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1.
Physiother Can ; 74(1): 66-74, 2022 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-35185250

RESUMO

Purpose: The purpose of this study was to determine current physiotherapy practice for managing chronic low back pain (LBP). Method: We administered a cross-sectional survey to all physiotherapists working in Eastern Health (EH) Regional Health Authority, Newfoundland and Labrador, by email. To ascertain how physiotherapists assessed and treated patients with LBP, the survey included multiple-choice and open-ended questions, along with case vignettes. We explored the respondents' confidence about implementing all aspects of guideline-based care, as well as their use of treatment outcome measures. Results: A total of 76 physiotherapists responded to the survey (84% response rate); 56 (74%) reported that they treated patients with LBP as part of their regular practice. More than half had managed LBP for more than 10 years. The most frequently used treatments were self-management advice, followed by home and supervised exercise. The majority of respondents lacked confidence about implementing cognitive-behavioural treatment techniques. The Numeric Pain Rating Scale was the most commonly used outcome measure; disability outcome measures were not frequently used. Conclusions: The majority of LBP management in EH aligns with guideline recommendations. Increased uptake of guidelines recommending assessment and management of LBP using a bio-psychosocial approach will require training and support.


Objectif : déterminer les pratiques de physiothérapie actuelles pour traiter les douleurs lombaires chroniques. Méthodologie : les chercheurs ont distribué un sondage transversal par courriel à tous les physiothérapeutes de l'Autorité régionale de la santé de l'Est (SE) de Terre-Neuve-et-Labrador. Pour déterminer la manière dont les physiothérapeutes évaluent et traitent les patients ayant des douleurs lombaires, le sondage incluait des questions à choix multiples, des questions ouvertes et des scénarios de cas. Les chercheurs ont exploré la confiance des répondants envers l'adoption de tous les aspects des soins reposant sur des directives, de même qu'envers les mesures de résultat des traitements. Résultats : au total, 76 physiothérapeutes ont répondu au sondage, pour un taux de réponse de 84 %; 56 (74 %) ont déclaré traiter des patients ayant des douleurs lombaires dans le cadre de leur pratique régulière. Plus de la moitié traitaient des douleurs lombaires depuis plus de dix ans. Les traitements les plus utilisés étaient des conseils d'autogestion, suivis par des exercices à domicile et des exercices supervisés. La majorité des répondants n'avaient pas assez confiance pour adopter des techniques de thérapie cognitivo-comportementale. L'échelle numérique d'évaluation de la douleur était la mesure de résultat la plus utilisée, tandis que les mesures de résultats des incapacités étaient peu utilisées. Conclusion : à la SE, le traitement de la majorité des douleurs lombaires est conforme aux directives. Pour accroître les mises à jour des directives recommandant d'évaluer et de traiter les douleurs lombaires au moyen d'une approche biopsychosociale, il faudra une formation et un soutien.

2.
Health Technol Assess ; 26(15): 1-124, 2022 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-35220995

RESUMO

BACKGROUND: Upper limb problems are common after breast cancer treatment. OBJECTIVES: To investigate the clinical effectiveness and cost-effectiveness of a structured exercise programme compared with usual care on upper limb function, health-related outcomes and costs in women undergoing breast cancer surgery. DESIGN: This was a two-arm, pragmatic, randomised controlled trial with embedded qualitative research, process evaluation and parallel economic analysis; the unit of randomisation was the individual (allocated ratio 1 : 1). SETTING: Breast cancer centres, secondary care. PARTICIPANTS: Women aged ≥ 18 years who had been diagnosed with breast cancer and were at higher risk of developing shoulder problems. Women were screened to identify their risk status. INTERVENTIONS: All participants received usual-care information leaflets. Those randomised to exercise were referred to physiotherapy for an early, structured exercise programme (three to six face-to-face appointments that included strengthening, physical activity and behavioural change strategies). MAIN OUTCOME MEASURES: The primary outcome was upper limb function at 12 months as assessed using the Disabilities of Arm, Hand and Shoulder questionnaire. Secondary outcomes were function (Disabilities of Arm, Hand and Shoulder questionnaire subscales), pain, complications (e.g. wound-related complications, lymphoedema), health-related quality of life (e.g. EuroQol-5 Dimensions, five-level version; Short Form questionnaire-12 items), physical activity and health service resource use. The economic evaluation was expressed in terms of incremental cost per quality-adjusted life-year and incremental net monetary benefit gained from an NHS and Personal Social Services perspective. Participants and physiotherapists were not blinded to group assignment, but data collectors were blinded. RESULTS: Between 2016 and 2017, we randomised 392 participants from 17 breast cancer centres across England: 196 (50%) to the usual-care group and 196 (50%) to the exercise group. Ten participants (10/392; 3%) were withdrawn at randomisation and 32 (8%) did not provide complete baseline data. A total of 175 participants (89%) from each treatment group provided baseline data. Participants' mean age was 58.1 years (standard deviation 12.1 years; range 28-88 years). Most participants had undergone axillary node clearance surgery (327/392; 83%) and 317 (81%) had received radiotherapy. Uptake of the exercise treatment was high, with 181 out of 196 (92%) participants attending at least one physiotherapy appointment. Compliance with exercise was good: 143 out of 196 (73%) participants completed three or more physiotherapy sessions. At 12 months, 274 out of 392 (70%) participants returned questionnaires. Improvement in arm function was greater in the exercise group [mean Disabilities of Arm, Hand and Shoulder questionnaire score of 16.3 (standard deviation 17.6)] than in the usual-care group [mean Disabilities of Arm, Hand and Shoulder questionnaire score of 23.7 (standard deviation 22.9)] at 12 months for intention-to-treat (adjusted mean difference Disabilities of Arm, Hand and Shoulder questionnaire score of -7.81, 95% confidence interval -12.44 to -3.17; p = 0.001) and complier-average causal effect analyses (adjusted mean difference -8.74, 95% confidence interval -13.71 to -3.77; p ≤ 0.001). At 12 months, pain scores were lower and physical health-related quality of life was higher in the exercise group than in the usual-care group (Short Form questionnaire-12 items, mean difference 4.39, 95% confidence interval 1.74 to 7.04; p = 0.001). We found no differences in the rate of adverse events or lymphoedema over 12 months. The qualitative findings suggested that women found the exercise programme beneficial and enjoyable. Exercise accrued lower costs (-£387, 95% CI -£2491 to £1718) and generated more quality-adjusted life years (0.029, 95% CI 0.001 to 0.056) than usual care over 12 months. The cost-effectiveness analysis indicated that exercise was more cost-effective and that the results were robust to sensitivity analyses. Exercise was relatively cheap to implement (£129 per participant) and associated with lower health-care costs than usual care and improved health-related quality of life. Benefits may accrue beyond the end of the trial. LIMITATIONS: Postal follow-up was lower than estimated; however, the study was adequately powered. No serious adverse events directly related to the intervention were reported. CONCLUSIONS: This trial provided robust evidence that referral for early, supported exercise after breast cancer surgery improved shoulder function in those at risk of shoulder problems and was associated with lower health-care costs than usual care and improved health-related quality of life. FUTURE WORK: Future work should focus on the implementation of exercise programmes in clinical practice for those at highest risk of shoulder problems. TRIAL REGISTRATION: This trial is registered as ISRCTN35358984. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 15. See the NIHR Journals Library website for further project information.


WHAT IS THE PROBLEM?: Breast cancer is the most common cancer affecting women. Women now live longer because the detection and treatment of cancer has improved over the last 40 years. The side effects of breast cancer treatments can lead to complications, such as difficulties with arm movements, arm swelling (lymphoedema), pain and poor quality of life. These problems can last for many years after the cancer has been treated. Usual care after breast cancer surgery is to give patients an information leaflet explaining arm exercises that they can undertake after their operation. Offering exercise support from a physiotherapist may be a better way to help those at risk of developing shoulder problems after breast cancer treatment than providing a leaflet only. WHAT DID WE DO?: We compared two strategies to prevent shoulder problems in women having breast cancer treatment: information leaflets and an exercise programme. We invited women with a new diagnosis of breast cancer who were at higher risk of developing shoulder problems than other women with a new diagnosis of breast cancer. We recruited 392 women aged 28­88 years from 17 breast cancer units across England. Women were allocated to one of two groups by chance using a computer. Everyone was given information leaflets that explained what type of exercises to do after surgery. Half of the women (n = 196) were then invited to take part in an exercise programme, supported by a trained physiotherapist. These women followed a programme of shoulder mobility, stretching and strengthening exercises for up to 1 year. We measured changes in arm function, pain, arm swelling (lymphoedema) and physical and mental quality of life, and the cost of treatments during the whole first year of recovery, in everyone. We also spoke to the women and physiotherapists to find out whether or not these treatment strategies were acceptable to them. WHAT DID WE FIND OUT?: Women doing the exercise programme had better arm function, less pain and better quality of life than the women given an information leaflet only. Women said that the exercise programme helped with their recovery during cancer treatment. Exercise was cheap to deliver (£129 per person) and led to improved overall quality of life at 1 year after breast cancer surgery.


Assuntos
Neoplasias da Mama , Linfedema , Adulto , Idoso , Idoso de 80 Anos ou mais , Neoplasias da Mama/cirurgia , Análise Custo-Benefício , Exercício Físico , Feminino , Humanos , Pessoa de Meia-Idade , Dor , Qualidade de Vida , Ombro , Extremidade Superior
3.
Implement Sci Commun ; 2(1): 85, 2021 Aug 03.
Artigo em Inglês | MEDLINE | ID: mdl-34344486

RESUMO

BACKGROUND: The champion model is increasingly being adopted to improve uptake of guideline-based care in long-term care (LTC). Studies suggest that an on-site champion may improve the quality of care residents' health outcomes. This review assessed the effectiveness of the champion on staff adherence to guidelines and subsequent resident outcomes in LTC homes. METHOD: This was a systematic review and meta-analyses of randomised controlled trials. Eligible studies included residents aged 65 or over and nursing staff in LTC homes where there was a stand-alone or multi-component intervention that used a champion to improve staff adherence to guidelines and resident outcomes. The measured outcomes included staff adherence to guidelines, resident health outcomes, quality of life, adverse events, satisfaction with care, or resource use. Study quality was assessed with the Cochrane Risk of Bias tool; evidence certainty was assessed using the GRADE approach. RESULTS: After screening 4367 citations, we identified 12 articles that included the results of 1 RCT and 11 cluster-RCTs. All included papers evaluated the effects of a champion as part of a multicomponent intervention. We found low certainty evidence that champions as part of multicomponent interventions may improve staff adherence to guidelines. Effect sizes varied in magnitude across studies including unadjusted risk differences (RD) of 4.1% [95% CI: - 3%, 9%] to 44.8% [95% CI: 32%, 61%] for improving pressure ulcer prevention in a bed and a chair, respectively, RD of 44% [95% CI: 17%, 71%] for improving depression identification and RD of 21% [95% CI: 12%, 30%] for improving function-focused care to residents. CONCLUSION: Champions may improve staff adherence to evidence-based guidelines in LTC homes. However, methodological issues and poor reporting creates uncertainty around these findings. It is premature to recommend the widespread use of champions to improve uptake of guideline-based care in LTC without further study of the champion role and its impact on cost. TRIAL REGISTRATION: PROSPERO CRD42019145579 . Registered on 20 August 2019.

4.
Implement Sci ; 16(1): 68, 2021 07 02.
Artigo em Inglês | MEDLINE | ID: mdl-34215284

RESUMO

BACKGROUND: Despite international guideline recommendations, low back pain (LBP) imaging rates have been increasing over the last 20 years. Previous systematic reviews report limited effectiveness of implementation interventions aimed at reducing unnecessary LBP imaging. No previous reviews have analysed these implementation interventions to ascertain what behaviour change techniques (BCTs) have been used in this field. Understanding what techniques have been implemented in this field is an essential first step before exploring intervention effectiveness. METHODS: We searched EMBASE, Ovid (Medline), CINAHL and Cochrane CENTRAL from inception to February 1, 2021, as well as and hand-searched 6 relevant systematic reviews and conducted citation tracking of included studies. Two authors independently screened titles, abstracts, and full texts for eligibility and extracted data on study and intervention characteristics. Study interventions were qualitatively analysed by three coders to identify BCTs, which were mapped to mechanisms of action from the theoretical domains framework (TDF) using the Theory and Techniques Tool. RESULTS: We identified 36 eligible studies from 1984 citations in our electronic search and a further 2 studies from hand-searching resulting in 38 studies that targeted physician behaviour to reduce unnecessary LBP imaging. The studies were conducted in 6 countries in primary (n = 31) or emergency care (n = 7) settings. Thirty-four studies were included in our BCT synthesis which found the most frequently used BCTs were '4.1 instruction on how to perform the behaviour' (e.g. Active/passive guideline dissemination and/or educational seminars/workshops), followed by '9.1 credible source', '2.2 feedback on behaviour' (e.g. electronic feedback reports on physicians' image ordering) and 7.1 prompts and cues (electronic decision support or hard-copy posters/booklets for the office). This review highlighted that the majority of studies used education and/or feedback on behaviour to target the domains of knowledge and in some cases also skills and beliefs about capabilities to bring about a change in LBP imaging behaviour. Additionally, we found there to be a growing use of electronic or hard copy reminders to target the domains of memory and environmental context and resources. CONCLUSIONS: This is the first study to identify what BCTs have been used to target a reduction in physician image ordering behaviour. The majority of included studies lacked the use of theory to inform their intervention design and failed to target known physician-reported barriers to following LBP imaging guidelines. PROTOCOL REGISTATION: PROSPERO CRD42017072518.


Assuntos
Dor Lombar , Terapia Comportamental , Testes Diagnósticos de Rotina , Humanos , Dor Lombar/diagnóstico por imagem
5.
BMJ Open ; 11(5): e040116, 2021 05 11.
Artigo em Inglês | MEDLINE | ID: mdl-33980512

RESUMO

OBJECTIVES: To explore the experiences of women with breast cancer taking part in an early physiotherapy-led exercise intervention compared with the experiences of those receiving usual care. To understand physiotherapists' experience of delivering the trial intervention. To explore acceptability of the intervention and issues related to the implementation of the Prevention Of Shoulder Problems (PROSPER) programme from participant and physiotherapist perspective. DESIGN: Qualitative semistructured interviews with thematic analysis. SETTING: UK National Health Service. PARTICIPANTS: Twenty participants at high risk of shoulder problems after breast cancer surgery recruited to the UK PROSPER trial (10 each from the intervention arm and control arm), and 11 physiotherapists who delivered the intervention. Trial participants were sampled using convenience sampling. Physiotherapists were purposively sampled from high and low recruiting sites. RESULTS: Participants described that the PROSPER exercise intervention helped them feel confident in what their body could do and helped them regain a sense of control in the context of cancer treatment, which was largely disempowering. Control arm participants expressed less of a sense of control over their well-being. Physiotherapists found the exercise intervention enjoyable to deliver and felt it was valuable to their patients. The extra time allocated for appointments during intervention delivery made physiotherapists feel they were providing optimal care, being the 'perfect physio'. Lessons were learnt about the implementation of a complex exercise intervention for women with breast cancer, and the issues raised will inform the development of a future implementation strategy. CONCLUSIONS: A physiotherapist-delivered early supported exercise intervention with integrated behavioural strategies helped women at risk of shoulder problems following breast cancer treatment to feel more confident in their ability to mobilise their arm post-surgery. A physiotherapist-delivered early supported exercise intervention with integrated behavioural strategies may address the sense of powerlessness that many women experience during breast cancer treatment.Trial registration number ISRCTN35358984.


Assuntos
Neoplasias da Mama , Neoplasias da Mama/terapia , Terapia por Exercício , Feminino , Humanos , Modalidades de Fisioterapia , Medicina Estatal , Reino Unido
6.
Methods Mol Biol ; 2249: 571-595, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33871865

RESUMO

Health-related behavior change refers to a body of behavior change strategies that aim to align people's behavior with advances in evidence-based knowledge and decision-making. However, human behavior is complex, and changing it often requires a combination of strategies to be effective. The challenge is in choosing the combination of strategies that will work best. Implementation science, the study of behavior change, has rapidly expanded in recent years and has pioneered work in providing more transparent and theory-based methods for choosing and evaluating behavior change strategies. There are several models and frameworks that underlie the science of implementation, the most recent and comprehensive of which include the Implementation of Change Model, the COM-B (capability, motivation, and behavior) Model, and the Theoretical Domains Framework, as well as the behavior change techniques (BCTs) taxonomy. These models and frameworks can be applied to help support the development and evaluation of behavior change interventions. In this chapter, we will review the latest advances and lessons learned from implementation science as it applies to health-related behavior change.


Assuntos
Comportamentos Relacionados com a Saúde , Ciência da Implementação , Canadá , Medicina Baseada em Evidências , Conhecimentos, Atitudes e Prática em Saúde , Humanos
7.
BMC Public Health ; 21(1): 682, 2021 04 08.
Artigo em Inglês | MEDLINE | ID: mdl-33832463

RESUMO

BACKGROUND: Low back pain (LBP) is one of the most common reasons for seeking health care and is costly to the health care system. Recent evidence has shown that LBP care provided by many providers is divergent from guidelines and one reason may be patient's beliefs and expectations about treatment. Thus, examining the nature of patient beliefs and expectations regarding low back pain treatment will help coordinate efforts to improve consistency and quality of care. METHODS: This study was a cross-sectional population-based survey of adults living in Newfoundland, Canada. The survey included demographic information (e.g. age, gender, back pain status and care seeking behaviors) and assessed outcomes related to beliefs about the inevitable consequences of back pain with the validated back beliefs questionnaire as well as six additional questions relating beliefs about imaging, physical activity and medication. Surveys were mailed to 3000 households in July-August 2018 and responses collected until September 30th, 2018. RESULTS: Fout hundred twenty-eight surveys were returned (mean age 55 years (SD 14.6), 66% female, 90% had experienced an episode of LBP). The mean Back Beliefs Questionnaire score was 27.3 (SD 7.2), suggesting that people perceive back pain to have inevitable negative consequences. Large proportions of respondents held the following beliefs that are contrary to best available evidence: (i) having back pain means you will always have weakness in your back (49.3%), (ii) it will get progressively worse (48.0%), (iii) resting is good (41.4%) and (iv) x-rays or scans are necessary to get the best medical care for LBP (54.2%). CONCLUSIONS: A high proportion of the public believe LBP to have inevitable negative consequences and hold incorrect beliefs about diagnosis and management options, which is similar to findings from other countries. This presents challenges for clinicians and suggests that considering how to influence beliefs about LBP in the broader community could have value. Given the high prevalence of LBP and that many will consult a range of healthcare professionals, future efforts could consider using broad reaching public health campaigns that target patients, policy makers and all relevant health providers with specific content to change commonly held unhelpful beliefs.


Assuntos
Dor Lombar , Adulto , Canadá , Estudos Transversais , Feminino , Humanos , Dor Lombar/diagnóstico , Dor Lombar/terapia , Masculino , Pessoa de Meia-Idade , Terra Nova e Labrador , Prognóstico , Inquéritos e Questionários
8.
BMJ Open ; 10(11): e040834, 2020 11 30.
Artigo em Inglês | MEDLINE | ID: mdl-33257487

RESUMO

INTRODUCTION: There is global recognition that low back pain (LBP) should be managed with a biopsychosocial approach. Previous implementation of this approach resulted in low uptake and highlighted the need for ongoing support. This study aims to explore the feasibility of (i) training and using a champion to support implementation, (ii) using a cluster randomised controlled trial (RCT), (iii) collecting patient reported outcome measures in a Canadian public healthcare setting and to identify contextual barriers to implementation. METHODS: A pragmatic cluster RCT with embedded qualitative study with physiotherapists treating LBP in publicly funded physiotherapy departments in Newfoundland and Labrador, Canada. Participants will complete a previously developed online training course to equip them to deliver a biopsychosocial intervention for LBP. Clusters randomised to the intervention arm will receive additional support from a champion. A minimum champion training package has been developed based on known barriers in the literature. This includes strategies to target barriers relating to group-based scheduling issues, lack of managerial support, perceived patient factors such as addressing patient expectations for other types of treatments or selecting which patients might be best suited for this intervention, and anxiety about delivering something new. This package will be further codeveloped with study champions based on identified implementation barriers using the Behaviour Change Wheel. Clusters will be monitored for 6 months to assess champion and physiotherapist recruitment and retention, acceptability and implementation of the champion training, and the viability of conducting a cluster RCT in this setting. A purposive sample of physiotherapists will be interviewed from both arms. ETHICS AND DISSEMINATION: This study was approved by Newfoundland and Labrador Health Research Ethics Authority in December 2018. Results will be disseminated to academic audiences through conferences and peer reviewed publications; to all study participants, their clinical leads, and patients with LBP. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT04377529; Memorial University of Newfoundland Protocol Record 20190025; Pre-results.


Assuntos
Dor Lombar , Fisioterapeutas , Canadá , Estudos de Viabilidade , Humanos , Dor Lombar/terapia , Terra Nova e Labrador , Ensaios Clínicos Controlados Aleatórios como Assunto
9.
Physiotherapy ; 109: 4-12, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-32795621

RESUMO

OBJECTIVES: 1) Evaluate implementation of the Back Skills Training (BeST) programme, a group cognitive behavioural approach for patients with low back pain (LBP) developed for a clinical trial, into the National Health Service (NHS) in the United Kingdom; 2) Compare patient outcomes with the BeST Trial results. DESIGN: Two stage observational cohort implementation study. PARTICIPANTS: Stage 1: NHS Clinicians enrolled in BeST online training. Stage 2: Patients with LBP attending NHS physiotherapy departments and enrolled in the BeST programme. INTERVENTION: An online training and implementation programme. OUTCOMES: Stage 1: LBP attitudes and beliefs, self-rated competence, intention and actual implementation were collected before, immediately, 4- and 12-months post-training. Stage 2: Patients rated pain, function, recovery and satisfaction before and up to one year after attending the BeST programme. RESULTS: Stage 1: 1324 clinicians (157 NHS Trusts) enrolled in the training; 586 (44%) clinicians (101 NHS Trusts) completed training; 443/586 (76%) clinicians provided post-training data; 253/443 (57%) clinicians intended to implement the programme; 148/381 (39%) clinicians (54 NHS Trusts) provided follow-up data; 49/148 (33.1%) clinicians (27 NHS Trusts) implemented the programme. Attitudes and beliefs shifted towards a biopsychosocial model post-training. Stage 2: 923 patients were enrolled. Patients reported improvements in function (mean change: 1.55; 95%CI: 1.25, 1.86) and pain (-0.84; -1.1, -0.58) at follow-up. The majority rated themselves improved and satisfied with the programme. CONCLUSION: Online training had good reach into NHS Trusts although, not everyone went onto implement the programme. Improvements in function that were consistent with the original trial were demonstrated.


Assuntos
Terapia Cognitivo-Comportamental/métodos , Instrução por Computador/métodos , Conhecimentos, Atitudes e Prática em Saúde , Dor Lombar/terapia , Avaliação de Programas e Projetos de Saúde , Adulto , Idoso , Estudos de Coortes , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Inquéritos e Questionários , Reino Unido
10.
Implement Sci ; 14(1): 49, 2019 05 07.
Artigo em Inglês | MEDLINE | ID: mdl-31064375

RESUMO

BACKGROUND: Adoption of low back pain guidelines is a well-documented problem. Information to guide the development of behaviour change interventions is needed. The review is the first to synthesise the evidence regarding physicians' barriers to providing evidence-based care for LBP using the Theoretical Domains Framework (TDF). Using the TDF allowed us to map specific physician-reported barriers to individual guideline recommendations. Therefore, the results can provide direction to future interventions to increase physician compliance with evidence-based care for LBP. METHODS: We searched the literature for qualitative studies from inception to July 2018. Two authors independently screened titles, abstracts, and full texts for eligibility and extracted data on study characteristics, reporting quality, and methodological rigour. Guided by a TDF coding manual, two reviewers independently coded the individual study themes using NVivo. After coding, we assessed confidence in the findings using the GRADE-CERQual approach. RESULTS: Fourteen studies (n = 318 physicians) from 9 countries reported barriers to adopting one of the 5 guideline-recommended behaviours regarding in-clinic diagnostic assessments (9 studies, n = 198), advice on activity (7 studies, n = 194), medication prescription (2 studies, n = 39), imaging referrals (11 studies, n = 270), and treatment/specialist referrals (8 studies, n = 193). Imaging behaviour is influenced by (1) social influence-from patients requesting an image or wanting a diagnosis (n = 252, 9 studies), (2) beliefs about consequence-physicians believe that providing a scan will reassure patients (n = 175, 6 studies), and (3) environmental context and resources-physicians report a lack of time to have a conversation with patients about diagnosis and why a scan is not needed (n = 179, 6 studies). Referrals to conservative care is influenced by environmental context and resources-long wait-times or a complete lack of access to adjunct services prevented physicians from referring to these services (n = 82, 5 studies). CONCLUSIONS: Physicians face numerous barriers to providing evidence-based LBP care which we have mapped onto 7 TDF domains. Two to five TDF domains are involved in determining physician behaviour, confirming the complexity of this problem. This is important as interventions often target a single domain where multiple domains are involved. Interventions designed to address all the domains involved while considering context-specific factors may prove most successful in increasing guideline adoption. REGISTRATION: PROSPERO 2017, CRD42017070703.


Assuntos
Medicina Baseada em Evidências , Fidelidade a Diretrizes , Dor Lombar/diagnóstico , Dor Lombar/terapia , Padrões de Prática Médica/estatística & dados numéricos , Teoria Psicológica , Humanos , Pesquisa Qualitativa , Encaminhamento e Consulta
11.
J Med Internet Res ; 21(3): e11123, 2019 03 07.
Artigo em Inglês | MEDLINE | ID: mdl-30843863

RESUMO

BACKGROUND: By adaptation of the face-to-face physiotherapist-training program previously used in the Self-management of Osteoarthritis and Low back pain through Activity and Skills (SOLAS) feasibility trial, an asynchronous, interactive, Web-based, e-learning training program (E-SOLAS) underpinned by behavior and learning theories was developed. OBJECTIVE: This study investigated the effect of the E-SOLAS training program on relevant outcomes of effective training and implementation. METHODS: Thirteen physiotherapists from across Ireland were trained via E-SOLAS by using mixed methods, and seven physiotherapists progressed to implementation of the 6-week group-based SOLAS intervention. The effectiveness of E-SOLAS was evaluated using the Kirkpatrick model at the levels of reaction (physiotherapist engagement and satisfaction with E-SOLAS training methods and content), learning (pre- to posttraining changes in physiotherapists' confidence and knowledge in delivering SOLAS content and self-determination theory-based communication strategies, administered via a SurveyMonkey questionnaire), and behavior (fidelity to delivery of SOLAS content using physiotherapist-completed weekly checklists). During implementation, five physiotherapists audio recorded delivery of one class, and the communication between physiotherapists and clients was assessed using the Health Care Climate Questionnaire (HCCQ), the Controlling Coach Behaviour Scale (CCBS), and an intervention-specific measure (ISM; 7-point Likert scale). A range of implementation outcomes were evaluated during training and delivery (ie, acceptability, appropriateness, feasibility, fidelity, and sustainability of E-SOLAS) using a posttraining feedback questionnaire and individual semistructured telephone interviews. RESULTS: With regard to their reaction, physiotherapists (n=13) were very satisfied with E-SOLAS posttraining (median 5.0; interquartile range 1.0; min-max 4.0-5.0) and completed training within 3-4 weeks. With regard to learning, there were significant increases in physiotherapists' confidence and knowledge in delivery of all SOLAS intervention components (P<.05). Physiotherapists' confidence in 7 of 10 self-determination theory-based communication strategies increased (P<.05), whereas physiotherapists' knowledge of self-determination theory-based strategies remained high posttraining (P>.05). In terms of behavior, physiotherapists delivered SOLAS in a needs supportive manner (HCCQ: median 5.2, interquartile range 1.3, min-max 3.7-5.8; CCBS: median 6.6, interquartile range 1.0, min-max 5.6-7.0; ISM: median 4.5, interquartile range 1.2, min-max 2.8-4.8). Fidelity scores were high for SOLAS content delivery (total %mean fidelity score 93.5%; SD 4.9%). The posttraining questionnaire and postdelivery qualitative interviews showed that physiotherapists found E-SOLAS acceptable, appropriate, feasible, and sustainable within primary care services to support the implementation of the SOLAS intervention. CONCLUSIONS: This study provides preliminary evidence of the effectiveness, acceptability, and feasibility of an e-learning program to train physiotherapists to deliver a group-based self-management complex intervention in primary care settings, which is equivalent to face-to-face training outcomes and would support inclusion of physiotherapists in a definitive trial of SOLAS.


Assuntos
Instrução por Computador/métodos , Dor Lombar/terapia , Osteoartrite/terapia , Autogestão/métodos , Feminino , Humanos , Masculino
12.
BMC Health Serv Res ; 18(1): 463, 2018 06 18.
Artigo em Inglês | MEDLINE | ID: mdl-29914494

RESUMO

BACKGROUND: Musculoskeletal shoulder problems are common after breast cancer treatment. There is some evidence to suggest that early postoperative exercise is safe and may improve shoulder function. We describe the development and delivery of a complex intervention for evaluation within a randomised controlled trial (RCT), designed to target prevention of musculoskeletal shoulder problems after breast cancer surgery (The Prevention of Shoulder Problems Trial; PROSPER). METHODS: A pragmatic, multicentre RCT to compare the clinical and cost-effectiveness of best practice usual care versus a physiotherapy-led exercise and behavioural support intervention in women at high risk of shoulder problems after breast cancer treatment. PROSPER will recruit 350 women from approximately 15 UK centres, with follow-up at 6 and 12 months. The primary outcome is shoulder function at 12 months; secondary outcomes include postoperative pain, health related quality of life, adverse events and healthcare resource use. A multi-phased approach was used to develop the PROSPER intervention which was underpinned by existing evidence and modified for implementation after input from clinical experts and women with breast cancer. The intervention was tested and refined further after qualitative interviews with patients newly diagnosed with breast cancer; a pilot RCT was then conducted at three UK clinical centres. DISCUSSION: The PROSPER intervention incorporates three main components: shoulder-specific exercises targeting range of movement and strength; general physical activity; and behavioural strategies to encourage adherence and support exercise behaviour. The final PROSPER intervention is fully manualised with clear, documented pathways for clinical assessment, exercise prescription, use of behavioural strategies, and with guidance for treatment of postoperative complications. This paper adheres to TIDieR and CERT recommendations for the transparent, comprehensive and explicit reporting of complex interventions. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number: ISRCTN 35358984 .


Assuntos
Neoplasias da Mama/cirurgia , Terapia por Exercício , Mastectomia/reabilitação , Doenças Musculoesqueléticas/prevenção & controle , Complicações Pós-Operatórias/prevenção & controle , Ombro/fisiopatologia , Terapia Comportamental , Neoplasias da Mama/epidemiologia , Análise Custo-Benefício , Terapia por Exercício/métodos , Feminino , Humanos , Cooperação do Paciente , Avaliação de Resultados da Assistência ao Paciente , Projetos Piloto , Qualidade de Vida , Reino Unido/epidemiologia
13.
BMJ Open ; 8(3): e019078, 2018 03 23.
Artigo em Inglês | MEDLINE | ID: mdl-29574439

RESUMO

Musculoskeletal shoulder problems are common after breast cancer treatment. Early postoperative exercises targeting the upper limb may improve shoulder function. This protocol describes a National Institute for Health Research-funded randomised controlled trial (RCT) to evaluate the clinical and cost-effectiveness of an early supervised structured exercise programme compared with usual care, for women at high risk of developing shoulder problems after breast cancer surgery. METHODS: This pragmatic two-armed, multicentre RCT is underway within secondary care in the UK. PRevention Of Shoulder ProblEms tRial (PROSPER) aims to recruit 350 women from approximately 15 UK centres with follow-up at 6 weeks, 6 and 12 months after randomisation. Recruitment processes and intervention development were optimised through qualitative research during a 6-month internal pilot phase. Participants are randomised to the PROSPER intervention or best practice usual care only. The PROSPER intervention is delivered by physiotherapists and incorporates three main components: shoulder-specific exercises targeting range of movement and strength; general physical activity and behavioural strategies to encourage adherence and support exercise behaviour. The primary outcome is upper arm function assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire at 12 months postrandomisation. Secondary outcomes include DASH subscales, acute and chronic pain, complications, health-related quality of life and healthcare resource use. We will interview a subsample of 20 participants to explore their experiences of the trial interventions. DISCUSSION: The PROSPER study is the first multicentre UK clinical trial to investigate the clinical and cost-effectiveness of supported exercise in the prevention of shoulder problems in high-risk women undergoing breast cancer surgery. The findings will inform future clinical practice and provide valuable insight into the role of physiotherapy-supported exercise in breast cancer rehabilitation. PROTOCOL VERSION: Version 2.1; dated 11 January 2017 TRIAL REGISTRATION NUMBER: ISRCTN35358984; Pre-results.


Assuntos
Neoplasias da Mama/cirurgia , Terapia por Exercício , Doenças Musculoesqueléticas/prevenção & controle , Complicações Pós-Operatórias/prevenção & controle , Ombro/fisiopatologia , Terapia Comportamental/economia , Neoplasias da Mama/complicações , Análise Custo-Benefício , Terapia por Exercício/economia , Feminino , Humanos , Modelos Lineares , Qualidade de Vida , Projetos de Pesquisa , Inquéritos e Questionários , Reino Unido
14.
Disabil Rehabil ; 40(1): 1-9, 2018 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-27871193

RESUMO

PURPOSE: To determine if physiotherapist-led cognitive-behavioural (CB) interventions are effective for low back pain (LBP) and described sufficiently for replication. METHOD: Randomised controlled trials (RCTs) of patients with LBP treated by physiotherapists using a CB intervention were included. Outcomes of disability, pain, and quality of life were assessed using the GRADE approach. Intervention reporting was assessed using the Template for Intervention Description and Replication. RESULTS: Of 1898 titles, 5 RCTs (n = 1390) were identified. Compared to education and/or exercise interventions, we found high-quality evidence that CB had a greater effect (SMD; 95% CI) on reducing disability (-0.19; -0.32, -0.07), pain (-0.21; -0.33, -0.09); and moderate-quality evidence of little difference in quality of life (-0.06; -0.18 to 0.07). Sufficient information was provided on dose, setting, and provider; but not content and procedural information. Studies tended to report the type of CB component used (e.g., challenging unhelpful thoughts) with little detail on how it was operationalised. Moreover, access to treatment manuals, patient materials and provider training was lacking. CONCLUSIONS: With additional training, physiotherapists can deliver effective CB interventions. However, without training or resources, successful translation and implementation remains unlikely. Researchers should improve reporting of procedural information, provide relevant materials, and offer accessible provider training. Implications for Rehabilitation Previous reviews have established that traditional biomedical-based treatments (e.g., acupuncture, manual therapy, massage, and specific exercise programmes) that focus only on physical symptoms do provide short-term benefits but the sustained effect is questionable. A cognitive-behavioural (CB) approach includes techniques to target both physical and psychosocial symptoms related to pain and provides patients with long-lasting skills to manage these symptoms on their own. This combined method has been used in a variety of settings delivered by different health care professionals and has been shown to produce long-term effects on patient outcomes. What has been unclear is if these programmes are effective when delivered by physiotherapists in routine physiotherapy settings. Our study synthesises the evidence for this context. We have confirmed with high-quality evidence that with additional training, physiotherapists can deliver CB interventions that are effective for patients with back pain. Physiotherapists who are considering enhancing their treatment for patients with low back pain should consider undertaking some additional training in how to incorporate CB techniques into their practice to optimise treatment benefits and help patients receive long-lasting treatment effects. Importantly, our results indicate that using a CB approach, including a variety of CB techniques that could be easily adopted in a physical therapy setting, provides greater benefits for patient outcomes compared to brief education, exercise or physical techniques (such as manual therapy) alone. This provides further support that a combined treatment approach is likely better than one based on physical techniques alone. Notably, we identified a significant barrier to adopting any of these CB interventions in practice. This is because no study provided a description of the intervention or accessible training materials that would allow for accurate replication. Without access to provider training and/or resources, we cannot expect this evidence to be implemented in practice with optimal effects. Thus, we would urge physiotherapists to directly contact authors of the studies for more information on how to incorporate their interventions into their settings.


Assuntos
Terapia Cognitivo-Comportamental/métodos , Dor Lombar , Fisioterapeutas , Modalidades de Fisioterapia , Terapia Combinada , Atenção à Saúde , Humanos , Dor Lombar/psicologia , Dor Lombar/reabilitação
15.
Physiotherapy ; 104(1): 107-115, 2018 03.
Artigo em Inglês | MEDLINE | ID: mdl-28826744

RESUMO

OBJECTIVES: Our objectives were two-fold: (i) to describe physiotherapists' experiences of implementing a cognitive behavioural approach (CBA) for managing low back pain (LBP) after completing an extensive online training course (iBeST), and (ii) to identify how iBeST could be enhanced to support long-term implementation before scale up for widespread use. DESIGN: We conducted semi-structured interviews with 11 physiotherapists from six National Health Service departments in the Midlands, Oxfordshire and Derbyshire. Questions centred on (i) using iBeST to support implementation, (ii) what barriers they encountered to implementation and (iii) what of information or resources they required to support sustained implementation. Interviews were transcribed and thematically analysed using NVivo. Themes were categorised using the Theoretical Domains Framework (TDF). Evidence-based techniques were identified using the behaviour change technique taxonomy to target relevant TDF domains. RESULTS: Three themes emerged from interviews: anxieties about using a CBA, experiences of implementing a CBA, and sustainability for future implementation of a CBA. Themes crossed multiple TDF domains and indicated concerns with knowledge, beliefs about capabilities and consequences, social and professional roles, social influences, emotion, and environmental context and resources. We identified evidence-based strategies that may support sustainable implementation of a CBA for LBP in a physiotherapy setting. CONCLUSIONS: This study highlighted potential challenges for physiotherapists in the provision of evidence-based LBP care within the current UK NHS. Using the TDF provided the foundation to develop a tailored, evidence-based, implementation intervention to support long term use of a CBA by physiotherapists managing LBP within UK NHS outpatient departments.


Assuntos
Atitude do Pessoal de Saúde , Dor Lombar/psicologia , Dor Lombar/reabilitação , Fisioterapeutas/psicologia , Modalidades de Fisioterapia , Adulto , Idoso , Educação Continuada , Feminino , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Entrevistas como Assunto , Masculino , Pessoa de Meia-Idade , Papel Profissional , Reino Unido
16.
BMC Med Educ ; 17(1): 227, 2017 Nov 23.
Artigo em Inglês | MEDLINE | ID: mdl-29169393

RESUMO

BACKGROUND: Online training is growing in popularity and yet its effectiveness for training licensed health professionals (HCPs) in clinical interventions is not clear. We aimed to systematically review the literature on the effectiveness of online versus alternative training methods in clinical interventions for licensed Health Care Professionals (HCPs) on outcomes of knowledge acquisition, practical skills, clinical behaviour, self-efficacy and satisfaction. METHODS: Seven databases were searched for randomised controlled trials (RCTs) from January 2000 to June 2015. Two independent reviewers rated trial quality and extracted trial data. Comparative effects were summarised as standardised mean differences (SMD) and 95% confidence intervals. Pooled effect sizes were calculated using a random-effects model for three contrasts of online versus (i) interactive workshops (ii) taught lectures and (iii) written/electronic manuals. RESULTS: We included 14 studies with a total of 1089 participants. Most trials studied medical professionals, used a workshop or lecture comparison, were of high risk of bias and had small sample sizes (range 21-183). Using the GRADE approach, we found low quality evidence that there was no difference between online training and an interactive workshop for clinical behaviour SMD 0.12 (95% CI -0.13 to 0.37). We found very low quality evidence of no difference between online methods and both a workshop and lecture for knowledge (workshop: SMD 0.04 (95% CI -0.28 to 0.36); lecture: SMD 0.22 (95% CI: -0.08, 0.51)). Lastly, compared to a manual (n = 3/14), we found very low quality evidence that online methods were superior for knowledge SMD 0.99 (95% CI 0.02 to 1.96). There were too few studies to draw any conclusions on the effects of online training for practical skills, self-efficacy, and satisfaction across all contrasts. CONCLUSIONS: It is likely that online methods may be as effective as alternative methods for training HCPs in clinical interventions for the outcomes of knowledge and clinical behaviour. However, the low quality of the evidence precludes drawing firm conclusions on the relative effectiveness of these training methods. Moreover, the confidence intervals around our effect sizes were large and could encompass important differences in effectiveness. More robust, adequately powered RCTs are needed.


Assuntos
Instrução por Computador , Atenção à Saúde/normas , Educação de Pós-Graduação em Medicina/normas , Pessoal de Saúde/educação , Internato e Residência/normas , Atitude Frente aos Computadores , Protocolos Clínicos , Humanos , Licenciamento , Avaliação de Resultados em Cuidados de Saúde , Ensaios Clínicos Controlados Aleatórios como Assunto , Autoeficácia
17.
Phys Ther ; 97(2): 227-238, 2017 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-27634919

RESUMO

Background: Tai chi is recommended for musculoskeletal conditions; however, the evidence for its clinical effectiveness is uncertain. Purpose: The aim of this study was to determine whether tai chi is beneficial for clinical outcomes in people with musculoskeletal pain. Data Sources: Seven databases were searched: Embase, PEDro, AMED, MEDLINE, CINAHL, SPORTDiscus, and the Cochrane Central Register of Controlled Trials. Study Selection: Randomized controlled trials of tai chi for people with a chronic musculoskeletal condition were included. Data Extraction: Two reviewers extracted data and rated risk of bias. Standardized mean differences (SMDs) and 95% confidence intervals (CI) were calculated for individual trials and pooled effect sizes were calculated using a random-effects model. Data Synthesis: Fifteen studies were identified; these studies included people with osteoarthritis (80%), back pain (13%), and headache (7%). Using the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach, moderate-quality evidence was found that tai chi was more effective than no treatment or usual care at short term on pain (SMD=-0.66 [95% CI=-0.85, -0.48]) and disability (SMD=-0.66 [95% CI=-0.85, -0.46]). The evidence for other outcomes was of low or very low quality and there was little information regarding long-term effects. Thus, although the number of publications in this area has increased, the rigor has not, hindering physical therapists' ability to provide reliable recommendations for clinical practice. Limitations: The evidence provided in this review is limited by trials with small sample sizes, low methodological quality, and lack of long-term assessment. Conclusions: In order for tai chi to be recommended as an effective intervention, more high-quality trials with large sample sizes assessing tai chi versus other evidence-based treatments at short term and at long term are needed.


Assuntos
Dor Crônica/terapia , Dor Musculoesquelética/terapia , Tai Chi Chuan , Artrite/terapia , Humanos , Dor Lombar/terapia , Ensaios Clínicos Controlados Aleatórios como Assunto , Cefaleia do Tipo Tensional/terapia
18.
Nurs Times ; 112(18): 12-4, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27344895

RESUMO

Low back pain is not only commonplace the world over, but also costly to treat. A training programme was developed so health professionals from many different specialties, from nursing to occupational health, can have a positive impact on patients with the condition, easing their disability and consequently also, the financial burden on healthcare institutions and systems. This article describes the programme and outlines how NHS nurses can train to use the programme no matter where they are based.


Assuntos
Terapia Cognitivo-Comportamental/métodos , Dor Lombar/terapia , Análise Custo-Benefício , Educação em Enfermagem , Prática Clínica Baseada em Evidências , Terapia por Exercício/métodos , Humanos , Dor Lombar/psicologia , Papel do Profissional de Enfermagem , Medicina Estatal , Reino Unido
19.
BMC Med Educ ; 16: 163, 2016 Jun 18.
Artigo em Inglês | MEDLINE | ID: mdl-27316705

RESUMO

BACKGROUND: Cognitive behavioural (CB) approaches are effective in the management of non-specific low back pain (LBP). We developed the CB Back Skills Training programme (BeST) and previously provided evidence of clinical and cost effectiveness in a large pragmatic trial. However, practice change is challenged by a lack of treatment guidance and training for clinicians. We aimed to explore the feasibility and acceptability of an online programme (iBeST) for providing training in a CB approach. METHODS: This mixed methods study comprised an individually randomised controlled trial of 35 physiotherapists and an interview study of 8 physiotherapists. Participants were recruited from 8 National Health Service departments in England and allocated by a computer generated randomisation list to receive iBeST (n = 16) or a face-to-face workshop (n = 19). Knowledge (of a CB approach), clinical skills (unblinded assessment of CB skills in practice), self-efficacy (reported confidence in using new skills), attitudes (towards LBP management), and satisfaction were assessed after training. Engagement with iBeST was assessed with user analytics. Interviews explored acceptability and experiences with iBeST. Data sets were analysed independently and jointly interpreted. RESULTS: Fifteen (94 %) participants in the iBeST group and 16 (84 %) participants in the workshop group provided data immediately after training. We observed similar scores on knowledge (MD (95 % CI): 0.97 (-1.33, 3.26)), and self-efficacy to deliver the majority of the programme (MD (95 % CI) 0.25 (-1.7; 0.7)). However, the workshop group showed greater reduction in biomedical attitudes to LBP management (MD (95 % CI): -7.43 (-10.97, -3.89)). Clinical skills were assessed in 5 (33 %) iBeST participants and 7 (38 %) workshop participants within 6 months of training and were similar between groups (MD (95 % CI): 0.17(-0.2; 0.54)). Interviews highlighted that while initially sceptical, participants found iBeST acceptable. A number of strategies were identified to enhance future versions of iBeST such as including more skills practice. CONCLUSIONS: Combined quantitative and qualitative data indicated that online training was an acceptable and promising method for providing training in an evidence based complex intervention. With future enhancement, the potential reach of this training method may facilitate evidence-based practice through large scale upskilling of the workforce. TRIAL REGISTRATION: Current Controlled Trials ISRCTN82203145 (registered prospectively on 03.09.2012).


Assuntos
Competência Clínica/normas , Terapia Cognitivo-Comportamental/educação , Instrução por Computador/métodos , Prática Clínica Baseada em Evidências/educação , Dor Lombar/terapia , Médicos de Atenção Primária/educação , Adolescente , Adulto , Idoso , Análise Custo-Benefício , Estudos de Viabilidade , Feminino , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Dor Lombar/psicologia , Masculino , Pessoa de Meia-Idade , Médicos de Atenção Primária/normas , Desenvolvimento de Programas , Avaliação de Programas e Projetos de Saúde , Adulto Jovem
20.
PLoS One ; 10(8): e0134192, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26244668

RESUMO

OBJECTIVES: To assess whether cognitive behavioural (CB) approaches improve disability, pain, quality of life and/or work disability for patients with low back pain (LBP) of any duration and of any age. METHODS: Nine databases were searched for randomised controlled trials (RCTs) from inception to November 2014. Two independent reviewers rated trial quality and extracted trial data. Standardised mean differences (SMD) and 95% confidence intervals were calculated for individual trials. Pooled effect sizes were calculated using a random-effects model for two contrasts: CB versus no treatment (including wait-list and usual care (WL/UC)), and CB versus other guideline-based active treatment (GAT). RESULTS: The review included 23 studies with a total of 3359 participants. Of these, the majority studied patients with persistent LBP (>6 weeks; n=20). At long term follow-up, the pooled SMD for the WL/UC comparison was -0.19 (-0.38, 0.01) for disability, and -0.23 (-0.43, -0.04) for pain, in favour of CB. For the GAT comparison, at long term the pooled SMD was -0.83 (-1.46, -0.19) for disability and -0.48 (-0.93, -0.04) for pain, in favour of CB. While trials varied considerably in methodological quality, and in intervention factors such as provider, mode of delivery, dose, duration, and pragmatism, there were several examples of lower intensity, low cost interventions that were effective. CONCLUSION: CB interventions yield long-term improvements in pain, disability and quality of life in comparison to no treatment and other guideline-based active treatments for patients with LBP of any duration and of any age. SYSTEMATIC REVIEW REGISTRATION: PROSPERO protocol registration number: CRD42014010536.


Assuntos
Terapia Cognitivo-Comportamental/métodos , Dor Lombar/terapia , Avaliação da Deficiência , Humanos , Medição da Dor , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
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