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1.
Muscles Ligaments Tendons J ; 6(2): 216-223, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27900295

RESUMO

BACKGROUND: Many strategies have been used to improve the visualisation of the ACL including sagittal, coronal oblique sequences, and 3D volume imaging. Nevertheless, the ACL may not always be visualised. METHODS: Two hundred and thirty-one consecutive patients (77 females; 154 males; average age 43.5, range 18 to 82 years; 205 with chronic, 20 acute, and 6 acute on chronic symptoms) underwent knee arthroscopy for mechanical symptoms within a week of MRI. After routine orthogonal sequences, if general MRI radiographers, with over four years experience, were not able to identify the presence of the ACL, then two 3D volume sequences and 2D limited sagittal oblique T1 sequences were performed. Patients requiring extra sequences, missed by the radiography technicians, were recalled. The MRI sequences were evaluated in a blinded fashion by three radiologists, and compared to the knee arthroscopy findings, with the normal ACL acting as internal controls. The radiography technicians performed additional ACL sequences in 63 patients (27%); of these, 10 patients had a partial and 12 patients had a complete ACL tear. Only 2 patients (0.6%) were recalled (one with a normal, and one with a full thickness ACL tear). RESULTS: The filmed ACL evaluation for complete tears and a normal ACL had a sensitivity of 100%, specificity of 97.1% and accuracy of 97.3%, slightly higher than evaluating on the monitor. Volume sequences had specificities and accuracies over 95%, with good intraobserver reliability (Kappa 0.859, 95% CI 0.705-1.0). Experienced radiographers identified most cases requiring supplementary MRI ACL sequences. An additional volume sequence was beneficial when filmed. Use of the monitor can offer some benefits. Limited oblique T1 sequence of the intercondylar notch was unreliable.

2.
Environ Sci Process Impacts ; 15(2): 329-35, 2013 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-25208696

RESUMO

Perfluorooctane sulphonate (PFOS) is a persistent organic pollutant that is toxic, bioaccumulative and undergoes wide transportation across all environmental media. It has been widely detected in environmental samples but there is limited information about the health effects on humans from environmental exposure. This paper presents the findings of a review of the literature on the impact of PFOS on the health of the general population. Fifteen relevant epidemiological studies were identified that looked at the association between human PFOS exposure and a range of health related outcomes. Small but statistically significant associations have been reported with PFOS and total cholesterol, glucose metabolism, body mass index (BMI), thyroid function, infertility, breast feeding, uric acid and attention deficit/hyperactivity disorder (ADHD). The true significance of these findings is uncertain due to the inconsistencies in some of the study results and the limitations of the literature. The majority of studies were cross-sectional and considered surrogate markers of health (e.g. cholesterol levels). The available literature is also limited in ascertaining the link between PFOS concentrations in the environment, exposure pathways and health effects. We conclude that the current evidence is inconclusive and further large-scale prospective cohort studies would be useful to assess the association between environmental exposure to PFOS, appropriate biomarkers (e.g. serum levels of PFOS) and health outcomes.


Assuntos
Ácidos Alcanossulfônicos/metabolismo , Exposição Ambiental/estatística & dados numéricos , Poluentes Ambientais/metabolismo , Fluorocarbonos/metabolismo , Ácidos Alcanossulfônicos/análise , Ácidos Alcanossulfônicos/toxicidade , Biomarcadores/metabolismo , Poluentes Ambientais/análise , Poluentes Ambientais/toxicidade , Fluorocarbonos/análise , Fluorocarbonos/toxicidade
5.
Int J Technol Assess Health Care ; 25(4): 577-83, 2009 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-19845989

RESUMO

OBJECTIVES: A randomized controlled trial (RCT) showed magnetic resonance imaging for patients waiting for knee arthroscopy did not reduce the number of arthroscopies. Our study aimed to identify decisions made by orthopedic surgeons about whether patients on a waiting list should proceed to arthroscopy, and to describe surgeons' decisions. METHODS: Five surgeons were asked to Think Aloud (TA) as they made their decisions for twelve patients from the original RCT. Audiotapes of the decision making were transcribed for analysis. RESULTS: For five patients, surgeons agreed about proceeding with arthroscopy, although reasoning differed. In no cases did surgeons agree about not proceeding to arthroscopy. Agreement was more likely in patients with clinically diagnosed meniscal abnormality, and less likely in patients with osteoarthritis. CONCLUSIONS: Surgeons' decisions were influenced by patient wishes. For some patients, the decision to proceed with arthroscopy was based solely on clinical diagnosis; MRI may not be advantageous in these instances. Surgeons disagreed more often than they agreed about the decision to proceed with arthroscopy, particularly when OA was diagnosed. This has implications for decision making in the current NHS patient choice environment. Patients may choose a treatment provider from a list of available providers at time of original clinical assessment and diagnosis. The treating surgeon does not necessarily re-examine the patient until the day of surgery. Given the variation between surgeons about the merits of proceeding with arthroscopy, surgeons may end up in the invidious position of providing surgery to patients whom they do not believe will benefit from arthroscopy.


Assuntos
Artroscopia/estatística & dados numéricos , Tomada de Decisões , Articulação do Joelho/cirurgia , Adulto , Idoso , Progressão da Doença , Feminino , Humanos , Imageamento por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Osteoartrite do Joelho/cirurgia , Fatores Socioeconômicos
6.
Acta Orthop Belg ; 75(2): 245-51, 2009 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-19492565

RESUMO

We report the prevalence and incidence of methicillin-resistant Staphylococcus aureus (MRSA) colonisation during the patient journey for patients admitted to orthopaedic and trauma wards. Patients were swabbed for MRSA colonisation on admission, transfer, and discharge from hospital. Elective patients undergoing major joint surgery were also swabbed at a pre-operative assessment clinic. Of the 559 patients admitted, 323 (101 elective, 192 trauma and 30 non-orthopaedic) were included in the study. Of these, 27 elective (27%), 41 trauma (21%), and seven non-orthopaedic (23%) patients were colonised with MRSA at any time during the audit period. There is a high prevalence of MRSA colonisation in patients admitted to the orthopaedic and trauma wards in our setting. A policy of pre-admission screening, though able to identify MRSA carriage, does not guarantee that patients are not colonised in the period between screening and admission. We suggest to screen for MRSA all patients admitted to an orthopaedic ward.


Assuntos
Infecção Hospitalar/epidemiologia , Staphylococcus aureus Resistente à Meticilina , Infecções Estafilocócicas/epidemiologia , Infecção dos Ferimentos/epidemiologia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Infecção Hospitalar/prevenção & controle , Inglaterra/epidemiologia , Feminino , Hospitais Universitários , Humanos , Masculino , Pessoa de Meia-Idade , Procedimentos Ortopédicos , Prevalência , Infecções Estafilocócicas/prevenção & controle , Infecção da Ferida Cirúrgica/epidemiologia
7.
Knee ; 16(3): 216-22, 2009 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-19135375

RESUMO

In a prospective single-centre longitudinal randomized controlled trial 116 patients were allocated to the sub-vastus approach, and 115 to the medial parapatellar approach. At one week follow-up, compared to baseline, range of motion, Knee Society (KS) global, KS knee, and KS pain scores were significantly better in the sub-vastus group. At the one year follow-up, WOMAC global and pain scores, SF36 physical function and role-physical scores, and EuroQol utility and pain score were significantly better in the sub-vastus group. The ease of exposure in the sub-vastus approach was significantly worse. There was no significant difference in length of stay or analgesia intake. The sub-vastus approach to total knee arthroplasty was more effective than a medial parapatellar approach at both one week and one year post-operatively, but surgeons reported a less easy exposure in the sub-vastus group.


Assuntos
Artroplastia do Joelho/métodos , Osteoartrite do Joelho/cirurgia , Patela/cirurgia , Músculo Quadríceps/cirurgia , Idoso , Feminino , Nível de Saúde , Indicadores Básicos de Saúde , Humanos , Articulação do Joelho/fisiopatologia , Articulação do Joelho/cirurgia , Masculino , Osteoartrite do Joelho/fisiopatologia , Medição da Dor , Estudos Prospectivos , Qualidade de Vida , Amplitude de Movimento Articular , Resultado do Tratamento
8.
Cochrane Database Syst Rev ; (4): CD001161, 2008 Oct 08.
Artigo em Inglês | MEDLINE | ID: mdl-18843615

RESUMO

BACKGROUND: Fracture of the calcaneus (os calcis or heel bone) comprises one to two per cent of all fractures. OBJECTIVES: To identify and evaluate randomised trials of treatments for calcaneal fractures. SEARCH STRATEGY: MEDLINE, EMBASE, CINAHL, the Cochrane Controlled Trials Register, and the Cochrane Musculoskeletal Injuries Group Trials Register were searched. We checked reference lists of relevant articles and contacted trialists and experts in the field. Date of the most recent search: October 1998. SELECTION CRITERIA: Randomised and quasi-randomised trials comparing interventions for treating patients with calcaneal fractures. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality, using a 12 item scale, and extracted data. Wherever appropriate and possible, results were pooled. MAIN RESULTS: Of the six relevant randomised trials identified, four were included, one excluded and one is ongoing.All four included trials had methodological flaws.Three trials, involving 134 patients, compared open reduction and internal fixation with non-operative management of displaced intra-articular fractures. Pooled results showed no apparent difference in residual pain (24/40 versus 24/42; Peto odds ratio 0.90, 95% confidence interval 0.34 to 2.36), but a lower proportion of the operative group was unable to return to the same work (11/45 versus 23/45; Peto odds ratio 0.30, 95% confidence interval 0.13 to 0.71), and was unable to wear the same shoes as before (12/52 versus 24/54; Peto odds ratio 0.37, 95% confidence interval 0.17 to 0.84).One trial, involving 23 patients, evaluated impulse compression therapy. At one year there was a mean difference of 1.40 pain units on a visual analogue score (scale 0-10) (95% confidence interval 0.02 to 2.82) in favour of the treated group. The impulse compression group had greater subtalar movement (mean difference 14.0 degrees, 95% confidence interval 3.2 to 24.6) at three months. On average, patients in the impulse compression group returned to work three months earlier than those in the control group. AUTHORS' CONCLUSIONS: Randomised trials of management of calcaneal fractures are few, small and generally of poor quality.Even where there is some evidence of benefit of operative compared with non-operative treatment, it remains unclear whether the possible advantages of surgery are worth its risks. Given this it seems best to wait for the results of one large ongoing trial on open reduction and internal fixation against conservative treatment.One very small trial suggests that impulse compression therapy for intra-articular calcaneal fractures may be beneficial.More large-scale, high quality randomised controlled trials are needed to confirm these results, and to test other interventions in the treatment of calcaneal fractures.


Assuntos
Calcâneo/lesões , Fraturas Ósseas/terapia , Humanos
9.
Arthroscopy ; 23(11): 1167-1173.e1, 2007 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-17986403

RESUMO

PURPOSE: The purpose of this study was to investigate whether magnetic resonance imaging (MRI) in patients waiting for knee arthroscopy could reduce arthroscopy rates and improve patient outcome. METHODS: A prospective randomized controlled trial was conducted in a teaching hospital setting. All participating patients had knee MRI before arthroscopy. In the intervention group the MRI report was seen by surgeons, and in the control group it was not. The primary outcome measure was the proportion of patients who did not have an arthroscopy. Secondary outcome measures included the Short Form 36, EuroQol EQ-5D, Knee Injury and Osteoarthritis Score, and Knee Society Score. RESULTS: Surgeons changed both their diagnosis and management plan in 47% of patients in the intervention group compared with 1% in the control group, with no difference between groups in the proportion of patients who underwent an arthroscopy. In the intervention group 7 of 125 patients (5.6%) did not have an arthroscopy compared with 8 of 127 patients (6.3%) in the control group. In one instance a surgeon decided against arthroscopy based on the MRI report. There was no significant difference between groups in other outcome measures. CONCLUSIONS: We found no effect of MRI on the decision to perform arthroscopy or patient outcome. Performing MRI in patients already on the waiting list for arthroscopy may not be effective in reducing utilization of surgery. LEVEL OF EVIDENCE: Level I, therapeutic randomized controlled trial with no statistically significant difference but with narrow confidence intervals.


Assuntos
Artroscopia , Artropatias/diagnóstico , Artropatias/cirurgia , Articulação do Joelho/cirurgia , Imageamento por Ressonância Magnética , Adulto , Distribuição de Qui-Quadrado , Tomada de Decisões , Feminino , Humanos , Modelos Lineares , Masculino , Estudos Prospectivos , Resultado do Tratamento
10.
Br Med Bull ; 84: 5-23, 2007.
Artigo em Inglês | MEDLINE | ID: mdl-17785279

RESUMO

PURPOSE: Magnetic resonance imaging (MRI) is of great aid in the diagnosis of knee lesions. Most diagnostic studies comparing MRI and arthroscopy have shown good diagnostic performance in detecting lesions of the menisci and cruciate ligaments. Nevertheless, arthroscopy has remained the reference standard for the diagnosis of internal derangements of the knee, against which alternative diagnostic modalities should be compared. METHODS: We took arthroscopy to be the 'gold standard', and we undertook a systematic review of MRI and arthroscopy in the diagnosis of internal derangements of the knee. We used Coleman scoring methodology to identify scientifically sound articles in a reproducible format. RESULTS: MRI is highly accurate in diagnosing meniscal and anterior cruciate ligament (ACL) tears. It is the most appropriate screening tool before therapeutic arthroscopy. It is preferable to diagnostic arthroscopy in most patients because it avoids the surgical risks of arthroscopy. The results of MRI differ for medial and lateral meniscus and ACL, with only 85% accuracy. CONCLUSIONS: Study design characteristics should also be taken into account whenever a study on MRI assessing its diagnostic performance is designed or reviewed.


Assuntos
Lesões do Ligamento Cruzado Anterior , Artroscopia/normas , Traumatismos do Joelho/diagnóstico , Imageamento por Ressonância Magnética/normas , Lesões do Menisco Tibial , Artroscopia/métodos , Humanos , Imageamento por Ressonância Magnética/métodos , Sensibilidade e Especificidade
11.
BMC Musculoskelet Disord ; 8: 87, 2007 Aug 31.
Artigo em Inglês | MEDLINE | ID: mdl-17764554

RESUMO

BACKGROUND: Fifty thousand knee replacements are performed annually in the UK at an estimated cost of pound 150 million. Post-operative improvement depends on a number of factors including implant design and patient associated factors. To our knowledge there are no published study's comparing the results of AP glide and rotating platform designs of LCS knee arthroplasty. Therefore we feel that a study is required to investigate and compare the effects of two types of LCS total knee arthroplasty on joint proprioception and range of motion. METHODS/DESIGN: Patients will be randomised to receive either a LCS AP glide or Rotating platform prosthesis. Clinical scores (Oxford knee score, American knee society score, EuroQol), range of motion and proprioception will be assessed prior to and at 3,6, 12 and 24 months after the operation. Proprioception will be assessed in terms of absolute error angle (mean difference between the target angle and the response angle). Knee angles will be measured in degrees using an electromagnetic tracking device, Polhemus 3Space Fastrak that detects positions of sensors placed on the test limb. Student's t-test will be used to compare the mean of two groups. DISCUSSION: Evidence is lacking concerning the best prosthesis to use for patients undergoing total knee replacement. This pragmatic randomised trial will test the null hypothesis that anteroposterior glide LCS knee arthroplasty does not result in better post operative knee motion and proprioception as compared to rotating platform LCS knee.


Assuntos
Artroplastia do Joelho/instrumentação , Artroplastia do Joelho/métodos , Prótese do Joelho , Desenho de Prótese/métodos , Projetos de Pesquisa , Fenômenos Biomecânicos/métodos , Humanos , Articulação do Joelho/fisiologia , Articulação do Joelho/cirurgia , Prótese do Joelho/normas , Propriocepção/fisiologia , Desenho de Prótese/normas , Amplitude de Movimento Articular/fisiologia
13.
BMC Musculoskelet Disord ; 7: 61, 2006 Jul 31.
Artigo em Inglês | MEDLINE | ID: mdl-16879741

RESUMO

BACKGROUND: Nearly 20,000 patients per year in the UK receive total knee arthroplasty (TKA). One of the problems faced by the health services of many developed countries is the length of time patients spend waiting for elective treatment. We therefore report the results of a study in which the Salisbury Priority Scoring System (SPSS) was used by both the surgeon and their patients to ascertain whether there were differences between the surgeon generated and patient generated Salisbury Priority Scores. METHODS: The Salisbury Priority Scoring System (SPSS) was used to assign relative priority to patients with knee osteoarthritis as part of a randomised controlled trial comparing the standard medial parapatellar approach versus the sub-vastus approach in TKA. The operating surgeons and each patient completed the SPSS at the same pre-assessment clinic. The SPSS assesses four criteria, namely progression of disease, pain or distress, disability or dependence on others, and loss of usual occupation. Crosstabs and agreement measures (Cohen's kappa) were performed. RESULTS: Overall, the four SPSS criteria showed a kappa value of 0.526, 0.796, 0.813, and 0.820, respectively, showing moderate to very good agreement between the patient and the operating consultant. Male patients showed better agreement than female patients. CONCLUSION: The Salisbury Priority Scoring System is a good means of assessing patients' needs in relation to elective surgery, with high agreement between the patient and the operating surgeon.


Assuntos
Artroplastia do Joelho , Alocação de Recursos para a Atenção à Saúde , Osteoartrite do Joelho/fisiopatologia , Osteoartrite do Joelho/cirurgia , Seleção de Pacientes , Índice de Gravidade de Doença , Artroplastia do Joelho/métodos , Progressão da Doença , Feminino , Humanos , Masculino , Pacientes , Médicos , Inquéritos e Questionários
14.
Trials ; 7: 23, 2006 Jul 31.
Artigo em Inglês | MEDLINE | ID: mdl-16879744

RESUMO

BACKGROUND: Thirty thousand knee replacements are performed annually in the UK. There is uncertainty as to the best surgical approach to the knee joint for knee arthroplasty. We planned a randomised controlled trial to compare a standard medial parapatellar arthrotomy with sub-vastus arthrotomy for patients undergoing primary total knee arthroplasty in terms of short and long term knee function. METHODS: Patients undergoing primary total knee arthroplasty at the local NHS Trust are to be recruited into the study. Patients are to be randomised into either the sub-vastus or medial parapatellar approach to knee arthroplasty. The primary outcome measures will be the American Knee Society and WOMAC Scores. The secondary outcome measures will be patient based measures of EuroQol and SF-36. All outcomes will be measured pre-operatively, 1, 6, 12 and 52 weeks post-operatively. We will also review pain intensity using a pain and analgesia diary. Ease of surgical exposure and complications will also be analysed. DISCUSSION: Evidence is lacking concerning the best surgical approach to the knee joint for patients undergoing primary total knee replacement. This pragmatic randomised trial tests the hypothesis that the sub-vastus approach is significantly superior to the standard medial parapatellar approach in terms of short and long term knee function.

15.
Br J Gen Pract ; 55(518): 704-9, 2005 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-16176738

RESUMO

BACKGROUND: Attempts to manage general practice demand for orthopaedic outpatient consultations have been made in several areas of the NHS, with little robust evidence on whether or not they work. AIM: To evaluate the effect of the North Staffordshire 'orthopaedic slot system' on the demand for general practice referrals to orthopaedic outpatients. METHOD: A prospective study of 12 general practices in the slot system, 24 controls, and the 63 other general practices in North Staffordshire. Comparison periods were the baseline year (0); the first calendar year (1); and the first half of the second calendar year (2). A multifactor linear regression model was used. RESULTS: Mean referral rate decreased 22% in the slot group in period 1, and was maintained in period 2 (9.40, 7.29, 7.31 referrals per 10,000 population per month for periods 0, 1 and 2, respectively). The control and other groups showed a small decrease in period 1, but in period 2 higher referral rates were observed. The reduction in referrals of 20-40% in participating practices compared to other practices equates to 2-4 referrals per 10,000 patients per month. CONCLUSIONS: Our study suggests that practices willing and able to take up an offer of a slot system for managing their orthopaedic referrals will be able to significantly reduce referral rates for their patients when compared to similar practices who do not. Further research on the generalisability, effectiveness and cost-effectiveness of such systems is warranted.


Assuntos
Medicina de Família e Comunidade/estatística & dados numéricos , Ortopedia/estatística & dados numéricos , Encaminhamento e Consulta/estatística & dados numéricos , Adolescente , Adulto , Assistência Ambulatorial/estatística & dados numéricos , Inglaterra , Necessidades e Demandas de Serviços de Saúde , Humanos , Estudos Longitudinais , Padrões de Prática Médica , Estudos Prospectivos
16.
Health Expect ; 8(3): 234-43, 2005 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-16098153

RESUMO

BACKGROUND: We report a population-based comparison of psychosexual health 5 years after contrasting amounts of surgical treatments for heavy periods [dysfunctional uterine bleeding (DUB)]. Women's fears about sexual function after hysterectomy might not be unfounded. The psychosexual problems may return and/or develop with time. The removal of ovaries at the time of hysterectomy is associated with greater deterioration of self-reported sexual function. Surgical menopause significantly impairs sexual wellbeing. We failed to observe uniform beneficial effects of hormone replacement therapy (HRT) on reported psychosexual health. OBJECTIVE: To compare self-reported bothersome sexual function; loss of interest in sex, difficulty in becoming sexually excited and vaginal dryness 5 years after surgical management of DUB [transcervical endometrial resection/ablation (TCRE) or subtotal and total hysterectomy, with and without prophylactic bilateral oophorectomy (BO)]. DESIGN: Prospective cohort study up to 5 years post-surgery for DUB, TCRE or hysterectomy, with or without BO. SETTING: Over 400 NHS and private hospitals in England, Northern Ireland and Wales. COHORT: Of 11,325 women who responded to the 5-year questionnaire, over 9500 (84%) were valid cases, and over 8900 (94%) did complete the questions relating to psychosexual function. Most were between the ages of 39 and 45 years, married or cohabiting. MAIN OUTCOMES: Self-reported experience of bother, recorded as 'some', 'severe' and 'extreme', to questions on (1) libido loss, (2) difficulty with sexual arousal, and (3) vaginal dryness during the past 4 weeks, 5 years after surgery. RESULTS: Five years after surgery for DUB, the crude and adjusted prevalence of psychosexual problems was higher after hysterectomy than after TCRE. Amongst the women with concurrent BO, the age- and HRT-adjusted odds ratios for extreme psychosexual problems were increased by 80% (libido loss), 82% (difficult sex arousal) and 69% (vaginal dryness) compared with TCRE. CONCLUSIONS: Five years after hysterectomy more women reported having bothersome psychosexual function than did the women who had a less invasive operation. Hormone therapy, although related to surgical method, did not reduce this long-term detrimental effect. The odds were particularly high amongst women with concurrent BO. Women should be advised that they might be at higher risk of psychosexual problems following hysterectomy, compared with a less invasive procedure.


Assuntos
Ablação por Cateter/efeitos adversos , Histerectomia/efeitos adversos , Menorragia/cirurgia , Comportamento Sexual/psicologia , Disfunções Sexuais Psicogênicas/etiologia , Adulto , Ablação por Cateter/psicologia , Endométrio/cirurgia , Terapia de Reposição de Estrogênios , Feminino , Humanos , Histerectomia/psicologia , Libido , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde , Ovariectomia/efeitos adversos , Ovariectomia/psicologia , Estudos Prospectivos , Comportamento Sexual/fisiologia , Disfunções Sexuais Psicogênicas/epidemiologia , Medicina Estatal , Inquéritos e Questionários , Reino Unido/epidemiologia , Vagina/fisiopatologia , Saúde da Mulher
17.
BMJ ; 328(7432): 129, 2004 Jan 17.
Artigo em Inglês | MEDLINE | ID: mdl-14711749

RESUMO

OBJECTIVE: To compare the effects of laparoscopic hysterectomy and abdominal hysterectomy in the abdominal trial, and laparoscopic hysterectomy and vaginal hysterectomy in the vaginal trial. DESIGN: Two parallel, multicentre, randomised trials. SETTING: 28 UK centres and two South African centres. PARTICIPANTS: 1380 women were recruited; 1346 had surgery; 937 were followed up at one year. Primary outcome Rate of major complications. RESULTS: In the abdominal trial laparoscopic hysterectomy was associated with a higher rate of major complications than abdominal hysterectomy (11.1% v 6.2%, P = 0.02; difference 4.9%, 95% confidence interval 0.9% to 9.1%) and the number needed to treat to harm was 20. Laparoscopic hysterectomy also took longer to perform (84 minutes v 50 minutes) but was less painful (visual analogue scale 3.51 v 3.88, P = 0.01) and resulted in a shorter stay in hospital after the operation (3 days v 4 days). Six weeks after the operation, laparoscopic hysterectomy was associated with less pain and better quality of life than abdominal hysterectomy (SF-12, body image scale, and sexual activity questionnaires). In the vaginal trial we found no evidence of a difference in major complication rates between laparoscopic hysterectomy and vaginal hysterectomy (9.8% v 9.5%, P = 0.92; difference 0.3%, -5.2% to 5.8%), and the number needed to treat to harm was 333. We found no evidence of other differences between laparoscopic hysterectomy and vaginal hysterectomy except that laparoscopic hysterectomy took longer to perform (72 minutes v 39 minutes) and was associated with a higher rate of detecting unexpected pathology (16.4% v 4.8%, P = < 0.01). However, this trial was underpowered. CONCLUSIONS: Laparoscopic hysterectomy was associated with a significantly higher rate of major complications than abdominal hysterectomy. It also took longer to perform but was associated with less pain, quicker recovery, and better short term quality of life. The trial comparing vaginal hysterectomy with laparoscopic hysterectomy was underpowered and is inconclusive on the rate of major complications; however, vaginal hysterectomy took less time.


Assuntos
Histerectomia/métodos , Laparoscopia/métodos , Complicações Pós-Operatórias/etiologia , Adulto , Feminino , Humanos , Histerectomia/efeitos adversos , Histerectomia Vaginal/métodos , Laparoscopia/efeitos adversos , Tempo de Internação , Qualidade de Vida , África do Sul , Reino Unido
18.
Arthroscopy ; 19(9): 1000-6, 2003 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-14608321

RESUMO

Randomization and blinding are important tools in determining the effectiveness of a new intervention and ensuring the validity of a clinical trial. However, randomness and haphazardness are not equivalent. Randomization cannot overcome poor experimental design or technique. Several types of randomization including historical controls and pseudorandomization are discussed, as well as methods of treatment allocation, stratification, and minimization techniques. The importance of decreasing bias and the advantages and disadvantages of blinding in randomized clinical trials are also covered.


Assuntos
Método Duplo-Cego , Distribuição Aleatória , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Método Simples-Cego , Viés , Grupos Controle , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Estudos de Amostragem
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