RESUMEN
PURPOSE: We sought to evaluate 1) patient- and anesthesiologist-reported rates of postoperative delirium (POD) risk discussion during preoperative meetings, 2) patients' and anesthesiologists' ratings of the importance of POD, and 3) predictors of patient-reported discussion of POD risk during preoperative meetings. METHODS: In this multicentre two-part cross-sectional survey study, patients ≥ 65 yr scheduled to undergo elective noncardiac surgery completed a five-minute survey after preoperative anesthesia consultation. Patients were asked about their perception of POD importance, and whether they discussed or were assessed for POD risk. Anesthesiologists were surveyed using self-administered surveys circulated via institutional email lists. Anesthesiologists were asked about the frequency of POD risk assessment and discussion in older adults, tools used, and perception of POD-screening barriers. RESULTS: Four hundred and twelve (of 510 approached) patients (50% male; mean age, 73 yr) and 267 anesthesiologists (of 1,205 invited via e-mail) participated in this study conducted in five Canadian hospitals. Postoperative delirium screening and discussion was reported by 88/412 (22%) patients and 229/267 (86%) anesthesiologists. Postoperative delirium was rated as "somewhat-extremely" important by 64% of patients. A previous history of delirium, higher education, the number of daily medications, and longer surgical duration were associated with POD discussion. On average, anesthesiologists rated the importance of POD at 8/10, and 42% ranked "patient risk factors" as the top reason prompting discussion. CONCLUSION: The combined evaluation of patients' and anesthesiologists' perspectives provides valuable information on preoperative POD screening and risk assessment, and highlights areas for improvement in the current practice. Most factors we identified to be associated with higher odds of POD discussion are recognized risk factors of POD.
RéSUMé: OBJECTIF: Nous avons cherché à évaluer 1) les taux de discussion concernant le risque de delirium postopératoire (DPO) déclarés par les patient·es et les anesthésiologistes lors des rencontres préopératoires, 2) les évaluations des patient·es et des anesthésiologistes de l'importance de DPO, et 3) les prédicteurs d'une discussion telle que rapportée par les patient·es sur le risque de DPO pendant les rencontres préopératoires. MéTHODE: Dans ce sondage transversal multicentrique en deux parties, les patient·es ≥ 65 ans devant subir une chirurgie non cardiaque non urgente ont rempli un sondage de cinq minutes après la consultation d'anesthésie préopératoire. Les patient·es ont été interrogé·es sur leur perception de l'importance du DPO et si leur risque de DPO avait été discuté ou évalué. Des sondages auto-administrés ont été distribués aux anesthésiologistes via les listes de courriels institutionnelles. Ce sondage interrogeait les anesthésiologistes quant à la fréquence de l'évaluation et de la discussion des risques de DPO chez les personnes âgées, aux outils utilisés et à la perception des obstacles au dépistage de DPO. RéSULTATS: Quatre cent douze (des 510 personnes approchées) patient·es (50 % d'hommes; âge moyen, 73 ans) et 267 anesthésiologistes (sur 1205 invité·es par courriel) ont participé à cette étude menée dans cinq hôpitaux canadiens. Le dépistage et la discussion sur le delirium postopératoire ont été signalés par 88/412 (22 %) des patient·es et 229/267 (86 %) des anesthésiologistes. Le delirium postopératoire a été jugé « assez extrêmement ¼ important par 64 % des patient·es. Des antécédents de delirium, des études supérieures, le nombre de médicaments quotidiens et une durée chirurgicale plus longue ont été associés à la discussion sur le DPO. En moyenne, les anesthésiologistes ont évalué l'importance du DPO à 8/10, et 42 % ont classé les « facteurs de risque liés au/à la patient·e ¼ comme la principale raison suscitant la discussion. CONCLUSION: L'évaluation combinée des points de vue des patient·es et des anesthésiologistes fournit des informations précieuses sur le dépistage préopératoire des DPO et l'évaluation des risques, et met en évidence les domaines à améliorer dans la pratique actuelle. La plupart des facteurs que nous avons identifiés comme étant associés à des probabilités plus élevées de discussion sur le DPO sont des facteurs de risque reconnus de DPO.
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Delirio , Delirio del Despertar , Humanos , Masculino , Anciano , Femenino , Estudios Transversales , Anestesiólogos , Delirio/diagnóstico , Delirio/epidemiología , Delirio/complicaciones , Canadá , Factores de Riesgo , Complicaciones Posoperatorias/etiologíaRESUMEN
Importance: In arthroscopic knee and shoulder surgery, there is growing evidence that opioid-sparing protocols may reduce postoperative opioid consumption while adequately addressing patients' pain. However, there are a lack of prospective, comparative trials evaluating their effectiveness. Objective: To evaluate the effect of a multimodal, opioid-sparing approach to postoperative pain management compared with the current standard of care in patients undergoing arthroscopic shoulder or knee surgery. Design, Setting, and Participants: This randomized clinical trial was performed at 3 clinical sites in Ontario, Canada, and enrolled 200 patients from March 2021 to March 2022 with final follow-up completed in April 2022. Adult patients undergoing outpatient arthroscopic shoulder or knee surgery were followed up for 6 weeks postoperatively. Interventions: The opioid-sparing group (100 participants randomized) received a prescription of naproxen, acetaminophen (paracetamol), and pantoprazole; a limited rescue prescription of hydromorphone; and a patient educational infographic. The control group (100 participants randomized) received the current standard of care determined by the treating surgeon, which consisted of an opioid analgesic. Main Outcomes and Measures: The primary outcome was postoperative oral morphine equivalent (OME) consumption at 6 weeks after surgery. There were 5 secondary outcomes, including pain, patient satisfaction, opioid refills, quantity of OMEs prescribed at the time of hospital discharge, and adverse events at 6 weeks all reported at 6 weeks after surgery. Results: Among the 200 patients who were randomized (mean age, 43 years; 73 women [38%]), 193 patients (97%) completed the trial; 98 of whom were randomized to receive standard care and 95 the opioid-sparing protocol. Patients in the opioid-sparing protocol consumed significantly fewer opioids (median, 0 mg; IQR, 0-8.0 mg) than patients in the control group (median, 40.0 mg; IQR, 7.5-105.0; z = -6.55; P < .001). Of the 5 prespecified secondary end points, 4 showed no significant difference. The mean amount of OMEs prescribed was 341.2 mg (95% CI, 310.2-372.2) in the standard care group and 40.4 mg (95% CI, 39.6-41.2) in the opioid-sparing group (mean difference, 300.8 mg; 95% CI, 269.4-332.3; P < .001). There was no significant difference in adverse events at 6 weeks (2 events [2.1%] in the standard care group vs 3 events [3.2%] in the opioid-sparing group), but more patients reported medication-related adverse effects in the standard care group (32% vs 19%, P = .048). Conclusions and Relevance: Among patients who underwent arthroscopic knee or shoulder surgery, a multimodal opioid-sparing postoperative pain management protocol, compared with standard opioid prescribing, significantly reduced postoperative opioid consumption over 6 weeks. Trial Registration: ClinicalTrials.gov Identifier: NCT04566250.
Asunto(s)
Analgésicos no Narcóticos , Analgésicos Opioides , Artroscopía , Articulación de la Rodilla , Dolor Postoperatorio , Articulación del Hombro , Acetaminofén/efectos adversos , Acetaminofén/uso terapéutico , Adulto , Analgésicos no Narcóticos/efectos adversos , Analgésicos no Narcóticos/uso terapéutico , Analgésicos Opioides/efectos adversos , Analgésicos Opioides/uso terapéutico , Antiulcerosos/efectos adversos , Antiulcerosos/uso terapéutico , Protocolos Clínicos , Quimioterapia Combinada , Femenino , Humanos , Hidromorfona/efectos adversos , Hidromorfona/uso terapéutico , Articulación de la Rodilla/cirugía , Masculino , Naproxeno/efectos adversos , Naproxeno/uso terapéutico , Ontario , Dolor Postoperatorio/tratamiento farmacológico , Dolor Postoperatorio/etiología , Pantoprazol/efectos adversos , Pantoprazol/uso terapéutico , Educación del Paciente como Asunto , Cuidados Posoperatorios , Articulación del Hombro/cirugíaRESUMEN
BACKGROUND: Gender-based and sexual harassment are prevalent in the medical profession. We aimed to quantify the prevalence of such behaviours within orthopedic surgery in Canada and to identify any risk factors for experiencing gender-based or sexual harassment in the workplace. METHODS: In collaboration with the Canadian Orthopaedic Association, we conducted a Canada-wide email questionnaire survey in June 2019 of all orthopedic surgeons registered with the Canadian Orthopaedic Association and the Canadian Orthopaedic Residents' Association. The development of our questionnaire was informed by a review of the literature and published surveys on gender-based and sexual harassment, and consultation with researchers in intimate partner violence. We conducted a multivariable logistic regression analysis to identify risk factors for harassment. RESULTS: Of the 1783 surgeons invited to participate, 465 returned the questionnaire (response rate 26.1%); the response rate was 48.1% for females and 22.1% for males. Overall, 331/433 respondents (76.4%, 95% confidence interval [CI] 72%-80%) and 315/423 respondents (74.5%, 95% CI 70%-78%) reported having experienced at least 1 occurrence of gender-based and sexual harassment, respectively. Women were significantly more likely than men to have experienced both gender-based and sexual harassment (odds ratio [OR] 16.2, 95% CI 4.8-54.0, and OR 2.2, 95% CI 1.2-4.0, respectively). Respondents who identified as nonwhite were significantly less likely than those who identified as white to have experienced gender-based harassment (OR 0.5, 95% CI 0.3-0.99). CONCLUSION: The prevalence of gender-based and sexual harassment is high within Canadian orthopedic surgery, and women are at highest risk for experiencing harassment. The results may provide the impetus for orthopedic societies to develop action plans and to re-examine and enforce policies to address these damaging behaviours appropriately.
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Acoso no Sexual/estadística & datos numéricos , Cirujanos Ortopédicos/estadística & datos numéricos , Sexismo/estadística & datos numéricos , Acoso Sexual/estadística & datos numéricos , Lugar de Trabajo/estadística & datos numéricos , Adulto , Canadá , Estudios Transversales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Prevalencia , Factores de Riesgo , Sociedades MédicasRESUMEN
BACKGROUND: The opioid epidemic is one of the biggest public health crises of our time, and overprescribing of opioids after surgery has the potential to lead to long-term use. The purpose of this review was to identify and summarize the available evidence on interventions aimed at reducing opioid use after orthopedic surgery. METHODS: We searched CENTRAL, Embase and Medline from inception until August 2019 for studies comparing interventions aimed at reducing opioid use after orthopedic surgery to a control group. We recorded demographic data and data on intervention success, and recorded or calculated percent opioid reduction compared to control. RESULTS: We included 141 studies (20 963 patients) in the review, of which 113 (80.1%) were randomized controlled trials (RCTs), 6 (4.3%) were prospective cohort studies, 16 (11.4%) were retrospective cohort studies, 5 (3.6%) were case reports, and 1 (0.7%) was a case series. The majority of studies (95 [67.4%]) had a follow-up duration of 2 days or less. Interventions included the use of local anesthetics and/or nerve blocks (42 studies [29.8%]), nonsteroidal anti-inflammatory drugs (31 [22.0%]), neuropathic pain medications (9 [6.4%]) and multimodal analgesic combinations (25 [17.7%]. In 127 studies (90.1%), a significant decrease in postoperative opioid consumption compared to the control intervention was reported; the median opioid reduction in these studies was 39.7% (range 5%-100%). Despite these reductions in opioid use, the effect on pain scores and on incidence of adverse effects was inconsistent. CONCLUSION: There is a large body of evidence from randomized trials showing the promise of a variety of interventions for reducing opioid use after orthopedic surgery. Rigorously designed RCTs are needed to determine the ideal interventions or combination of interventions for reducing opioid use, for the good of patients, medicine and society.
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Trastornos Relacionados con Opioides , Procedimientos Ortopédicos , Humanos , Analgésicos Opioides/uso terapéutico , Anestésicos Locales , Procedimientos Ortopédicos/efectos adversos , Trastornos Relacionados con Opioides/epidemiología , Trastornos Relacionados con Opioides/prevención & control , Analgésicos , Antiinflamatorios no Esteroideos , Dolor Postoperatorio/tratamiento farmacológico , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
PURPOSE: The purpose of this systematic review is to examine the rates of postoperative recurrence of instability, functional outcomes, and complications after treatment with bone augmentation procedures or arthroscopic Bankart repair with remplissage for recurrent anterior shoulder instability in the setting of subcritical glenoid bone loss. METHODS: EMBASE, PubMed, and MEDLINE were searched from database inception until June 2019 for articles examining either bone block augmentation to the glenoid or Bankart repair with remplissage (BRR) in the setting of subcritical glenoid bone loss. Search and data extraction were performed by 2 reviewers independently and in duplicate. A separate analysis was done for comparative studies. RESULTS: Overall, 145 studies were identified, including 4 comparative studies. Across all studies, postoperative recurrence rates ranged from 0% to 42.8% for bone block augmentation and 0% to 15% for Bankart repair with remplissage. In comparative studies reporting subcritical glenoid bone loss, rates were 5.7% to 11.6% in the Latarjet group and 0% to 13.3% in the Bankart repair with remplissage group. However, in all studies reporting 10% to 15% mean glenoid bone loss, there was an increased rate of recurrent instability with arthroscopic soft tissue repair (6.1% to 13.2%) in comparison with bony augmentation (0% to 8.2%). Lastly, complication rates ranged from 0% to 66.7% for the bone block group and 0% to 2.3% for arthroscopic Bankart repair with remplissage. CONCLUSION: Both bone block augmentation and Bankart repair with remplissage are effective treatment options for recurrent anterior shoulder instability in patients with bipolar bone loss but subcritical glenoid bone loss. Both have comparable functional outcomes, albeit bone block procedures carry an increased risk of complications. Arthroscopic BRR may be associated with a higher failure rate for preoperative glenoid bone loss >10%. Therefore, it may represent a stabilization procedure best suited for cases of recurrent anterior instability with glenoid bone loss <10% and the presence of a significant, off-track Hill-Sachs lesion. LEVEL OF EVIDENCE: Level IV, systematic review of Level II-IV studies.
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Artroscopía , Resorción Ósea/complicaciones , Inestabilidad de la Articulación/complicaciones , Inestabilidad de la Articulación/cirugía , Articulación del Hombro/cirugía , Adulto , Artroscopía/efectos adversos , Femenino , Humanos , Masculino , Complicaciones Posoperatorias/etiología , Sesgo de Publicación , Ensayos Clínicos Controlados Aleatorios como Asunto , Recurrencia , Riesgo , Escápula/cirugía , Resultado del TratamientoAsunto(s)
Artroplastia de Reemplazo de Cadera , Artroplastia de Reemplazo de Rodilla , Procedimientos Quirúrgicos Electivos , Humanos , Artroplastia de Reemplazo de Rodilla/efectos adversos , Artroplastia de Reemplazo de Cadera/efectos adversos , Hemorragia Posoperatoria/prevención & control , Hemorragia Posoperatoria/etiología , Resultado del Tratamiento , Metaanálisis en Red , Factores de Riesgo , Anticoagulantes/uso terapéuticoRESUMEN
AIMS: Investigate awareness in the multidisciplinary orthopaedic trauma team regarding intimate partner violence (IPV), willingness to ask patients and knowledge of available support. METHODS: Orthopaedic staff in several UK centres completed an anonymous online validated questionnaire reflecting their opinions on IPV in orthopaedics. Respondents from orthopaedic surgery, nursing, and physiotherapy participated. RESULTS: There were 121 respondents with a mean 10 years' experience. 52% of respondents had previously had a disclosure of IPV from at least one orthopaedic patient. Doctors and nurses were equally likely to have cared for IPV patients (50% versus 56%), but doctors thought abuse was less common (57% doctors compared to 15% nurses thought IPV affected less than 1% of trauma patients, p < 0.05). 74% of respondents reported asking patients about abuse (77/104 answered) but only 24% (29/121) knew about the support currently available. Staff who did not know about available support were less likely to ask about possible abuse (46% versus 22% respectively, p < 0.05). 74% of respondents felt it was important/very important to ask about IPV. CONCLUSIONS: This is the first study investigating IPV in UK orthopaedics. Although three quarters of the staff interviewed thought that it was important to ask trauma patients about IPV, only 2% routinely ask patients presenting with musculoskeletal injuries about IPV. Orthopaedic staff are well placed to identify vulnerable patients. This study highlights the need for training staff on how to identify IPV and manage disclosures of abuse given that the incidence of IPV is on the increase.
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Concienciación , Violencia de Pareja , Sistema Musculoesquelético/lesiones , Ortopedia , Grupo de Atención al Paciente , Femenino , Humanos , Masculino , Estudios Prospectivos , Encuestas y Cuestionarios , Reino UnidoRESUMEN
INTRODUCTION: Registering study protocols in a trial registry is important for methodologic transparency and reducing selective reporting bias. The objective of this investigation was to determine whether published studies of intimate partner violence (IPV) that had been registered matched the registration record on key study design elements. METHODS: We systematically searched three trial registries to identify registered IPV studies and the published literature for the associated publication. Two authors independently determined for each study whether key study elements in the registry matched those in the published paper. RESULTS: We included 66 studies published between 2006 and 2017. Nearly half (29/66, 44%) were registered after study completion. Many (26/66, 39%) had discrepancies regarding the primary outcome, and nearly two-thirds (42/66, 64%) had discrepancies in secondary outcomes. Discrepancies in study design were less frequent (13/66, 20%). However, large changes in sample size (26/66, 39%) and discrepancies in funding source (28/66, 42%) were frequently observed. CONCLUSIONS: Trial registries are important tools for research transparency and identifying and preventing outcome switching and selective outcome reporting bias. Published IPV studies often differ from their records in trial registries. Researchers should pay close attention to the accuracy of trial registry records.
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Violencia de Pareja , Sesgo de Publicación , Publicaciones/normas , Edición/normas , Sistema de Registros/normas , Femenino , Humanos , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
Background: Medical cannabis use is an emerging topic of interest in orthopedics. Although there is a large amount of literature on medical cannabis use for managing various types of pain, few studies have focused on orthopedic conditions. There is little high-quality evidence in core orthopedic areas. The objective of this study was to summarize the literature on the efficacy of cannabis use for pain related to orthopedic conditions. Methods: We conducted a systematic review of the literature on the use of cannabinoids for pain management in core orthopedic conditions. Two independent reviewers extracted information on reporting quality, risk of bias, drugs, population, control, duration of study, pain outcomes and the authors' conclusions regarding efficacy for pain outcomes. Results: We identified 33 orthopedic studies, including 21 primary studies and 12 reviews. Study quality was generally low to moderate. Six of the included studies had a control group and 15 were noncontrolled studies. Methodologies, drugs and protocols of administration varied greatly across studies. Study conclusions were generally positive in noncontrolled studies and mixed in controlled studies. Studies using higher doses tended to conclude that cannabis use was effective, but the potential for harmful effects may also be increased with higher doses. Conclusion: Variability in the methodologies used in cannabis research makes it challenging to draw conclusions about dosing, routes and frequency of administration. Most of the existing evidence suggests that medical cannabis use is effective, but this efficacy has been demonstrated only when either there is no comparator or cannabis is compared with placebo. Studies using an active comparator have not demonstrated efficacy. Future research should focus on improving study reporting and methodologic quality so that protocols that optimize pain control while minimizing harmful effects can be determined.
Contexte: La consommation de cannabis à des fins médicales est un sujet d'intérêt émergent en orthopédie. Malgré l'existence d'un important corpus de littérature médicale sur l'utilisation du cannabis pour traiter divers types de douleurs, peu d'études ont porté sur les problèmes orthopédiques. On dispose de peu de données probantes de grande qualité relatives aux principaux domaines de l'orthopédie. L'objectif de cette étude était de résumer la littérature sur l'efficacité du cannabis à soulager les douleurs orthopédiques. Méthodes: Nous avons réalisé une revue systématique de la littérature sur l'utilisation des cannabinoïdes pour la prise en charge de la douleur associée aux principaux problèmes orthopédiques. Deux examinateurs indépendants ont extrait l'information sur la qualité des rapports, le risque de biais, les médicaments, les populations et groupes témoins, la durée des études, les scores de douleur et les conclusions des auteurs quant à l'efficacité au plan des scores de douleur. Résultats: Nous avons recensé 33 études orthopédiques, dont 21 études primaires et 12 revues. La qualité des études était généralement de faible à moyenne. Six des études incluses étaient contrôlées et 15 ne l'étaient pas. Les méthodologies, les médicaments et les protocoles d'administration variaient grandement d'une étude à l'autre. Les conclusions étaient généralement positives dans les études non contrôlées, et mixtes dans les études contrôlées. Les études qui utilisaient des doses plus fortes avaient tendance à conclure que le cannabis était efficace, mais le risque d'effets négatifs pouvait également être proportionnel à la dose. Conclusion: En raison de la variabilité des méthodologies utilisées dans la recherche sur le cannabis, il est difficile de tirer des conclusions sur la posologie, les voies et la fréquence d'administration. La plupart des preuves disponibles donnent à penser que le cannabis médical est efficace, mais cette efficacité n'a été démontrée que s'il n'y avait pas de comparateur ou si le cannabis était comparé à un placebo. Les études ayant utilisé un comparateur actif n'ont pas fait état d'efficacité. La recherche future devrait veiller à améliorer les rapports et la qualité méthodologique des études afin de déterminer quels protocoles améliorent la maîtrise de la douleur tout en réduisant les effets négatifs.
Asunto(s)
Artritis/terapia , Dolor de Espalda/terapia , Marihuana Medicinal/uso terapéutico , Procedimientos Ortopédicos/efectos adversos , Dolor Postoperatorio/terapia , Cannabinoides/administración & dosificación , Esquema de Medicación , Humanos , Dolor Postoperatorio/etiologíaRESUMEN
STUDY DESIGN: Descriptive, cross-sectional. INTRODUCTION: Intimate partner violence (IPV) may involve physical, psychological, or sexual abuse. Although hand injuries are reported as common sequelae of IPV, there is limited attention to this issue in hand therapy research reports or practice recommendations. PURPOSE OF THE STUDY: The primary aim is to describe the attitudes and beliefs of hand therapists (HTs) about IPV issues. METHODS: A sample of 189 HT completed a standardized survey investigating perceptions regarding issues pertaining to IPV. Areas addressed included self-efficacy (in dealing with IPV), perceived systemic support, victim blaming, professional role responsibility, and safety. Data were analyzed using descriptive statistics while between-group comparisons evaluating the impact of prior IPV experience and demographic variables of gender, country, certified hand therapy, and occupation on questionnaire scores used Mann-Whitney U analysis. RESULTS: The majority of therapists (66%) had some prior experience with IPV. HTs reported neutral perceptions about self-efficacy (M = 2.9/5), client or personal safety (M = 3/5), and support systems available when addressing IPV in practice (M = 3/5). However, therapists considered intervening as part of their professional role (M = 3.8/5) and reported low levels of victim-blaming attitudes (M = 4.4/5). Those with firsthand IPV experience reported lower victim blaming (mdn = 4.9/5 vs 4.6/5, P = .02). Additionally, females were less likely to blame victims of IPV than males (mdn = 4.7/5 vs 4.3/5, P = .003). DISCUSSION: Although Hand Therapists believe their professional role includes addressing IPV, confidence to deal with IPV, access/awareness of resources and perceived safety were substantive barriers. CONCLUSION: Continuing research should identify effective tools to educate and assist therapists to identify and support victims of IPV in hand therapy.
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Actitud del Personal de Salud , Violencia de Pareja , Fisioterapeutas , Autoeficacia , Adulto , Anciano , Estudios Transversales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Competencia Profesional , Rol Profesional , Factores Sexuales , Encuestas y Cuestionarios , Adulto JovenRESUMEN
BACKGROUND: There is good evidence that trauma-focused therapies for Post-Traumatic Stress Disorder are effective. However, they are not always feasible to deliver due a shortage of trained therapists and demands on the patient. An online trauma-focused Guided Self-Help (GSH) programme which could overcome these barriers has shown promise in a pilot study. This study will be the first to evaluate GSH against standard face-to-face therapy to assess its suitability for use in the NHS. METHODS: The study is a large-scale multi-centre pragmatic randomised controlled non-inferiority trial, with assessors masked to treatment allocation. One hundred and ninety-two participants will be randomly allocated to receive either face-to-face trauma-focused cognitive behaviour therapy (TFCBT) or trauma-focused online guided self-help (GSH). The primary outcome will be the severity of symptoms of PTSD over the previous week as measured by the Clinician Administered PTSD Scale for DSM5 (CAPS-5) at 16 weeks post-randomisation. Secondary outcome measures include PTSD symptoms over the previous month as measured by the CAPS-5 at 52 weeks plus the Impact of Event Scale - revised (IES-R), Work and Social Adjustment Scale (WSAS), Patient Health Questionnaire-9 (PHQ-9), General Anxiety Disorder-7 (GAD-7), Alcohol Use Disorders Test (AUDIT-O), Multidimensional Scale for Perceived Social Support (MSPSS), short Post-Traumatic Cognitions Inventory (PTCI), Insomnia Severity Index (ISI) and General Self Efficacy Scale (GSES) measured at 16 and 52 weeks post-randomisation. Changes in health-related quality of life will be measured by the EQ-5D and the level of healthcare resource utilisation for health economic analysis will be determined by an amended version of the Client Socio-Demographic and Service Receipt Inventory European Version. The Client Satisfaction Questionnaire (CSQ) will be collected at 16 weeks post-randomisation to evaluate treatment satisfaction. DISCUSSION: This study will be the first to compare online GSH with usual face-to-face therapy for PTSD. The strengths are that it will test a rigorously developed intervention in a real world setting to inform NHS commissioning. The potential challenges of delivering such a pragmatic study may include participant recruitment, retention and adherence, therapist retention, and fidelity of intervention delivery. TRIAL REGISTRATION: ISRCTN13697710 registered on 20/12/2016.
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Terapia Cognitivo-Conductual/métodos , Rehabilitación Psiquiátrica/métodos , Autocuidado/métodos , Trastornos por Estrés Postraumático/terapia , Heridas y Lesiones/psicología , Adulto , Femenino , Humanos , Masculino , Proyectos Piloto , Ensayos Clínicos Pragmáticos como Asunto , Evaluación de Programas y Proyectos de Salud , Rehabilitación Psiquiátrica/psicología , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Autocuidado/psicología , Trastornos por Estrés Postraumático/psicología , Resultado del TratamientoRESUMEN
BACKGROUND: Existing guidance for developing public health interventions does not provide information for researchers about how to work with intervention providers to co-produce and prototype the content and delivery of new interventions prior to evaluation. The ASSIST + Frank study aimed to adapt an existing effective peer-led smoking prevention intervention (ASSIST), integrating new content from the UK drug education resource Talk to Frank ( www.talktofrank.com ) to co-produce two new school-based peer-led drug prevention interventions. A three-stage framework was tested to adapt and develop intervention content and delivery methods in collaboration with key stakeholders to facilitate implementation. METHODS: The three stages of the framework were: 1) Evidence review and stakeholder consultation; 2) Co-production; 3) Prototyping. During stage 1, six focus groups, 12 consultations, five interviews, and nine observations of intervention delivery were conducted with key stakeholders (e.g. Public Health Wales [PHW] ASSIST delivery team, teachers, school students, health professionals). During stage 2, an intervention development group consisting of members of the research team and the PHW ASSIST delivery team was established to adapt existing, and co-produce new, intervention activities. In stage 3, intervention training and content were iteratively prototyped using process data on fidelity and acceptability to key stakeholders. Stages 2 and 3 took the form of an action-research process involving a series of face-to-face meetings, email exchanges, observations, and training sessions. RESULTS: Utilising the three-stage framework, we co-produced and tested intervention content and delivery methods for the two interventions over a period of 18 months involving external partners. New and adapted intervention activities, as well as refinements in content, the format of delivery, timing and sequencing of activities, and training manuals resulted from this process. The involvement of intervention delivery staff, participants and teachers shaped the content and format of the interventions, as well as supporting rapid prototyping in context at the final stage. CONCLUSIONS: This three-stage framework extends current guidance on intervention development by providing step-by-step instructions for co-producing and prototyping an intervention's content and delivery processes prior to piloting and formal evaluation. This framework enhances existing guidance and could be transferred to co-produce and prototype other public health interventions. TRIAL REGISTRATION: ISRCTN14415936 , registered retrospectively on 05 November 2014.