Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 130
Filtrar
1.
Trials ; 22(1): 678, 2021 Oct 07.
Artigo em Inglês | MEDLINE | ID: mdl-34620194

RESUMO

BACKGROUND: Randomised controlled trials in surgery can be a challenge to design and conduct, especially when including a non-surgical comparison. As few as half of initiated surgical trials reach their recruitment target, and failure to recruit is cited as the most frequent reason for premature closure of surgical RCTs. The aim of this qualitative evidence synthesis was to identify and synthesise findings from qualitative studies exploring the challenges in the design and conduct of trials directly comparing surgical and non-surgical interventions. METHODS: A qualitative evidence synthesis using meta-ethnography was conducted. Six electronic bibliographic databases (Medline, Central, Cinahl, Embase and PsycInfo) were searched up to the end of February 2018. Studies that explored patients' and health care professionals' experiences regarding participating in RCTs with a surgical and non-surgical comparison were included. The GRADE-CERQual framework was used to assess confidence in review findings. RESULTS: In total, 3697 abstracts and 49 full texts were screened and 26 published studies reporting experiences of patients and healthcare professionals were included. The focus of the studies (24/26) was primarily related to the challenge of recruitment. Two studies explored reasons for non-compliance to treatment allocation following randomisation. Five themes related to the challenges to these types of trials were identified: (1) radical choice between treatments; (2) patients' discomfort with randomisation: I want the best treatment for me as an individual; (3) challenge of equipoise: patients' a priori preferences for treatment; (4) challenge of equipoise: clinicians' a priori preferences for treatment and (5) imbalanced presentation of interventions. CONCLUSION: The marked dichotomy between the surgical and non-surgical interventions was highlighted in this review as making recruitment to these types of trials particularly challenging. This review identified factors that increase our understanding of why patients and clinicians may find equipoise more challenging in these types of trials compared to other trial comparisons. Trialists may wish to consider exploring the balance of potential factors influencing patient and clinician preferences towards treatments before they start recruitment, to enable issues specific to a particular trial to be identified and addressed. This may enable trial teams to make more efficient considered design choices and benefit the delivery of such trials.


Assuntos
Antropologia Cultural , Atitude do Pessoal de Saúde , Pessoal de Saúde , Humanos , Seleção de Pacientes , Pesquisa Qualitativa
2.
Health Technol Assess ; 25(53): 1-52, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-34505829

RESUMO

BACKGROUND: The use of placebo comparisons for randomised trials assessing the efficacy of surgical interventions is increasingly being considered. However, a placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges. OBJECTIVES: To provide a summary of knowledge on placebo controls in surgical trials and to summarise any recommendations for designers, evaluators and funders of placebo-controlled surgical trials. DESIGN: To carry out a state-of-the-art workshop and produce a corresponding report involving key stakeholders throughout. SETTING: A workshop to discuss and summarise the existing knowledge and to develop the new guidelines. RESULTS: To assess what a placebo control entails and to assess the understanding of this tool in the context of surgery is considered, along with when placebo controls in surgery are acceptable (and when they are desirable). We have considered ethics arguments and regulatory requirements, how a placebo control should be designed, how to identify and mitigate risk for participants in these trials, and how such trials should be carried out and interpreted. The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics rationale. Surgical placebos might be most appropriate when there is poor evidence for the efficacy of the procedure and a justified concern that results of a trial would be associated with a high risk of bias, particularly because of the placebo effect. CONCLUSIONS: The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics rationale. Feasibility work is recommended to optimise the design and implementation of randomised controlled trials. An outline for best practice was produced in the form of the Applying Surgical Placebo in Randomised Evaluations (ASPIRE) guidelines for those considering the use of a placebo control in a surgical randomised controlled trial. LIMITATIONS: Although the workshop participants involved international members, the majority of participants were from the UK. Therefore, although every attempt was made to make the recommendations applicable to all health systems, the guidelines may, unconsciously, be particularly applicable to clinical practice in the UK NHS. FUTURE WORK: Future work should evaluate the use of the ASPIRE guidelines in making decisions about the use of a placebo-controlled surgical trial. In addition, further work is required on the appropriate nomenclature to adopt in this space. FUNDING: Funded by the Medical Research Council UK and the National Institute for Health Research as part of the Medical Research Council-National Institute for Health Research Methodology Research programme.

3.
BMJ Open ; 11(9): e052758, 2021 Sep 17.
Artigo em Inglês | MEDLINE | ID: mdl-34535486

RESUMO

INTRODUCTION: People presenting with shoulder pain considered to be of musculoskeletal origin is common in primary care but diagnosing the cause of the pain is contentious, leading to uncertainty in management. To inform optimal primary care for patients with shoulder pain, the study aims to (1) to investigate the short-term and long-term outcomes (overall prognosis) of shoulder pain, (2) estimate costs of care, (3) develop a prognostic model for predicting individuals' level and risk of pain and disability at 6 months and (4) investigate experiences and opinions of patients and healthcare professionals regarding diagnosis, prognosis and management of shoulder pain. METHODS AND ANALYSIS: The Prognostic And Diagnostic Assessment of the Shoulder (PANDA-S) study is a longitudinal clinical cohort with linked qualitative study. At least 400 people presenting to general practice and physiotherapy services in the UK will be recruited. Participants will complete questionnaires at baseline, 3, 6, 12, 24 and 36 months. Short-term data will be collected weekly between baseline and 12 weeks via Short Message Serevice (SMS) text or software application. Participants will be offered clinical (physiotherapist) and ultrasound (sonographer) assessments at baseline. Qualitative interviews with ≈15 dyads of patients and their healthcare professional (general practitioner or physiotherapist).Short-term and long-term trajectories of Shoulder Pain and Disability Index (using SPADI) will be described, using latent class growth analysis. Health economic analysis will estimate direct costs of care and indirect costs related to work absence and productivity losses. Multivariable regression analysis will be used to develop a prognostic model predicting future levels of pain and disability at 6 months using penalisation methods to adjust for overfitting. The added predictive value of prespecified physical examination tests and ultrasound findings will be examined. For the qualitative interviews an inductive, exploratory framework will be adopted using thematic analysis to investigate decision making, perspectives of patients and clinicians on the importance of diagnostic and prognostic information when negotiating treatment and referral options. ETHICS AND DISSEMINATION: The PANDA-S study has ethical approval from Yorkshire and The Humber-Sheffield Research Ethics Committee, UK (18/YH/0346, IRAS Number: 242750). Results will be disseminated through peer-reviewed publications, social and mainstream media, professional conferences, and the patient and public involvement and engagement group supporting this study, and through newsletters, leaflets and posters in participating sites. TRIAL REGISTRATION NUMBER: ISRCTN46948079.

4.
BMJ Open ; 11(8): e052598, 2021 08 27.
Artigo em Inglês | MEDLINE | ID: mdl-34452970

RESUMO

OBJECTIVES: To evaluate whether a home-based rehabilitation programme for people assessed as being at risk of a poor outcome after knee arthroplasty offers superior outcomes to traditional outpatient physiotherapy. DESIGN: A prospective, single-blind, two-arm randomised controlled superiority trial. SETTING: 14 National Health Service physiotherapy departments in the UK. PARTICIPANTS: 621 participants identified at high risk of a poor outcome after knee arthroplasty using a bespoke screening tool. INTERVENTIONS: A multicomponent home-based rehabilitation programme delivered by rehabilitation assistants with supervision from qualified therapists versus usual care outpatient physiotherapy. MAIN OUTCOME MEASURES: The primary outcome was the Late-Life Function and Disability Instrument (LLFDI) at 12 months. Secondary outcomes were the Oxford Knee Score (a disease-specific measure of function), Knee injury and Osteoarthritis Outcome Score Quality of Life subscale, Physical Activity Scale for the Elderly, 5 dimension, 5 level version of Euroqol (EQ-5D-5L) and physical function assessed using the Figure of 8 Walk test, 30 s Chair Stand Test and Single Leg Stance. RESULTS: 621 participants were randomised between March 2015 and January 2018. 309 were assigned to CORKA (Community Rehabilitation after Knee Arthroplasty) home-based rehabilitation, receiving a median five treatment sessions (IQR 4-7). 312 were assigned to usual care, receiving a median 4 sessions (IQR 2-6). The primary outcome, LLFDI function total score at 12 months, was collected for 279 participants (89%) in the home-based CORKA group and 287 participants (92%) in the usual care group. No clinically or statistically significant difference was found between the groups (intention-to-treat adjusted difference=0.49 points; 95% CI -0.89 to 1.88; p=0.48). There were no statistically significant differences between the groups on any of the patient-reported or physical secondary outcome measures at 6 or 12 months.There were 18 participants in the intervention group reporting a serious adverse event (5.8%), only one directly related to the intervention, all other adverse events recorded throughout the trial related to underlying chronic medical conditions. CONCLUSIONS: The CORKA intervention was not superior to usual care. The trial detected no significant differences, clinical or statistical, between the two groups on either primary or secondary outcomes. CORKA offers an evaluation of an intervention utilising a different service delivery model for this patient group. TRIAL REGISTRATION NUMBER: ISRCTN13517704.


Assuntos
Artroplastia do Joelho , Idoso , Análise Custo-Benefício , Humanos , Modalidades de Fisioterapia , Estudos Prospectivos , Qualidade de Vida , Método Simples-Cego , Medicina Estatal
5.
Pain ; 2021 Aug 02.
Artigo em Inglês | MEDLINE | ID: mdl-34382608

RESUMO

ABSTRACT: The number of placebo surgical trials on musculoskeletal conditions is increasing, but little is known about the quality of their design and methods. This review aimed to (1) assess the level of placebo fidelity (ie, degree to which the placebo control mimicked the index procedure) in placebo trials of musculoskeletal surgery, (2) describe the trials' methodological features using the adapted Applying Surgical Placebo in Randomised Evaluations (ASPIRE) checklist, and (3) describe each trial's characteristics. We searched 4 electronic databases from inception until February 18, 2021, for randomised trials of surgery that included a placebo control for any musculoskeletal condition. Protocols and full text were used to assess placebo fidelity (categorised as minimal, low, or high fidelity). The adapted 26-item ASPIRE checklist was also completed on each trial. PROSPERO registration number: CRD42021202131. A total of 30,697 studies were identified in the search, and 22 placebo-controlled surgical trials of 2045 patients included. Thirteen trials (59%) included a high-fidelity placebo control, 7 (32%) used low fidelity, and 2 (9%) minimal fidelity. According to the ASPIRE checklist, included trials had good reporting of the "rationale and ethics" (68% overall) and "design" sections (42%), but few provided enough information on the "conduct" (13%) and "interpretation and translation" (11%) of the placebo trials. Most trials sufficiently reported their rationale and ethics, but interpretation and translation are areas for improvement, including greater stakeholder involvement. Most trials used a high-fidelity placebo procedure suggesting an emphasis on blinding and controlling for nonspecific effects.

6.
Pilot Feasibility Stud ; 7(1): 163, 2021 Aug 20.
Artigo em Inglês | MEDLINE | ID: mdl-34416915

RESUMO

BACKGROUND: A rotator cuff tear is a common disabling shoulder problem. Symptoms include pain, weakness, lack of mobility and sleep disturbance. Many patients require surgery to repair the tear; however, there is a high failure rate. There is a pressing need to improve the outcome of rotator cuff surgery. The use of patch augmentation to provide support to the healing process and improve patient outcomes holds new promise. Different materials (e.g. human/animal skin or intestine tissue, and completely synthetic materials) and processes (e.g. woven or a mesh) have been used to produce patches. However, clinical evidence on their use is limited. The patch augmented rotator cuff surgery (PARCS) feasibility study aimed to determine the design of a definitive randomised controlled trial (RCT) assessing the effectiveness and cost-effectiveness of a patch to augment surgical repair of the rotator cuff that is both acceptable to stakeholders and feasible. METHODS: A mixed methods feasibility study of conducing a subsequent RCT. The project involved six stages: a systematic review of clinical evidence; a survey of the British Elbow and Shoulder Society's (BESS) surgical membership; a survey of surgeon trialists; focus groups and interviews with stakeholders; a two-round Delphi study administered via online questionnaires and a 2-day consensus meeting. RESULTS: The BESS surgeons' survey identified a variety of patches in use (105 (21%) responses received). Twenty-four surgeons (77%) completed the trialist survey relating to trial design. Four focus groups were conducted involving 24 stakeholders. Twenty-nine (67% of invited) individuals took part in the Delphi. Differing views were held on a number of aspects including the appropriate patient population for trial participation. Agreement on the key research questions and the outline of two potential RCTs were achieved through the Delphi study and the consensus meeting. CONCLUSIONS: Randomised comparisons of on-lay patch use for completed rotator cuff repairs, and bridging patch use for partial rotator cuff repairs were identified as areas for further research. The value of an observational study to assess safety concerns of patch use was also highlighted. The main limitation was that the findings were influenced by the participants, who might not necessarily reflect all stakeholders.

7.
J Appl Physiol (1985) ; 131(2): 689-701, 2021 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-34197228

RESUMO

This study investigated whether artificial gravity (AG), induced by short-radius centrifugation, mitigated deterioration in standing balance and anticipatory postural adjustments (APAs) of trunk muscles following 60-day head-down tilt bed rest. Twenty-four participants were allocated to one of three groups: control group (n = 8); 30-min continuous AG daily (n = 8); and intermittent 6 × 5 min AG daily (n = 8). Before and immediately after bed rest, standing balance was assessed in four conditions: eyes open and closed on both stable and foam surfaces. Measures including sway path, root mean square, and peak sway velocity, sway area, sway frequency power, and sway density curve were extracted from the center of pressure displacement. APAs were assessed during rapid arm movements using intramuscular or surface electromyography electrodes of the rectus abdominis; obliquus externus and internus abdominis; transversus abdominis; erector spinae at L1, L2, L3, and L4 vertebral levels; and deep lumbar multifidus muscles. The relative latency between the EMG onset of the deltoid and each of the trunk muscles was calculated. All three groups had poorer balance performance in most of the parameters (all P < 0.05) and delayed APAs of the trunk muscles following bed rest (all P < 0.05). Sway path and sway velocity were deteriorated, and sway frequency power was less in those who received intermittent AG than in the control group (all P < 0.05), particularly in conditions with reduced proprioceptive feedback. These data highlight the potential of intermittent AG to mitigate deterioration of some aspects of postural control induced by gravitational unloading, but no protective effects on trunk muscle responses were observed.NEW & NOTEWORTHY This study presents novel insights into the effect of artificial gravity (AG) on the deterioration of standing balance and anticipatory postural adjustments (APAs) of trunk muscles induced by 60-day strict head-down bed rest. The results indicated severe balance dysfunction and delayed APAs during rapid arm movement. AG partially mitigated the deterioration in standing balance and may thus be considered as a potential countermeasure for future planetary surface explorations. Optimization of AG protocols might enhance effects.

8.
Phys Ther ; 2021 Jul 30.
Artigo em Inglês | MEDLINE | ID: mdl-34331766

RESUMO

Physical therapy is routinely delivered to patients after discharge from the hospital following knee arthroplasty (KA). Posthospitalization physical therapy is thought to be beneficial, particularly for those patients most at risk for poor outcome, the subgroup with persistent function-limiting pain despite an apparently successful surgery. Research teams have undertaken 3 large-scale multicenter Phase III randomized clinical trials designed specifically for patients at risk for poor outcome following KA. All 3 trials screened for poor outcome risk using different methods and investigated different physical therapist interventions delivered in different ways. Despite the variety of types of physical therapy and mode of delivery, all trials found no effects of the enhanced treatment as compared with usual care. In all cases, usual care required a lower dosage of physical therapy as compared with the enhanced interventions. This Perspective compares and contrasts the 3 trials, speculates on factors that may explain the no-effect findings, and proposes areas for future study designed to benefit the poor outcome phenotype.

9.
J Appl Physiol (1985) ; 131(1): 356-368, 2021 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-34080918

RESUMO

Exposure to axial unloading induces adaptations in paraspinal muscles, as shown after spaceflights. This study investigated whether daily exposure to artificial gravity (AG) mitigated lumbar spine flattening and muscle atrophy associated with 60-day head-down tilt (HDT) bed rest (Earth-based space analog). Twenty-four healthy individuals participated in the study: 8 received 30-min continuous AG; 8 received 6 × 5-min AG interspersed with rest periods; and 8 received no AG exposure (control group). Magnetic resonance imaging (MRI) of the lumbopelvic region was conducted at baseline (BDC) and at day 59 of HDT (HDT59). Longitudinal relaxation time (T1)-weighted images were used to assess morphology of the lumbar spine (spinal length, intervertebral disk angles, disk area) and volumes of the lumbar multifidus (LM), lumbar erector spinae (LES), quadratus lumborum (QL), and psoas major (PM) muscles from L1/L2 to L5/S1 vertebral levels. A chemical shift-based two-point lipid/water Dixon sequence was used to evaluate muscle composition. Results showed that spinal length and disk area increased (P < 0.05); intervertebral disk angles (P < 0.05) and muscle volumes of LM, LES, and QL reduced (P < 0.01); and lipid-to-water ratio for the LM and LES muscles increased (P < 0.01) after HDT59 in all groups. Neither of the AG protocols mitigated the lumbar spinae deconditioning induced by HDT bed rest. The increase in lipid-to-water ratio in LM and LES muscles indicates an increased relative intramuscular lipid concentration. Altered muscle composition in atrophied muscles may impair lumbar spine function after body unloading, which could increase injury risk to vulnerable soft tissues. This relationship needs further investigation.NEW & NOTEWORTHY This study presents novel insights into the morphological adaptations occurring in the lumbar spine after 60-day head-down bed rest and the potential role of artificial gravity (AG) to mitigate them. Results demonstrated no protective effect of AG protocols used in this study. In atrophied paraspinal muscles, the ratio of lipids versus intramuscular water increased in the postural lumbar muscles, which could impair muscle function during upright standing. These findings have relevance for future space explorations.


Assuntos
Repouso em Cama , Gravidade Alterada , Repouso em Cama/efeitos adversos , Decúbito Inclinado com Rebaixamento da Cabeça , Humanos , Vértebras Lombares/diagnóstico por imagem , Região Lombossacral , Imageamento por Ressonância Magnética , Atrofia Muscular/etiologia
10.
J Arthroplasty ; 36(8): 2887-2895.e7, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-33840536

RESUMO

BACKGROUND: The aim of the study was to investigate changes in patient-reported outcome measures (PROMs) after revision total knee arthroplasty (rTKA). METHODS: A total of 10,727 patients undergoing elective rTKA were recruited from the UK National Health Service PROMs data set from 2013 to 2019. PROMs were collected at baseline and six months to assess joint function (Oxford Knee Score, OKS) and quality of life (EQ-5D). Associations with a change in the OKS (COKS) were investigated through multiple linear regression. RESULTS: The mean COKS was 12.4 (standard deviation 10.7) points. A total of 6776 of 10,329 (65.6%) patients demonstrated increase in the OKS above the minimal important change of 7.5 points. The median change in the EQ-5D utility was 0.227 (interquartile range 0.000 to 0.554). A total of 4917 of 9279 (53.0%) patients achieved a composite endpoint of improvement greater than the minimal important change for joint function and 'better' QoL as per the Paretian analysis. A total of 7477 of 10,727 (69.7%) patients reported satisfaction with rTKA. A total of 7947 of 10,727 (74.1%) patients felt surgery was a success. A total of 4888 of 10,632 (46.0%) patients reported one or more adverse events. A higher preoperative OKS was associated with a lower COKS (coefficient -0.63 [95% confidence interval -0.67 to -0.60]). Other factors associated with a lower COKS were postoperative complication(s), age under 60 years, longer duration of knee problems, patients who identified as disabled, problems in EQ-5D dimensions of anxiety/depression and self-care, comorbid conditions (circulatory problems, diabetes, and depression), and earlier year of procedure in the data set. CONCLUSION: Two-thirds of patients experienced a meaningful improvement in joint function after rTKA. However, there was a high frequency of patient-reported complications. These findings may enable better informed discussion of the risks and benefits of discretionary rTKA.


Assuntos
Artroplastia do Joelho , Qualidade de Vida , Artroplastia do Joelho/efeitos adversos , Humanos , Pessoa de Meia-Idade , Medidas de Resultados Relatados pelo Paciente , Satisfação Pessoal , Medicina Estatal
11.
Bone Joint J ; 103-B(4): 627-634, 2021 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-33789485

RESUMO

AIMS: To estimate the measurement properties for the Oxford Knee Score (OKS) in patients undergoing revision knee arthroplasty (responsiveness, minimal detectable change (MDC-90), minimal important change (MIC), minimal important difference (MID), internal consistency, construct validity, and interpretability). METHODS: Secondary data analysis was performed for 10,727 patients undergoing revision knee arthroplasty between 2013 to 2019 using a UK national patient-reported outcome measure (PROM) dataset. Outcome data were collected before revision and at six months postoperatively, using the OKS and EuroQol five-dimension score (EQ-5D). Measurement properties were assessed according to COnsensus-based Standards for the selection of health status Measurement Instruments (COSMIN) guidelines. RESULTS: A total of 9,219 patients had complete outcome data. Mean preoperative OKS was 16.7 points (SD 8.1), mean postoperative OKS 29.1 (SD 11.4), and mean change in OKS + 12.5 (SD 10.7). Median preoperative EQ-5D index was 0.260 (interquartile range (IQR) 0.055 to 0.691), median postoperative EQ-5D index 0.691 (IQR 0.516 to 0.796), and median change in EQ-5D index + 0.240 (IQR 0.000 to 0.567). Internal consistency was good with Cronbach's α 0.88 (baseline) and 0.94 (post-revision). Construct validity found a high correlation of OKS total score with EQ-5D index (r = 0.76 (baseline), r = 0.83 (post-revision), p < 0.001). The OKS was responsive with standardized effect size (SES) 1.54 (95% confidence interval (CI) 1.51 to 1.57), compared to SES 0.83 (0.81 to 0.86) for the EQ-5D index. The MIC for the OKS was 7.5 points (95% CI 5.5 to 8.5) based on the optimal cut-off with specificity 0.72, sensitivity 0.60, and area under the curve 0.66. The MID for the OKS was 5.2 points. The MDC-90 was 3.9 points. The OKS did not demonstrate significant floor or ceiling effects. CONCLUSION: This study found that the OKS was a useful and valid instrument for assessment of outcome following revision knee arthroplasty. The OKS was responsive to change and demonstrated good measurement properties. Cite this article: Bone Joint J 2021;103-B(4):627-634.


Assuntos
Artroplastia do Joelho , Osteoartrite do Joelho/cirurgia , Medidas de Resultados Relatados pelo Paciente , Reoperação , Idoso , Feminino , Humanos , Masculino , Qualidade de Vida , Reino Unido
12.
Health Technol Assess ; 25(13): 1-138, 2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-33646096

RESUMO

BACKGROUND: A rotator cuff tear is a common, disabling shoulder problem. Symptoms may include pain, weakness, lack of shoulder mobility and sleep disturbance. Many patients require surgery to repair the tear; however, there is a high failure rate. There is a need to improve the outcome of rotator cuff surgery, and the use of patch augmentation (on-lay or bridging) to provide support to the healing process and improve patient outcomes holds promise. Patches have been made using different materials (e.g. human/animal skin or tissue and synthetic materials) and processes (e.g. woven or mesh). OBJECTIVES: The aim of the Patch Augmented Rotator Cuff Surgery (PARCS) feasibility study was to determine the design of a definitive randomised controlled trial assessing the clinical effectiveness and cost-effectiveness of a patch to augment surgical repair of the rotator cuff that is both acceptable to stakeholders and feasible. DESIGN: A mixed-methods feasibility study of a randomised controlled trial. DATA SOURCES: MEDLINE, EMBASE and the Cochrane Library databases were searched between April 2006 and August 2018. METHODS: The project involved six stages: a systematic review of clinical evidence, a survey of the British Elbow and Shoulder Society's surgical membership, a survey of surgeon triallists, focus groups and interviews with stakeholders, a two-round Delphi study administered via online questionnaires and a 2-day consensus meeting. The various stakeholders (including patients, surgeons and industry representatives) were involved in stages 2-6. RESULTS: The systematic review comprised 52 studies; only 15 were comparative and, of these, 11 were observational (search conducted in August 2018). These studies were typically small (median number of participants 26, range 5-152 participants). There was some evidence to support the use of patches, although most comparative studies were at a serious risk of bias. Little to no published clinical evidence was available for a number of patches in clinical use. The membership survey of British Elbow and Shoulder surgeons [105 (21%) responses received] identified a variety of patches in use. Twenty-four surgeons (77%) completed the triallist survey relating to trial design. Four focus groups were conducted, involving 24 stakeholders. Differing views were held on a number of aspects of trial design, including the appropriate patient population (e.g. patient age) to participate. Agreement on the key research questions and the outline of two potential randomised controlled trials were achieved through the Delphi study [29 (67%)] and the consensus meeting that 22 participants attended. LIMITATIONS: The main limitation was that the findings were influenced by the participants, who are not necessarily representative of the views of the relevant stakeholder groups. CONCLUSION: The need for further clinical studies was clear, particularly given the range and number of different patches available. FUTURE WORK: Randomised comparisons of on-lay patch use for completed rotator cuff repairs and bridging patch use for partial rotator cuff repairs were identified as areas for further research. The value of an observational study to assess safety concerns of patch use was also highlighted. These elements are included in the trial designs proposed in this study. STUDY REGISTRATION: The systematic review is registered as PROSPERO CRD42017057908. 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. 25, No. 13. See the NIHR Journals Library website for further project information.

13.
ANZ J Surg ; 91(5): 975-979, 2021 05.
Artigo em Inglês | MEDLINE | ID: mdl-33559283

RESUMO

BACKGROUND: Impact factor (IF) is widely accepted as a measure of a journal's quality but it can be influenced by self-citation. However, the SCImago Journal Rank (SJR) is based on journal prestige, excludes self-citation and considers quality of citations of a journal. This study aimed to investigate journal editors' use of self-citation and whether this correlated with IFs or SJR in trauma and orthopaedic (T&O) journals. METHODS: T&O journals on the SJR database were identified. From each journal, data including country of publication, number of annual issues, IF, SJR indicator and citable articles were extracted. The editorial(s) of each issue in 2018 were reviewed. The total number of times the editors cited their own previous work or their journal (in the preceding 2 years, 2016-2017) were identified. Regression analyses were performed to investigate the association of editorial self-citation with journal IF or SJR indicator. RESULTS: Of the 270 journals identified, 43 T&O journals with 151 editorials were included in the final analysis. A positive correlation between journal self-citation in the editorial and IF (P = 0.02) and SJR indicator (P = 0.02) was found. Citation by editors of their own publications within editorials also positively correlated with IF (P = 0.04) but not for SJR indicator (P = 0.19). There was a positive linear relationship between journal IF and SJR indicators (P < 0.01). CONCLUSION: Editor self-citation influences the IF and SJR indicators in T&O journals. Therefore, these metrics should be considered in conjunction with other factors such as audience, topics included and international presence when evaluating journals.


Assuntos
Ortopedia , Publicações Periódicas como Assunto , Benchmarking , Bibliometria , Humanos , Fator de Impacto de Revistas
14.
J Plast Reconstr Aesthet Surg ; 74(1): 94-100, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-32917568

RESUMO

Fingernail deformity is common, yet current methods used to define cosmetic appearance following trauma are mainly descriptive. In order to quantify the cosmetic appearance of the fingernail, we developed the Oxford Fingernail Appearance Score using a three stage iterative process. The score has five cosmetic components marked as binary outcomes composed of nail shape, nail adherence, eponychial appearance, nail surface appearance and presence of a split. In the first stage, two assessors independently assessed 25 photographs of fingernails taken at a minimum of four months following paediatric nail bed repair and compared them to the corresponding contralateral uninjured finger. Following refinement in the score, ten different assessors scored a further 62 photographs of fingernails taken after paediatric nail bed repair. Assessors completed each of the five components, and the overall component score was calculated by statisticians post-hoc, taking the ideal appearance of each component as 1 ("identical to opposite" for nail shape, eponychium and surface, "complete" for adherence, "absent" for split) and all the non-ideal appearances as 0. Assessors effectively scored the photographs' integer values between 0 (least optimal appearance) and 5 (most optimal appearance). Refinements in the scoring system resulted in an improvement in a weighted kappa statistic of 0.36 (95% CI:0.09,0.68) in the initial score to 0.52 (95% CI: 0.42, 0.61). The Oxford Fingernail Appearance Score is a user-friendly and reliable scoring system which has application in a clinical trial setting.


Assuntos
Traumatismos dos Dedos/complicações , Unhas Malformadas/classificação , Unhas Malformadas/patologia , Criança , Humanos , Unhas Malformadas/etiologia , Variações Dependentes do Observador , Fotografação
15.
Acta Orthop ; 92(1): 85-90, 2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-33047623

RESUMO

Background and purpose - Meaningful interpretation of postoperative Oxford Knee Score (OKS) levels is challenging. We established Patient Acceptable Symptoms State (PASS) and Treatment Failure (TF) values for the OKS in patients undergoing primary total knee replacement (TKR) in Denmark.Patients and methods - Data from patients undergoing primary TKR between February 2015 and January 2019 was extracted from the arthroplasty registry at the Copenhagen University Hospital, Hvidovre in Denmark. Data included 3, 12, and 24 months postoperative responses to the OKS and 2 anchor questions asking whether they considered their symptom state to be satisfactory, and if not, whether they considered the treatment to have failed. PASS and TF threshold values were calculated using the adjusted predictive modeling method. Non-parametric bootstrapping was used to derive 95% confidence intervals (CI).Results - Complete 3, 12, and 24 months postoperative data was obtained for 187 of 209 (89%), 884 of 915 (97%), and 575 of 586 (98%) patients, with median ages from 68 to 70 years (59 to 64% female). 72%, 77%, and 79% considered as having satisfactory symptoms, while 6%, 11%, and 11% considered the treatment to have failed, at 3, 12, and 24 months postoperatively, respectively. OKS PASS values (CI) were 27 (26-28), 30 (29-31), and 30 (29-31) at 3, 12, and 24 months postoperatively. TF values were 27 (26-28) and 27 (26-29) at 12 and 24 months postoperatively.Interpretation - The OKS PASS values can be used to guide the interpretation of TKR outcome and support quality assessment in institutional and national registries.


Assuntos
Artroplastia do Joelho , Medidas de Resultados Relatados pelo Paciente , Satisfação do Paciente , Idoso , Dinamarca , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Medição da Dor , Resultado do Tratamento
16.
J Clin Epidemiol ; 132: 18-25, 2021 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-33301905

RESUMO

OBJECTIVES: The objective of the study was to create an interpretive categorical classification for the transition in the Oxford Knee Score (OKS) change score (ΔOKS) using the anchor-based method. STUDY DESIGN AND SETTING: Registry data from 46,094 total knee replacements from the year 2014/15, were accessed via the Health and Social Care Information Center official website. Data included preoperative and 6-month follow-up OKS and response to the transition anchor question. Categories were determined using Gaussian approximation probability and k-fold cross-validation. RESULTS: Four categories were identified with the corresponding ΔOKS intervals: "1. much better" (≥16), "2. a little better" (7-15), "3. about the same" (1-6), and "4. much worse" (≤0) based on the anchor questions' original five categories. The mean 10-fold cross-validation error was 0.35 OKS points (95% confidence interval 0.12 to 0.63). Sensitivity ranged from 0.34 to 0.68; specificity ranged from 0.74 to 0.95. CONCLUSION: We have categorized the change score into a clinically meaningful classification. We argue it should be an addition to the continuous OKS outcome to contextualize the results in a way more applicable to the shared decision-making process and for interpreting research results.

17.
BMJ Open ; 10(12): e039552, 2020 12 07.
Artigo em Inglês | MEDLINE | ID: mdl-33293307

RESUMO

OBJECTIVE: To appraise studies reporting on clinical effectiveness and safety of surgical meshes used to augment rotator cuff repairs (RCRs). DESIGN: Systematic review and meta-analysis. DATA SOURCES: MEDLINE, Embase and Cochrane databases were searched between April 2006 and April 2020. ELIGIBILITY CRITERIA: All studies evaluating adults (≥18 years) undergoing RCR were considered. There were no language restrictions. DATA EXTRACTION AND SYNTHESIS: Screening, data extraction and quality appraisal were conducted by two independent reviewers. Meta-analysis was conducted using a random-effects models if ≥2 comparative studies reported the same outcome measure. Risk of bias assessment was undertaken for randomised (RoB2, Cochrane) and comparative studies (ROBINS-I, Cochrane). RESULTS: We included 60 studies, consisting of 7 randomised controlled trials, 13 observational comparative studies and 40 observational case series. All comparative studies reported on shoulder-specific functional outcome scores, 18 on the radiographic occurrence of re-tear and 14 on pain score metrics. All studies contained some risk of bias.Compared with non-augmented repair, a small improvement in shoulder-specific function or pain scores was observed for synthetic patches with a mean improvement of 6.7 points on the University of California Los Angles (UCLA) shoulder score (95% CI 0.1 to 13.4) and 0.46 point reduction on the Visual Analogue Scale (95% CI -0.74 to -0.17), respectively. A reduced likelihood of radiologically observed re-tear was observed for synthetic (risk ratio (RR) 0.41, 95% CI 0.27 to 0.61) and allograft (RR 0.34, 95% CI 0.18 to 0.65) patches. A total of 49 studies reported on the occurrence of complications. Slightly higher crude complication rates were observed following patch-augmented repair (2.1%) than standard repair (1.6%). CONCLUSIONS: While several studies suggest a decreased failure rate and small improvements in shoulder function and pain following augmented RCR, a paucity of rigorous clinical evaluation, for both effectiveness and safety, prevents firm recommendations. PROSPERO REGISTRATION NUMBER: CRD42017057908.


Assuntos
Lesões do Manguito Rotador , Manguito Rotador , Artroplastia , Humanos , Manguito Rotador/cirurgia , Lesões do Manguito Rotador/cirurgia , Ombro , Resultado do Tratamento
18.
Health Technol Assess ; 24(65): 1-116, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-33250068

RESUMO

BACKGROUND: Over 100,000 primary knee arthroplasty operations are undertaken annually in the UK. Around 15-30% of patients do not report a good outcome. Better rehabilitation strategies may improve patient-reported outcomes. OBJECTIVES: To compare the outcomes from a traditional outpatient physiotherapy model with those from a home-based rehabilitation programme for people assessed as being at risk of a poor outcome after knee arthroplasty. DESIGN: An individually randomised, two-arm controlled trial with a blinded outcome assessment, a parallel health economic evaluation and a nested qualitative study. SETTING: The trial took place in 14 NHS physiotherapy departments. PARTICIPANTS: People identified as being at high risk of a poor outcome after knee arthroplasty. INTERVENTIONS: A multicomponent home-based rehabilitation package delivered by rehabilitation assistants with supervision from qualified therapists compared with usual-care outpatient physiotherapy. MAIN OUTCOME MEASURES: The primary outcome was the Late Life Function and Disability Instrument at 12 months. Secondary outcomes were the Oxford Knee Score (a disease-specific measure of function); Knee injury and Osteoarthritis Outcome Score; Quality of Life subscale; Physical Activity Scale for the Elderly; EuroQol-5 Dimensions, five-level version; and physical function assessed using the Figure-of-8 Walk Test, 30-Second Chair Stand Test and Single Leg Stance. Data on the use of health-care services, time off work and informal care were collected using participant diaries. RESULTS: In total, 621 participants were randomised. A total of 309 participants were assigned to the COmmunity based Rehabilitation after Knee Arthroplasty (CORKA) home-based rehabilitation programme, receiving a median of five treatment sessions (interquartile range 4-7 sessions). A total of 312 participants were assigned to usual care, receiving a median of four sessions (interquartile range 2-6 sessions). The primary outcome, Late Life Function and Disability Instrument function total score at 12 months, was collected for 279 participants (89%) in the home-based CORKA group and 287 participants (92%) in the usual-care group. No clinically or statistically significant difference was found between the groups (intention-to-treat adjusted difference 0.49 points, 95% confidence interval -0.89 to 1.88 points; p = 0.48). There were no statistically significant differences between the groups in any of the patient-reported or physical secondary outcome measures at 6 or 12 months post randomisation. The health economic analysis found that the CORKA intervention was cheaper to provide than usual care (£66 less per participant). Total societal costs (combining health-care costs and other costs) were lower for the CORKA intervention than usual care (£316 less per participant). Adopting a societal perspective, CORKA had a 75% probability of being cost-effective at a threshold of £30,000 per quality-adjusted life-year. Adopting the narrower health and social care perspective, CORKA had a 43% probability of being cost-effective at the same threshold. LIMITATIONS: The interventions were of short duration and were set within current commissioning guidance for UK physiotherapy. Participants and treating therapists could not be blinded. CONCLUSIONS: This randomised controlled trial found no important differences in outcomes when post-arthroplasty rehabilitation was delivered using a home-based, rehabilitation assistant-delivered rehabilitation package or a traditional outpatient model. However, the health economic evaluation found that when adopting a societal perspective, the CORKA home-based intervention was cost-saving and more effective than, and thus dominant over, usual care, owing to reduced time away from paid employment for this group. Further research could look at identifying the risk of poor outcome and further evaluation of a cost-effective treatment, including the workforce model to deliver it. TRIAL REGISTRATION: Current Controlled Trials ISRCTN13517704. 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. 24, No. 65. See the NIHR Journals Library website for further project information.

19.
BMJ ; 371: m3576, 2020 10 13.
Artigo em Inglês | MEDLINE | ID: mdl-33051212

RESUMO

OBJECTIVE: To evaluate whether a progressive course of outpatient physiotherapy offers superior outcomes to a single physiotherapy review and home exercise based intervention when targeted at patients with a predicted poor outcome after total knee arthroplasty. DESIGN: Parallel group randomised controlled trial. SETTING: 13 secondary and tertiary care centres in the UK providing postoperative physiotherapy. PARTICIPANTS: 334 participants with knee osteoarthritis who were defined as at risk of a poor outcome after total knee arthroplasty, based on the Oxford knee score, at six weeks postoperatively. 163 were allocated to therapist led outpatient rehabilitation and 171 to a home exercise based protocol. INTERVENTIONS: All participants were reviewed by a physiotherapist and commenced 18 sessions of rehabilitation over six weeks, either as therapist led outpatient rehabilitation (progressive goal oriented functional rehabilitation protocol, modified weekly in one-one contact sessions) or as physiotherapy review followed by a home exercise based regimen (without progressive input from a physiotherapist). MAIN OUTCOME MEASURES: Primary outcome was Oxford knee score at 52 weeks, with a 4 point difference between groups considered to be clinically meaningful. Secondary outcomes included additional patient reported outcome measures of pain and function at 14, 26, and 52 weeks post-surgery. RESULTS: 334 patients were randomised. Eight were lost to follow-up. Intervention compliance was more than 85%. The between group difference in Oxford knee score at 52 weeks was 1.91 (95% confidence interval -0.18 to 3.99) points, favouring the outpatient rehabilitation arm (P=0.07). When all time point data were analysed, the between group difference in Oxford knee score was a non-clinically meaningful 2.25 points (0.61 to 3.90, P=0.01). No between group differences were found for secondary outcomes of average pain (0.25 points, -0.78 to 0.28, P=0.36) or worst pain (0.22 points, -0.71 to 0.41, P=0.50) at 52 weeks or earlier time points, or of satisfaction with outcome (odds ratio 1.07, 95% confidence interval 0.71 to 1.62, P=0.75) or post-intervention function (4.64 seconds, 95% confidence interval -14.25 to 4.96, P=0.34). CONCLUSIONS: Outpatient therapist led rehabilitation was not superior to a single physiotherapist review and home exercise based regimen in patients at risk of poor outcomes after total knee arthroplasty. No clinically relevant differences were observed across primary or secondary outcome measures. TRIALS REGISTRATION: Current Controlled Trials ISRCTN23357609 and ClinicalTrials.gov NCT01849445.


Assuntos
Artroplastia do Joelho/reabilitação , Terapia por Exercício/métodos , Osteoartrite do Joelho/reabilitação , Dor Pós-Operatória/reabilitação , Modalidades de Fisioterapia , Idoso , Artroplastia do Joelho/efeitos adversos , Protocolos Clínicos , Feminino , Humanos , Articulação do Joelho/patologia , Articulação do Joelho/cirurgia , Masculino , Pessoa de Meia-Idade , Osteoartrite do Joelho/cirurgia , Medição da Dor , Dor Pós-Operatória/etiologia , Cooperação do Paciente , Medidas de Resultados Relatados pelo Paciente , Resultado do Tratamento
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA
...