Rates and risk factors for persistent opioid use after cardiothoracic surgery: A cohort study.

BACKGROUND: This study's aim was to estimate potential risk factors for persistent opioid use after cardiothoracic surgery. METHODS: This study included participants in the McGill University Health Centre clinical trial (2014 to 2016). Provincial medical services, prescription claims, and medical charts data were linked. Persistent opioid use was defined as an initial peri-operative opioid dispensation followed by an opioid dispensation between 91 and 180 days postdischarge. Multivariable Cox Proportional Hazards models were used to assess factors associated with persistent opioid use. RESULTS: A cohort of 815 patients (mean age: 68.9 [standard deviation = 8.9]) was assembled, of which 8.2% became persistent opioid users. Factors such as higher Charlson Comorbidity Index (adjusted hazard ratio: 3.4, 95% confidence interval: 1.1-10.6), history of diabetes (adjusted hazard ratio: 2.1, 95% confidence interval: 1.3-3.4), substance and alcohol abuse (adjusted hazard ratio: 16.3, 95% confidence interval: 5.3-49.5), and radiotherapy (adjusted hazard ratio: 2.4, 95% confidence interval: 1.5-4.1) were associated with a higher hazard of persistent opioid use. Previous opioid use (adjusted hazard ratio: 1.7, 95% CI: 1.0-2.8), daily peri-operative opioid dose (adjusted hazard ratio: 2.3, 95% confidence interval: 1.5-3.7), having an opioid dispensation 30 days pre-admission (adjusted hazard ratio: 1.7, 95% confidence interval: 1.0-2.8), and pre-admission analgesic use (adjusted hazard ratio: 1.7, 95% confidence interval: 1.0-2.8), were also associated with an increased hazard of persistent use. Being prescribed multimodal analgesia at discharge (adjusted hazard ratio: 0.54, 95% confidence interval: 0.32-0.92) was associated with a 46% decreased hazard of developing persistent opioid use. CONCLUSION: Multiple patient- and medication-related characteristics were associated with an increased hazard of persistent opioid use.

Patients' experiences undergoing cancer surgery during the COVID-19 pandemic: a qualitative study.

PURPOSE: This study aimed to understand patients' experiences undergoing cancer surgery during the COVID-19 pandemic. In response to COVID-19, many elective cancer surgeries were delayed creating a massive backlog of cases. Patients' experiences with surgical delays may inform healthcare systems' responses to the backlog of cases and guide preparations for future healthcare emergencies. METHODS: This was a qualitative description study. Patients undergoing general surgery for cancer at two university-affiliated hospitals between March 2020 and January 2021 were invited to one-to-one interviews. Patients were purposefully selected using quota sampling until interviews produced no new information (i.e., thematic saturation). Interviews were conducted using a semi-structured guide and analyzed according to inductive thematic analysis. RESULTS: Twenty patients were included [mean age 64 ± 12.9; male (n = 10); surgical delay (n = 14); cancer sites: breast (n = 8), skin (n = 4), hepato-pancreato-biliary (n = 4), colorectal (n = 2), and gastro-esophageal (n = 2)]. When determining their willingness to undergo surgery, patients weighed the risk of COVID-19 infection against the urgency of their disease. Changes to the hospital environment (e.g., COVID-19 preventative measures) and deviations from expected treatment (e.g., alternative treatments, remote consultations, rescheduled care) caused diverse psychological responses, ranging from increased satisfaction to severe distress. Patients employed several coping strategies to mitigate distress, including eliciting reassurance from care providers, seeking information from unconventional sources, and reframing care interruptions. CONCLUSIONS: Changes in care during the pandemic elicited diverse psychological responses from patients undergoing cancer surgery. Coping was facilitated by consistent communication with providers, emphasizing the importance of patient-centered expectation setting as we prepare for the future within and beyond the pandemic.

Understanding the Impact of Bowel Dysfunction on Quality of Life After Rectal Cancer Surgery From the Patient's Perspective.

BACKGROUND: Bowel dysfunction is an important consequence of rectal cancer surgery' and the specific quality-of-life domains that are affected remain unclear and unaddressed by generic surveys. OBJECTIVE: This study aimed to identify quality-of-life domains most affected by rectal cancer surgery. DESIGN: Qualitative content analysis. SETTINGS: Semistructured interviews conducted by telephone with patients recruited from a single university-affiliated colorectal referral center. PATIENTS: Adult patients were included if they underwent rectal cancer surgery with sphincter preservation from July 2017 to July 2020. Patients were excluded if their surgery was <1 year since the recruitment date, received a permanent stoma, or developed recurrence or metastasis. MAIN OUTCOME MEASURES: Bowel dysfunction was evaluated via the low anterior resection syndrome score. Interview transcripts were coded by 2 independent reviewers and evaluated for concordance. Qualitative content analysis was used to identify themes, and their frequency of occurrence was quantified (percent total number of interviews). RESULTS: A total of 54 patient interviews were conducted. Analysis revealed 5 quality-of-life-related themes impacted by bowel dysfunction: experiencing psychological and emotional stress, challenging roles and relationships within society, encountering physical limitations, restricting leisure and recreational activities, and learning self-empowerment and adapting to change. Patients with minor and major bowel dysfunction were more likely to report disruption to their social activities and their role as a sexual partner versus those with no bowel dysfunction. Patients with major bowel dysfunction were more likely to report effects on sleep versus those with no and minor bowel dysfunction. LIMITATIONS: Single center, self-reported, and observer bias. CONCLUSION: The impact of bowel dysfunction on quality of life includes a wide range of themes that extend beyond traditional measures. These results may help better inform patients in the preoperative setting and serve as a basis for the development of a more patient-centered quality-of-life survey. COMPRENDER EL IMPACTO DE LA DISFUNCIN INTESTINAL EN LA CALIDAD DE VIDA DESPUS DE LA CIRUGA DE CNCER DE RECTO DESDE LA PERSPECTIVA DEL PACIENTE: ANTECEDENTES:La disfunción intestinal es una consecuencia importante de la cirugía del cáncer de recto y los dominios específicos de la calidad de vida que se ven afectados siguen sin estar claros y sin abordarse en las encuestas genéricas.OBJETIVO:Identificar los dominios de calidad de vida más afectados por la cirugía del cáncer de recto.DISEÑO:Análisis cualitativo de contenido.ÁMBITOS:Entrevistas semiestructuradas realizadas por teléfono con pacientes reclutados de un único centro de referencia colorrectal afiliado a una universidad.PACIENTES:Pacientes adultos intervenidos de cáncer de recto con preservación de esfínter del 07/2017 al 07/2020. Los pacientes fueron excluidos si su cirugía fue <1 año desde la fecha de reclutamiento, recibieron un estoma permanente o desarrollaron recurrencia o metástasis.PRINCIPALES MEDIDAS DE RESULTADO:La disfunción intestinal se evaluó a través de la puntuación del síndrome de resección anterior baja. Dos revisores independientes codificaron las transcripciones de las entrevistas y evaluaron su concordancia. Se utilizó el análisis de contenido cualitativo para identificar los temas, cuantificando su frecuencia de aparición (porcentaje del número total de entrevistas).RESULTADOS:Se realizaron un total de 54 entrevistas a pacientes. El análisis reveló cinco temas relacionados con la calidad de vida afectados por la disfunción intestinal: experimentar estrés psicológico y emocional, roles y relaciones desafiantes dentro de la sociedad, encontrar limitaciones físicas, restringir actividades recreativas y de ocio, y autoempoderamiento y adaptación al cambio. Los pacientes con disfunción intestinal menor y mayor tenían más probabilidades de informar la interrupción de las actividades sociales y el papel como pareja sexual en comparación con aquellos sin disfunción intestinal. Los pacientes con disfunción intestinal importante tenían más probabilidades de informar efectos sobre el sueño en comparación con aquellos sin disfunción intestinal o con disfunción intestinal menor.LIMITACIONES:Sesgo de un solo centro, autoinformado y observador.CONCLUSIÓN:El impacto de la disfunción intestinal en la calidad de vida incluye una amplia gama de temas que se extienden más allá de las medidas tradicionales. Estos resultados pueden ayudar a informar mejor a los pacientes en el entorno preoperatorio y servir como base para el desarrollo de una encuesta de calidad de vida más centrada en el paciente. (Traducción-Dr. Yesenia Rojas-Khalil ).

S110-Opioid-free analgesia after outpatient general surgery: A qualitative study focused on the perspectives of patients and clinicians involved in a pilot trial.

BACKGROUND: Opioid-free analgesia (OFA) may mitigate opioid-related harms after outpatient general surgery; however, the comparative effectiveness of this approach should be assessed in robust randomized controlled trials (RCTs). Undertaking an RCT on OFA raises important practical concerns, including surgeon and patient hesitation regarding pain management without opioids. We conducted a qualitative study to explore patients' and clinicians' perspectives and experiences with a pilot trial focused on OFA after outpatient general surgery. METHODS: Patients undergoing outpatient abdominal and breast procedures were randomized to receive post-discharge opioid analgesia (OA) or OFA. Semi-structured interviews with patients and clinicians involved in the trial were conducted to elicit personal perspectives and experiences. Purposive sampling for maximum variation was used to recruit participants with diverse characteristics. Transcribed interviews were assessed using inductive thematic analysis. RESULTS: Ten patients (5 abdominal, 5 breast) and 10 clinicians (6 surgeons, 2 anesthesiologists, 2 nurses) were interviewed. Five major themes emerged: readiness for trial engagement, pre-trial thoughts about the interventions, postoperative pain experiences, intervention acceptability, and trial refinement. Most patients were open to OFA. Clinicians expressed willingness to prescribe OFA, particularly after less invasive procedures and when using peripheral nerve blocks (PNBs). Concerns were raised regarding the adequacy of pain control and side effects of non-opioid drugs (e.g., NSAID-induced bleeding, kidney injury). Overall, participants were enthusiastic about the trial and recognized its relevance; clinicians praised the study design and organization; and patients valued the use of electronic questionnaires. Suggestions for improvements included preventing potential bias arising from the use of PNBs (i.e., via standardization or stratification) and reducing patient burden (i.e., decreasing postoperative questionnaires). CONCLUSION: Patients and clinicians who participated in a pilot RCT generally accept the clinical equipoise between OA versus OFA after outpatient general surgery and recognize the need for methodologically robust trials to inform evidence-based analgesia prescribing.

Feasibility of Prospectively Comparing Opioid Analgesia With Opioid-Free Analgesia After Outpatient General Surgery: A Pilot Randomized Clinical Trial.

Importance: The overprescription of opioids to surgical patients is recognized as an important factor contributing to the opioid crisis. However, the value of prescribing opioid analgesia (OA) vs opioid-free analgesia (OFA) after postoperative discharge remains uncertain. Objective: To investigate the feasibility of conducting a full-scale randomized clinical trial (RCT) to assess the comparative effectiveness of OA vs OFA after outpatient general surgery. Design, Setting, and Participants: This parallel, 2-group, assessor-blind, pragmatic pilot RCT was conducted from January 29 to September 3, 2020 (last follow-up on October 2, 2020). at 2 university-affiliated hospitals in Montreal, Quebec, Canada. Participants were adult patients (aged ≥18 years) undergoing outpatient abdominal (ie, cholecystectomy, appendectomy, or hernia repair) or breast (ie, partial or total mastectomy) general surgical procedures. Exclusion criteria were contraindications to drugs used in the trial, preoperative opioid use, conditions that could affect assessment of outcomes, and intraoperative or early complications requiring hospitalization. Interventions: Patients were randomized 1:1 to receive OA (around-the-clock nonopioids and opioids for breakthrough pain) or OFA (around-the-clock nonopioids with increasing doses and/or addition of nonopioid medications for breakthrough pain) after postoperative discharge. Main Outcomes and Measures: Main outcomes were a priori RCT feasibility criteria (ie, rates of surgeon agreement, patient eligibility, patient consent, treatment adherence, loss to follow-up, and missing follow-up data). Secondary outcomes included pain intensity and interference, analgesic intake, 30-day unplanned health care use, and adverse events. Between-group comparison of outcomes followed the intention-to-treat principle. Results: A total of 15 surgeons were approached; all (100%; 95% CI, 78%-100%) agreed to have patients recruited and adhered to the study procedures. Rates of patient eligibility and consent were 73% (95% CI, 66%-78%) and 57% (95% CI, 49%-65%), respectively. Seventy-six patients were randomized (39 [51%] to OA and 37 [49%] to OFA) and included in the intention-to-treat analysis (mean [SD] age, 55.5 [14.5] years; 50 [66%] female); 40 (53%) underwent abdominal surgery, and 36 (47%) underwent breast surgery. Seventy-five patients (99%; 95% CI, 93%-100%) adhered to the allocated treatment; 1 patient randomly assigned to OFA received an opioid prescription. Seventeen patients (44%) randomly assigned to OA consumed opioids after discharge. Seventy-three patients (96%; 95% CI, 89%-99%) completed the 30-day follow-up. The rate of missing questionnaires was 37 of 3724 (1%; 95% CI, 0.7%-1.4%). All the a priori RCT feasibility criteria were fulfilled. Conclusions and Relevance: The findings of this pilot RCT support the feasibility of conducting a robust, full-scale RCT to inform evidence-based prescribing of analgesia after outpatient general surgery. Trial Registration: ClinicalTrials.gov Identifier: NCT04254679.

Chlorhexidine (di)gluconate locking device for central line infection prevention in intensive care unit patients: a multi-unit, pilot randomized controlled trial.

PURPOSE: Intensive care unit (ICU) patients are at risk for central line-associated bloodstream infection (CLABSI) with significant attributable mortality and increased hospital length of stay, readmissions, and costs. Chlorhexidine (di)gluconate (CHG) is used as a disinfectant for central line insertion; however, the feasibility and efficacy of using CHG as a locking solution is unknown. METHODS: Patients with a central venous access device (CVAD) in situ were randomized to standard care or a CHG lock solution (CHGLS) within 72 hours of ICU admission. The CHG solution was instilled in the lumen of venous catheters not actively infusing. CVAD blood cultures were taken at baseline and every 48 hours. The primary outcome was feasibility including recruitment rate, consent rate, protocol adherence, and staff uptake. Secondary outcomes included CVAD colonization, bacteraemia, and clinical endpoints. RESULTS: Of 3,848 patients screened, 122 were eligible for the study and consent was obtained from 82.0% of the patients or substitute decision makers approached. Fifty participants were allocated to each group. Tracking logs indicated that the CHGLS was used per protocol 408 times. Most nurses felt comfortable using the CHGLS. The proportion of central line colonization was significantly higher in the standard care group with 40 (29%) versus 26 (18.7%) in the CHGLS group (P=0.009). CONCLUSIONS: Using a device that delivers CHG into CVADs was feasible in the ICU. Findings from this trial will inform a full-scale randomized controlled trial and provide preliminary data on the effectiveness of CHGLS. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT03309137, registered on October 13, 2017.

Construct validity and responsiveness of the Duke Activity Status Index (DASI) as a measure of recovery after colorectal surgery.

BACKGROUND: Returning to preoperative levels of physical function is highly valued by patients recovering from surgery. The Duke Activity Status Index (DASI, a 12-item questionnaire) may be a simple yet robust tool to assess postoperative recovery of functional capacity. This study assessed construct validity and responsiveness of the DASI as a measure of recovery after colorectal surgery. METHODS: Data from a trial on early mobilization after colorectal surgery were analyzed. Patients completed the DASI questionnaire preoperatively and at postoperative weeks (POW) 2 and 4. Construct validity was assessed by testing the primary a priori hypotheses that postoperative DASI scores (1) are higher in patients without vs with postoperative complications and (2) correlate with six-minute walk test distance (6MWD). Exploratory analyses assessed the association between DASI scores and (1) preoperative physical status [higher (ASA ≤ 2) vs lower (ASA > 2)], (2) stoma creation (no stoma vs stoma), (3) age [younger (≤ 75 years) vs older (> 75 years)], (4) time to readiness for discharge [shorter (≤ 4 days) vs longer (> 4 days)], and (5) surgical approach (laparoscopic vs open). Responsiveness was assessed by testing a priori hypotheses that DASI scores are higher (1) preoperatively vs at POW2 and (2) at POW4 vs POW2. Mean differences in DASI scores were obtained using linear regression. The association between DASI and 6MWD was assessed via Pearson correlation. RESULTS: We analyzed data from 100 patients undergoing colorectal surgery (mean age 65; 57% male; 81% laparoscopic). Mean DASI scores were 47.9 ± 12.1 preoperatively, 22.4 ± 12.7 at POW2, and 33.2 ± 15.7 at POW4. The data supported our two primary construct validity hypotheses, as well as 3/5 exploratory hypotheses. Both responsiveness hypotheses were supported. CONCLUSIONS: Our findings support that the DASI questionnaire can be a useful tool to assess postoperative recovery of functional capacity in research and clinical practice.

Chlorhexidine locking device for central line infection prevention in ICU patients: protocol for an open-label pilot and feasibility randomized controlled trial.

BACKGROUND: Critically ill patients in the intensive care unit (ICU) are at risk for central line-associated bloodstream infection (CLABSI) with an incidence up to 6.9 per 1000 catheter days. CLABSI has a significant attributable mortality and increases in-hospital length of stay, readmissions, and costs. Chlorhexidine gluconate (CHG), a broad-spectrum biocide, has been shown to effectively reduce infections including CLABSI; however, few trials have utilized CHG for prevention of central line infections. Our preclinical work has demonstrated a device that diffuses CHG into the intravenous lock solution of central venous catheters and decreases bacterial growth on the catheter lumen. We designed a clinical trial to test the feasibility of using a CHG device in an ICU patient population. METHODS: The proposed pilot trial will be a single centre, open-label, two-arm, parallel group feasibility randomized controlled trial (RCT). Participants will have a central line in situ and will be enrolled within 72 h of admittance to 3 ICUs at a single academic hospital. Exclusion criteria will include suspected infection, chronic indwelling catheters, and CHG allergy. Informed consent will be obtained from eligible participants or their substitute decision maker prior to randomization. Participants will be randomized to receive either usual care or the CHG locking device. Blood cultures will be drawn from all participants every 48 h. The primary objective of this study will be to determine the feasibility of using this protocol to conduct a larger trial. Feasibility will be assessed through the following outcomes: (1) consent rate, (2) recruitment rate, (3) protocol adherence, and (4) comfort level with the device. The secondary objective of this study will be to establish the preliminary efficacy of the device. DISCUSSION: This study will be the first human RCT to investigate a CHG locking device for the prevention of central line infections. Findings from this trial will inform the feasibility of conducting a large RCT and provide preliminary data on the efficacy of a CHG locking device. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03309137, registered on October 13, 2017.