet. Objective: The aim was to establish the effectiveness of manual TrP compared to minimal active or no active interventions in terms of frequency, intensity, and duration of attacks in adult people with primary headaches. Methods: We searched MEDLINE, COCHRANE, Web Of Science, and PEDro databases up to November 2017 for randomized controlled trials (RCTs). Two independent reviewers appraised the risk-of-bias (RoB) and the grading of recommendations, assessment, development, and evaluation (GRADE) to evaluate the overall quality of evidence. Results: Seven RCTs that compared manual treatment vs minimal active intervention were included: 5 focused on tension-type headache (TTH) and 2 on Migraine (MH); 3 out of 7 RCTs had high RoB. Combined TTH and MH results show statistically significant reduction for all outcomes after treatment compared to controls, but the level of evidence was very low. Subgroup analysis showed a statistically significant reduction in attack frequency (no. of attacks per month) after treatment in TTH (MD -3.50; 95% CI from -4.91 to -2.09; 4 RCTs) and in MH (MD -1.92; 95% CI from -3.03 to -0.80; 2 RCTs). Pain intensity (0-100 scale) was reduced in TTH (MD -12.83; 95% CI from -19.49 to -6.17; 4 RCTs) and in MH (MD -13.60; 95% CI from -19.54 to -7.66; 2RCTs). Duration of attacks (hours) was reduced in TTH (MD -0.51; 95% CI from -0.97 to -0.04; 2 RCTs) and in MH (MD -10.68; 95% CI from -14.41 to -6.95; 1 RCT). Conclusion: Manual TrPs treatment of head and neck muscles may reduce frequency, intensity, and duration of attacks in TTH and MH, but the quality of evidence according to GRADE approach was very low for the presence of few studies, high RoB, and imprecision of results.

10.
J Phys Ther Sci ; 29(8): 1463-1471, 2017 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-28878484

RESUMO

[Purpose] To present legislation comparing direct and referred access-or other measures-to physical therapy. The focus is on the management of the most burdensome musculoskeletal disorders in terms of regulations, costs, effectiveness, safety and cost-effectiveness. [Methods] Main biomedical databases and gray literature were searched ranging from a global scenario to the analysis of targeted geographical areas and specifically Italy and the Region Piedmont. [Results] legislation on Direct Access highlights inconsistencies among the countries belonging to World Confederation for Physical Therapy. Direct Access could be an effective, safe and efficient organization model for the management of patients with musculoskeletal diseases and seems to be more effective safer and cost effective. [Conclusion] Direct Access is a virtuous model which can help improve the global quality of physical therapy services. Further studies are required to confirm this approach and determine whether the findings of the present overview can be replicated in different countries and healthcare systems.

11.
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
12.
J Clin Pathol ; 70(4): 282-294, 2017 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-28073996

RESUMO

BACKGROUND: False-positive histological diagnoses have the same consequences of overdiagnosis in terms of unnecessary treatment. The aim of this systematic review is to assess their frequency at needle core biopsy (CB) and/or surgical excision of the breast. METHODS: PubMed, Embase, Cochrane Library were systematically searched up to 30 October 2015. Eligibility criteria: cross-sectional studies assessing diagnostic accuracy of CB compared with surgical excision; studies assessing reproducibility of pathologists reading the same slides. OUTCOMES: false-positive rates; Misclassification of Benign as Malignant (MBM) histological diagnosis; K statistic. Independent reviewers extracted data and assessed quality using an adapted QUADAS-2 tool. RESULTS: Sixteen studies assessed CB false-positive rates. In 10 studies (41 989 screen-detected lesions), the range of false-positive rates was 0%-7.1%. Twenty-seven studies assessed pathologists' reproducibility. Studies with consecutive, random or stratified samples of all the specimens: at CB the MBM range was 0.25%-2.4% (K values 0.83-0.98); at surgical excision, it was 0.67%-1.2% (K values 0.86-0.94). Studies with enriched samples: the MBM range was 1.4%-6.2% (K values 0.57-0.86). Studies of cases selected for second opinion: the MBM range was 0.29%-12.2% (K values 0.48 and 0.50). CONCLUSIONS: High heterogeneity of the included studies precluded formal pooling estimates. When considering studies of higher sample size or methodological quality, false-positive rates and MBM are around 1%. The impact of false-positive histological diagnoses of breast cancer on unnecessary treatment, as well as that of overdiagnosis, is not negligible and is of importance in clinical practice.


Assuntos
Neoplasias da Mama/diagnóstico , Reações Falso-Positivas , Feminino , Humanos
13.
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.

14.
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.

15.
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
16.
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
17.
Int J Cancer ; 139(3): 554-73, 2016 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-27004723

RESUMO

The general aim of this systematic review is to mitigate breast cancer (BC) overdiagnosis and overtreatment. The specific aim is to summarize available data on the occurrence and features of indolent invasive or in situ (DCIS) BC, and precisely survival of untreated cases, prevalence of occult cancers found in autopsies, frequency of regressive BC. PubMed, Embase and Cochrane Library were systematically searched up to 3/31/2014. Eligibility criteria were: cohort studies, case-control studies, uncontrolled case series assessing survival in women with a diagnosis of BC who did not receive treatment compared to treated women; case series of autopsies estimating the prevalence of undiagnosed BC; cohort studies, case-control studies, uncontrolled case series, case reports assessing the occurrence of spontaneous regression of BC in women with a confirmed histology diagnosis. Untreated BC: 8 cohort studies and 12 case series (3593 BC) were included. In three controlled cohort studies (diagnoses 1978-2006), the 5-years overall survival was 19-43%. Occult BC: 8 case series (2279 autopsies) were included. The prevalence of invasive BC undiagnosed during lifetime range was 0-1.5%, while for DCIS the range was 0.2-14.7%. Spontaneous regression: 2 cohort studies, 3 case reports, 1 case series included. In the cohort studies the relative risk of regression for screen detected compared with nonscreened BC was estimated as 1.2 and 1.1. It seems plausible that around 10% of invasive BC are not symptomatic during life, and that one fith of BC patients if untreated would be alive after 5 years. Around 1 of 10 screen-detected BC may regress according two studies.


Assuntos
Neoplasias da Mama/epidemiologia , Neoplasias da Mama/patologia , Autopsia , Neoplasias da Mama/mortalidade , Neoplasias da Mama/terapia , Progressão da Doença , Feminino , Humanos , Regressão Neoplásica Espontânea , Estadiamento de Neoplasias , Avaliação de Resultados da Assistência ao Paciente , Prevalência , Análise de Sobrevida
18.
Spine (Phila Pa 1976) ; 40(19): 1495-504, 2015 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-26192729

RESUMO

STUDY DESIGN: Systematic review of randomized-controlled trials (RCTs). OBJECTIVE: To assess the effects of cognitive-behavioral therapy (CBT) on neck pain (NP). SUMMARY OF BACKGROUND DATA: Although research on nonpharmacological and nonsurgical treatments for NP is progressing, there remains uncertainty about the efficacy of CBT. METHODS: We searched electronic databases for RCTs. We included RCTs assessing the use of CBT on adults with subacute and chronic NP. 2 independent reviewers extracted data on pain (primary outcome), disability, psychological indicator, and quality of life. We calculated standardized mean differences and 95% confidence intervals. We used the Cochrane Collaboration's tool to assess risk of bias and the GRADE approach to evaluate the quality of evidence and summarize conclusions. RESULTS: We included 10 studies (836 participants), 4 at low risk of bias. With regard to chronic NP, there was low quality evidence that CBT was better than no treatment for improving pain, disability, and quality of life, whereas no effect was found on kinesiophobia. The clinical importance of these benefits is uncertain. When comparing both CBT to other interventions and CBT in addition to another intervention to the other intervention alone, no difference was found for pain and disability, whereas a positive effect was achieved for kinesiophobia only when comparing CBT with other interventions. On subacute NP, CBT was found to be better than other interventions for pain, whereas no difference was found for secondary outcomes. CONCLUSION: CBT was shown to induce changes on pain and disability for chronic NP only when compared with no treatment. On subacute NP, benefit was found on pain relief but not on disability when comparing CBT with other interventions. However, none of these effects were clinically meaningful. Due to the low quality of the evidence, our conclusions might change over time whereas new data are available. LEVEL OF EVIDENCE: 1.


Assuntos
Comportamento/fisiologia , Dor Crônica/terapia , Ensaios Clínicos como Assunto , Terapia Cognitivo-Comportamental , Cervicalgia/terapia , Qualidade de Vida , Humanos
19.
Cochrane Database Syst Rev ; (5): CD010664, 2015 May 26.
Artigo em Inglês | MEDLINE | ID: mdl-26006174

RESUMO

BACKGROUND: Although research on non-surgical treatments for neck pain (NP) is progressing, there remains uncertainty about the efficacy of cognitive-behavioural therapy (CBT) for this population. Addressing cognitive and behavioural factors might reduce the clinical burden and the costs of NP in society. OBJECTIVES: To assess the effects of CBT among individuals with subacute and chronic NP. Specifically, the following comparisons were investigated: (1) cognitive-behavioural therapy versus placebo, no treatment, or waiting list controls; (2) cognitive-behavioural therapy versus other types of interventions; (3) cognitive-behavioural therapy in addition to another intervention (e.g. physiotherapy) versus the other intervention alone. SEARCH METHODS: We searched CENTRAL, MEDLINE, EMBASE, CINAHL, PsycINFO, SCOPUS, Web of Science, and PubMed, as well as ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform up to November 2014. Reference lists and citations of identified trials and relevant systematic reviews were screened. SELECTION CRITERIA: We included randomised controlled trials that assessed the use of CBT in adults with subacute and chronic NP. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed the risk of bias in each study and extracted the data. If sufficient homogeneity existed among studies in the pre-defined comparisons, a meta-analysis was performed. We determined the quality of the evidence for each comparison with the GRADE approach. MAIN RESULTS: We included 10 randomised trials (836 participants) in this review. Four trials (40%) had low risk of bias, the remaining 60% of trials had a high risk of bias.The quality of the evidence for the effects of CBT on patients with chronic NP was from very low to moderate. There was low quality evidence that CBT was better than no treatment for improving pain (standard mean difference (SMD) -0.58, 95% confidence interval (CI) -1.01 to -0.16), disability (SMD -0.61, 95% CI -1.21 to -0.01), and quality of life (SMD -0.93, 95% CI -1.54 to -0.31) at short-term follow-up, while there was from very low to low quality evidence of no effect on various psychological indicators at short-term follow-up. Both at short- and intermediate-term follow-up, CBT did not affect pain (SMD -0.06, 95% CI -0.33 to 0.21, low quality, at short-term follow-up; MD -0.89, 95% CI -2.73 to 0.94, low quality, at intermediate-term follow-up) or disability (SMD -0.10, 95% CI -0.40 to 0.20, moderate quality, at short-term follow-up; SMD -0.24, 95% CI-0.54 to 0.07, moderate quality, at intermediate-term follow-up) compared to other types of interventions. There was moderate quality evidence that CBT was better than other interventions for improving kinesiophobia at intermediate-term follow-up (SMD -0.39, 95% CI -0.69 to -0.08, I(2) = 0%). Finally, there was very low quality evidence that CBT in addition to another intervention did not differ from the other intervention alone in terms of effect on pain (SMD -0.36, 95% CI -0.73 to 0.02) and disability (SMD -0.10, 95% CI -0.56 to 0.36) at short-term follow-up.For patients with subacute NP, there was low quality evidence that CBT was better than other interventions at reducing pain at short-term follow-up (SMD -0.24, 95% CI -0.48 to 0.00), while no difference was found in terms of effect on disability (SMD -0.12, 95% CI -0.36 to 0.12) and kinesiophobia.None of the included studies reported on adverse effects. AUTHORS' CONCLUSIONS: With regard to chronic neck pain, CBT was found to be statistically significantly more effective for short-term pain reduction only when compared to no treatment, but these effects could not be considered clinically meaningful. When comparing both CBT to other types of interventions and CBT in addition to another intervention to the other intervention alone, no differences were found. For patients with subacute NP, CBT was significantly better than other types of interventions at reducing pain at short-term follow-up, while no difference was found for disability and kinesiophobia. Further research is recommended to investigate the long-term benefits and risks of CBT including for the different subgroups of subjects with NP.


Assuntos
Dor Aguda/terapia , Dor Crônica/terapia , Terapia Cognitivo-Comportamental/métodos , Cervicalgia/terapia , Manejo da Dor/métodos , Dor Aguda/psicologia , Dor Crônica/psicologia , Humanos , Cervicalgia/psicologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Viés de Seleção
20.
Clin Biomech (Bristol, Avon) ; 30(2): 149-52, 2015 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-25556040

RESUMO

INTRODUCTION: The study of neck kinematics during high-velocity, low-amplitude manipulations of the atlanto-axial segment is essential to understanding cervical motion mechanisms and their impact and possible risk for soft-tissue injuries during treatment of spine disorders. METHODS: Twenty fresh-frozen specimens were tested during manual application of an axial rotation technique. FINDINGS: The kinematics indicate the thrust induced motion components of approximately 1° at the treated segment around all three axes of the local embedded reference frame. Moreover, an equal amount of axial rotation motion took place at the adjacent atlanto-occipital joint. INTERPRETATION: Overall atlanto-axial motion remained below the level of slow regional mobilization of the cervical spine. These findings can be correlated to literature data concerning the limited increase in vertebral artery strain during high-velocity, low-amplitude manipulation.


Assuntos
Vértebra Cervical Áxis/fisiologia , Vértebra Cervical Áxis/fisiopatologia , Atlas Cervical/fisiologia , Atlas Cervical/fisiopatologia , Idoso , Idoso de 80 Anos ou mais , Fenômenos Biomecânicos , Cadáver , Feminino , Humanos , Masculino , Manipulação da Coluna/efeitos adversos , Pessoa de Meia-Idade , Lesões do Pescoço/etiologia , Lesões do Pescoço/fisiopatologia , Amplitude de Movimento Articular , Fatores de Risco , Rotação
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