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1.
Lancet ; 400(10353): 680-690, 2022 08 27.
Artículo en Inglés | MEDLINE | ID: mdl-36007534

RESUMEN

BACKGROUND: Diabetic peripheral neuropathic pain (DPNP) is common and often distressing. Most guidelines recommend amitriptyline, duloxetine, pregabalin, or gabapentin as initial analgesic treatment for DPNP, but there is little comparative evidence on which one is best or whether they should be combined. We aimed to assess the efficacy and tolerability of different combinations of first-line drugs for treatment of DPNP. METHODS: OPTION-DM was a multicentre, randomised, double-blind, crossover trial in patients with DPNP with mean daily pain numerical rating scale (NRS) of 4 or higher (scale is 0-10) from 13 UK centres. Participants were randomly assigned (1:1:1:1:1:1), with a predetermined randomisation schedule stratified by site using permuted blocks of size six or 12, to receive one of six ordered sequences of the three treatment pathways: amitriptyline supplemented with pregabalin (A-P), pregabalin supplemented with amitriptyline (P-A), and duloxetine supplemented with pregabalin (D-P), each pathway lasting 16 weeks. Monotherapy was given for 6 weeks and was supplemented with the combination medication if there was suboptimal pain relief (NRS >3), reflecting current clinical practice. Both treatments were titrated towards maximum tolerated dose (75 mg per day for amitriptyline, 120 mg per day for duloxetine, and 600 mg per day for pregabalin). The primary outcome was the difference in 7-day average daily pain during the final week of each pathway. This trial is registered with ISRCTN, ISRCTN17545443. FINDINGS: Between Nov 14, 2017, and July 29, 2019, 252 patients were screened, 140 patients were randomly assigned, and 130 started a treatment pathway (with 84 completing at least two pathways) and were analysed for the primary outcome. The 7-day average NRS scores at week 16 decreased from a mean 6·6 (SD 1·5) at baseline to 3·3 (1·8) at week 16 in all three pathways. The mean difference was -0·1 (98·3% CI -0·5 to 0·3) for D-P versus A-P, -0·1 (-0·5 to 0·3) for P-A versus A-P, and 0·0 (-0·4 to 0·4) for P-A versus D-P, and thus not significant. Mean NRS reduction in patients on combination therapy was greater than in those who remained on monotherapy (1·0 [SD 1·3] vs 0·2 [1·5]). Adverse events were predictable for the monotherapies: we observed a significant increase in dizziness in the P-A pathway, nausea in the D-P pathway, and dry mouth in the A-P pathway. INTERPRETATION: To our knowledge, this was the largest and longest ever, head-to-head, crossover neuropathic pain trial. We showed that all three treatment pathways and monotherapies had similar analgesic efficacy. Combination treatment was well tolerated and led to improved pain relief in patients with suboptimal pain control with a monotherapy. FUNDING: National Institute for Health Research (NIHR) Health Technology Assessment programme.


Asunto(s)
Diabetes Mellitus , Neuropatías Diabéticas , Neuralgia , Amitriptilina , Analgésicos , Estudios Cruzados , Método Doble Ciego , Clorhidrato de Duloxetina , Humanos , Pregabalina , Resultado del Tratamiento , Ácido gamma-Aminobutírico
2.
Pract Neurol ; 23(2): 139-145, 2023 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-36162855

RESUMEN

In carefully selected patients, autologous haematopoietic stem cell transplantation (HSCT) is a safe, highly effective and cost-saving treatment modality for treatment-resistant, and potentially treatment-naïve, immune-mediated neurological disorders. Although the evidence base has been growing in the last decade, limited understanding has led to confusion, mistrust and increasing use of health tourism. In this article, we discuss what autologous HSCT is, which immune-mediated conditions can be treated with it, how to select patients, what are the expected outcomes and potential adverse effects, and how cost-effective this treatment is.


Asunto(s)
Trasplante de Células Madre Hematopoyéticas , Esclerosis Múltiple , Enfermedades del Sistema Nervioso , Humanos , Enfermedades del Sistema Nervioso/terapia , Enfermedades del Sistema Nervioso/etiología
3.
Emerg Med J ; 39(4): 317-324, 2022 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-35140074

RESUMEN

BACKGROUND: Tools proposed to triage patient acuity in COVID-19 infection have only been validated in hospital populations. We estimated the accuracy of five risk-stratification tools recommended to predict severe illness and compared accuracy to existing clinical decision making in a prehospital setting. METHODS: An observational cohort study using linked ambulance service data for patients attended by Emergency Medical Service (EMS) crews in the Yorkshire and Humber region of England between 26 March 2020 and 25 June 2020 was conducted to assess performance of the Pandemic Respiratory Infection Emergency System Triage (PRIEST) tool, National Early Warning Score (NEWS2), WHO algorithm, CRB-65 and Pandemic Medical Early Warning Score (PMEWS) in patients with suspected COVID-19 infection. The primary outcome was death or need for organ support. RESULTS: Of the 7549 patients in our cohort, 17.6% (95% CI 16.8% to 18.5%) experienced the primary outcome. The NEWS2 (National Early Warning Score, version 2), PMEWS, PRIEST tool and WHO algorithm identified patients at risk of adverse outcomes with a high sensitivity (>0.95) and specificity ranging from 0.3 (NEWS2) to 0.41 (PRIEST tool). The high sensitivity of NEWS2 and PMEWS was achieved by using lower thresholds than previously recommended. On index assessment, 65% of patients were transported to hospital and EMS decision to transfer patients achieved a sensitivity of 0.84 (95% CI 0.83 to 0.85) and specificity of 0.39 (95% CI 0.39 to 0.40). CONCLUSION: Use of NEWS2, PMEWS, PRIEST tool and WHO algorithm could improve sensitivity of EMS triage of patients with suspected COVID-19 infection. Use of the PRIEST tool would improve sensitivity of triage without increasing the number of patients conveyed to hospital.


Asunto(s)
COVID-19 , Servicios Médicos de Urgencia , Adulto , COVID-19/diagnóstico , Estudios de Cohortes , Humanos , Pronóstico , Estudios Retrospectivos , Triaje
4.
Diabetes Spectr ; 32(2): 145-151, 2019 May.
Artículo en Inglés | MEDLINE | ID: mdl-31168286

RESUMEN

PURPOSE: Many people with diabetes have difficulty achieving glycemic targets, and social and psychosocial determinants of health may influence their ability to obtain glycemic goals. The objective of this study was to identify characteristics independently associated with A1C >9% or untested A1C compared to those with A1C ≤9% at a federally qualified health center. METHODS: This retrospective cohort study included people with a diagnosis of diabetes, who were 18-89 years of age and had a medical evaluation from a primary care provider between 1 September 2016 and 31 August 2017. The primary outcome was to identify characteristics associated with an A1C >9% or untested A1C compared to those with an A1C ≤9%. RESULTS: Of 6,185 patients meeting inclusion criteria, 2,965 (48%) had uncontrolled A1C. In the uncontrolled A1C group, 1,549 patients (52%) were female, 1,296 (44%) preferred care in a language other than English (1,273 [43%] in Spanish), and 535 (18%) had a concurrent mental health diagnosis. Multivariable logistic regression of 4,774 patients with complete data revealed that poor appointment adherence (odds ratio [OR] 3.24, 95% CI 2.30-4.57) and/or a positive Patient Health Questionnaire-2 depression screen (OR 1.35, 95% CI 1.12-1.62) had an increased risk of being in the uncontrolled A1C group. Patients with a prescription for antidepressant medication were more likely to be in the controlled group. CONCLUSION: Poor adherence to appointments and presence of depressive symptoms were associated with high A1C values. Interventions can be developed targeting these determinants to improve blood glucose levels.

5.
Contemp Clin Trials ; 142: 107573, 2024 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-38759865

RESUMEN

INTRODUCTION: Accurately estimating the costs of clinical trials is challenging. There is currently no reference class data to allow researchers to understand the potential costs associated with database change management in clinical trials. METHODS: We used a case-based approach, summarising post-live changes in eleven clinical trial databases managed by Sheffield Clinical Trials Research Unit. We reviewed the database specifications for each trial and summarised the number of changes, change type, change category, and timing of changes. We pooled our experiences and made observations in relation to key themes. RESULTS: Median total number of changes across the eleven trials was 71 (range 40-155) and median number of changes per study week was 0.48 (range 0.32-1.34). The most common change type was modification (median 39, range 20-90), followed by additions (median 32, range 18-55), then deletions (median 7, range 1-12). In our sample, changes were more common in the first half of the trial's lifespan, regardless of its overall duration. Trials which saw continuous changes seemed more likely to be external pilots or trials in areas where the trial team was either less experienced overall or within the particular therapeutic area. CONCLUSIONS: Researchers should plan trials with the expectation that clinical trial databases will require changes within the life of the trial, particularly in the early stages or with a less experienced trial team. More research is required to understand potential differences between clinical trial units and database types.


Asunto(s)
Ensayos Clínicos como Asunto , Bases de Datos Factuales , Humanos , Ensayos Clínicos como Asunto/organización & administración , Ensayos Clínicos como Asunto/métodos , Ensayos Clínicos como Asunto/normas , Reino Unido , Manejo de Datos/métodos
6.
BMJ Open ; 14(2): e083582, 2024 02 05.
Artículo en Inglés | MEDLINE | ID: mdl-38316583

RESUMEN

INTRODUCTION: Autologous haematopoietic stem cell transplantation (aHSCT) is increasingly used as treatment for patients with active multiple sclerosis (MS), typically after failure of disease-modifying therapies (DMTs). A recent phase III trial, 'Multiple Sclerosis International Stem Cell Transplant, MIST', showed that aHSCT resulted in prolonged time to disability progression compared with DMTs in patients with relapsing remitting MS (RRMS). However, the MIST trial did not include many of the current high-efficacy DMTs (alemtuzumab, ocrelizumab, ofatumumab or cladribine) in use in the UK within the control arm, which are now offered to patients with rapidly evolving severe MS (RES-MS) who are treatment naïve. There remain, therefore, unanswered questions about the relative efficacy and safety of aHSCT over these high-efficacy DMTs in these patient groups. The StarMS trial (Autologous Stem Cell Transplantation versus Alemtuzumab, Ocrelizumab, Ofatumumab or Cladribine in Relapsing Remitting Multiple Sclerosis) will assess the efficacy, safety and long-term impact of aHSCT compared with high-efficacy DMTs in patients with highly active RRMS despite the use of standard DMTs or in patients with treatment naïve RES-MS. METHODS AND ANALYSIS: StarMS is a multicentre parallel-group rater-blinded randomised controlled trial with two arms. A total of 198 participants will be recruited from 19 regional neurology secondary care centres in the UK. Participants will be randomly allocated to the aHSCT arm or DMT arm in a 1:1 ratio. Participants will remain in the study for 2 years with follow-up visits at 3, 6, 9, 12, 18 and 24 months postrandomisation. The primary outcome is the proportion of patients who achieve 'no evidence of disease activity' during the 2-year postrandomisation follow-up period in an intention to treat analysis. Secondary outcomes include efficacy, safety, cost-effectiveness and immune reconstitution of aHSCT and the four high-efficacy DMTs. ETHICS AND DISSEMINATION: The study was approved by the Yorkshire and Humber-Leeds West Research Ethics Committee (20/YH/0061). Participants will provide written informed consent prior to any study specific procedures. The study results will be submitted to a peer-reviewed journal and abstracts will be submitted to relevant national and international conferences. TRIAL REGISTRATION NUMBER: ISRCTN88667898.


Asunto(s)
Anticuerpos Monoclonales Humanizados , Trasplante de Células Madre Hematopoyéticas , Esclerosis Múltiple Recurrente-Remitente , Esclerosis Múltiple , Humanos , Cladribina/uso terapéutico , Alemtuzumab/uso terapéutico , Esclerosis Múltiple Recurrente-Remitente/tratamiento farmacológico , Trasplante Autólogo , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Multicéntricos como Asunto
7.
BMJ Qual Saf ; 2022 Mar 30.
Artículo en Inglés | MEDLINE | ID: mdl-35354665

RESUMEN

OBJECTIVE: To assess accuracy of telephone triage in identifying need for emergency care among those with suspected COVID-19 infection and identify factors which affect triage accuracy. DESIGN: Observational cohort study. SETTING: Community telephone triage provided in the UK by Yorkshire Ambulance Service NHS Trust (YAS). PARTICIPANTS: 40 261 adults who contacted National Health Service (NHS) 111 telephone triage services provided by YAS between 18 March 2020 and 29 June 2020 with symptoms indicating COVID-19 infection were linked to Office for National Statistics death registrations and healthcare data collected by NHS Digital. OUTCOME: Accuracy of triage disposition was assessed in terms of death or need for organ support up to 30 days from first contact. RESULTS: Callers had a 3% (1200/40 261) risk of serious adverse outcomes (death or organ support). Telephone triage recommended self-care or non-urgent assessment for 60% (24 335/40 261), with a 1.3% (310/24 335) risk of adverse outcomes. Telephone triage had 74.2% sensitivity (95% CI: 71.6 to 76.6%) and 61.5% specificity (95% CI: 61% to 62%) for the primary outcome. Multivariable analysis suggested respiratory comorbidities may be overappreciated, and diabetes underappreciated as predictors of deterioration. Repeat contact with triage service appears to be an important under-recognised predictor of deterioration with 2 contacts (OR 1.77, 95% CI: 1.14 to 2.75) and 3 or more contacts (OR 4.02, 95% CI: 1.68 to 9.65) associated with false negative triage. CONCLUSION: Patients advised to self-care or receive non-urgent clinical assessment had a small but non-negligible risk of serious clinical deterioration. Repeat contact with telephone services needs recognition as an important predictor of subsequent adverse outcomes.

8.
BMJ Open ; 12(5): e058628, 2022 05 16.
Artículo en Inglés | MEDLINE | ID: mdl-35577471

RESUMEN

OBJECTIVE: To assess accuracy of emergency medical service (EMS) telephone triage in identifying patients who need an EMS response and identify factors which affect triage accuracy. DESIGN: Observational cohort study. SETTING: Emergency telephone triage provided by Yorkshire Ambulance Service (YAS) National Health Service (NHS) Trust. PARTICIPANTS: 12 653 adults who contacted EMS telephone triage services provided by YAS between 2 April 2020 and 29 June 2020 assessed by COVID-19 telephone triage pathways were included. OUTCOME: Accuracy of call handler decision to dispatch an ambulance was assessed in terms of death or need for organ support at 30 days from first contact with the telephone triage service. RESULTS: Callers contacting EMS dispatch services had an 11.1% (1405/12 653) risk of death or needing organ support. In total, 2000/12 653 (16%) of callers did not receive an emergency response and they had a 70/2000 (3.5%) risk of death or organ support. Ambulances were dispatched to 4230 callers (33.4%) who were not conveyed to hospital and did not deteriorate. Multivariable modelling found variables of older age (1 year increase, OR: 1.05, 95% CI: 1.04 to 1.05) and presence of pre-existing respiratory disease (OR: 1.35, 95% CI: 1.13 to 1.60) to be predictors of false positive triage. CONCLUSION: Telephone triage can reduce ambulance responses but, with low specificity. A small but significant proportion of patients who do not receive an initial emergency response deteriorated. Research to improve accuracy of EMS telephone triage is needed and, due to limitations of routinely collected data, this is likely to require prospective data collection.


Asunto(s)
COVID-19 , Servicios Médicos de Urgencia , Adulto , Ambulancias , Estudios de Cohortes , Recolección de Datos , Humanos , Medicina Estatal , Teléfono , Triaje
9.
Health Technol Assess ; 26(39): 1-100, 2022 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-36259684

RESUMEN

BACKGROUND: The mainstay of treatment for diabetic peripheral neuropathic pain is pharmacotherapy, but the current National Institute for Health and Care Excellence guideline is not based on robust evidence, as the treatments and their combinations have not been directly compared. OBJECTIVES: To determine the most clinically beneficial, cost-effective and tolerated treatment pathway for diabetic peripheral neuropathic pain. DESIGN: A randomised crossover trial with health economic analysis. SETTING: Twenty-one secondary care centres in the UK. PARTICIPANTS: Adults with diabetic peripheral neuropathic pain with a 7-day average self-rated pain score of ≥ 4 points (Numeric Rating Scale 0-10). INTERVENTIONS: Participants were randomised to three commonly used treatment pathways: (1) amitriptyline supplemented with pregabalin, (2) duloxetine supplemented with pregabalin and (3) pregabalin supplemented with amitriptyline. Participants and research teams were blinded to treatment allocation, using over-encapsulated capsules and matching placebos. Site pharmacists were unblinded. OUTCOMES: The primary outcome was the difference in 7-day average 24-hour Numeric Rating Scale score between pathways, measured during the final week of each pathway. Secondary end points included 7-day average daily Numeric Rating Scale pain score at week 6 between monotherapies, quality of life (Short Form questionnaire-36 items), Hospital Anxiety and Depression Scale score, the proportion of patients achieving 30% and 50% pain reduction, Brief Pain Inventory - Modified Short Form items scores, Insomnia Severity Index score, Neuropathic Pain Symptom Inventory score, tolerability (scale 0-10), Patient Global Impression of Change score at week 16 and patients' preferred treatment pathway at week 50. Adverse events and serious adverse events were recorded. A within-trial cost-utility analysis was carried out to compare treatment pathways using incremental costs per quality-adjusted life-years from an NHS and social care perspective. RESULTS: A total of 140 participants were randomised from 13 UK centres, 130 of whom were included in the analyses. Pain score at week 16 was similar between the arms, with a mean difference of -0.1 points (98.3% confidence interval -0.5 to 0.3 points) for duloxetine supplemented with pregabalin compared with amitriptyline supplemented with pregabalin, a mean difference of -0.1 points (98.3% confidence interval -0.5 to 0.3 points) for pregabalin supplemented with amitriptyline compared with amitriptyline supplemented with pregabalin and a mean difference of 0.0 points (98.3% confidence interval -0.4 to 0.4 points) for pregabalin supplemented with amitriptyline compared with duloxetine supplemented with pregabalin. Results for tolerability, discontinuation and quality of life were similar. The adverse events were predictable for each drug. Combination therapy (weeks 6-16) was associated with a further reduction in Numeric Rating Scale pain score (mean 1.0 points, 98.3% confidence interval 0.6 to 1.3 points) compared with those who remained on monotherapy (mean 0.2 points, 98.3% confidence interval -0.1 to 0.5 points). The pregabalin supplemented with amitriptyline pathway had the fewest monotherapy discontinuations due to treatment-emergent adverse events and was most commonly preferred (most commonly preferred by participants: amitriptyline supplemented with pregabalin, 24%; duloxetine supplemented with pregabalin, 33%; pregabalin supplemented with amitriptyline, 43%; p = 0.26). No single pathway was superior in cost-effectiveness. The incremental gains in quality-adjusted life-years were small for each pathway comparison [amitriptyline supplemented with pregabalin compared with duloxetine supplemented with pregabalin -0.002 (95% confidence interval -0.011 to 0.007) quality-adjusted life-years, amitriptyline supplemented with pregabalin compared with pregabalin supplemented with amitriptyline -0.006 (95% confidence interval -0.002 to 0.014) quality-adjusted life-years and duloxetine supplemented with pregabalin compared with pregabalin supplemented with amitriptyline 0.007 (95% confidence interval 0.0002 to 0.015) quality-adjusted life-years] and incremental costs over 16 weeks were similar [amitriptyline supplemented with pregabalin compared with duloxetine supplemented with pregabalin -£113 (95% confidence interval -£381 to £90), amitriptyline supplemented with pregabalin compared with pregabalin supplemented with amitriptyline £155 (95% confidence interval -£37 to £625) and duloxetine supplemented with pregabalin compared with pregabalin supplemented with amitriptyline £141 (95% confidence interval -£13 to £398)]. LIMITATIONS: Although there was no placebo arm, there is strong evidence for the use of each study medication from randomised placebo-controlled trials. The addition of a placebo arm would have increased the duration of this already long and demanding trial and it was not felt to be ethically justifiable. FUTURE WORK: Future research should explore (1) variations in diabetic peripheral neuropathic pain management at the practice level, (2) how OPTION-DM (Optimal Pathway for TreatIng neurOpathic paiN in Diabetes Mellitus) trial findings can be best implemented, (3) why some patients respond to a particular drug and others do not and (4) what options there are for further treatments for those patients on combination treatment with inadequate pain relief. CONCLUSIONS: The three treatment pathways appear to give comparable patient outcomes at similar costs, suggesting that the optimal treatment may depend on patients' preference in terms of side effects. TRIAL REGISTRATION: The trial is registered as ISRCTN17545443 and EudraCT 2016-003146-89. FUNDING: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme, and will be published in full in Health Technology Assessment; Vol. 26, No. 39. See the NIHR Journals Library website for further project information.


The number of people with diabetes is growing rapidly in the UK and is predicted to rise to over 5 million by 2025. Diabetes causes nerve damage that can lead to severe painful symptoms in the feet, legs and hands. One-quarter of all people with diabetes experience these symptoms, known as 'painful diabetic neuropathy'. Current individual medications provide only partial benefit, and in only around half of patients. The individual drugs, and their combinations, have not been compared directly against each other to see which is best. We conducted a study to see which treatment pathway would be best for patients with painful diabetic neuropathy. The study included three treatment pathways using combinations of amitriptyline, duloxetine and pregabalin. Patients received all three treatment pathways (i.e. amitriptyline treatment for 6 weeks and pregabalin added if needed for a further 10 weeks, duloxetine treatment for 6 weeks and pregabalin added if needed for a further 10 weeks and pregabalin treatment for 6 weeks and amitriptyline added if needed for a further 10 weeks); however, the order of the treatment pathways was decided at random. We compared the level of pain that participants experienced in each treatment pathway to see which worked best. On average, people said that their pain was similar after each of the three treatments and their combinations. However, two treatments in combination helped some patients with additional pain relief if they only partially responded to one. People also reported improved quality of life and sleep with the treatments, but these were similar for all the treatments. In the health economic analysis, the value for money and quality of life were similar for each pathway, and this resulted in uncertainty in the cost-effectiveness conclusions, with no one pathway being more cost-effective than the others. The treatments had different side effects, however; pregabalin appeared to make more people feel dizzy, duloxetine made more people nauseous and amitriptyline resulted in more people having a dry mouth. The pregabalin supplemented by amitriptyline pathway had the smallest number of treatment discontinuations due to side effects and may be the safest for patients.


Asunto(s)
Diabetes Mellitus , Neuralgia , Adulto , Humanos , Pregabalina/uso terapéutico , Clorhidrato de Duloxetina/uso terapéutico , Amitriptilina/efectos adversos , Calidad de Vida , Neuralgia/tratamiento farmacológico , Neuralgia/inducido químicamente , Análisis Costo-Beneficio
10.
Curr Pharm Teach Learn ; 10(8): 1149-1153, 2018 08.
Artículo en Inglés | MEDLINE | ID: mdl-30314552

RESUMEN

BACKGROUND AND PURPOSE: The primary objective of this study was to assess changes in pharmacy students' attitudes and perceptions toward providing care to underserved populations after a six-week clinical experience within a Federally Qualified Health Center (FQHC) clinic. EDUCATIONAL ACTIVITY AND SETTING: A pre-post survey design was utilized to evaluate third- and fourth-year pharmacy students' attitudes and perceptions before and after a six-week clinical rotation providing direct patient care to underserved patients in FQHC clinics. Results were collected via self-administered online surveys that collected information on participants' (1) demographics, (2) past experiences interacting with underserved populations, (3) type of clinical activities completed during the rotation, and (4) personal opinions and perceptions of providing care to underserved populations. FINDINGS: Responses to seven of the 18 attitudinal questions showed a statistically significant positive change from baseline, with three questions being related to educational satisfaction. Changes in attitudes for questions related to domains of personal impact and perceptions/barriers were also significant. DISCUSSION/SUMMARY: Clinical rotations within an FQHC clinic can positively impact pharmacy students' attitudes towards underserved populations. If more students are exposed to direct patient care with underserved populations throughout their experiential training, the number of graduating student pharmacists that explore job opportunities within underserved areas may increase. Clinical rotations within an FQHC clinic can positively impact pharmacy students' attitudes towards underserved populations. If more students are exposed to direct patient care with underserved populations throughout their experiential training, the number of graduating student pharmacists that explore job opportunities within underserved areas may increase.


Asunto(s)
Percepción , Preceptoría/normas , Estudiantes de Farmacia/psicología , Adulto , Centros Comunitarios de Salud/organización & administración , Gobierno Federal , Femenino , Humanos , Masculino , Preceptoría/métodos , Preceptoría/estadística & datos numéricos , Estudiantes de Farmacia/estadística & datos numéricos , Encuestas y Cuestionarios , Poblaciones Vulnerables/estadística & datos numéricos
11.
Trials ; 19(1): 578, 2018 Oct 22.
Artículo en Inglés | MEDLINE | ID: mdl-30348206

RESUMEN

BACKGROUND: The number of people with diabetes is growing rapidly. Diabetes can cause nerve damage leading to severe pain in the feet, legs and hands, which is known as diabetic peripheral neuropathic pain (DPNP). In the UK, the National Institute for Health and Care Excellence (NICE) recommends amitriptyline, duloxetine, pregabalin or gabapentin as initial treatment for DPNP. If this is not effective, adding one of the other drugs in combination with the first is recommended. NICE points out that these recommendations are not based on robust evidence. The OPTION-DM randomised controlled trial has been designed to address this evidence deficit, with the aims of determining the most clinically beneficial, cost-effective and tolerated treatment pathway for patients with DPNP. METHODS/DESIGN: A multicentre, double-blind, centre-stratified, multi-period crossover study with equal allocation to sequences (1:1:1:1:1:1) of treatment pathways. Three hundred and ninety-two participants will be recruited from secondary care DPNP centres in the UK. There are three treatment pathways: amitriptyline supplemented with pregabalin, pregabalin supplemented with amitriptyline and duloxetine supplemented with pregabalin. All participants will receive all three pathways and randomisation will determine the order in which they are received. The primary outcome is the difference between 7-day average 24-h pain scores on an 11-point NRS scale measured during the final follow-up week of the treatment pathway. Secondary outcomes for efficacy, cost-effectiveness, safety, patient-perceived tolerability and subgroup analysis will be measured at week 6 and week 16 of each pathway. DISCUSSION: The study includes direct comparisons of the mainstay treatment for DPNP. This novel study is designed to examine treatment pathways and capture clinically relevant outcomes which will make the results generalisable to current clinical practice. The study will also provide information on health economic outcomes and will include a subgroup study to provide information on whether patient phenotypes predict response to treatment. TRIAL REGISTRATION: ISRCTN17545443 . Registered on 12 September 2016.


Asunto(s)
Amitriptilina/uso terapéutico , Analgésicos/uso terapéutico , Neuropatías Diabéticas/terapia , Clorhidrato de Duloxetina/uso terapéutico , Manejo del Dolor/métodos , Pregabalina/uso terapéutico , Amitriptilina/efectos adversos , Analgésicos/efectos adversos , Estudios Cruzados , Neuropatías Diabéticas/diagnóstico , Método Doble Ciego , Quimioterapia Combinada , Clorhidrato de Duloxetina/efectos adversos , Humanos , Estudios Multicéntricos como Asunto , Manejo del Dolor/efectos adversos , Dimensión del Dolor , Pregabalina/efectos adversos , Ensayos Clínicos Controlados Aleatorios como Asunto , Factores de Tiempo , Resultado del Tratamiento , Reino Unido
13.
Am J Pharm Educ ; 75(6): 121, 2011 Aug 10.
Artículo en Inglés | MEDLINE | ID: mdl-21931459

RESUMEN

OBJECTIVE: To integrate fourth-year doctor of pharmacy (PharmD) students within a level II trauma center team to improve their patient care and professional communication skills. DESIGN: PharmD students completed 2 consecutive 4-week internal medicine APPEs during the course of their fourth year, which included approximately 5 weeks working on an interprofessional trauma team. During patient rounds with the interprofessional trauma team, students provided patient care in a stepwise approach, drug information responses, patient counseling, and other services requested by team members. ASSESSMENT: Ability-based outcomes (ABOs) assessment, faculty evaluations, and student self-assessment were conducted in the following areas: effective communication, drug therapy assessment and decision making, critical thinking and problem solving, and drug information retrieval. Students' mean score in these areas was 3.8 on a 5-point scale. Areas in which students needed improvement included: providing recommendations in a timely manner, self-confidence, identifying opportunity to verbally communicate with other team members, and addressing insecurities when answering drug information questions posed by the team. CONCLUSION: Integrating fourth-year PharmD students within a trauma and acute surgery team and use of ABO assessment allowed for identification of areas of the curriculum in which improvements were needed, resulting in a more targeted approach earlier in the curriculum to improve students' abilities to provide appropriate and effective patient care in an interprofessional setting.


Asunto(s)
Competencia Clínica , Curriculum , Educación en Farmacia/métodos , Aprendizaje Basado en Problemas , Estudiantes de Farmacia , Heridas y Lesiones/tratamiento farmacológico , Comunicación , Consejo/métodos , Servicios de Información sobre Medicamentos , Evaluación Educacional/métodos , Docentes , Humanos , Atención al Paciente , Autoevaluación (Psicología) , Centros Traumatológicos
14.
J Am Acad Nurse Pract ; 20(7): 359-66, 2008 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-18638175

RESUMEN

PURPOSE: To describe the diagnostic and treatment patterns for depression and anxiety in clients receiving care at a free clinic. DATA SOURCES: Charts for 43 clients who received antidepressant or anxiolytic medications were randomly selected and reviewed. CONCLUSIONS: Clients presented to the clinic symptomatic; almost two thirds had been treated elsewhere. Most clients received pharmacological treatment and referral for counseling. Forty-four percent of the clients were still being treated at their last visit, but 33% were no longer being seen, and it could not be determined if they were receiving care at another clinic. IMPLICATIONS FOR PRACTICE: If sustained relationships with clients with depression and anxiety can be developed, appropriate care can be provided.


Asunto(s)
Instituciones de Atención Ambulatoria/organización & administración , Ansiolíticos/uso terapéutico , Antidepresivos/uso terapéutico , Ansiedad/tratamiento farmacológico , Trastorno Depresivo/tratamiento farmacológico , Pobreza , Servicios de Salud Rural/organización & administración , Adulto , Instituciones de Atención Ambulatoria/estadística & datos numéricos , Ansiedad/psicología , Ansiedad/terapia , Comorbilidad , Consejo , Trastorno Depresivo/psicología , Trastorno Depresivo/terapia , Femenino , Humanos , Masculino , Registros Médicos , Persona de Mediana Edad , Derivación y Consulta , Estudios Retrospectivos , Servicios de Salud Rural/estadística & datos numéricos
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