Towards Opioid-Free Elective Spine Surgery: A Prospective Cohort Study

Abstract INTRODUCTION The opioid crisis is a national emergency. We conducted a prospective cohort study to determine whether elective spine surgery can be performed without any opioids whatsoever. METHODS Every consecutive elective spine surgery performed by author R.A.B. between January 1st and December 31st of 2018 was included. For cohort A, between January and April 15th, opioids were minimized but PRN doses were given. For cohort B, between April 15th and December, the goal was to eliminate opioids altogether. Pain scores were collected at discharge, 1 wk, and 1-mo follow-up. Patient-reported outcomes (PRO) were collected at baseline and at 3 mo for lumbar procedures. Emergency room visits and readmissions were tracked. Student's t-tests were used to compare pain scores and PROs, and multivariate regression analyses were performed to understand drivers of opioid use. RESULTS A total of 158 patients were included. In cohort A, 37.9% of patients took no opioids between PACU and 1 mo. Average pain scores were 5.2 in PACU and 2.5 at 1 mo. In cohort B, 86.7% took no opioids after PACU. Average pain scores were 4.2 in PACU and 2.5 at 1 mo. Both cohorts had equivalent improvements in PROs. Multivariate regression revealed that, adjusting for case mix differences, cohort B had lower odds of opioid use after PACU (P < .0001). Moreover, preoperative opioid use is a driver of postoperative opioid use (P = .02), whereas procedure type/invasiveness is not. CONCLUSION We have shown that opioid-free spine surgery, including lumbar fusions, is feasible and effective. In all 87% of patients in our opioid-elimination cohort took no opioids from PACU until 1 mo after surgery, and 94% were taking none at the 1-mo visit. Pain scores and PROs were favorable. We have also shown that preoperative opioids are a driver of postoperative opioid use, however procedural invasiveness is not.

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A Prospective Cohort Study Towards Improving Enhanced Recovery After Cesarean (ERAC) Pathways.

10.1101/2021.11.07.21265950 ◽

2021 ◽

Author(s):

Liviu Cojocaru ◽

Autusa Pahlavan ◽

Suzanne Alton ◽

Martha Coghlan ◽

Hyunuk Seung ◽

...

Keyword(s):

Cohort Study ◽

Postpartum Depression ◽

Prospective Cohort Study ◽

Prospective Cohort ◽

Enhanced Recovery ◽

Postoperative Recovery ◽

Opioid Use ◽

Pain Scores ◽

Number Of Patients ◽

Patient Reported

Background: Enhanced Recovery After Surgery (ERAS) or, more specifically for obstetrics, Enhanced Recovery after Cesarean (ERAC) pathways have emerged as a multidisciplinary standardized bundled care approach to improve maternal outcomes. Despite this, ERAS pathways have not been fully embraced in obstetrics, leaving significant space for improvement. Moreover, most of the studies have not extended ERAC pathways to specific populations such as opioid-naive patients, patients with postpartum depression, or patients receiving Magnesium Sulfate, allowing aforementioned confounders to affect the magnitude of the measured outcome. Objectives: To evaluate whether an Enhanced Recovery After Cesarean (ERAC) pathways reduces inpatient and outpatient opioid use, pain scores and improves the indicators of postoperative recovery. Furthermore, the specifics of our protocol are intended to decrease the knowledge gaps in ERAC pathways. Study design: This is a prospective cohort study of all patients older than 18 undergoing an uncomplicated cesarean delivery (CD) at an academic medical center. We excluded CD done under general anesthesia, those complicated by massive transfusion events, bowel injury, requiring recovery in the intensive care unit, and skin incision other than Pfannenstiel. Additionally, we excluded patients with chronic pain disorders, chronic opioid use, acute postpartum depression, or mothers whose neonate demised before their discharge. Lastly, we excluded non-English and non-Spanish speaking patients. Our study compared the outcomes in patients before (pre-ERAC) and after (post-ERAC) implementation of an ERAC pathways. Primary outcomes were inpatient morphine milligram equivalent (MME) use and the patient's delta pain scores (patient's reported goal subtracted from patient's pain score). Secondary outcomes were outpatient MME prescriptions as well as indicators of postoperative recovery (e.g., fasting time, time to feeding, time to indwelling urinary catheter removal, time to ambulation, and time to hospital discharge). Baseline demographics and outcomes were compared between pre-ERAC and post-ERAC cohorts. Multivariate logistic regression models were used to control for potential confounders. Results: Of 308 patients undergoing CD from October 2019 to September 2020, 196 were enrolled in the pre-ERAC cohort and 112 in the post-ERAC cohort. Patients in the post-ERAC cohort were less likely to require opioids in the postoperative period compared to the pre-ERAC cohort (35.7% vs. 18.4%, p<0.001). In addition, there was a significant reduction in the MME per stay in this cohort [16.8 MME (11.2-33.9) vs. 30 MME (20-49), p<0.001]. In the post-ERAC cohort, there was also a reduction in the number of patients who required prescribed opioids at the time of discharge (86.6 vs. 98%, p<0.001) as well as in the amount of MMEs prescribed [150 MME (112-150) vs. 150 MME (150-225), p<0.001; different shape of distribution]. Patients in the post-ERAC cohort had lower delta pain scores on postoperative days 1 to 4 as well as lower overall delta pain scores [2.2 (1.3-3.7) vs. 3.3 (2.3-4.7), p<0.001]. Conclusion: Our study has illustrated that our ERAC pathways reduced inpatient and outpatient opioid use as well as patient-reported pain scores while improving indicators of postoperative recovery.

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Patient-reported Quality of Life following Stereotactic Body Radiation Therapy for Primary Kidney Cancer – Results from a Prospective Cohort Study

Clinical Oncology ◽

10.1016/j.clon.2021.03.002 ◽

2021 ◽

Author(s):

A. Swaminath ◽

P. Cheung ◽

R.M. Glicksman ◽

E.K. Donovan ◽

M. Niglas ◽

...

Keyword(s):

Quality Of Life ◽

Radiation Therapy ◽

Cohort Study ◽

Kidney Cancer ◽

Prospective Cohort Study ◽

Prospective Cohort ◽

Stereotactic Body Radiation Therapy ◽

Stereotactic Body Radiation ◽

Patient Reported

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Shoulder function after constraint-induced movement therapy assessed with 3D kinematics and clinical and patient reported outcomes: a prospective cohort study

Journal of Electromyography and Kinesiology ◽

10.1016/j.jelekin.2021.102547 ◽

2021 ◽

pp. 102547

Author(s):

Gunhild Mo Hansen ◽

Susanne Wulff Svendsen ◽

Asger Roer Pedersen ◽

Uwe Gustav Kersting ◽

Hanne Pallesen ◽

...

Keyword(s):

Cohort Study ◽

Prospective Cohort Study ◽

Prospective Cohort ◽

Patient Reported Outcomes ◽

Movement Therapy ◽

Shoulder Function ◽

3D Kinematics ◽

Constraint Induced Movement Therapy ◽

Patient Reported

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The INTREST registry: protocol of a multicenter prospective cohort study of predictors of women’s response to integrative breast cancer treatment

BMC Cancer ◽

10.1186/s12885-021-08468-2 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Heidemarie Haller ◽

Petra Voiß ◽

Holger Cramer ◽

Anna Paul ◽

Mattea Reinisch ◽

...

Keyword(s):

Breast Cancer ◽

Clinical Trial ◽

Cohort Study ◽

Cancer Treatment ◽

Prospective Cohort Study ◽

Cancer Care ◽

Prospective Cohort ◽

Breast Cancer Treatment ◽

Cancer Data ◽

Patient Reported

Abstract Background Cancer registries usually assess data of conventional treatments and/or patient survival. Beyond that, little is known about the influence of other predictors of treatment response related to the use of complementary therapies (CM) and lifestyle factors affecting patients’ quality and quantity of life. Methods INTREST is a prospective cohort study collecting register data at multiple German certified cancer centers, which provide individualized, integrative, in- and outpatient breast cancer care. Patient-reported outcomes and clinical cancer data of anticipated N = 715 women with pTNM stage I-III breast cancer are collected using standardized case report forms at the time of diagnosis, after completing neo−/adjuvant chemotherapy, after completing adjuvant therapy (with the exception of endocrine therapy) as well as 1, 2, 5, and 10 years after baseline. Endpoints for multivariable prediction models are quality of life, fatigue, treatment adherence, and progression-based outcomes/survival. Predictors include the study center, sociodemographic characteristics, histologic cancer and comorbidity data, performance status, stress perception, depression, anxiety, sleep quality, spirituality, social support, physical activity, diet behavior, type of conventional treatments, use of and belief in CM treatments, and participation in a clinical trial. Safety is recorded following the Common Terminology Criteria for Adverse Events. Discussion This trial is currently recruiting participants. Future analyses will allow to identify predictors of short- and long-term response to integrative breast cancer treatment in women, which, in turn, may improve cancer care as well as quality and quantity of life with cancer. Trial registration German Clinical Trial Register DRKS00014852. Retrospectively registered at July 4th, 2018.

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Australia IBD Microbiome (AIM) Study: protocol for a multicentre longitudinal prospective cohort study

BMJ Open ◽

10.1136/bmjopen-2020-042493 ◽

2021 ◽

Vol 11 (2) ◽

pp. e042493

Author(s):

Astrid-Jane Williams ◽

Ramesh Paramsothy ◽

Nan Wu ◽

Simon Ghaly ◽

Steven Leach ◽

...

Keyword(s):

Cohort Study ◽

Environmental Factors ◽

Prospective Cohort Study ◽

Clinical Data ◽

Prospective Cohort ◽

Response To Therapy ◽

Psychological State ◽

Local Health ◽

Microbial Composition ◽

Patient Reported

IntroductionCrohn’s disease and ulcerative colitis are common chronic idiopathic inflammatory bowel diseases (IBD), which cause considerable morbidity. Although the precise mechanisms of disease remain unclear, evidence implicates a strong multidirectional interplay between diet, environmental factors, genetic determinants/immune perturbations and the gut microbiota. IBD can be brought into remission using a number of medications, which act by suppressing the immune response. However, none of the available medications address any of the underlying potential mechanisms. As we understand more about how the microbiota drives inflammation, much interest has focused on identifying microbial signals/triggers in the search for effective therapeutic targets. We describe the establishment of the Australian IBD Microbiota (AIM) Study, Australia’s first longitudinal IBD bioresource, which will identify and correlate longitudinal microbial and metagenomics signals to disease activity as evaluated by validated clinical instruments, patient-reported surveys, as well as biomarkers. The AIM Study will also gather extensive demographic, clinical, lifestyle and dietary data known to influence microbial composition in order to generate a more complete understanding of the interplay between patients with IBD and their microbiota.MethodsThe AIM Study is an Australian multicentre longitudinal prospective cohort study, which will enrol 1000 participants; 500 patients with IBD and 500 healthy controls over a 5-year period. Assessment occurs at 3 monthly intervals over a 24-month period. At each assessment oral and faecal samples are self-collected along with patient-reported outcome measures, with clinical data also collected at baseline, 12 and 24 months. Intestinal tissue will be sampled whenever a colonoscopy is performed. Dietary intake, general health and psychological state will be assessed using validated self-report questionnaires. Samples will undergo metagenomic, transcriptomic, proteomic, metabolomic and culturomic analyses. Omics data will be integrated with clinical data to identify predictive biomarkers of response to therapy, disease behaviour and environmental factors in patients with IBD.Ethics and disseminationEthical approval for this study has been obtained from the South Eastern Sydney Local Health District Research Ethics Committee (HREC 2019/ETH11443). Findings will be reported at national and international gastroenterology meetings and published in peer-reviewed journals.Trial registration numberACTRN12619000911190.

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