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Introduction: Mechanical restraints are widely used in health care practice, despite the numerous ethical conflicts they raise. The aim of this study is to evaluate the ethical considerations contemplated in the current protocols on mechanical restraint in Spain., Method: Systematic review in PubMed, WOS and Scopus, Google and Google Scholar. An ad hoc list of 30 items was used to evaluate the ethical content of the protocols. The quality of guidelines was assessed with AGREE II., Results: The need for informed consent (IC) is reflected in 72% of the documents, the IC model sheet is included in only 41% of them, the rest of the analyzed characteristics on IC are fulfilled in percentages between 6% (the document includes the need to reevaluate the indication for IC) and 31% (the document contemplates to whom it should be requested). More than 20 ethical contents are reflected in 31% of them and less than 10 in 19% of the guidelines. The quality of the guides, according to AGREE II, ranged from 27 to 116 points (maximum possible 161), with a mean score of 68.7. Only 9% of the documents were classified as high quality. Finally, the correlation between ethical content and quality measured with AGREE II was 0.75., Conclusions: The variability of ethical contents in guidelines on mechanical restraints is very high. The ethical requirements to be included in protocols, consensus or Clinical Practice Guidelines should be defined., (Copyright © 2024. Publicado por Elsevier España, S.L.U.)

Objective: To analyze the prevalence and severity of the opioid-induced bowel dysfunction (OBD) symptoms., Design: Epidemiological, observational and cross-sectional study., Location: Six Spanish centers participated., Participants: A total of 317 outpatients with a diagnosis of cancer pain or non-cancer pain treated with a unique opioid were recruited., Main Measurements: The prevalence of OBD symptoms was measured using a visual analog scale (VAS: 0-100), and constipation was also assessed by the Bowel Function Index (BFI). The treatment for gastrointestinal symptoms was recorded, and the frequency of symptoms between different opioid treatments was compared. Finally, quality of life was evaluated., Results: The prevalence of OBD with at least one gastrointestinal disorder was 94.6%, with constipation being the most frequent symptom (BFI: 91.6%; VAS: 90.2%) and nearly half of the patients showed three or more symptoms with a VAS ≥ 4. No significant differences were detected in the prevalence of symptoms between the opioid groups. A decrease in the wellbeing of patients was detected related to moderate to severe gastrointestinal symptoms., Conclusions: A high rate of gastrointestinal disorders probably related to OBD have been confirmed in patients on opioid therapy, highlighting the need for new drug strategies., (Copyright © 2012 Elsevier España, S.L. All rights reserved.)

Background and Objective: To achieve a linguistic adaptation and psychometric validation into Spanish of the ID-Pain questionnaire for the screening of differential diagnosis of pain with a neuropathic component., Material and Method: Cross-sectional validation study carried out in 2 phases (cultural adaptation into Spanish language and validation study to test psychometric properties of the scale) in men and women > 18 years, with neuropathic (NP) and nociceptive (NNP) chronic pain for more than 6 months. Feasibility and reliability were explored. Criterion and convergent validity were studied by means of ID-Pain association with reference diagnosis and LANNS (Leeds Assessment of Neuropathic Symptoms and Signs) scale scores. Factor and ROC curves analysis, agreement with reference diagnosis and sensitivity and specificity values were assessed., Results: A total of 283 subjects -64.4% women; mean age (standard deviation): 59.1 (14.9) years-, 145 (51.2%) with NP and 138 (48.8%) with NNP were included in the study. Administration time was 4.2 (3.0) min. Only 15% of participants required help for test completion. Factor analysis indicated a unifactorial solution accounting for 35.5% of the variance. The instrument was time-stable (test-retest r-Pearson = 0.98; p < 0.0005). Mean score differentiated NP from NNP patients; 3.5 (1.2) vs. 1.2 (1.4) (p < 0.0005). Optimum cut-off value was > or = 3 points, showing an area under the curve = 0.89; p < 0.0005, sensitivity value of 0.81, specificity of 0.84 and kappa coefficient of agreement with reference clinical diagnosis of 0.65. The scale also showed good concurrent validity with LANSS classification of subjects (kappa = 0.61; p < 0.0005)., Conclusions: The Spanish version of the ID-Pain questionnaire is feasible, reliable and appropriated as a self-administered screening tool for pain with a neuropathic component.

Objectives: To assess the effectiveness and tolerability of zoledronic acid in prostate cancer patients with bone metastases at the hormone-sensitive (HS) and hormone-independent (HI) stages., Materials and Methods: A nationwide, observational, prospective, open and multi-centre trial was devised, with a total of 218 male patients diagnosed with prostate cancer at the HS stage (36%) or HI stage (64%) who were administered zoledronic acid (4 mg/IV/month for 6 months) in addition to their specific oncological treatment. Effectiveness was assessed by the following means: 1) Assessment of the improvement in pain and mobility; 2) Incidence and time to onset of skeletal-related events (SREs) and 3) Analysis of bone markers. Tolerability was assessed by means of registering the number and type of adverse effects. A satisfaction survey was carried out amongst the patients after the end of the trial., Results: Out of the 218 patients, 170 (78%) were evaluable for effectiveness. A decrease in pain ratings at rest and during movement was observed in all patients, whether in the HS or HI groups (p < 0.0001). Improved mobility was observed likewise (p = 0.005), as was quality of life. The global incidence of skeletal events was 11.2%, with a time to onset of SREs of 10.7 months. There were no significant differences observed between HS vs. HI patients. Osteolysis markers (N-telopeptide) decreased significantly with the treatment across both the HS and HI groups. For safety reasons. 212 patients were evaluable (97.2%). The incidence of adverse drug reactions was 16% (34/212) and was found to be significantly higher in HS patients (22.4%) compared with HI patients (11.9%). Overall, the tolerability of zoledronic acid was good, with no significant morbidity in either group (HS and HI). 66% of the patients reported feeling satisfied or very satisfied., Conclusions: Zoledronic acid proved effective in the relief of pain, improving mobility and quality of life as well as reducing or delaying the occurrence of skeletal-related events in prostate cancer patients presenting metastatic bone disease, regardless of the phase, whether HS or HI, they found themselves in. Tolerability and patient satisfaction were rates as good.

Background and Objective: This study was intended to achieve a linguistic adaptation and validation into Spanish of the LANNS scale for the differential diagnosis of neuropathic pain., Material and Method: Cross-sectional validation study carried out in two phases: first, cultural adaptation into Spanish language, by means of a conceptual equivalence approach, including forward and backward translations in duplicate and review by experts; and second, validation study of the scale in patients with neuropathic, noniceptive and mixed pain, in which the scale properties of reliability (internal consistency and inter-rater agreement with kappa and intra-class correlation coefficients) and validity (ROC curves analisys, agreement with reference diagnosis and determination of sensitivity, specificity and positive and negatives predictive values) were evaluated., Results: A total of 156 subjects (90 women, 58.4%), 89 with pain of neuropathic origin (mean age [SD], 59.6 [19.4] years, 22 with mixed pain due to radiculopathy) and 67 with nociceptive pain (66.6 [11.8] years) were included in the study. Diagnosis of the type of pain was performed by standard clinical criteria. The scale was administrated by trained interviewers, in duplicate and blinded to the reference diagnosis. The scale showed good reliability (internal consistency: Cronbach and Guttman split-half coefficients between 0.68 and 0.71; inter-rater agreement: kappa coefficient of 0.70 and intra-class correlation coefficients between 0.77 and 0.92) and validity for a cut-off value > or = 12 points, which represented the best value to discriminate between patients with neuropathic and nociceptive components of pain (kappa coefficient = 0.70; CI 95%, 0.59-0.81; p < 0.0001); area under the curve, 0.929; (p < 0.0001); specificity, 89.4% (CI 95%, 79.4%-95.6%) and positive value, 91.1%; CI 95%, 82.6%-96.4%)., Conclusions: The Spanish version of the LANSS scale is reliable and valid for the differential diagnosis of neuropathic pain.

A narrative systematic medical literature review on prevalence of neuropathic pain (NP) in Spain from 1990 to 2004 was conducted. The average number of publications was 3 per year. Prevalence data varied depending on studied population, definition of pain/pathology and time of pain evolution. The most commonly studied pathologies included: mononeuropathies and polyneuropathies: 42%, multiple sclerosis: 35% and entrapment neuropathies: 16%. Some episodes of NP were left untreated. One third of patients with back pain receiving analgesic treatment still had high intensity pain. Future studies on the prevalence of NP should use work definitions and criteria reached by consensus. An awareness of the clinical presentation of NP and an appropriate and early treatment could minimize its clinical, working and health care implications. NP is a diverse and highly prevalent condition in Spain. Efforts should be conducted towards the achievement of diagnostic criteria consensus and higher rates of analgesic success.

Background and Objective: Our goal was to validate the Spanish version of the Brief Pain Inventory (BPI) questionnaire used to measure the intensity of oncological pain and its impact on activities of daily living in patients with cancer., Patients and Method: Patients with oncological pain were consecutively included in the study. These patients filled up the Spanish version of the BPI questionnaire (CBD) and the Rotterdam Symptom Checklist (RCSL) during the inclusion visit and again after 3-5 days (patients with clinically stable oncological pain) or after one month (patients with unstable oncological pain)., Results: 126 patients were assessed; 85.1% of them had suffered some episode of irruptive pain 24 hours prior to their inclusion in the study. 86.5% of patients fully completed the questionnaire. The CBD showed mild to moderate correlations with the patients perception of pain severity and with the presence of tumor dissemination. The <> dimension of the RCSL displayed the highest correlation with the dimensions of the BPI (<> and <>). The internal consistency and the test-retest reliability between dimensions were good (0.87 and 0.89) and low to moderate (0.53 and 0.77), respectively. The CBD questionnaire was found to be a tool capable of detecting changes in pain intensity. The changes observed in the two CBD dimensions between study visits fairly reflected the patients perceived changes in pain intensity., Conclusions: The Spanish version of BPI is valid for measuring the intensity of oncological pain and its impact on activities of daily living in conditions of usual clinical practice.

The role of adhesivity as a factor of virulence in cases of N. meningitidis has not yet been established. Unlike other bacteria in which the presence of adhesivity reflects an enhanced virulence, a high capacity of adherence is associated with a low virulence and invasive capacity in cases of meningococcus. In order to gain more insight into the knowledge of this phenomenon we have studied the adhesivity of 109 strains of N. meningitidis to human pharyngeal epithelial cells. Twenty nine out of the 109 strains were isolated from blood or spinal fluid of patients with meningococcal infection (meningitis or septicemia), whereas the remaining 80 strains were obtained from pharyngeal smears of healthy carriers. The adhesivity was measured as the number of meningococci adhered to 50 epithelial cells according to Craven's scale. Strains of healthy carriers showed a greater adhesivity than that of patients (p less than 0.001). The relevance of the pharyngeal area in the evaluation of the adhesive capacity is in accordance with the hypothesis that meningococcal adhesivity decreases when the microorganism crosses the pharyngeal epithelium. The results would support the concept that the virulence of N. meningitidis is related to its adhesiveness.