Critical thinking among institutional academic advisors and sociodemographic, professional and academic variables: A multicenter correlation study.

BACKGROUND: In nursing education, essential skills include Critical Thinking (CT). There is scant evidence on how nurse educators could promote CT in students in a clinical context. OBJECTIVE: To analyse the level of CT and correlated variables in healthcare nurses overseeing the clinicals of nursing undergraduates. METHODS: The study population were all nurse educators for clinicals at hospitals with nursing undergraduates. To evaluate the CT skills of nurses the Nursing Critical Thinking in Clinical Practice Questionnaire (N-CT-4 practice) was administered. Frequencies, percentages and measures of central tendency and scatter were obtained. A bivariate analysis was performed to analyze the correlation between the nurse educators' CT level and the sociodemographic, professional and academic levels. The nonparametric Mann-Whitney and Kruskal-Wallis tests were used to compare two independent groups. Statistical significance was defined as P < .05. RESULTS: The total number of participants was 639. The highest mean CT level was seen in clinical nurses involved in undergraduate nursing instruction and with experience of up to 10 years (mean CT score = 372 (33.3), p = .007). Global CT levels were similar in women and men (mean CT score: 364 (31.9) in women and 358 (40.5) in men, p = .187), with statistically significant differences only observed in the intellectual and cognitive indicator (P = .022). CONCLUSIONS: CT levels are high in teaching healthcare professionals in the clinical environment.

Pensamiento crítico en tutoras de práctica clínica / Critical thought in female clinical practice mentors

Objetivo: conceptualizar el estado actual del pensamiento crítico en tutoras académicas y tutoras institucionales en el contexto de la práctica clínica e identificar los instrumentos más utilizados para medir el pensamiento crítico de estas.Método: revisión integrativa para la que se consultaron las bases de datos PubMed y Scopus en el periodo comprendido entre enero de 1998 y marzo de 2022. La búsqueda se efectuó utilizando los términos de lenguaje controlado (critical thinking; mentor; nurse educator; clinical practice; preceptor; Education; Nursing), y artículos publicados en español, inglés y portugués. El proceso de selección de artículos fue asistido con el software Rayyan y descrito con el diagrama de flujo de PRISMA. Se realizó un análisis de contenido de los artículos seleccionados para identificar los temas emergentes.Resultados: se incluyeron 72 artículos originales. 25 eran estudios cualitativos, tres de método mixto, un estudio Delphi, 18 descriptivos, seis cuasi-experimentales, cuatro ensayos clínicos aleatorizados, un estudio analítico, ocho revisiones de la literatura, cuatro estudios correlacionales y una revisión sistemática. Tres fueron las temáticas emergentes: los factores de contexto del pensamiento crítico, las estrategias de promoción y los instrumentos de evaluación del pensamiento crítico.Conclusiones: la profesión enfermera no ha adoptado todavía un estándar para evaluar el pensamiento crítico, esto dificulta el comparar resultados sobre el efecto de determinadas intervenciones relacionadas con el desarrollo del pensamiento crítico.(AU)

Objective: to conceptualise the current situation regarding critical thought in female academic mentors and institutional mentors in the clinical practice setting, and to identify the most widely used instruments to measure their critical thought.Method: an integrative review where the PubMed and Scopus databases were consulted in the period between January 1998 and March 2022. The search was conducted using these controlled language terms: critical thinking; mentor; nurse educator; clinical practice; preceptor; Education; Nursing; and in articles published in Spanish, English and Portuguese. The article selection process was assisted by the Rayyan software and described with the PRISMA flow diagram. There was content analysis of the articles selected, in order to identify the emerging subjects.Results: the study included 72 original articles: 25 qualitative studies, three with mixed method, one Delphi study, 18 descriptive studies, six quasi-experimental studies, four randomized clinical trials, one analytical study, eight literature reviews, four correlational studies, and one systematic review. There were three emerging subjects: context factors of critical thought, promotion strategies, and instruments for critical thought evaluation.Conclusions: the Nursing profession has not yet adopted a standard evaluation for critical thought: this makes it difficult to compare results regarding the effect of certain interventions associated with critical thought development.(AU)

Effect of ear acupuncture on pregnancy-related pain in the lower back and posterior pelvic girdle: A multicenter randomized clinical trial.

INTRODUCTION: Ear acupuncture carried out in primary care by trained midwives, with no specialist training in acupuncture, may be effective in alleviating pregnancy-related lower back and/or posterior pelvic girdle pain (LBPGP). The objective of this study was to assess the effect of ear acupuncture associated with standard obstetric care, in the primary-care setting, on LBPGP experienced by pregnant women. MATERIAL AND METHODS: This four-group, multicenter, randomized controlled trial was conducted at 18 public primary care centers in three regions in Spain, with the participation of 220 pregnant women at 24-36 weeks of gestation, aged 18 years or more, diagnosed with pregnancy-related LBPGP and who had not previously received ear acupuncture. The trial was conducted from March 2014 to December 2016. Participants were randomly assigned (1:1:1:1) to receive standard obstetric care plus two sessions (over 2 weeks) of verum ear acupuncture, or nonspecific ear acupuncture, or placebo ear acupuncture, or standard obstetric care alone. The primary outcome was change in pain intensity, assessed using a visual analog scale (0-100 mm) from baseline to the end of treatment (T2). Secondary outcomes included change or presence of pain at 3 months (T3) and at 1 year (T4) postpartum, and changes in responses to the Roland-Morris disability questionnaire (RMDQ) and Short Form-12 Health Survey (SF-12) at the end of treatment. RESULTS: A total of 55 women were randomized to each group, and 205 completed the study. With respect to baseline values, the reduction in pain intensity among the verum ear acupuncture group vs standard obstetric care was significantly greater, both at T2 (65.8%, 95%CI 56.2-75.3 vs 25.1%, 95%CI 15.3-34.9) and at T3 (93.8%, 95%CI 88.7-99.0 vs 67.9%, 95%CI 55.3-80.5). Moreover, significant changes were found in the verum ear acupuncture group vs standard obstetric care at T2, in reduced RMDQ scores (70.9%, 95%CI 61.8-80.1 vs 21.2%, 95%CI 8.6-33.7) and in increased SF-12 scores on the physical scale (40.5%, 95%CI 31.5-49.4 vs 8.1%, 95%CI 0.8-15.5). CONCLUSIONS: After 2 weeks of treatment, ear acupuncture applied by midwives and associated with standard obstetric care significantly reduces lumbar and pelvic pain in pregnant women, improves quality of life and reduces functional disability.

Importancia de las habilidades comunicativas de las supervisoras de Enfermería / Importance of the communication skills in Nurse Managers

OBJETIVO: describir aspectos relevantes relacionados con las habilidades comunicativas de las supervisoras de Enfermería. MÉTODO: revisión narrativa. Se llevó a cabo una búsqueda bibliográfica de la literatura publicada desde el año 2013 al 2017. Para ello se han empleado como fuentes de información las siguientes bases de datos: Pubmed, Cinahl, Scopus, Cochrane Library y Cochrane Plus. La búsqueda se efectuó usando los términos en inglés "nurse manager", "nursing" y "communication skills". Se aceptaron los artículos que hablaran de la influenciade la comunicación de las supervisoras de Enfermería, tanto en el ámbito hospitalario como de Atención Primaria y/o psiquiatría. RESULTADOS: se encontraron un total de 150 artículos en las diferentes bases de datos consultadas. Se seleccionaron para la revisión narrativa un total de 15 artículos. Los principales aspectos relacionados con las habilidades de comunicación de las supervisoras enfermeras incluyen: el clima y satisfacción laboral, la resolución de conflictos,liderazgo, formación y seguridad del paciente. CONCLUSIONES: tanto para enfermeras como para las propias gestoras es muy importante disponer de habilidades comunicativas, puesto que ello puede mejorar el clima laboral y la eficaciade los equipos repercutiendo directamente en los pacientes

OBJECTIVE: to describe relevant aspects associated with the communication skills of Nurse Managers. METHOD: a narrative review. A bibliographic search was conducted in literature published between the years 2013 and 2017. To this aim, the following databases were used as information sources: Pubmed, CINAHL, SCOPUS, Cochrane Library and Cochrane Plus. The search was conducted using the following terms in English: "nurse manager", "nursing" and "communication skills". All articles accepted should discuss the influence of communication by Nurse Managers both in the hospital setting and in Primary Care and/or Psychiatry. RESULTS: in total, 150 articles were found in the different databases consulted; 15 articles were selected for the narrative review. The main aspects associated with the communication skills by Nurse Managers included: work environment and satisfaction, solution of conflicts, leadership, training, and patient safety. CONCLUSIONS: having communication skills is very important for nurses as well as for managers, because this can improve the work environment and team efficacy, with a direct impact on patients

TRPA1 polymorphisms in chronic and complete spinal cord injury patients with neuropathic pain: a pilot study.

STUDY DESIGN: Pilot study. OBJECTIVES: Single-nucleotide polymorphisms (SNPs) in TRPA1 gene are related to the etiology of chronic pain. The study is a pilot study with the primary objective of analyzing these SNPs in Spanish patients with chronic and complete spinal cord injury (SCI) and neuropathic pain (NPP). SETTING: Asepeyo Hospital Department of Chronic and Complete SCI. METHODS: Twelve patients with chronic and complete SCI and NPP, and 12 patients with chronic and complete SCI with no pain were reviewed. International Spinal Cord Injury Pain Classification (LANSS) and visual analog score (VAS) were chosen to classify pain syndrome. SNPs were identified by melting analysis after DNA amplification with real-time fluorescence PCR. RESULTS: There were differences in rs11988795 variant: GG homozygous (p = 0.01) and G allele (p = 0.001) were more frequent in SCI patients with no pain. There were differences in rs13255063 variant: TT homozygous were prevalent (p = 0.03) in patients with NPP. CONCLUSIONS: Until now this is the first study to show a description of TRPA1 SNPs in Spanish patients with chronic and complete SCI and NPP. These results suggest that GG genotype in rs11988795 variant and G allele could be protective factors against NPP. TT genotype in rs13255063 variant could be a risk factor for NPP. Neuropathic pain after spinal cord injuries may have genetic contributions.

Acupuncture for fibromyalgia in primary care: a randomised controlled trial.

OBJECTIVES: To evaluate the efficacy of an individualised acupuncture protocol for patients with fibromyalgia. METHODS: Randomised controlled multicentre trial, blinded to participants and to data analysts. Conducted in three primary care centres in southern Spain. A total of 164 participants aged over 17 years and diagnosed with fibromyalgia were enrolled in this trial; 153 participants completed the study. Participants were randomly assigned to either the real intervention (individualised acupuncture, IA) or the sham intervention (sham acupuncture, SA). In both the IA and SA groups, one session per week (lasting 20 min) was provided, in addition to usual pharmacological treatment. The primary outcome was change in pain intensity at 10 weeks. RESULTS: Intention-to-treat analysis revealed that the decrease in pain intensity at 10 weeks was greater (p=0.001) in the IA group (-41.0%, 95% CI -47.2% to -34.8%) than in the SA group (-27.1%, 95% CI -33.2% to -20.9%). During the follow-up period, significant differences (p<0.01) in favour of the IA group persisted at 12 months (IA: -19.9%, 95% CI -24.6% to -15.1%; vs SA: -6.2%, 95% CI -11.2% to -1.2%). CONCLUSIONS: Individualised acupuncture treatment in primary care in patients with fibromyalgia proved efficacious in terms of pain relief, compared with placebo treatment. The effect persisted at 1 year, and its side effects were mild and infrequent. Therefore, the use of individualised acupuncture in patients with fibromyalgia is recommended. TRIAL REGISTRATION NUMBER: ISRCTN60217348.

Evolución del virus de la hepatitis C oculto tras inmunosupresión en enfermedad renal crónica avanzada / The evolution of occult Hepatitis C Virus after immunosuppression in advanced CKD patients

No disponible

Auricular acupuncture for primary care treatment of low back pain and posterior pelvic pain in pregnancy: study protocol for a multicentre randomised placebo-controlled trial.

BACKGROUND: About 45% of all pregnant women suffer low back pain and/or pelvic girdle pain (LBPGP). This study seeks to evaluate the effect of auricular acupuncture on LBPGP compared with placebo auricular acupuncture and with standard obstetric care in the field of primary health care. METHODS AND DESIGN: This study will be a four-parallel-arm, multicentre, randomised, placebo-controlled trial. A total of 212 pregnant women (24 to 36 weeks' gestation), aged at least 17 years, with LBPGP, will be randomly assigned to the verum auricular acupuncture plus standard obstetric care group (VAAc), to the non-specific auricular acupuncture plus standard obstetric care group (NSAAc), to the non-specific placebo auricular acupuncture plus standard obstetric care group (PAAc), or the standard obstetric care group (SOC). The VAAc, NSAAc, and PAAc groups will receive treatment at three auricular acupuncture points (specific points for the VAAc group or non-specific ones for the NSAAc and PAAc groups), once a week for 2 weeks; the SOC group will receive only standard obstetric care during the same period. The primary outcome will be the reduction in pain intensity, according to the visual analogue scale (iVAS), at 2 weeks after the start of treatment. The secondary outcomes will be functional status with respect to LBPGP (according to the Roland-Morris disability questionnaire), health-related quality of life (SF12) at 2 weeks after the start of treatment, and iVAS at 12 and 48 weeks postpartum. DISCUSSION: This trial will implement a high-quality methodology and may provide evidence for the efficacy, safety, and specificity of auricular acupuncture as a treatment for pregnant women with LBPGP. TRIAL REGISTRATION: Current Controlled Trials ISRCTN41033073 (date 20/03/2014).

Efficacy and safety of auriculopressure for primary care patients with chronic non-specific spinal pain: a multicentre randomised controlled trial.

BACKGROUND: Chronic uncomplicated musculoskeletal pain in the spine (cervical, thoracic or lumbar) is highly prevalent and may severely limit the daily activities of those affected by it. OBJECTIVE: To evaluate the efficacy and safety of treatment with auriculopressure applied to patients with non-specific spinal pain. METHODS: A multicentre randomised controlled trial with two parallel arms (true auriculopressure (TAP) and placebo auriculopressure (PAP)) was performed. The intervention phase lasted 8 weeks and outcomes were measured 1 week after the last intervention (T1) and 6 months after baseline (T2). The primary outcome measure was change in pain intensity according to a 100 mm visual analogue scale (pain VAS) at T1. Secondary outcome measures were the Lattinen index, the McGill Pain Questionnaire and the SF-12 health-related quality of life scale (Spanish version in every case). RESULTS: There were 265 participants (TAP group, n=130; PAP group, n=135). Pain was most frequently located in the upper back (55.1%, n=146), followed by the lower back (25.3%, n=67) and the dorsal area (12.5%, n=33). Nineteen patients (7.2%) reported pain affecting the entire spine. There were statistically significant differences between TAP and PAP in the change in the pain VAS at T1 of 10 mm (95% CI 2.8 to 17.3, p=0.007) and in the change in the pain VAS at T2 of 7.2 mm (95% CI 0.02 to 14.3, p=0.049) in favour of TAP. We also observed a statistically significant difference of 3.4 points in the physical component of the SF-12 in favour of TAP at T2 (95% CI 0.45 to 6.3, p=0.024). No severe adverse effects were detected or reported during treatment. CONCLUSIONS: The application of auriculopressure in patients with non-specific spinal pain in primary healthcare is effective and safe, and therefore should be considered for inclusion in the portfolio of primary healthcare services. TRIAL REGISTRATION NUMBER: ISRCTN01897462.

Using moxibustion in primary healthcare to correct non-vertex presentation: a multicentre randomised controlled trial.

OBJECTIVE: To compare the effectiveness of additional moxibustion at point BL67 with moxibustion at a non-specific acupuncture point and with usual care alone to correct non-vertex presentation. METHODS: This was a multicentre randomised controlled trial in which 406 low-risk pregnant women with a fetus in ultrasound breech presentation, with a gestational age of 33-35 weeks, were assigned to (1) true moxibustion at point BL67 plus usual care; (2) moxibustion at SP1, a non-specific acupuncture point (sham moxibustion) plus usual care; or (3) usual care alone. The primary outcome was cephalic presentation at birth. Women were recruited at health centres in primary healthcare. RESULTS: In the true moxibustion group, 58.1% of the full-term presentations were cephalic compared with 43.4% in the sham moxibustion group (RR 1.34, 95% CI 1.05 to 1.70) and 44.8% of those in the usual care group (RR 1.29, 95% CI 1.02 to 1.64). The reduction in RR of the primary outcome in women allocated to the true moxibustion group compared with the usual care group was 29.7% (95% CI 3.1% to 55.2%) and the number needed to treat was 8 (95% CI 4 to 72). There were no severe adverse effects during the treatment. CONCLUSIONS: Moxibustion at acupuncture point BL67 is effective and safe to correct non-vertex presentation when used between 33 and 35 weeks of gestation. We believe that moxibustion represents a treatment option that should be considered to achieve version of the non-vertex fetus. TRIAL REGISTRATION: Current Controlled Trials ISRCTN10634508.

Acupuncture in patients with acute low back pain: a multicentre randomised controlled clinical trial.

Reviews of the efficacy of acupuncture as a treatment for acute low back pain have concluded that there is insufficient evidence for its efficacy and that more research is needed to evaluate it. A multicentre randomized controlled trial was conducted at 4 primary-care centres in Spain to evaluate the effects of acupuncture in patients with acute nonspecific low back pain in the context of primary care. A total of 275 patients with nonspecific acute low back pain (diagnosed by their general practitioner) were recruited and assigned randomly to 4 different groups: conventional treatment either alone or complemented by 5 sessions over a 2-week period of true acupuncture, sham acupuncture, or placebo acupuncture per patient. Patients were treated from February 2006 to January 2008. The primary outcome was the reduction in Roland Morris Disability Questionnaire scores of 35% or more after 2weeks' treatment. The patients in the 3 types of acupuncture groups were blinded to the treatments, but those who received conventional treatment alone were not. In the analysis adjusted for the total sample (true acupuncture relative risk 5.04, 95% confidence interval 2.24-11.32; sham acupuncture relative risk 5.02, 95% confidence interval 2.26-11.16; placebo acupuncture relative risk 2.57 95% confidence interval 1.21-5.46), as well as for the subsample of occupationally active patients, all 3 modalities of acupuncture were better than conventional treatment alone, but there was no difference among the 3 acupuncture modalities, which implies that true acupuncture is not better than sham or placebo acupuncture.

[Occult hepatitis C virus infection]. / Infección oculta por el virus de la hepatitis C.

Occult hepatitis C virus (HCV) infection is characterized by the detection of HCV-RNA in liver in the absence of anti-HCV and serum HCV-RNA determined by conventional techniques. The development of a new enzyme immunoassay for the detection of antibodies against a conserved epitope in the HCV core protein, together with the detection of HCV-RNA in peripheral blood mononuclear cells and in serum after concentrating the viral particles by ultracentrifugation, allow diagnosis of more than 90% of patients with occult HCV without the need to perform a liver biopsy. Histological damage in occult HCV infection ranges from minimal changes to liver cirrhosis and hepatocellular carcinoma, although in general this disease is less severe than classical chronic hepatitis C. A significant prevalence of occult HCV infection has been identified in risk groups such as hemodialysis patients and the family members of patients with occult hepatitis C. This occult HCV infection can also be found in subjects without clinical or biochemical evidence of liver disease.

Effects of acupuncture on patients with fibromyalgia: study protocol of a multicentre randomized controlled trial.

BACKGROUND: Fibromyalgia is a multidimensional disorder for which treatment as yet remains unsatisfactory. Studies of an acupuncture-based approach, despite its broad acceptance among patients and healthcare staff, have not produced sufficient evidence of its effectiveness in treating this syndrome. The present study aims to evaluate the effectiveness of individualized acupuncture for patients with fibromyalgia, with respect to reducing their pain and level of incapacity, and improving their quality of life. METHODS/DESIGN: Randomized controlled multicentre study, with 156 outpatients, aged over 17 years, diagnosed with fibromyalgia according to American College of Rheumatology criteria, either alone or associated with severe depression, according to the criteria of the Diagnostic and Statistical Manual for Mental Disorders. The participants will be randomly assigned to receive either "True acupuncture" or "Sham acupuncture". They will be evaluated using a specific measurement system, constituted of the Fibromyalgia Impact Questionnaire and the Hamilton rating scale for depression. Also taken into consideration will be the clinical and subjective pain intensity, the patient's family structure and relationships, psychological aspects, quality of life, the duration of previous temporary disability, the consumption of antidepressant, analgesic and anti-inflammatory medication, and the potential effect of factors considered to be predictors of a poor prognosis. All these aspects will be examined by questionnaires and other suitably-validated instruments. The results obtained will be analysed at 10 weeks, and 6 and 12 months from the start of treatment. DISCUSSION: This trial will utilize high quality trial methodologies in accordance with CONSORT guidelines. It may provide evidence for the effectiveness of acupuncture as a treatment for fibromyalgia either alone or associated with severe depression. TRIAL REGISTRATION: ISRCTN trial number ISRCTN60217348 (19 October 2010).

Infección oculta por el virus de la hepatitis C / Occult hepatitis C virus infection

La infección oculta por el virus de la hepatitis C (VHC) se caracteriza por la detección del ARN-VHC en hígado en ausencia de anti-VHC y de ARN-VHC en suero determinados mediante técnicas convencionales. El desarrollo de un nuevo EIA para la detección de anticuerpos frente a un epítopo conservado de la proteína core del VHC junto con la determinación del ARN-VHC en células mononucleares de sangre periférica y en suero tras concentrar las partículas virales mediante ultracentrifugación, permite diagnosticar a más del 90% de los pacientes con infección oculta por VHC sin necesidad de realizar una biopsia hepática. El daño histológico causado por la infección oculta por VHC comprende desde cambios mínimos hasta cirrosis y carcinoma hepatocelular, aunque en general es una enfermedad más benigna que la hepatitis crónica C clásica. Se ha detectado una prevalencia significativa de infección oculta por VHC en grupos de riesgo como pacientes en hemodiálisis y familiares de pacientes diagnosticados de hepatitis C oculta. Además, esta infección oculta puede darse en sujetos sin evidencias clínicas ni bioquímicas de enfermedad hepática (AU)

Occult hepatitis C virus (HCV) infection is characterized by the detection of HCV-RNA in liver in the absence of anti-HCV and serum HCV-RNA determined by conventional techniques. The development of a new enzyme immunoassay for the detection of antibodies against a conserved epitope in the HCV core protein, together with the detection of HCV-RNA in peripheral blood mononuclear cells and in serum after concentrating the viral particles by ultracentrifugation, allow diagnosis of more than 90% of patients with occult HCV without the need to perform a liver biopsy. Histological damage in occult HCV infection ranges from minimal changes to liver cirrhosis and hepatocellular carcinoma, although in general this disease isless severe than classical chronic hepatitis C. A significant prevalence of occult HCV infection has been identified in risk groups such as hemodialysis patients and the family members of patients with occult hepatitis C. This occult HCV infection can also be found in subjects without clinical or biochemical evidence of liver disease (AU)

Randomised controlled study in the primary healthcare sector to investigate the effectiveness and safety of auriculotherapy for the treatment of uncomplicated chronic rachialgia: a study protocol.

BACKGROUND: Uncomplicated chronic rachialgia is a highly prevalent complaint, and one for which therapeutic results are contradictory. The aim of the present study is to evaluate the effectiveness and safety of treatment with auriculopressure, in the primary healthcare sector, carried out by trained healthcare professionals via a 30-hour course. METHODS/DESIGN: The design consists of a multi-centre randomized controlled trial, with placebo, with two parallel groups, and including an economic evaluation. Patients with chronic uncomplicated rachialgia, whose GP is considering referral for auriculopressure sensory stimulation, are eligible for inclusion. Sampling will be by consecutive selection, and randomised allocation to one of the two study arms will be determined using a centralised method, following a 1:1 plan (true auriculopressure; placebo auriculopressure). The implants (true and placebo) will be replaced once weekly, and the treatment will have a duration of 8 weeks. The primary outcome measure will be the change in pain intensity, measured on a visual analogue scale (VAS) of 100 mm, at 9 weeks after beginning the treatment. A follow up study will be performed at 6 months after beginning treatment. An assessment will also be made of the changes measured in the Spanish version of the McGill Pain Questionnaire, of the changes in the Lattinen test, and of the changes in quality of life (SF-12). Also planned is an analysis of cost-effectiveness and also, if necessary, a cost-benefit analysis. DISCUSSION: This study will contribute to developing evidence on the use of auriculotherapy using Semen vaccariae [wang bu liu xing] for the treatment of uncomplicated chronic rachialgia. TRIAL REGISTRATION: Current Controlled Trials ISRCTN01897462.

Effectiveness of acupuncture, special dressings and simple, low-adherence dressings for healing venous leg ulcers in primary healthcare: study protocol for a cluster-randomized open-labeled trial.

BACKGROUND: Venous leg ulcers constitute a chronic recurring complaint that affects 1.0-1.3% of the adult population at some time in life, and which corresponds to approximately 75% of all chronic ulcers of the leg. Multilayer compression bandaging is, at present, the only treatment that has been proved to be effective in treating this type of ulcer. There is no consensus, however, about the dressings that may be applied, beneath the compression, to promote the healing of this type of ulcer, as there does not seem to be any added benefit from using special dressings rather than simple, low-adherence ones. As well as analgesia, acupuncture provokes peripheral vasodilation, in skin and muscles - which has been demonstrated both experimentally and in clinical practice - probably due to the axon reflex, among other mechanisms. The aim of the present study is to measure the effectiveness and cost of compression treatment for venous leg ulcers combined with special dressings, in comparison with low-adherence ones and acupuncture. METHODS/DESIGN: Cluster-randomized open-labeled trial, at 15 primary healthcare clinics in the Sevilla-Sur Healthcare District, with a control group treated with compression bandaging and low-adherence dressings; the experiment will consist, on the one hand, of the compression treatment applied in combination with special dressings (Treatment 1), and on the other, the compression treatment applied in association with low-adherence dressings, together with acupuncture (Treatment 2). DISCUSSION: The results will be measured and recorded in terms of the median time elapsed until complete healing of the ulcer, and the rate of complete healing at 3 months after beginning the treatment. An economic analysis will also be made. This study, carried out in the context of real clinical practice, will provide information for decision-taking concerning the effectiveness of special dressings. Moreover, for the first time a high-quality study will evaluate the effectiveness of acupuncture in the process of healing venous leg ulcers. TRIAL REGISTRATION: Current Controlled Trials ISRCTN26438275.

Correcting non cephalic presentation with moxibustion: study protocol for a multi-centre randomised controlled trial in general practice.

BACKGROUND: Non cephalic presentation in childbirth involves various risks to both the mother and the foetus. The incidence in Spain is 3.8% of all full-term pregnancies. The most common technique used to end the gestation in cases of non cephalic presentation is that of caesarian section, and although it provokes a lower rate of morbi-mortality than does vaginal delivery in such situations, there remains the possibility of traumatic injury to the foetal head and neck, while maternal morbidity is also increased. The application of heat (moxibustion) to an acupuncture point, in order to correct non cephalic presentation, has been practised in China since ancient times, but as yet there is insufficient evidence of its real effectiveness. METHODS/DESIGN: The experimental design consists of a multi-centre randomised controlled trial with three parallel arms, used to compare real moxibustion, sham moxibustion and the natural course of events, among pregnant women with a non cephalic presentation and a gestational duration of 33-35 weeks (estimated by echography). The participants in the trial will be blinded to both interventions. The results obtained will be analyzed by professionals, blinded with respect to the allocation to the different types of intervention. In addition, we intend to carry out a economic analysis. DISCUSSION: This trial will contribute to the development of evidence concerning moxibustion in the correction of non cephalic presentations. The primary outcome variable is the proportion of cephalic presentations at term. As secondary outcomes, we will evaluate the proportion of cephalic presentations at week 38 of gestation, determined by echography, together with the safety of the technique, the specificity of moxibustion and the control of the blinding process. This study has been funded by the Health Ministry of the Andalusian Regional Government. TRIAL REGISTRATION: Current Controlled Trials ISRCTN10634508.