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OBJECTIVES: We conducted a health economic sub-study within a feasibility RCT comparing a non-operative treatment pathway as an alternative to appendicectomy for the treatment of uncomplicated acute appendicitis in children. The objectives were to understand and assess data collection tools and methods and to determine indicative costs and benefits assessing the feasibility of conducting a full economic evaluation within the definitive trial. METHODS: We compared different methods of estimating treatment costs including micro-costing, hospital administrative data (PLICS) and health system (NHS) reference costs. We compared two different HRQoL instruments (CHU-9D and EQ-5D-5L) in terms of data completeness and sensitivity to change over time, including potential ceiling effects. We also explored how the timing of data collection and duration of the analysis could affect QALYs (Quality Adjusted Life Years) and the results of the cost-utility analysis (CUA) within the future RCT. RESULTS: Using a micro-costing approach, the total per treatment costs were in alignment with hospital administrative data (PLICS). Average health system reference cost data (macro-costing using NHS costs) could potentially underestimate these treatment costs, particularly for non-operative treatment. Costs incurred following hospital discharge in the primary care setting were minimal, and limited family borne costs were reported by parents/carers. While both HRQoL instruments performed relatively well, our results highlight the problem of ceiling effect and the importance of the timing of data collection and the duration of the analysis in any future assessment using QALYs and CUA. CONCLUSIONS: We highlighted the importance of obtaining accurate individual-patient cost data when conducting economic evaluations. Our results suggest that timing of data collection and duration of the assessment are important considerations when evaluating cost-effectiveness and reporting cost per QALY. CLINICAL TRIAL REGISTRATION: Current Controlled Trials ISRCTN15830435.
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Apendicite , Humanos , Criança , Apendicite/cirurgia , Qualidade de Vida/psicologia , Análise Custo-Benefício , Custos de Cuidados de Saúde , Análise de Custo-Efetividade , Anos de Vida Ajustados por Qualidade de VidaRESUMO
INTRODUCTION: There remains a need for a non-invasive, low-cost and easily accessible way of identifying women at risk of developing hypertensive disorders in pregnancy. This study evaluated the predictive value of longitudinal salivary uric acid measurement. MATERIAL AND METHODS: Pregnant women (n = 137) from 20 weeks of gestation were recruited at St Richards Hospital, Chichester, UK, for this prospective cohort study. Weekly samples of salivary uric acid were analyzed until delivery. Information regarding pregnancy and labor were obtained from the patient's record after delivery. Independent t tests were used to compare mean levels of salivary uric acid in women with hypertensive complications and adverse fetal outcomes with women with normal pregnancies. Main outcome measures were preeclampsia, pregnancy-induced hypertension, spontaneous preterm delivery and small-for-gestational-age babies. RESULTS: From 21 weeks of gestation until delivery, levels of salivary uric acid increased significantly in women who subsequently developed preeclampsia and pregnancy-induced hypertension compared with women with normal pregnancies (preeclampsia-mean at gestational age 21-24, 95% confidence interval [95% CI] [mean GA21-24 ): 108 [63-185] vs 47 (39-55) µmol/L; P = .005; pregnancy-induced hypertension-mean GA21-24 : 118 [54-258] vs 47 [39-55] µmol/L; P = .004). In women who had spontaneous preterm delivery, salivary uric acid levels increased significantly from 29 to 32 weeks of gestation compared with women with normal pregnancies (mean GA29-32 : 112 (57-221) vs 59 (50-71) µmol/L; P = .04). In women who had babies small-for-gestational-age <10th percentile and small-for-gestational-age <3rd percentile, differences in salivary uric acid levels were insignificant. CONCLUSIONS: Elevated levels of salivary uric acid precede the onset of preeclampsia, pregnancy-induced hypertension and preterm delivery. Salivary uric acid may prove to be an early biomarker of hypertensive complications of pregnancy and spontaneous preterm delivery.
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Hipertensão Induzida pela Gravidez/metabolismo , Pré-Eclâmpsia/metabolismo , Nascimento Prematuro/metabolismo , Saliva/metabolismo , Ácido Úrico/metabolismo , Adulto , Biomarcadores/metabolismo , Estudos de Coortes , Feminino , Humanos , Recém-Nascido , Recém-Nascido Pequeno para a Idade Gestacional , Projetos Piloto , GravidezRESUMO
BACKGROUND: Recent literature has raised concern regarding the occurrence of late dysplasia after normal screening in breech babies. One paper states a late dysplasia incidence of 29%. This finding is in contrast with other published work, which suggests breech presentation is predictive of spontaneous stabilization of the unstable neonatal hip. We decided to identify the rate of late dysplasia after normal screening in our patient cohort and also to investigate the use of a prophylactic abduction diaper. METHODS: During the study period of December 2012 to June 2014, breech babies referred to the screening program at our institution were identified. Ninety babies were prospectively enrolled into the study and randomized to either the observational arm or prophylactic treatment with the Healthy Hip Diaper (HALO, Minnetonka, MN). All babies had a normal initial clinical examination and ultrasound. Regular follow-up including clinical and ultrasound examination was undertaken culminating in pelvic x-rays performed at 13±1 months. A total of 63% of patients elected against their randomization to prophylactic treatment, 28% opted for prophylactic treatment against their randomization to observation only, meaning a total of 40% of babies proceeded against their initial randomization. In total, 75% of recruited babies completed follow-up. Dysplasia was defined as an acetabular index >2 SD from the mean sex, age, and side-specific values. RESULTS: The overall rate of radiographic dysplasia at 13 months was 7.4%. The rate was 5% in those using a Healthy Hip Diaper and 8.3% in those under observation only. This was not a statistically significant difference. Two patients required operative intervention, one requiring capsulorraphy with acetabuloplasty, the other requiring an arthrogram. Overall compliance with the abduction diaper was low. CONCLUSIONS: We conclude that late radiographic dysplasia does occur after normal clinical and ultrasound screening in breech babies, although not to the same extent as recently published data. We cannot recommend prophylactic abduction devices for breech babies who have a normal hip ultrasound at 6 weeks of age. Consideration must be given to further clinical and radiographic follow-up for hip dysplasia when the risk factor of breech presentation is present. LEVEL OF EVIDENCE: Level II-prospective comparative trial.
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Apresentação Pélvica , Luxação Congênita de Quadril/epidemiologia , Triagem Neonatal/métodos , Ultrassonografia/métodos , Feminino , Luxação Congênita de Quadril/diagnóstico , Humanos , Incidência , Lactente , Recém-Nascido , Masculino , Gravidez , Estudos Prospectivos , Fatores de Risco , Estados Unidos/epidemiologiaRESUMO
BACKGROUND: Chronic pelvic pain is a debilitating condition. It is unknown if there is a clinical phenotype for adhesive disorders. This study aimed to determine if the presence or absence, nature, severity and extent of adhesions correlated with demographic and patient reported clinical characteristics of women presenting with CPP. METHODS: Women undergoing a laparoscopy for the investigation of chronic pelvic pain were recruited prospectively; their pain and phenotypic characteristics were entered into a hierarchical cluster analysis. The groups with differing baseline clinical and operative characteristics in terms of adhesions involvement were analyzed. RESULTS: Sixty two women were recruited where 37 had adhesions. A low correlation was found between women's reported current pain scores and that of most severe (r = 0.34) or average pain experienced (r = 0.44) in the last 6 months. Three main groups of women with CPP were identified: Cluster 1 (n = 35) had moderate severity of pain, with poor average and present pain intensity; Cluster 2 (n = 14) had a long duration of symptoms/diagnosis, the worst current pain and worst physical, emotional and social functions; Cluster 3 (n = 11) had the shortest duration of pain and showed the best evidence of coping with low (good) physical, social and emotional scores. This cluster also had the highest proportion of women with adhesions (82%) compared to 51% in Cluster 1 and 71% in Cluster 2. CONCLUSIONS: In this study, we found that there is little or no correlation between patient-reported pain, physical, emotional and functional characteristics scores with the presence or absence of intra-abdominal/pelvic adhesions found during investigative laparoscopy. Most women who had adhesions had the lowest reported current pain scores.
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Dor Crônica/psicologia , Dor Pélvica/psicologia , Qualidade de Vida , Aderências Teciduais/complicações , Adulto , Dor Crônica/complicações , Análise por Conglomerados , Emoções , Feminino , Humanos , Laparoscopia , Medição da Dor , Dor Pélvica/complicações , Inquéritos e Questionários , Aderências Teciduais/cirurgiaRESUMO
BACKGROUND: Slipped upper femoral epiphysis (SUFE) has an incidence of 1 to 7 per 100,000 adolescents in the United Kingdom and its link with obesity is well established. With an increasing number of pediatric orthopaedic patients presenting with vitamin D deficiency, the aim of our study was to establish the prevalence of vitamin D deficiency in SUFE patients presenting to an orthopaedic department in the United Kingdom and whether a low vitamin D level increases the time to proximal femoral physeal fusion after surgical fixation. METHODS: A total of 27 pediatric patients, with a female to male ratio of 17:10 and a mean age of 11.5 years (SD=1.99), range 8 to 16 years, presented with a SUFE and their vitamin D level was assessed during the study period, June 2007 to July 2012 (inclusive). The majority of these patients (85.2%) were assessed as vitamin D deficient, with a serum 25-(OH)D<52 nmol/L. The time taken for >50% physeal fusion on anteroposterior radiography after surgical fixation reported in the literature is 9.6 months, with no reported vitamin D deficiency or insufficiency. RESULTS: In our study, the median time to physeal fusion in the vitamin D-deficient and vitamin D-insufficient patients was 25 months (interquartile range, 17 to 43 mo; mean of 29 mo, SD=16.8). A negative correlation was also observed between vitamin D level and the time taken for physeal fusion after surgical fixation. CONCLUSIONS: We conclude that a high prevalence of vitamin D deficiency has been observed in our SUFE patients. Comparing the time taken for physeal closure of 9.6 months in the literature with vitamin D-deficient patients, this is prolonged. Indeed, a negative correlation has been shown between vitamin D level and time to physeal fusion. This study highlights the need for regular vitamin D status assessment in SUFE patients to allow early implementation of treatment with vitamin D supplementation. The impact of vitamin D screening and supplementation on SUFE outcomes should be investigated further.
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Escorregamento das Epífises Proximais do Fêmur/epidemiologia , Escorregamento das Epífises Proximais do Fêmur/cirurgia , Deficiência de Vitamina D/sangue , Deficiência de Vitamina D/epidemiologia , Adolescente , Criança , Feminino , Lâmina de Crescimento/diagnóstico por imagem , Lâmina de Crescimento/fisiologia , Humanos , Masculino , Prevalência , Fatores de Tempo , Reino Unido/epidemiologia , Vitamina D/análogos & derivados , Vitamina D/sangue , Deficiência de Vitamina D/cirurgia , CicatrizaçãoRESUMO
BACKGROUND: Avascular necrosis (AVN) of the femoral head is an irreversible complication seen in the treatment of developmental dysplasia of hip (DDH) with the Pavlik harness. Its incidence is reported to be low after successful reduction of the hip but high if the hip is not concentrically relocated. We aim to investigate its incidence after failed Pavlik harness treatment. METHODS: We prospectively followed up a group of children who failed Pavlik harness treatment for DDH treated at our institution by the senior author between 1988 and 2001 and compared their rates of AVN with a group of children who presented late and hence were treated surgically. AVN was graded as described by Kalamchi and MacEwen and only grade 2 to 4 AVN was considered significant and included in the analysis. RESULTS: Thirty-seven hips were included in the failed Pavlik group (group 1) and 86 hips in the no Pavlik group (group 2). Ten hips in group 1 developed AVN (27%), whereas only 7 hips in group 2 (8%) developed AVN; the odds of developing AVN after failed Pavlik treatment was 4.7 (95% confidence interval, 1.3-14.1) (P=0.009) with a relative risk of 3.32 (range, 1.37 to 8.05). CONCLUSIONS: There was no statistically significant association observed with duration of splintage and severity of AVN (Spearman's correlation, -0.46; P=0.18). However, there was a positive correlation noted with age at presentation and severity of AVN. Therefore, we advise close monitoring of hips in the Pavlik harness and discontinue its use if the hips are not reduced within 3 weeks. LEVEL OF EVIDENCE: Level III.
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Necrose da Cabeça do Fêmur , Cabeça do Fêmur/diagnóstico por imagem , Luxação Congênita de Quadril , Procedimentos Ortopédicos/efeitos adversos , Posicionamento do Paciente/efeitos adversos , Braquetes/efeitos adversos , Pré-Escolar , Feminino , Necrose da Cabeça do Fêmur/diagnóstico , Necrose da Cabeça do Fêmur/epidemiologia , Necrose da Cabeça do Fêmur/etiologia , Seguimentos , Luxação Congênita de Quadril/complicações , Luxação Congênita de Quadril/epidemiologia , Luxação Congênita de Quadril/terapia , Humanos , Incidência , Lactente , Masculino , Procedimentos Ortopédicos/métodos , Posicionamento do Paciente/métodos , Estudos Prospectivos , Fatores de Risco , Falha de Tratamento , Ultrassonografia , Reino Unido/epidemiologiaRESUMO
BACKGROUND: Quality improvement strategies to increase and maintain the numbers of arteriovenous fistulas (AVFs) are a critical drive in enhancing the quality of care of patients receiving treatment with hemodialysis. How the AVF is needled is an important consideration in AVF survival; the ideal cannulation technique has not been established to date. STUDY DESIGN: Prospective randomized single-center trial. SETTING & PARTICIPANTS: Patients on maintenance hemodialysis therapy (N = 140). INTERVENTION: A 1-year intervention of buttonhole (constant site) or usual-practice (different site) cannulation. OUTCOMES: Primary study outcome was AVF survival over 1 year, in which AVF failure was defined as an AVF no longer used for hemodialysis (also referred to as assisted patency). Secondary outcomes included primary patency, number of access interventions, bleeding time, infection rate, cannulation time and pain, and aneurysm formation. RESULTS: Demographic data were similar for both groups. The primary outcome measure of AVF survival at 1 year was statistically significantly increased in the buttonhole group (100% vs 86% with usual practice; P = 0.005, log-rank test). In the buttonhole group, there were fewer interventions (19% vs 39% in usual practice) and less existing aneurysm enlargement (23% vs 67% in usual practice). There were no bacteremia events in the buttonhole group and 2 in the usual-practice group (0.09/1,000 AVF days). There were no significant differences in bleeding times and lignocaine use between the 2 groups. LIMITATIONS: A single-center study, lack of blinding. CONCLUSIONS: In this study, AVF survival was significantly greater when using buttonhole cannulation. The buttonhole technique significantly decreased the need for access interventions and reduced existing aneurysm enlargement. Concerns of increased infection rates or prolonged bleeding times with the buttonhole technique were not seen in this study. The buttonhole technique should be considered the cannulation technique of choice for AVFs.
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Derivação Arteriovenosa Cirúrgica/métodos , Cateteres de Demora , Cimento de Policarboxilato , Polietilenoglicóis/administração & dosagem , Diálise Renal/métodos , Idoso , Idoso de 80 Anos ou mais , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Cimento de Policarboxilato/uso terapêutico , Resultado do TratamentoRESUMO
BACKGROUND: The success of early dexamethasone therapy for hospitalised COVID-19 cases in treatment of Sars-CoV-2 infection may predominantly reflect its anti-inflammatory action against a hyperinflammation (HI) response. It is likely that there is substantial heterogeneity in HI responses in COVID-19. METHODS: Blood CRP, ferritin, neutrophil, lymphocyte and platelet counts were scored to assess HI (HI5) and combined with a validated measure of generalised medical deterioration (NEWS2) before day 2. Our primary outcome was 28 day mortality from early treatment with dexamethasone stratified by HI5-NEWS2 status. FINDINGS: Of 1265 patients, high risk of HI (high HI5-NEWS2) (n = 367, 29.0%) conferred a strikingly increased mortality (36.0% vs 7.8%; Age adjusted hazard ratio (aHR) 5.9; 95% CI 3.6-9.8, p<0.001) compared to the low risk group (n = 455, 36.0%). An intermediate risk group (n = 443, 35.0%) also showed significantly higher mortality than the low risk group (17.6% vs 7.8%), aHR 2.2, p = 0.005). Early dexamethasone treatment conferred a 50.0% reduction in mortality in the high risk group (36.0% to 18.0%, aHR 0.56, p = 0.007). The intermediate risk group showed a trend to reduction in mortality (17.8% to 10.3%, aHR 0.82, p = 0.46) which was not observed in the low risk group (7.8% to 9.2%, aHR 1.4, p = 0.31). INTERPRETATION: Higher HI5-NEWS2 scores measured at COVID-19 diagnosis, strongly associate with increased mortality at 28 days. Significant reduction in mortality with early dexamethasone treatment was only observed in the high risk group. Therefore, the HI5-NEWS2 score could be utilised to stratify randomised clinical trials to test whether intensified anti-inflammatory therapy would further benefit high risk patients and whether alternative approaches would benefit low risk groups. Considering its recognised morbidity, we suggest that early dexamethasone should not be routinely prescribed for HI5-NEWS2 low risk individuals with COVID-19 and clinicians should cautiously assess the risk benefit of this intervention in all cases.
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COVID-19 , Humanos , SARS-CoV-2 , Teste para COVID-19 , Tratamento Farmacológico da COVID-19 , Anti-Inflamatórios/uso terapêutico , Dexametasona/uso terapêuticoRESUMO
While non-operative treatment has emerged as an alternative to surgery for the treatment of uncomplicated acute appendicitis in children, comparative patient-centred outcomes are not well documented. We investigated these in a feasibility randomised trial. Of 57 randomised participants, data were available for 26. Compared with appendicectomy, children allocated to non-operative treatment reported higher short-term quality of life scores, shorter duration of requiring analgesia, more rapid return to normal activities and shorter parental absence from work. These preliminary data suggest differences exist in recovery profile and quality of life between these treatments that are important to measure in a larger RCT. Trial registration number is ISRCTN15830435.
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Antibacterianos , Apendicite , Criança , Humanos , Doença Aguda , Antibacterianos/uso terapêutico , Apendicectomia , Apendicite/cirurgia , Apendicite/tratamento farmacológico , Manejo da Dor , Qualidade de Vida , Estudos de ViabilidadeRESUMO
OBJECTIVE: To explore the relationship between occupational exposures and lateral and medial epicondylitis, and the effect of epicondylitis on sickness absence in a population sample of working-aged adults. METHODS: This was a cross-sectional study of 9696 randomly selected adults aged 25-64 years involving a screening questionnaire and standardized physical examination. Age- and sex-specific prevalence rates of epicondylitis were estimated and associations with occupational risk factors explored. RESULTS: Among 6038 respondents, 636 (11%) reported elbow pain in the last week. Of those surveyed, 0.7% were diagnosed with lateral epicondylitis and 0.6% with medial epicondylitis. Lateral epicondylitis was associated with manual work [odds ratio (OR) 4.0, 95% CI 1.9, 8.4]. In multivariate analyses, repetitive bending/straightening elbow >1 h day was independently associated with lateral (OR 2.5, 95% CI 1.2, 5.5) and medial epicondylitis (OR 5.1, 95% CI 1.8, 14.3). Five per cent of adults with epicondylitis took sickness absence because of their elbow symptoms in the past 12 months (median 29 days). CONCLUSION: Repetitive exposure to bending/straightening the elbow was a significant risk factor for medial and lateral epicondylitis. Epicondylitis is associated with prolonged sickness absence in 5% of affected working-aged adults.
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Exposição Ocupacional/efeitos adversos , Licença Médica/estatística & dados numéricos , Cotovelo de Tenista/etiologia , Absenteísmo , Adulto , Idoso , Estudos Transversais , Transtornos Traumáticos Cumulativos/complicações , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Prevalência , Fatores de Risco , Inquéritos e Questionários , Cotovelo de Tenista/diagnósticoRESUMO
INTRODUCTION: Physical rehabilitation delivered early following admission to the intensive care unit (ICU) has the potential to improve short-term and long-term outcomes. The use of supine cycling together with other rehabilitation techniques has potential as a method of introducing rehabilitation earlier in the patient journey. The aim of the study is to determine the feasibility of delivering the designed protocol of a randomised clinical trial comparing a protocolised early rehabilitation programme including cycling with usual care. This feasibility study will inform a larger multicentre study. METHODS AND ANALYSIS: 90 acute care medical patients from two mixed medical-surgical ICUs will be recruited. We will include ventilated patients within 72 hours of initiation of mechanical ventilation and expected to be ventilated a further 48 hours or more. Patients will receive usual care or usual care plus two 30 min rehabilitation sessions 5 days/week.Feasibility outcomes are (1) recruitment of one to two patients per month per site; (2) protocol fidelity with >75% of patients commencing interventions within 72 hours of mechanical ventilation, with >70% interventions delivered; and (3) blinded outcome measures recorded at three time points in >80% of patients. Secondary outcomes are (1) strength and function, the Physical Function ICU Test-scored measured on ICU discharge; (2) hospital length of stay; and (3) mental health and physical ability at 3 months using the WHO Disability Assessment Schedule 2. An economic analysis using hospital health services data reported with an embedded health economic study will collect and assess economic and quality of life data including the Hospital Anxiety and Depression Scales core, the Euroqol-5 Dimension-5 Level and the Impact of Event Score. ETHICS AND DISSEMINATION: The study has ethical approval from the South Central Hampshire A Research Ethics Committee (19/SC/0016). All amendments will be approved by this committee. An independent trial monitoring committee is overseeing the study. Results will be made available to critical care survivors, their caregivers, the critical care societies and other researchers. TRIAL REGISTRATION NUMBER: NCT03771014.
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Unidades de Terapia Intensiva , Qualidade de Vida , Cuidados Críticos/métodos , Estudos de Viabilidade , Humanos , Estudos Multicêntricos como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Respiração ArtificialRESUMO
OBJECTIVES: To assess the prevalence and correlates of regional pain and associated disability in four groups of Japanese workers. METHODS: As part of a large international survey of musculoskeletal symptoms (the CUPID study), nurses, office workers, sales/marketing personnel and transportation operatives in Japan completed a self-administered questionnaire (response rate 83%) covering experience of pain in six anatomical regions, associated disability and sickness absence, and various possible occupational and psychosocial risk factors for these outcomes. Associations with risk factors were assessed by logistic regression. RESULTS: Analysis was based on 2290 subjects. Rates of regional pain were generally less than in the UK, with a particularly low prevalence of wrist/hand pain among office workers (6% in past month). The strongest and most consistent risk factor for regional pain in the past month was tendency to somatise (ORs (95% CIs) for report of ≥ 2 versus 0 distressing somatic symptoms 3.1 (2.4 to 4.0) for low back pain, 2.8 (2.1 to 3.8) for shoulder pain, and 2.5 (1.6 to 4.1) for wrist/hand pain). Sickness absence for regional pain complaints in the past year was reported by 5% of participants, the major risk factor for this outcome being absence during the same period for other medical reasons (OR 3.7, 95% CI 2.4 to 5.8). CONCLUSIONS: Japanese office workers have markedly lower rates of wrist/hand pain than their UK counterparts. In Japan, as in Western Europe, somatising tendency is a major risk factor for regional pain. Sickness absence attributed to regional pain complaints appears to be much less common in Japan than in the UK, and to be driven principally by a general propensity to take sickness absence.
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Transtornos Traumáticos Cumulativos/epidemiologia , Doenças Profissionais/epidemiologia , Adulto , Distribuição por Idade , Transtornos Traumáticos Cumulativos/etiologia , Transtornos Traumáticos Cumulativos/psicologia , Avaliação da Deficiência , Métodos Epidemiológicos , Feminino , Humanos , Japão/epidemiologia , Satisfação no Emprego , Dor Lombar/epidemiologia , Dor Lombar/etiologia , Dor Lombar/psicologia , Masculino , Pessoa de Meia-Idade , Cervicalgia/epidemiologia , Cervicalgia/etiologia , Cervicalgia/psicologia , Doenças Profissionais/etiologia , Doenças Profissionais/psicologia , Dor de Ombro/epidemiologia , Dor de Ombro/etiologia , Dor de Ombro/psicologia , Licença Médica/estatística & dados numéricos , Adulto JovemRESUMO
OBJECTIVE: To establish the feasibility of a multicentre randomised controlled trial to assess the effectiveness and cost-effectiveness of a non-operative treatment pathway compared with appendicectomy in children with uncomplicated acute appendicitis. DESIGN: Feasibility randomised controlled trial with embedded qualitative study to inform recruiter training to optimise recruitment and the design of a future definitive trial. SETTING: Three specialist paediatric surgery centres in the UK. PATIENTS: Children (aged 4-15 years) with a clinical diagnosis of uncomplicated acute appendicitis. INTERVENTIONS: Appendicectomy or a non-operative treatment pathway (comprising broad-spectrum antibiotics and active observation). MAIN OUTCOME MEASURES: Primary outcome measure was the proportion of eligible patients recruited. Secondary outcomes evaluated adherence to interventions, data collection during follow-up, safety of treatment pathways and clinical course. RESULTS: Fifty per cent of eligible participants (95% CI 40 to 59) approached about the trial agreed to participate and were randomised. Repeated bespoke recruiter training was associated with an increase in recruitment rate over the course of the trial from 38% to 72%. There was high acceptance of randomisation, good patient and surgeon adherence to trial procedures and satisfactory completion of follow-up. Although more participants had perforated appendicitis than had been anticipated, treatment pathways were found to be safe and adverse event profiles acceptable. CONCLUSION: Recruitment to a randomised controlled trial examining the effectiveness and cost-effectiveness of a non-operative treatment pathway compared with appendicectomy for the treatment of uncomplicated acute appendicitis in children is feasible. TRIAL REGISTRATION NUMBER: ISRCTN15830435.
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BACKGROUND: Although non-operative treatment is known to be effective for the treatment of uncomplicated acute appendicitis in children, randomised trial data comparing important outcomes of non-operative treatment with those of appendicectomy are lacking. OBJECTIVES: The objectives were to ascertain the feasibility of conducting a multicentre randomised controlled trial comparing the clinical effectiveness and cost-effectiveness of a non-operative treatment pathway with appendicectomy for the treatment of uncomplicated acute appendicitis in children. DESIGN: This was a mixed-methods study, which included a feasibility randomised controlled trial, embedded and parallel qualitative and survey studies, a parallel health economic feasibility study and the development of a core outcome set. SETTING: This study was set in three specialist NHS paediatric surgical units in England. PARTICIPANTS: Children (aged 4-15 years) clinically diagnosed with uncomplicated acute appendicitis participated in the feasibility randomised controlled trial. Children, their families, recruiting clinicians and other health-care professionals involved in caring for children with appendicitis took part in the qualitative study. UK specialist paediatric surgeons took part in the survey. Specialist paediatric surgeons, adult general surgeons who treat children, and children and young people who previously had appendicitis, along with their families, took part in the development of the core outcome set. INTERVENTIONS: Participants in the feasibility randomised controlled trial were randomised to a non-operative treatment pathway (broad-spectrum antibiotics and active observation) or appendicectomy. MAIN OUTCOME MEASURES: The primary outcome measure was the proportion of eligible patients recruited to the feasibility trial. DATA SOURCES: Data were sourced from NHS case notes, questionnaire responses, transcribed audio-recordings of recruitment discussions and qualitative interviews. RESULTS: Overall, 50% (95% confidence interval 40% to 59%) of 115 eligible patients approached about the trial agreed to participate and were randomised. There was high acceptance of randomisation and good adherence to trial procedures and follow-up (follow-up rates of 89%, 85% and 85% at 6 weeks, 3 months and 6 months, respectively). More participants had perforated appendicitis than had been anticipated. Qualitative work enabled us to communicate about the trial effectively with patients and families, to design and deliver bespoke training to optimise recruitment and to understand how to optimise the design and delivery of a future trial. The health economic study indicated that the main cost drivers are the ward stay cost and the cost of the operation; it has also informed quality-of-life assessment methods for future work. A core outcome set for the treatment of uncomplicated acute appendicitis in children and young people was developed, containing 14 outcomes. There is adequate surgeon interest to justify proceeding to an effectiveness trial, with 51% of those surveyed expressing a willingness to recruit with an unchanged trial protocol. LIMITATIONS: Because the feasibility randomised controlled trial was performed in only three centres, successful recruitment across a larger number of sites cannot be guaranteed. However, the qualitative work has informed a bespoke training package to facilitate this. Although survey results suggest adequate clinician interest to make a larger trial possible, actual participation may differ, and equipoise may have changed over time. CONCLUSIONS: A future effectiveness trial is feasible, following limited additional preparation, to establish appropriate outcome measures and case identification. It is recommended to include a limited package of qualitative work to optimise recruitment, in particular at new centres. FUTURE WORK: Prior to proceeding to an effectiveness trial, there is a need to develop a robust method for distinguishing children with uncomplicated acute appendicitis from those with more advanced appendicitis, and to reach agreement on a primary outcome measure and effect size that is acceptable to all stakeholder groups involved. TRIAL REGISTRATION: Current Controlled Trials ISRCTN15830435. 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. 10. See the NIHR Journals Library website for further project information.
Appendicitis is usually treated with an operation to remove the appendix. But we have learned, from other research, that some children with appendicitis may not need an operation, and could be treated with antibiotics instead. To find out how these two different treatments compare with one another, we need to do a big study. First, though, we need to see if doing that kind of study would even be possible (or 'feasible'). We carried out a feasibility study that had several parts. First, we did a small study with children who had appendicitis, whereby children were randomly allocated to have either antibiotics or an operation, with an equal chance of having either treatment. Second, we asked parents and health-care staff about why they wanted, or did not want, to take part in that small study. This helped us to understand how to make a bigger future study as acceptable as possible to children, families and surgeons. Third, we asked parents, patients and surgeons what they think are the most important things or 'outcomes' we should look at in future research on children who have appendicitis. From that, we developed a list of outcomes that should be included in our future big study, so we can be certain that the research we do is likely to help parents and surgeons. Overall, we established that a future big study is feasible and we have plenty of information to help us with how to plan it best, so that it has the greatest possible chance of success. We were also guided in all of these steps of the research by a group of parents, children and young people, some of whom had appendicitis and some of whom did not.
Assuntos
Apendicite , Adolescente , Adulto , Apendicite/tratamento farmacológico , Apendicite/cirurgia , Criança , Tratamento Conservador , Análise Custo-Benefício , Estudos de Viabilidade , Humanos , Inquéritos e Questionários , Reino UnidoRESUMO
BACKGROUND: Work in commercial fishing is physically demanding and hazardous, but unlike merchant seamen, fishermen are not required to hold a certificate of medical fitness. AIMS: To investigate the case for regulatory medical standards for commercial fishermen and to identify priorities for the prevention and management of occupational injuries at sea. METHODS: We surveyed a convenience sample of fishermen at three major fishing ports in South West England using a standardized interview-administered questionnaire. RESULTS: Interviews were completed by 210 (68%) of 307 fishermen approached. Over their careers, 56 subjects (27%) had been returned to shore as an emergency for medical reasons, a rate of 14.6 (95% confidence interval 11.5-18.2) per 1000 man-years. Most emergency evacuations were for acute injuries, and only five were for illness. A few participants suffered from chronic disease that would call into question their fitness to go to sea. Fifty-five fishermen had suffered injuries in the past 12 months, including 12 that had caused loss of more than 3 days from work. Subjects had self-stitched 4 of 15 reported hand lacerations, while others had been bound with 'gaffer' tape. CONCLUSIONS: Prevention of hand lacerations should be a high priority, with first-aid training and equipment for fishing crews to improve their care when prevention fails. No firm conclusions can be drawn about the value of regular medical screening for commercial fishermen, but such screening should be considered a lower priority than accident prevention.
Assuntos
Acidentes de Trabalho/estatística & dados numéricos , Pesqueiros , Saúde Ocupacional , Ferimentos e Lesões/epidemiologia , Acidentes de Trabalho/prevenção & controle , Adolescente , Adulto , Idoso , Doença Crônica , Emergências , Inglaterra/epidemiologia , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Avaliação das Necessidades , Inquéritos e Questionários , Ferimentos e Lesões/prevenção & controle , Adulto JovemRESUMO
BACKGROUND: Diagnosis of primary ciliary dyskinesia (PCD) relies on a combination of tests. High-speed video microscopy analysis (HSVA) is widely used to contribute to the diagnosis. It can be analyzed on the day of diagnostic consultation, but the qualitative analyses are subjective. Diagnostic accuracy and reliability of assessing ciliary function have not been robustly evaluated. We aimed to establish the accuracy of HSVA to diagnose PCD compared with a combination of tests, and to assess the interobserver reliability of HSVA analysis. METHODS: We randomly selected and anonymized archived videos from 120 patients seen at three UK PCD centers. Three experienced scientists independently reviewed six videos per patient, using a standardized proforma, blinded to diagnostic and clinical data. We compared study outcomes with two references: (1) a combination of diagnostic tests in accordance with the European Respiratory Society PCD diagnostic guidelines and (2) original clinical outcome determined by all available diagnostic tests. RESULTS: HSVA had excellent sensitivity and specificity to diagnose PCD: (1) 100% and 96%, respectively, compared with ERS guidelines, and (2) 96% and 91% compared with diagnostic outcomes. There was high interobserver agreement for "PCD-positive" outcomes (κ = 0.7). CONCLUSIONS: Specialist scientists accurately diagnosed PCD using HSVA, with high interobserver agreement. HSVA can be reliably used to counsel patients and commence treatment on the day of testing while awaiting confirmatory investigations.
Assuntos
Síndrome de Kartagener/diagnóstico , Microscopia Eletrônica de Transmissão/métodos , Microscopia de Vídeo/métodos , Cílios/patologia , Estudos de Coortes , Feminino , Humanos , Síndrome de Kartagener/fisiopatologia , Masculino , Variações Dependentes do Observador , Estudos Retrospectivos , Sensibilidade e Especificidade , Índice de Gravidade de DoençaRESUMO
DESIGN: This randomised crossover trial compared nocturnal auto-adjusting continuous positive airway pressure (APAP) and nocturnal oxygen therapy (NOT) in adults and children with sickle cell anaemia, with patient acceptability as the primary outcome. Secondary outcomes included pulmonary physiology (adults), safety, and daily pain during interventions and washout documented using tablet technology. METHODS: Inclusion criteria were age > 8 years and the ability to use an iPad to collect daily pain data. Trial participation was 4 weeks; week 1 involved baseline data collection and week 3 was a washout between interventions, which were administered for 7 days each during weeks 2 and 4 in a randomised order. Qualitative interviews were transcribed verbatim and analysed for content using a funnelling technique, starting generally and then gaining more detailed information on the experience of both interventions. Safety data included routine haematology and median pain days between each period. Missing pain day values were replaced using multiple imputation. RESULTS: Ten adults (three female, median age 30.2 years, range 18-51.5 years) and eleven children (five female, median age 12 years, range 8.7-16.9 years) enrolled. Nine adults and seven children completed interviews. Qualitative data revealed that the APAP machine was smaller, easier to handle, and less noisy. Of 16 participants, 10 preferred APAP (62.5%, 95% confidence interval (CI) 38.6-81.5%). Haemoglobin decreased from baseline on APAP and NOT (mean difference -3.2 g/L (95% CI -6.0 to -0.2 g/L) and -2.5 g/L (95% CI -4.6 to 0.3 g/L), respectively), but there was no significant difference between interventions (NOT versus APAP, 1.1 (-1.2 to 3.6)). Pulmonary function changed little. Compared with baseline, there were significant decreases in the median number of pain days (1.58 for APAP and 1.71 for NOT) but no significant difference comparing washout with baseline. After adjustment for carry-over and period effects, there was a non-significant median difference of 0.143 (95% CI -0.116 to 0.401) days additional pain with APAP compared with NOT. CONCLUSION: In view of the point estimate of patient preference for APAP, and no difference in haematology or pulmonary function or evidence that pain was worse during or in washout after APAP, it was decided to proceed with a Phase II trial of 6 months APAP versus standard care with further safety monitoring for bone marrow suppression and pain. TRIAL REGISTRATION: ISRCTN46078697 . Registered on 18 July 2014.
Assuntos
Anemia Falciforme/terapia , Pressão Positiva Contínua nas Vias Aéreas/métodos , Pulmão/fisiopatologia , Oxigenoterapia/métodos , Apneia Obstrutiva do Sono/terapia , Adolescente , Adulto , Anemia Falciforme/diagnóstico , Anemia Falciforme/fisiopatologia , Criança , Pressão Positiva Contínua nas Vias Aéreas/efeitos adversos , Estudos Cross-Over , Feminino , Humanos , Londres , Masculino , Pessoa de Meia-Idade , Oxigenoterapia/efeitos adversos , Dor/etiologia , Preferência do Paciente , Projetos Piloto , Qualidade de Vida , Apneia Obstrutiva do Sono/diagnóstico , Apneia Obstrutiva do Sono/fisiopatologia , Fatores de Tempo , Resultado do Tratamento , Adulto JovemRESUMO
OBJECTIVES: This study investigated risk factors for low-back pain among patients referred for magnetic resonance imaging (MRI), with special focus on whole-body vibration. METHODS: A case-control approach was used. The study population comprised working-aged persons from a catchment area for radiology services. The cases were those in a consecutive series referred for a lumbar MRI because of low-back pain. The controls were age- and gender-matched persons X-rayed for other reasons. Altogether, 252 cases and 820 controls were studied, including 185 professional drivers. The participants were questioned about physical factors loading the spine, psychosocial factors, driving, personal characteristics, mental health, and certain beliefs about low-back pain. Exposure to whole-body vibration was assessed by six measures, including weekly duration of professional driving, hours driven in one period, and current root mean square A(8). Associations with whole-body vibration were examined with adjustment for age, gender, and other potential confounders. RESULTS: Strong associations were found with poor mental health and belief in work as a causal factor for low-back pain, and with occupational sitting for > or =3 hours while not driving. Associations were also found for taller stature, consulting propensity, body mass index, smoking history, fear-avoidance beliefs, frequent twisting, low decision latitude, and low support at work. However, the associations with the six metrics of whole-body vibration were weak and not statistically significant, and no exposure-response relationships were found. CONCLUSIONS: Little evidence of a risk from professional driving or whole-body vibration was found. Drivers were substantially less heavily exposed to whole-body vibration than in some earlier surveys. Nonetheless, it seems that, at the population level, whole-body vibration is not an important cause of low-back pain among those referred for MRI.
Assuntos
Dor Lombar/etiologia , Imageamento por Ressonância Magnética , Exposição Ocupacional/efeitos adversos , Vibração/efeitos adversos , Adulto , Estudos de Casos e Controles , Feminino , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Modelos Logísticos , Dor Lombar/diagnóstico , Dor Lombar/epidemiologia , Dor Lombar/psicologia , Masculino , Saúde Mental , Pessoa de Meia-Idade , Saúde Ocupacional , Testes Psicológicos , Psicometria , Qualidade de Vida , Fatores de Risco , Reino Unido/epidemiologiaRESUMO
BACKGROUND: Acute appendicitis is one of the most common acute surgical emergencies in children and accounts for an annual cost of approximately £50 million to the National Health Service. Investigating alternative treatment options offers the best prospect of enhancing the quality of care for patients and potential opportunities for cost savings through better allocative efficiency. A feasibility randomised controlled trial (RCT) comparing a non-operative treatment pathway with appendicectomy for children with acute uncomplicated appendicitis is underway (CONTRACT feasibility RCT). AIMS: The prime objective of this economic substudy conducted alongside the CONTRACT feasibility RCT is to better understand and assess: (1) cost data collection tools and cost drivers by identifying patients' pathways and (2) patient quality of life by assessing alternative paediatric health-related quality of life (HRQoL) instruments. Outcomes from this study will inform a future efficacy RCT assessing the effectiveness and cost-effectiveness of non-operative treatment pathway for the treatment of acute uncomplicated appendicitis in children. METHODS: The economic substudy will use individual-level data and will be conducted from the health system perspective over the study's 6-month follow-up period. Microcosting will include health resource and service use, while potential benefits acquired will be measured using the HRQoL measures, Child Health Utility 9D (CHU-9D) and Euroqol-5 dimensions and 5 levels (EQ-5D-5L). We will assess the appropriateness of using the cost per quality-adjusted life year framework in the future RCT, as well as testing and identifying the most suitable HRQoL instrument. CONCLUSIONS: The outcomes of the investigational economic substudy will be used to inform the design of our future definitive RCT. However, the result from this economic study will also provide a detailed description and account of the issues inherent in paediatric Economic Evaluations Alongside Clinical Trials with an emphasis on costing methods of interventions taking place in secondary care settings. TRIAL REGISTRATION NUMBER: ISRCTN1583043.
RESUMO
BACKGROUND: Currently, the routine treatment for acute appendicitis in the United Kingdom is an appendicectomy. However, there is increasing scientific interest and research into non-operative treatment of appendicitis in adults and children. While a number of studies have investigated non-operative treatment of appendicitis in adults, this research cannot be applied to the paediatric population. Ultimately, we aim to perform a UK-based multicentre randomised controlled trial (RCT) to test the clinical and cost effectiveness of non-operative treatment of acute uncomplicated appendicitis in children, as compared with appendicectomy. First, we will undertake a feasibility study to assess the feasibility of performing such a trial. METHODS/DESIGN: The study involves a feasibility RCT with a nested qualitative research to optimise recruitment as well as a health economic substudy. Children (aged 4-15 years inclusive) diagnosed with acute uncomplicated appendicitis that would normally be treated with an appendicectomy are eligible for the RCT. Exclusion criteria include clinical/radiological suspicion of perforated appendicitis, appendix mass or previous non-operative treatment of appendicitis. Participants will be randomised into one of two arms. Participants in the intervention arm are treated with antibiotics and regular clinical assessment to ensure clinical improvement. Participants in the control arm will receive appendicectomy. Randomisation will be minimised by age, sex, duration of symptoms and centre. Children and families who are approached for the RCT will be invited to participate in the embedded qualitative substudy, which includes recording of recruitment consultants and subsequent interviews with participants and non-participants and their families and recruiters. Analyses of these will inform interventions to optimise recruitment. The main study outcomes include recruitment rate (primary outcome), identification of strategies to optimise recruitment, performance of trial treatment pathways, clinical outcomes and safety of non-operative treatment. We have involved children, young people and parents in study design and delivery. DISCUSSION: In this study we will explore the feasibility of performing a full efficacy RCT comparing non-operative treatment with appendicectomy in children with acute uncomplicated appendicitis. Factors determining success of the present study include recruitment rate, safety of non-operative treatment and adequate interest in the future RCT. Ultimately this feasibility study will form the foundation of the main RCT and reinforce its design. TRIAL REGISTRATION: ISRCTN15830435 . Registered on 8 February 2017.