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BACKGROUND/OBJECTIVES: Obesity and chronic oedema/lymphoedema are two distinct but related conditions, rarely investigated together. The aim was to study the impact of increased weight on chronic oedema and related factors. SUBJECTS/METHODS: A cross-sectional study, 38 centers, nine countries. Patients with clinically confirmed chronic oedema/lymphoedema of the leg were included. Weight category was estimated as: normal weight (BMI 20-30), class I-II obesity (BMI 30-40), or class III obesity (BMI > 40). Factors were tested for an association with increased weight, using a multivariable model. RESULTS: A total of 7397 patients were included; 43% with normal weight, 36% class I-II obesity and 21% class III obesity. Increased weight was associated with more advanced stages of chronic oedema (ISL stage III; the most advanced form); affecting 14% in normal weight, 18% class I-II obesity and 39% class III obesity (p < 0.001). Ten factors were independently associated with increased weight: diabetes (OR 2.4), secondary lymphoedema (OR 2.7), cellulitis/erysipelas within 12 months (OR 1.2), bilateral lymphoedema (OR 3.6), compression therapy (OR 2.1), increased swelling duration (1-2 years OR 1.3, 2-5 years OR 2.5, 5-10 years OR 3.6, >10 years OR 3.5) decreased mobility (walking with aid OR 1.9, being chair bound OR 1.2) and age (reference<45 years; 45-64 years OR 1.5, 75-84 years OR 0.6, 85+ years OR 0.2). Increased weight was associated with a lower presentation of peripheral arterial disease (OR 0.7) and poorer chronic oedema control (OR 0.8). Patients with obesity had lower function, appearance and more severe symptoms (LYMQOL) and lower quality of life (EuroQol). CONCLUSIONS: Obesity negatively impacts chronic oedema, leading to more advanced stages. Achieving good control of swelling with compression is more difficult in these patients. Increased awareness of chronic oedema/lymphoedema as a complication of obesity is important for early detection and for developing effective strategies to prevent and manage them.
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BACKGROUND: Numerous surgical approaches exist for the treatment of pilonidal disease. Current literature on treatment is of poor quality, limiting the ability to define optimal intervention. The aim of this study was to provide real-world data on current surgical practice and report patient and risk-adjusted outcomes, informing future trial design. METHODS: This UK-wide multicentre prospective cohort study, including patients (aged over 16 years) who had definitive treatment for symptomatic pilonidal disease, was conducted between May 2019 and March 2022. Patient and disease characteristics, and intervention details were analysed. Data on patient-reported outcomes, including pain, complications, treatment failure, wound issues, and quality of life, were gathered at various time points up to 6 months after surgery. Strategies were implemented to adjust for risk influencing different treatment choices and outcomes. RESULTS: Of the 667 participants consenting, 574 (86.1%) were followed up to the study end. Twelve interventions were observed. Broadly, 59.5% underwent major excisional surgery and 40.5% minimally invasive surgery. Complications occurred in 45.1% of the cohort. Those who had minimally invasive procedures had better quality of life and, after risk adjustment, less pain (score on day 1: mean difference 1.58, 95% c.i. 1.14 to 2.01), fewer complications (difference 17.5 (95% c.i. 9.1 to 25.9)%), more rapid return to normal activities (mean difference 25.9 (18.4 to 33.4) days) but a rate of higher treatment failure (difference 9.6 (95% c.i. 17.3 to 1.9)%). At study end, 25% reported an unhealed wound and 10% had not returned to normal activities. CONCLUSION: The burden after surgery for pilonidal disease is high and treatment failure is common. Minimally invasive techniques may improve outcomes at the expense of a 10% higher risk of treatment failure.
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Seio Pilonidal , Humanos , Idoso , Resultado do Tratamento , Estudos Prospectivos , Seio Pilonidal/cirurgia , Qualidade de Vida , Recidiva Local de Neoplasia , Dor , RecidivaRESUMO
BACKGROUND: Lymphoedema is a globally neglected health care problem and a common complication following breast cancer treatment. Lymphoedema is a well-known predisposing factor for cellulitis, but few have investigated the risk factors for cellulitis in this patient cohort on an international level. The aim of this study was to identify the frequency of cellulitis in patients with lymphoedema of the arm, including potential risk factors for cellulitis. METHODS: An international, multi-centre, cross-sectional study including patients with clinically assessed arm lymphoedema. The primary outcome was the incidence of cellulitis located to the arm with lymphoedema within the last 12 months, and its potential associated risk factors. The secondary outcome was life-time prevalence of cellulitis. Adults with clinically-assessed arm lymphoedema/chronic oedema (all causes) and able to give informed consent were included. End-of-life-patients or those judged as not in the patient's best interest were excluded. Both univariable and multivariable analysis were performed. RESULTS: A total of 2160 patients were included from Australia, Denmark, France, Ireland, Italy, Japan, Turkey and United Kingdom. Secondary lymphoedema was present in 98% of the patients; 95% of these were judged as related to cancer or its treatment. The lifetime prevalence of cellulitis was 22% and 1-year incidence 11%. Following multivariable analysis, factors associated with recent cellulitis were longer swelling duration and having poorly controlled lymphoedema. Compared to having lymphoedema less than 1 year, the risk increased with duration: 1-2 years (OR 2.15), 2-5 years (OR 2.86), 5-10 years (OR 3.15). Patients with well-controlled lymphoedema had a 46% lower risk of cellulitis (OR 0.54, 95% CI 0.39-0.73, p < 0.001). More advanced stages of lymphoedema were associated with cellulitis even after adjustment for swelling duration and control of swelling by logistic regression (stage II OR 5.44, stage III OR 9.13, p = 0.002), demonstrated in a subgroup analysis. CONCLUSION: Patients with advanced arm lymphoedema are at particular risk of developing cellulitis. Prevention of lymphoedema progression is crucial. The results lend towards a positive effect of having well-treated lymphoedema on the frequency of cellulitis.
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Neoplasias da Mama , Linfedema , Adulto , Humanos , Feminino , Celulite (Flegmão)/epidemiologia , Celulite (Flegmão)/complicações , Estudos Transversais , Braço , Linfedema/epidemiologia , Linfedema/etiologia , Edema/complicações , Neoplasias da Mama/complicaçõesRESUMO
AIM: Pilonidal sinus disease is a common condition treated by colorectal surgeons. There is a lack of literature in the field to guide optimal management of this condition. As part of the PITSTOP study, we aimed to identify policy and research priorities to provide direction to the field. METHOD: Patients and surgeons were invited to participate. A 'So what, now what' exercise was conducted, informed by data from PITSTOP. This generated statements for research and practice priorities. A three-round online Delphi study was conducted, ranking statements based on policy and research separately. Statements were rated 1 (not important) to 9 (important). Statements that were rated 7-9 by more than 70% of participants were entered into the consensus meeting. Personalized voting feedback was shown between rounds. A face-to-face meeting was held to discuss statements, and participants were asked to rank statements using a weighted choice vote. RESULTS: Twenty-two people participated in the focus group, generating 14 research and 19 policy statements. Statements were voted on by 56 participants in round 1, 53 in round 2 and 51 in round 3. A total of 15 policy statements and 19 research statements were discussed in the consensus round. Key policy statements addressed treatment strategies and intensity, surgeon training opportunities, need for classification and the impact of treatment on return to work. Research recommendations included design of future trials, methodology considerations and research questions. CONCLUSION: This study has identified research and policy priorities in pilonidal sinus disease which are relevant to patients and clinicians. These should inform practice and future research.
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AIM: Research in pilonidal disease faces several challenges, one of which is consistent and useful disease classification. The International Pilonidal Society (IPS) proposed a four-part classification in 2017. The aim of this work was to assess the validity and reliability of this tool using data from the PITSTOP cohort study. METHOD: Face validity was assessed by mapping the items/domains in the IPS tool against tools identified through a systematic review. Key concepts were defined as those appearing in more than two-thirds of published tools. Concurrent and predictive validity were assessed by comparing key patient-reported outcome measures between groups at baseline and at clinic visit. The outcomes of interest were health utility, Cardiff Wound Impact Questionnaire (CWIQ) and pain score between groups. Significance was set at p = 0.05 a priori. Interrater reliability was assessed using images captured during the PITSTOP cohort. Ninety images were assessed by six raters (two experts, two general surgeons and two trainees), and classified into IPS type. Interrater reliability was assessed using the unweighted kappa and unweighted Gwet's AC1 statistics. RESULTS: For face validity items represented in the IPS were common to other classification systems. Concurrent and predictive validity assessment showed differences in health utility and pain between groups at baseline, and for some treatment groups at follow-up. Assessors agreed the same classification in 38% of participants [chance-corrected kappa 0.52 (95% CI 0.42-0.61), Gwet's AC1 0.63 (95% CI 0.56-0.69)]. CONCLUSION: The IPS classification demonstrates key aspects of reliability and validity that would support its implementation.
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The aim of this scoping review was to provide an overview of current research into topical oxygen therapies including the under-researched singlet oxygen for wound healing. A scoping review was undertaken using five databases. After duplicates and ineligible studies were excluded, 49 studies were included for a narrative review. Out of the included 49 studies, 45 (91.8%) were published in the past 10 years (2013-2023) with 32 (65.3%) published in the past 5 years (2018-2023). Eight of the studies were systematic reviews and/or meta-analysis and 18 were RCTs. The search identified zero human RCTs on singlet oxygen, but one human cohort study and five studies in animals. There is evidence that topical oxygen therapy may be useful for the treatment of chronic wounds, mainly diabetic foot ulcers. Singlet oxygen has shown potential, but would need further confirmation in controlled human trials, including more research to understand the bio-properties.
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Pé Diabético , Oxigênio Singlete , Humanos , Estudos de Coortes , Cicatrização , Pé Diabético/terapia , Oxigênio/uso terapêuticoRESUMO
BACKGROUND: Lymphatic filariasis (LF) is a neglected tropical disease presenting mainly as lymphoedema (elephantiasis). At present, LF is not effectively treated. Integrative medicine (IM) treatment for lymphoedema uses a combination of Indian traditional medicine, Ayurveda, alongside yoga exercises, compression therapy, antibiotics and antifungal treatments, providing a useful combination where resources are limited and different practices are in use. OBJECTIVES: To assess the effectiveness of the IM in the existing clinical practice of lower-limb lymphoedema management and to determine whether the treatment outcomes align with the World Health Organization (WHO) global goal of LF management. METHODS: Institutional data from electronic medical records of all 1698 patients with LF between 2010 and 2019 were retrospectively analysed using pre- and post-treatment comparisons and the National Institute for Health and Care Excellence guidelines for clinical audit. The primary treatment outcomes evaluated were limb volume, bacterial entry points (BEEPs), episodes of cellulitis, and health-related quality of life (HRQoL). Secondary outcomes included the influence of the patient's sex, duration of illness, education and employment status on volume reduction. Multiple regression analysis, t-test, χ2-test, analysis of variance, Mann-Whitney U-test and the Kruskal-Wallis test were used to assess the association between IM and patients' treatment outcomes. RESULTS: Limb volume reduced by 24.5% [95% confidence interval (CI) 22.47-26.61; n = 1660] following an intensive supervised care period (mean 14.84â days, n = 1660). Limb volume further reduced by 1.42% (95% CI 0.76-2.07; n = 1259) at the first follow-up visit (mean 81.45â days), and by 2.3% between the first and second follow-up visits (mean 231.32â days) (95% CI 1.26-3.34; n = 796). BEEPs were reduced upon follow-up; excoriations (78.4%) and intertrigo (26.7%) were reduced at discharge and further improvements was achieved at the follow-up visits. In total, 4% of patients exhibited new BEEPs at the first follow-up [eczema (3.9%), folliculitis (6.5%), excoriations (11.9%) and intertrigo (15.4%); 4 of 7 BEEPs were recorded]. HRQoL, measured using the disease-specific Lymphatic Filariasis Specific Quality of Life Questionnaire, showed an average score of 73.9 on admission, which increased by 17.8 at the first follow-up and 18.6 at the second follow-up. No patients developed new cellulitis episodes at the first follow-up, and only five patients (5.3%) developed new episodes of cellulitis at the second follow-up. CONCLUSIONS: IM for lower-limb lymphoedema successfully reduces limb volume and episodes of cellulitis, and also reduces BEEPs, leading to improved HRQoL. IM aligns with the LF treatment goals of the WHO and is a low-cost, predominantly self-care management protocol. IM has the potential to change care models and improve the lives of patients with lymphoedema.
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Filariose Linfática , Medicina Integrativa , Intertrigo , Linfedema , Humanos , Filariose Linfática/complicações , Filariose Linfática/terapia , Qualidade de Vida , Celulite (Flegmão) , Autocuidado/métodos , Estudos Retrospectivos , Linfedema/terapia , Intertrigo/complicaçõesRESUMO
Venous leg ulcers (VLUs) are the most common type of leg ulcers with a significant socioeconomic burden due to slow healing. Cytokines may be involved in the pathogenesis of VLUs. In this systematic review, our objective was to investigate the association between cytokine levels, including growth factors, with the healing of VLUs. PubMed, Embase, Web of Science and Cochrane Library were searched from their inception to August 2021. We retrieved 28 articles investigating 38 different cytokines in 790 patients. Cytokines were most commonly investigated in wound fluid and less frequently in biopsies and serum. The studies were judged as having a moderate to high risk of bias, and the results were often inconsistent and sometimes conflicting. A meta-analysis was not performed due to clinical and methodological heterogeneities. We found weak evidence for elevated IL-1α, IL-6, IL-8, TNF-α and VEGF levels in non-healing VLUs, an elevation that declined with healing. TGF-ß1 levels tended to increase with VLU healing. Other cytokines warranting further investigations include EGF, FGF-2, GM-CSF, IL-1ß, IL-1Ra and PDGF-AA/PDGF-BB. We conclude that non-healing VLUs may be associated with an elevation of a palette of pro-inflammatory cytokines, possibly reflecting activated innate immunity in these wounds. There is a paucity of reliable longitudinal studies monitoring the dynamic changes in cytokine levels during wound healing.
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Úlcera da Perna , Úlcera Varicosa , Citocinas/metabolismo , Humanos , Úlcera da Perna/terapia , Úlcera Varicosa/metabolismo , Úlcera Varicosa/terapia , Fator A de Crescimento do Endotélio Vascular , CicatrizaçãoRESUMO
Wounds and chronic oedema are common disorders, but rarely studied together. The objective of this cross-sectional study was to investigate the point-prevalence and risk factors of wounds on the leg, in chronic leg oedema. Forty sites in nine countries were included. Of 7077 patients with chronic leg oedema, 12.70% had wounds. Independent risk factors were: peripheral arterial disease (odds ratio (OR) 4.87, 95% confidence intervals (CI) 3.63-6.52), cellulitis within the past 12 months (OR 2.69, 95% CI 2.25-3.21), secondary lymphoedema (OR 2.64, 95% CI 1.93-3.60), being male (OR 2.08, 95% CI 1.78-2.44), being over 85 years of age (OR 1.80, 95% CI 1.23-2.62), underweight (OR 1.79, 95% CI 1.14-2.79), bed bound (OR 1.79, 95% CI 1.01-3.16), chair bound (OR 1.52, 95% CI 1.18-1.97), diabetes (OR 1.47, 95% CI 1.23-1.77), and walking with aid (OR 1·41, 95% CI 1.17-1.69). 43.22% of those with wounds had clinically defined well-controlled oedema, associated with a significantly lower risk of wounds (OR 0.50, 95% CI 0.42-0.58, P < .001). Hard/fibrotic tissue (OR 1.71, 95% CI 1.19-2.48), and a positive Stemmers sign (OR 1.57, 95% CI 1.05-2.35) were associated with wounds. The study reinforces the importance of measures to control oedema, as controlled swelling was associated with a 50% lower risk of wounds.
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Perna (Membro) , Linfedema , Celulite (Flegmão) , Doença Crônica , Estudos Transversais , Edema/epidemiologia , Edema/etiologia , Humanos , Linfedema/epidemiologia , MasculinoRESUMO
AIM: Little is known about optimal management strategies for pilonidal sinus disease (PSD). We conducted a mixed-methods study to understand why patients make, and sometimes regret, treatment decisions. METHOD: We conducted longitudinal semi-structured interviews at the time of surgery and 6 months later with 20 patients from 13 UK hospitals. Framework analysis was performed, and themes were mapped to (1) the coping in deliberation framework and (2) an acceptability framework. Results were triangulated with those from structured survey instruments evaluating shared decision-making (SDM, best = 9) at baseline and decision regret (DR, most regret = 100) at 6 months. RESULTS: Nine of 20 patients were not offered a choice of treatment, but this was not necessarily seen as negative (SDM median 4; range 2-4). Factors that influenced decision-making included previous experience and anticipated recovery time. Median (range) DR was 5 (0-50). Those with the highest DR (scores 40-50) were, paradoxically, also amongst the highest scores on SDM (scores 4). Burden of wound care and the disparity between anticipated and actual recovery time were the main reasons for decision regret. CONCLUSION: To minimize regret about surgical decisions, people with PSD need better information about the burden of wound care and the risks of recurrence associated with different surgical approaches.
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Seio Pilonidal , Tomada de Decisões , Emoções , Humanos , Recidiva Local de Neoplasia , Participação do Paciente , Seio Pilonidal/cirurgiaRESUMO
OBJECTIVE: The purpose of this study was to explore the challenges of communication between patients and health professionals, and patient adherence to treatment for hard-to-heal wounds when using negative wound pressure therapy (NPWT). METHODS: Face-to-face, semi-structured interviews were conducted with patients undergoing NPWT. Specific features of the NPWT device were the priority for discussion although other factors central to communication and adherence were also explored. RESULTS: A total of 24 patients took part in the study. Data saturation was achieved during the analysis. Patients required ongoing support to understand complex and often protracted treatment and this was particularly important when specialist technology was used. A distinction was highlighted between those who decided not to adhere with therapy and those who did so unintentionally. Participants faced difficulties in their communications with health professionals and in ensuring their needs were listened to and addressed. CONCLUSION: Further research is needed to achieve a better understanding of this distinction and to evaluate interventions which can sustain adherence behaviours. Further exploration of how to establish concordant patient/health professional communications is warranted.
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Comunicação , Tratamento de Ferimentos com Pressão Negativa , Cooperação do Paciente , Relações Profissional-Paciente , Adulto , Idoso , Idoso de 80 Anos ou mais , Bandagens , Inglaterra , Feminino , Humanos , Entrevistas como Assunto , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Pesquisa QualitativaRESUMO
The reasons for the non-adherence to treatment for wound healing are complex and fall into unintentional and intentional categories. This study explored intentional and unintentional non-adherence to treatment from patient/carer and health care professional perspectives. Patients with wounds receiving ALLEVYN Life dressings (n = 20) and patients not receiving ALLEVYN Life dressings who were deemed to be non-adherent to treatment regimes (n = 6) took part in semi-structured interviews to explore their experiences of living with a wound, treatment and intentional and unintentional non-adherence. Three focus groups of health care professionals explored issues surrounding non-adherence to treatment regimes. Groups included nurses and doctors (n = 25). We found that relationships between participants and health care professionals varied in character across the groups. All participants expressed reasons for both intentional and unintentional adherence. Many reasons for intentional non-adherence are related to comfort and working the regime around patients' lives. Health care professionals considered the most common form of non-adherence to be unintentional. However, patients describe the most common form of non-adherence as being intentional. The relationship between patients and health care professionals varied in character between the groups. Discrepancies between professional and patient perspectives need to be reconciled and addressed to improve adherence to treatment regimes.
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Bandagens/estatística & dados numéricos , Doença Crônica/psicologia , Pessoal de Saúde/psicologia , Cooperação do Paciente/psicologia , Cooperação do Paciente/estatística & dados numéricos , Ferimentos e Lesões/psicologia , Ferimentos e Lesões/terapia , Adulto , Idoso , Idoso de 80 Anos ou mais , Atitude do Pessoal de Saúde , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Inquéritos e QuestionáriosRESUMO
Chronic oedema (CO) is a major clinical problem worldwide, which has many important secondary consequences for health, activity and participation. Effective treatment planning and organisation of services is dependent on an understanding of the condition and its epidemiology. This cross-sectional study was designed to estimate the point prevalence of CO within the health services of one UK urban population and to determine the proportions that have concurrent leg ulceration. Patients with CO in all anatomic sites were ascertained by health care professionals in one acute and one community hospital, all relevant outpatient and community nursing services, general practices and all nursing/residential homes in one urban catchment area (Derby City). The presence and distribution of oedema was confirmed through a brief clinical examination. A battery of demographic and clinical details was recorded for each case. Within the study population of Derby City residents, 971 patients were identified with CO [estimated crude prevalence 3·93 per 1000, 95% confidence interval (CI) 3·69-4·19]. The prevalence was the highest among those aged 85 or above (28·75 per 1000) and was higher among women (5·37 per 1000) than men (2·48 per 1000). The prevalence among hospital inpatients was 28·5%. Only five (3%) patients in the community population had oedema related to cancer or cancer treatment. Of the 304 patients identified with oedema from the Derby hospitals or community health services, 121 (40%) had a concurrent leg ulcer. Prevalence statistics and current demographic trends indicate that CO is a major and growing health care problem.
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Doença Crônica/epidemiologia , Atenção à Saúde/estatística & dados numéricos , Edema/epidemiologia , Edema/terapia , Úlcera da Perna/terapia , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Estudos Transversais , Feminino , Humanos , Úlcera da Perna/epidemiologia , Masculino , Pessoa de Meia-Idade , Prevalência , Fatores Sexuais , Reino Unido/epidemiologiaRESUMO
INTRODUCTION: Little is known about the risk of falling for people with venous leg ulcers (VLUs), and this subject has not been considered in UK populations. Many problems associated with living with VLUs are also known risk factors for sustaining a fall. This literature review considered the question: 'Do community-dwelling older adults with VLUs have different outcomes in physical function measures used to assess the risk of falling compared with those without VLUs?' METHOD: A review of quantitative literature relating to measures of physical function in people with and without VLUs was undertaken, the development of which was guided by the PRISMA guidelines. FINDINGS: People with VLUs have poorer scores in measures of physical function than in people without. Reliability of studies included in the review was hampered by small sample sizes and threats to internal validity and generalisability. CONCLUSIONS: People with VLUs may be at a greater risk of falling owing to limitations in balance and mobility. Improving physical function may result in ulcer healing and better quality of life. Reducing falls risk may also lead to improved patient safety and enhanced care outcomes. Further research is needed to better understand the problem.
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Acidentes por Quedas , Úlcera Varicosa/complicações , Bandagens Compressivas , Humanos , Qualidade de Vida , Reprodutibilidade dos Testes , Fatores de Risco , Úlcera Varicosa/terapia , CicatrizaçãoRESUMO
BACKGROUND: Researching the experiences of terminally ill patients with disfiguring wounds is likely to be a challenge anywhere, and this investigation came face-to-face with different attitudes on the part of both patients and nurses and doctors in England (the South-East) and Italy (Tuscany). AIM: To highlight the complexity of researching sensitive subjects and the difficulties encountered from the perspective of the researcher(s). METHODS: Some 14 patients were interviewed. In England access was relatively straightforward, with nurses linked to the hospice doing most of the recruitment. Access was more difficult in Italy, with some doctors expressing opposition. DISCUSSION: How ethical is it to treat dying patients as subjects for research? How does research of this kind vary from one culture to another? CONCLUSIONS: Interviewees can find it therapeutic to talk about their experiences to a sympathetic listener--although the listening does pose a considerable strain on the researcher.
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Neoplasias/patologia , Ferimentos e Lesões/patologia , Progressão da Doença , Inglaterra , Hospitais para Doentes Terminais , Humanos , Itália , Negociação , Neoplasias/enfermagem , Ferimentos e Lesões/enfermagemRESUMO
Over the past few decades, there has been a growing appreciation of the impact of leg ulceration on all aspects of a patient's life. Particular issues include uncontrolled pain, lack of sleep, odour, emotional problems and reduced mobility.
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Bandagens Compressivas , Úlcera da Perna/terapia , Humanos , Úlcera da Perna/fisiopatologia , CicatrizaçãoRESUMO
Background: There is no consensus on optimal management of pilonidal disease. Surgical practice is varied, and existing literature is mainly single-centre cohort studies of varied disease severity, interventions and outcome assessments. Objectives: A prospective cohort study to determine: ⢠disease severity and intervention relationship ⢠most valued outcomes and treatment preference by patients ⢠recommendations for policy and future research. Design: Observational cohort study with nested mixed-methods case study. Discrete choice experiment. Clinician survey. Three-stage Delphi survey for patients and clinicians. Inter-rater reliability of classification system. Setting: Thirty-one National Health Service trusts. Participants: Patients aged > 16 years referred for elective surgical treatment of pilonidal disease. Interventions: Surgery. Main outcome measures: Pain postoperative days 1 and 7, time to healing and return to normal activities, complications, recurrence. Outcomes compared between major and minor procedures using regression modelling, propensity score-based approaches and augmented inverse probability weighting to account for measured potential confounding features. Results: Clinician survey: There was significant heterogeneity in surgeon practice preference. Limited training opportunities may impede efforts to improve practice. Cohort study: Over half of patients (60%; Nâ =â 667) had a major procedure. For these procedures, pain was greater on day 1 and day 7 (mean difference day 1 pain 1.58 points, 95% confidence interval 1.14 to 2.01 points, nâ =â 536; mean difference day 7 pain 1.53 points, 95% confidence interval 1.12 to 1.95 points, nâ =â 512). There were higher complication rates (adjusted risk difference 17.5%, 95% confidence interval 9.1 to 25.9%, nâ =â 579), lower recurrence (adjusted risk difference -10.1%, 95% confidence interval -18.1 to -2.1%, nâ =â 575), and longer time to healing (>34 days estimated difference) and time to return to normal activities (difference 25.9 days, 95% confidence interval 18.4 to 33.4 days). Mixed-methods analysis: Patient decision-making was influenced by prior experience of disease and anticipated recovery time. The burden involved in wound care and the gap between expected and actual time for recovery were the principal reasons given for decision regret. Discrete choice experiment: The strongest predictors of patient treatment choice were risk of infection/persistence (attribute importance 70%), and shorter recovery time (attribute importance 30%). Patients were willing to trade off these attributes. Those aged over 30 years had a higher risk tolerance (22.35-34.67%) for treatment failure if they could experience rapid recovery. There was no strong evidence that younger patients were willing to accept higher risk of treatment failure in exchange for a faster recovery. Patients were uniform in rejecting excision-and-leave-open because of the protracted nursing care it entailed. Wysocki classification analysis: There was acceptable inter-rater agreement (κâ =â 0.52, 95% confidence interval 0.42 to 0.61). Consensus exercise: Five research and practice priorities were identified. The top research priority was that a comparative trial should broadly group interventions. The top practice priority was that any interventions should be less disruptive than the disease itself. Limitations: Incomplete recruitment and follow-up data were an issue, particularly given the multiple interventions. Assumptions were made regarding risk adjustment. Conclusions and future work: Results suggest the burden of pilonidal surgery is greater than reported previously. This can be mitigated with better selection of intervention according to disease type and patient desired goals. Results indicate a framework for future higher-quality trials that stratify disease and utilise broad groupings of common interventions with development of a patient-centred core outcome set. Trial registration: This trial is registered as ISRCTN95551898. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 17/17/02) and is published in full in Health Technology Assessment; Vol. 28, No. 33. See the NIHR Funding and Awards website for further award information.
Pilonidal disease is caused by ingrowing hairs between the buttocks. It can cause pain and infection and may need surgery. We do not know which operation gives the best results, or who operations help. PITSTOP aimed to find out which operation is the best and what is important to patients when deciding on surgery, and to suggest ideas for better treatment and future research. We looked at what operations were done and their outcomes. We interviewed patients about their experiences. Some completed a survey to help us understand what operations they might prefer based on risks and outcomes. Surgeons completed a survey about their experiences, and we explored whether a new tool could help us tell the difference between 'mild' and 'bad' disease. We used findings from these studies to help patients and surgeons give priorities for future practice and research. Six hundred and sixty-seven patients joined PITSTOP. People who had a major operation had more pain and took longer to return to normal activities. Some were still affected 6 months after surgery. However, disease recurrence was lower than after a minor procedure. Patients based decisions about treatment on the likelihood of success and the time to recover. The study and the surgeons' survey both showed marked differences in practice. Surgeons tended to offer one or two operations learned during training. A classification tool put cases in similar groups, but this did not influence treatment choices. The consensus exercise identified five research priorities, the top one being to put types of surgery into two groups. Of the five practice priorities, the top one was that surgery should not make the patient worse than the disease. There is variation in the treatment of pilonidal disease. Wound issues and impact on daily living should be avoided. The highlighted research questions should be addressed to improve care.
Assuntos
Seio Pilonidal , Humanos , Seio Pilonidal/cirurgia , Seio Pilonidal/terapia , Feminino , Masculino , Adulto , Estudos Prospectivos , Técnica Delphi , Recidiva , Pessoa de Meia-Idade , Adulto Jovem , Cicatrização , Dor Pós-Operatória , Preferência do Paciente , Índice de Gravidade de Doença , Adolescente , Reino UnidoRESUMO
In the acute phase of lymphoedema, patients require comprehensive decongestive therapy (CDT), which includes skin care, an exercise regimen, manual lymphatic drainage (MLD) and regular bandaging. This study was established to determine the effectiveness of a new system of bandage therapy, the 3M™ Coban™ 2 compression system. In total, 24 patients were entered into the study (12 from UK and 12 from Canada) with a variety of clinical presentations. The mean age of the groups was 57·4 years, which varied from 26 to 79 years. Body mass index (BMI) averaged 38·9 kg/m(2), with a range from 22·7 to 67·5 kg/m(2). Of the total, eight were women with arm lymphoedema, the remainder being men and women with lymphoedema of the lower limb. All were considered to be in need of CDT. After 19 days, the reduction of limb volume was measured, which indicated a mean limb volume reduction of 1210 ml (95% confidence interval, CI, 780-1641, P < 0·001). Leg affected patients experienced greater reduction than arm affected patients (1596 ml versus 438 ml), although both groups experienced significant reduction in limb volumes (both P < 0·001). Mean percentage changes in limb volume were 14·9% and 16·1% for legs and arms, respectively. The Measure Your Medical Outcome Profile questionnaire indicated significant improvement in symptoms considered important by the patient (P < 0·0001), which also led to improvements in skin quality by reducing skin thickness and firmness. The Coban 2 compression system provides good oedema reduction in both arms and legs to reduce limb volume and improvements in symptoms associated with lymphoedema.
Assuntos
Bandagens Compressivas , Linfedema/terapia , Cicatrização , Adulto , Idoso , Braço/patologia , Canadá , Feminino , Humanos , Perna (Membro)/patologia , Linfedema/patologia , Masculino , Pessoa de Meia-Idade , Tamanho do Órgão , Resultado do Tratamento , Reino UnidoRESUMO
This article explores the professional challenges of treating patients with complex/severe forms of chronic oedema/lymphoedema with compression therapy. Four focus groups were held, two in the UK and two in Canada, to examine the challenges faced by practitioners in their everyday practice. A number of challenges were identified by participants in both countries and include the changing profile of lymphoedema/chronic oedema and how increasing complexity is outpacing the development of services and research-based guidelines. Focus groups also highlighted a lack of public awareness, poor professional knowledge, delayed diagnosis and inappropriate treatment as having a significant impact on practice. Other practice-related issues include a poor understanding of treatment options among practitioners, a lack of evidence-based practice as well as difficulties associated with managing psychosocial problems and of ensuring concordance with treatment. In Canada, services tend to be more rural and remote than in the UK, autonomous specialist practice is less developed and practitioners were generally less confident and felt more vulnerable than their UK colleagues. There is a need for integrated, multi-disciplinary services in both countries, with improved education and training, as well as the development of cost-effective compression bandaging systems that can make a major contribution to meeting the challenges of contemporary lymphoedema practice.