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OBJECTIVE: Assess acceptability, appropriateness and feasibility of the Practical Guide to Implementing patient-reported outcome measures (PROMs) in Gender-Affirming Care (PG-PROM-GAC) from a sample of patients and healthcare professionals. DESIGN: Cross-sectional study conducted August-October 2023. SETTING: Participants were recruited from a National Health Service (NHS) gender clinic. PARTICIPANTS: Patient participants seeking care and healthcare professionals working at an NHS gender clinic were eligible for participation. The PG-PROM-GAC was sent to participants via email for review. OUTCOME MEASURES: Three validated tools to measure acceptability, appropriateness and feasibility were administered: the acceptability of intervention measure (AIM), intervention appropriateness measure (IAM) and feasibility of intervention measure (FIM). The percentage of participants indicating agreement or disagreement with items on the AIM, IAM and FIM was calculated. RESULTS: A total of 132 transgender and gender diverse (TGD) patients (mean age, SD: 33, 14) and 13 gender-affirming healthcare professionals (mean age, SD: 43, 11) completed the AIM, IAM and FIM, representing a range of gender identities. The cumulative percentage of patients indicating agree or strongly agree on the AIM, IAM and FIM for the patient-relevant strategies in the PG-PROM-GAC was over 50% for each item. The cumulative percentage of patients indicating disagree or strongly disagree on the AIM, IAM and FIM for the PG-PROM-GAC was less than 20% for each item. The cumulative percentage of healthcare professionals indicating agree or strongly agree on the AIM, IAM and FIM for the healthcare professional-relevant strategies in the PG-PROM-GAC was over 38% for each item. The cumulative percentage of healthcare professionals indicating disagree or strongly disagree on the AIM, IAM and FIM for the PG-PROM-GAC was less than 15% for each item. CONCLUSIONS: Gender-affirming healthcare professionals and TGD patients find the PG-PROM-GAC acceptable, appropriate and feasible. The PG-PROM-GAC is ready-to-use for clinicians, policy-makers and researchers committed to service improvement for gender-affirming care.
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Assistência à Saúde Afirmativa de Gênero , Medidas de Resultados Relatados pelo Paciente , Pessoas Transgênero , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Transversais , Estudos de Viabilidade , Medicina Estatal/estatística & dados numéricos , Inquéritos e Questionários , Pessoas Transgênero/estatística & dados numéricos , Pessoas Transgênero/psicologiaRESUMO
IMPORTANCE: The Practical Guide to Implementing PROMs in Gender-Affirming Care (PG-PROM-GAC) is an evidence-based resource, which was developed in response to international calls for improved patient-reported outcome measure (PROM) implementation in gender-affirming care. The PG-PROM-GAC has the potential to improve PROM implementation; however, its real-world effectiveness has not yet been investigated. OBJECTIVE: Investigate effectiveness and fidelity of three implementation strategies from the PG-PROM-GAC in a real-world gender clinic setting. DESIGN: Interrupted time series mixed-methods study investigating response rates to a PROM deployed alongside implementation strategies from the PG-PROM-GAC; and open-ended feedback on the fidelity and effectiveness of implementation strategies. SETTING: Participants were recruited from a National Health Service (NHS) gender clinic. PARTICIPANTS: Eligible participants were being seen at an NHS gender clinic for an appointment during the study period, and were invited to participate in this study via email. INTERVENTION: Three implementation strategies from the PG-PROM-GAC deployed alongside a PROM. MAIN OUTCOMES AND MEASURES: Response rates were calculated at 2-week intervals, in line with the deployment of each implementation strategy. Open-ended responses were thematically analysed by two researchers following guidance from implementation science and interpretation from Normalisation Process Theory. RESULTS: A total of 28 participants were included in this study with a mean (SD) age of 39 (17) years. In general, participants rated education material for PROMs as the most important for PROM implementation, and accessibility options for PROMs as the second most important. Response rates to PROM completion dropped as the study progressed, as the burden of reviewing implementation strategies increased. Results were used to construct recommendations for future PROM implementation efforts. CONCLUSIONS AND RELEVANCE: The PG-PROM-GAC and implementation strategy materials developed from this study (ie, educational video on PROMs co-developed with key stakeholders) can be used by clinicians, researchers and policymakers to lead PROM implementation efforts in gender-affirming care.
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Medidas de Resultados Relatados pelo Paciente , Humanos , Feminino , Masculino , Adulto , Pessoa de Meia-Idade , Análise de Séries Temporais Interrompida/métodos , Inquéritos e Questionários , Medicina Estatal/organização & administração , Medicina Estatal/estatística & dados numéricos , Pessoas Transgênero/estatística & dados numéricos , Pessoas Transgênero/psicologia , Assistência à Saúde Afirmativa de GêneroRESUMO
OBJECTIVE: Use CFIR guidance to create comprehensive, evidence-based, feasible, and acceptable gender-affirming care PROM implementation strategies. DESIGN, SETTING, PARTICIPANTS: A 3-Phase participatory process was followed to design feasible and acceptable strategies for integrating PROMs in gender-affirming care. In Phase 1, barriers and enablers to PROM implementation for gender-affirming care were identified from a previous systematic review and our prior qualitative study. We used the CFIR-ERIC tool to match previously identified barriers and enablers with expert-endorsed implementation strategies. In Phase 2, implementation strategy outputs from CFIR-ERIC were organised according to cumulative percentage value. In Phase 3, gender-affirming care PROM implementation strategies underwent iterative refinement based on rounds of stakeholder feedback with seven patient and public partners and a gender-affirming healthcare professional. RESULTS: The systematic review and qualitative study identified barriers and enablers to PROM implementation spanning all five CFIR domains, and 30 CFIR constructs. The top healthcare professional-relevant strategies to PROM implementation from the CFIR-ERIC output include: identifying and preparing implementation champions, collecting feedback on PROM implementation, and capturing and sharing local knowledge between clinics on implementation. Top patient-relevant strategies include: having educational material on PROMs, ensuring adaptability of PROMs, and collaborating with key local organisations who may be able to support patients. CONCLUSIONS: This study developed evidence-based, feasible, and acceptable strategies for integrating PROMs in gender-affirming care, representing evidence from a systematic review of 286 international articles, a qualitative study of 24 gender-affirming care patients and healthcare professionals, and iteration from 7 patient and public partners and a gender-affirming healthcare professional. The finalised strategies include patient- and healthcare professional-relevant strategies for implementing PROMs in gender-affirming care. Clinicians and researchers can select and tailor implementation strategies best applying to their gender-affirming care setting.
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Medidas de Resultados Relatados pelo Paciente , Humanos , Masculino , Feminino , Pesquisa Qualitativa , Pessoas Transgênero/psicologia , Assistência à Saúde Afirmativa de GêneroRESUMO
IMPORTANCE: Several international calls have been made for evidence-based patient-reported outcome measure (PROM) implementation for gender-affirming care. The Practical Guide to Implementing PROMs in Gender-Affirming Care (PG-PROM-GAC) is a resource which can help guide PROM implementation efforts, developed using a three-phase participatory research approach with transgender and gender-diverse (TGD) patients and gender-affirming healthcare professionals. However, thoughts and perspectives from TGD patients and gender-affirming healthcare professionals on the PG-PROM-GAC need to be investigated. OBJECTIVE: Investigate patient and healthcare professional perspectives on the PG-PROM-GAC through analysis of open-ended survey results. DESIGN: Qualitative study analysing open-ended responses from TGD patients and gender-affirming healthcare professionals. SETTING: Participants were recruited from a UK National Health System (NHS) gender clinic. PARTICIPANTS: Patients receiving care at an NHS gender clinic and healthcare professionals working at an NHS gender clinic were eligible for participation. Eligible participants were invited to participate in this study via email. INTERVENTION: Participants were sent an open-ended survey to collect responses on the PG-PROM-GAC. MAIN OUTCOMES AND MEASURES: Data were thematically analysed by two independent researchers and interpreted following guidance from established methods in implementation science. RESULTS: A total of 64 TGD patients and 9 gender-affirming healthcare professionals responded to the open-ended survey (mean (SD) age: 35 (16) and 48 (8), respectively). Four main themes emerged from the data: overall opinions and support for the PG-PROM-GAC, presentation of the PG-PROM-GAC, impact of gender clinic resources on PROM implementation and impact of PROM selection on implementation. Data were used to iterate the PG-PROM-GAC in response to participant feedback. CONCLUSIONS AND RELEVANCE: The PG-PROM-GAC is an acceptable and feasible resource that can be used by clinicians, researchers and policymakers to guide PROM implementation for gender-affirming care settings, helping to align gender-affirming care with patient needs.
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Instituições de Assistência Ambulatorial , Assistência à Saúde Afirmativa de Gênero , Humanos , Adulto , Pessoal de Saúde , Ciência da Implementação , Medidas de Resultados Relatados pelo PacienteRESUMO
OBJECTIVES: Patient and healthcare professional perspectives are needed to develop a gender-affirming care patient-reported outcome measure (PROM) implementation plan. We aimed to identify top considerations relevant to gender-affirming care PROM implementation from patient and healthcare professional perspectives. DESIGN, SETTINGS AND PARTICIPANTS: This qualitative study conducted in the UK between January and April 2023 includes focus groups with a patient sample diverse in age and gender identity, and a healthcare professional sample diverse in age and role. Established methods in implementation science and the Consolidated Framework for Implementation Research were used to create interview guides, and analyse data. Focus groups were audio recorded, transcribed verbatim and analysed by two independent researchers. Patient and healthcare professional focus groups were conducted separately. PRIMARY OUTCOME MEASURES: Patient and healthcare professional perspectives on PROM implementation were explored through focus groups and until data saturation. RESULTS: A total of 7 virtual focus groups were conducted with 24 participants (14 patients, mean (SD) age, 43 (14.5); 10 healthcare professionals, mean (SD) age, 46 (11.3)). From patient perspectives, key barriers to PROM implementation were mistrust with PROMs, lack of accessibility, burden, and lack of communication on why PROMs are important and how they will help care. From healthcare professional perspectives, key barriers to PROM implementation were lack of accessibility, burden with PROM administration and scoring, costs of implementation (financial and time), and lack of communication on what PROMs are and how they benefit service provision. CONCLUSION: Gender-affirming care PROM implementation must address: patient mistrust with PROMs, accessibility, communication on what PROMs are and how they can be used, reducing burden, and hybridised implementation. These factors may also be applicable to other clinical areas interested in implementing PROMs.
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Identidade de Gênero , Medidas de Resultados Relatados pelo Paciente , Humanos , Masculino , Feminino , Adulto , Pessoa de Meia-Idade , Pesquisa Qualitativa , Grupos Focais , Atenção à SaúdeRESUMO
Bizarre parosteal osteochondromatous proliferation, or Nora's lesion, is a rare benign tumour of the bone, most commonly described in the hands and feet. We present the case of a female patient in her 20s attending the hand clinic with a sudden onset, atraumatic swelling on the proximal phalanx of her right ring finger. The patient retains good hand function and remains asymptomatic 3 months after surgical excision. Our case highlights the importance of being aware of this diagnosis and differentiating it from other malignant, as well as benign tumours of the hand.
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Neoplasias Ósseas , Cartilagem Articular , Neoplasias de Tecido Conjuntivo , Osteocondroma , Neoplasias de Tecidos Moles , Humanos , Feminino , Osteocondroma/diagnóstico por imagem , Osteocondroma/cirurgia , Neoplasias Ósseas/diagnóstico por imagem , Neoplasias Ósseas/cirurgia , Cartilagem Articular/patologia , Dedos/patologia , Proliferação de CélulasRESUMO
Every year in the UK, around 10 000 children need to have operations to mend injuries to the bed of their fingernails. Currently, most children have their fingernail placed back on the injured nail bed after the operation. The NINJA trial found that children were slightly less likely to have an infection if the nail was thrown away rather than being put back, but the difference between groups was small and could have be due to chance. This study looked at whether replacing the nail is cost-effective compared with throwing it away. Using data from the NINJA trial, we compared costs, healthcare use, and quality of life and assessed the cost-effectiveness of replacing the nail. It was found that throwing the nail away after surgery would save the National Health Service (NHS) £75 (85) per operation compared with placing the nail back on the nail bed. Changing clinical practice could save the NHS in England £720 000 (819 000) per year.
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Análise de Custo-Efetividade , Unhas , Humanos , Criança , Análise Custo-Benefício , Unhas/cirurgia , Unhas/lesõesRESUMO
BACKGROUND: The relative motion (RM) orthosis was introduced over 40 years ago for extensor tendon rehabilitation and more recently applied to flexor tendon repairs. PURPOSE: We systematically reviewed the evidence for RM orthoses following surgical repair of finger extensor and flexor tendon injuries including indications for use, configuration and schedule of orthosis wear, and clinical outcomes. STUDY DESIGN: Systematic review. METHODS: A PRISMA-compliant systematic review searched eight databases and five trial registries, from database inception to January 7, 2022. The protocol was registered prospectively (CRD42020211579). We identified studies describing patients undergoing rehabilitation using RM orthoses after surgical repair of acute tendon injuries of the finger and hand. RESULTS: For extensor tendon repairs, ten studies, one trial registry and five conference abstracts met inclusion criteria, reporting outcomes of 521 patients with injuries in zones IV-VII. Miller's criteria were predominantly used to report range of motion; with 89.6% and 86.9% reporting good or excellent outcomes for extension lag and flexion deficit, respectively. For flexor tendon repairs, one retrospective case series was included reporting outcomes in eight patients following zones I-II repairs. Mean total active motion was 86%. No tendon ruptures were reported due to the orthosis not protecting the repair for either the RME or RMF approaches. DISCUSSION: Variation was seen in use of RME plus or only, use of night orthoses and orthotic wear schedules, which may be the result of evolution of the RM approach. Since Hirth et al's 2016 scoping review, there are five additional studies, including two RCTs reporting the use of the RM orthosis in extensor tendon rehabilitation. CONCLUSIONS: There is now good evidence that the RM approach is safe in zones V-VI extensor tendon repairs. Limited evidence currently exists for zones IV and VII extensor and for flexor tendon repairs. Further high-quality clinical studies are needed to demonstrate its safety and efficacy.
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Traumatismos dos Dedos , Traumatismos dos Tendões , Humanos , Estudos Retrospectivos , Aparelhos Ortopédicos , Traumatismos dos Tendões/cirurgia , Traumatismos dos Tendões/reabilitação , Tendões , Dedos , Traumatismos dos Dedos/cirurgia , Traumatismos dos Dedos/reabilitação , Amplitude de Movimento ArticularRESUMO
Importance: Gender-affirming care is a key clinical area that can benefit from implementation of patient-reported outcome measures (PROMs). Identifying barriers to and enablers of PROM implementation is needed to develop an evidence-based implementation strategy. Objective: To identify (1) PROMs previously implemented for gender-affirming care and constructs measured, (2) how patients completed PROMs and how results were reported and used, and (3) barriers to and enablers of PROM implementation. Evidence Review: In this systematic review, PubMed, Embase, MEDLINE, PsycINFO, CINAHL, and Web of Science were searched from inception to October 25, 2021, and updated on December 16, 2022. Gray literature was searched through gray literature database, online search engine, and targeted website searching. Inclusion criteria were (1) original articles of (2) a formally developed PROM or ad hoc instrument administered for gender-affirming care to (3) patients accessing gender-affirming care. The Critical Appraisal Skills Programme tool was used to evaluate quality of included studies. This review was registered on PROSPERO (CRD42021233080). Findings: In total, 286 studies were included, representing 85 395 transgender and nonbinary patients from more than 30 countries. A total of 205 different PROMs were used in gender-affirming care. No studies described using an implementation science theory, model, or framework to support PROM deployment. Key barriers to PROM implementation included issues with evidence strength and quality of the PROM, engaging participants, and PROM complexity. Key enablers of PROM implementation included using PROMs validated for gender-affirming care, implementing PROMs able to be deployed online or in person, implementing PROMs that are shorter and reduce patient burden, engaging key stakeholders and participants as part of developing an implementation plan, and organizational climate. Conclusions and Relevance: In this systematic review of barriers to and enablers of PROM implementation in gender-affirming care, PROM implementation was inconsistent and did not follow evidence-based approaches in implementation science. There was also a lack of patient input in creating implementation strategies, suggesting a need for patient-centered approaches to PROM implementation. Frameworks created from these results can be used to develop evidence-based PROM implementation initiatives for gender-affirming care and have potential generalizability for other clinical areas interested in implementing PROMs.
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Pessoas Transgênero , Transexualidade , Humanos , Medidas de Resultados Relatados pelo Paciente , Qualidade de VidaRESUMO
BACKGROUND: Surgery for nail bed injuries in children is common. One of the key surgical decisions is whether to replace the nail plate following nail bed repair. The aim of this RCT was to assess the clinical effectiveness and cost-effectiveness of nail bed repair with fingernail replacement/substitution compared with repair without fingernail replacement. METHODS: A two-arm 1 : 1 parallel-group open multicentre superiority RCT was performed across 20 secondary-care hospitals in the UK. The co-primary outcomes were surgical-site infection at around 7 days after surgery and cosmetic appearance summary score at a minimum of 4 months. RESULTS: Some 451 children presenting with a suspected nail bed injury were recruited between July 2018 and July 2019; 224 were allocated to the nail-discarded arm, and 227 to the nail-replaced arm. There was no difference in the number of surgical-site infections at around 7 days between the two interventions or in cosmetic appearance. The mean total healthcare cost over the 4 months after surgery was 84 (95 per cent c.i. 34 to 140) lower for the nail-discarded arm than the nail-replaced arm (P < 0.001). CONCLUSION: After nail bed repair, discarding the fingernail was associated with similar rates of infection and cosmesis ratings as replacement of the finger nail, but was cost saving. Registration number: ISRCTN44551796 (http://www.controlled-trials.com).
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Unhas , Infecção da Ferida Cirúrgica , Humanos , Criança , Unhas/cirurgia , Unhas/lesões , Infecção da Ferida Cirúrgica/etiologia , Infecção da Ferida Cirúrgica/prevenção & controle , Resultado do Tratamento , Custos de Cuidados de Saúde , Análise Custo-BenefícioRESUMO
INTRODUCTION: Open extremity fractures can be life-changing events. Clinical guidelines on the management of these injuries aim to standardise the care of patients by presenting evidence-based recommendations. We performed a scoping systematic review to identify all national clinical practice guidelines published to date. MATERIALS AND METHODS: A PRISMA-compliant scoping systematic review was designed to identify all national or federal guidelines for the management of open fractures, with no limitations for language or publication date. EMBASE and MEDLINE database were searched. Article screening and full-text review was performed in a blinded fashion in parallel by two authors. RESULTS: Following elimination of duplicates, 376 individual publications were identified and reviewed. In total, 12 clinical guidelines were identified, authored by groups in the UK, USA, the Netherlands, Finland, and Malawi. Two of these focused exclusively on antibiotic prophylaxis and one on combat-related injuries, with the remaining nine presented wide-scope recommendations with significant content overlap. DISCUSSION: Clinical practice guidelines serve clinicians in providing evidence-based and cost-effective care. We only identified one open fractures guideline developed in a low- or middle-income country, from Malawi. Even though the development of these guidelines can be time and resource intensive, the benefits may outweigh the costs by standardising the care offered to patients in different healthcare settings. International collaboration may be an alternative for adapting guidelines to match local resources and healthcare systems for use across national borders.
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Fraturas Expostas , Humanos , Antibioticoprofilaxia , Análise de Custo-Efetividade , Bases de Dados Factuais , Extremidades , Fraturas Expostas/cirurgiaRESUMO
Optimal management of pedunculated ulnar polydactyly is not defined. This systematic review summarises objective and patient-reported outcomes following primary treatment. Two authors screened articles for inclusion according to a PROSPERO published protocol. The meta-analysis of adverse events was performed, and a narrative synthesis of satisfaction and patient-reported outcomes was reported. The risk of bias was assessed using Cochrane's ROBINS-I tool. Of 1650 articles identified, 15 were eligible, including 13 single-arm and 2 multi-arm studies. Complications were 6 times as likely with ligation procedures (22%), compared to surgical removal (1%) whether this was performed in the outpatient setting or operating theatre (OR 6.89 [95% CI 1.73, 27]). Parent-reported satisfaction was high for all treatments. Studies were at high risk of bias and low methodological quality. Outcome measurement and follow-up were heterogenous. Well-designed prospective observational and experimental studies are required to inform practice, incorporating clinician and parent-reported outcomes and economic analyses. Level of evidence: I.
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The incidence of open tibia/fibula fractures in the elderly is increasing, but current national guidelines focus on the aggressive treatment of high-energy injuries in younger patients. There is conflicting evidence regarding whether older age affects treatment provision and outcomes in open fractures. The aim of this study was to determine if elderly patients are sustaining a different injury to younger patients and how their treatment and outcomes differ. This may have implications for future guidelines and verify their application in the elderly. In this retrospective single centre cohort study (December 2015-July 2018), we compared the injury characteristics, operative management and outcomes of elderly (≥65 years) and younger (18-65 years) patients with open tibia/fibula fractures. An extended cohort examined free flap reconstruction. In total, 157 patients were included. High-energy injuries were commoner in younger patients (88% vs 37%; p<0.001). Most were Gustilo-Anderson IIIb in both age groups. Elderly patients waited longer until debridement (21:19 vs 19:00 h) and had longer inpatient stays (23 vs 15 days). There was no difference in time to antibiotics, operative approach or post-operative complications. Despite the low-energy nature of elderly patients' injuries, the severity of soft tissue insult was equivalent to younger patients with high-energy injuries. Our data suggest that age and co-morbidities should not prohibit lower limb reconstruction. The current application of generic guidelines appears suitable in the elderly, particularly in the acute management. We suggest current management pathways and targets be reviewed to reflect the greater need for peri-operative optimisation and rehabilitation in elderly patients.
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BACKGROUND: The factors typically considered to be associated with Dupuytren disease have been described, such as those in the "Dupuytren diathesis." However, the quality of studies describing them has not been appraised. This systematic review aimed to analyze the evidence for all factors investigated for potential association with the development, progression, outcome of treatment, or recurrence of Dupuytren disease. METHODS: A systematic review of the Cochrane Central Register of Controlled Trials, MEDLINE, Embase, and Cumulative Index to Nursing and Allied Health Literature databases was conducted using a Preferred Reporting Items for Systematic Reviews and Meta-Analyses-compliant methodology up to September of 2019. Articles were screened in duplicate. Prognostic studies were quality assessed using the Quality in Prognosis Study tool. RESULTS: This study identified 2301 records; 51 met full inclusion criteria reporting data related to 54,491 patients with Dupuytren disease. In total, 46 candidate factors associated with the development of Dupuytren disease were identified. There was inconsistent evidence between the association of Dupuytren disease and the presence of "classic" diathesis factors. The quality of included studies varied, and the generalizability of studies was low. There was little evidence describing the factors associated with functional outcome. CONCLUSIONS: This systematic review challenges conventional notions of diathesis factors. Traditional diathesis factors are associated with disease development and recurrence, although they are not significantly associated with poor outcome following intervention based on the current evidence.
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Aponeurose/cirurgia , Contratura de Dupuytren/etiologia , Fasciotomia/métodos , Aponeurose/efeitos dos fármacos , Aponeurose/patologia , Progressão da Doença , Contratura de Dupuytren/epidemiologia , Contratura de Dupuytren/patologia , Contratura de Dupuytren/cirurgia , Fáscia/efeitos dos fármacos , Fáscia/patologia , Fasciotomia/estatística & dados numéricos , Humanos , Injeções Intralesionais , Colagenase Microbiana/administração & dosagem , Prognóstico , Recidiva , Fatores de Risco , Resultado do TratamentoRESUMO
INTRODUCTION: Venous thromboembolism (VTE) represents a major cause of morbidity and mortality. A variety of novel physical therapies have been proposed for patients in whom standard prophylaxis, including early mobilisation, is contraindicated. This article presents a systematic literature review of alternative physical treatments for VTE prophylaxis, focusing on surgical and trauma patients. METHODS: Following protocol registration in PROSPERO, a systematic review was conducted in accordance with PRISMA. MEDLINE and EMBASE databases were searched for all studies indexed before 27th of July 2019. Two authors independently screened these articles. Data gathering for eligible articles was also undertaken in parallel by two authors. A formal risk of bias assessment was conducted for each study along with an assessment on the quality of the evidence using the GRADE framework. RESULTS: A total of 272 abstracts were identified. After exclusion of duplicates and non-eligible articles, 10 publications were reviewed in detail. Two studies involving electrostimulation, another using a portable intermittent compression device and one study using postoperative calf massage reported a statistically significant reduction in the incidence of deep venous thrombosis when used in conjunction with LMWH. The remaining six articles did not show any significant benefits. DISCUSSION: All studies reporting significant benefits have methodological flaws, with a high risk of bias. The evidence base informing alternative physical treatments as prophylactic measures in VTE is limited. Our data suggest that the use of these physical modalities can be beneficial in patients who also received LMWH, whilst these alone are of no benefit. LEVEL OF EVIDENCE: II - Systematic Review Systematic Review Registration Number PROSPERO CRD42019133684.
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Tromboembolia Venosa , Trombose Venosa , Anticoagulantes/uso terapêutico , Heparina de Baixo Peso Molecular/uso terapêutico , Humanos , Incidência , Tromboembolia Venosa/epidemiologia , Tromboembolia Venosa/etiologia , Tromboembolia Venosa/prevenção & controle , Trombose Venosa/tratamento farmacológico , Trombose Venosa/epidemiologia , Trombose Venosa/prevenção & controleRESUMO
BACKGROUND: Hand fractures are common and sometimes require surgery to restore function. Placement of Kirschner wires (K-wires) is the most common form of surgical fixation. After placement, a key decision is whether to bury the end of a K-wire or leave it protruding from the skin (exposed). A recent systematic review found no evidence to support either approach and a national clinician and surgeon survey demonstrated further uncertainty. We aim to determine the design of a definitive randomised controlled trial assessing the cost and clinical effectiveness of buried versus exposed Kirschner wires for adults with metacarpal or phalangeal fractures. METHODS: We will employ three methodologies: a national service evaluation of current clinical practice, patient and surgeon focus groups and a consensus meeting to finalise the protocol for a randomised controlled trial. For the service evaluation, all outcomes will be summarised using descriptive statistics overall and split by group (buried versus exposed K-wires). Information collected in the patient focus groups will be analysed thematically. The surgeon consensus meeting will address each part of the design in turn and through discussion agree a final protocol. DISCUSSION: The study may be monitored, or audited in accordance with the current approved protocol, Good Clinical Practice (GCP), relevant regulations and standard operating procedures. The Chief Investigator will submit and, where necessary, obtain approval from the above parties for all substantial amendments to the original approved documents. A feasibility study report will be published by the Wire Study Steering committee. Additional members of the steering group and citable collaborators will be listed within the manuscript and their roles identified.
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OBJECTIVE: Prioritisation of important treatment uncertainties for 'Common Conditions Affecting the Hand and Wrist' via a UK-based James Lind Alliance Priority Setting Partnership. SETTING: This process was funded by a national charitable organisation and based in the UK. PARTICIPANTS: Anyone with experience of common conditions affecting the adult hand and wrist, including patients, carers and healthcare professionals. All treatment modalities delivered by a hand specialist, including therapists, surgeons or other allied professionals, were considered. INTERVENTIONS: Established James Lind Alliance Priority Setting Partnership methods were employed.Electronic and paper questionnaires identified potential uncertainties. These were subsequently confirmed using relevant, up-to-date systematic reviews. A final list of top 10 research uncertainties was developed via a face-to-face workshop with representation from patients and clinicians. Impact of research was sought by surveying hand clinicians electronically. OUTCOME MEASURES: The survey responses and prioritisation-both survey and workshop based. RESULTS: There were 889 individually submitted questions from the initial survey, refined to 59 uncertainties across 32 themes. Eight additional uncertainties were added from published literature before prioritisation by 261 participants and the workshop allowed the final top 10 list to be finalised. The top 10 has so far contributed to the award of over £3.8 million of competitively awarded funding. CONCLUSIONS: The Common Conditions in the Hand and Wrist Priority Setting Partnership identified important research questions and has allowed research funders to identify grant applications which are important to both patients and clinicians.