Jessica Kasza

Physical Therapist-Delivered Pain Coping Skills Training and Exercise for Knee Osteoarthritis: Randomized Controlled Trial.

To investigate whether a 12‐week physical therapist–delivered combined pain coping skills training (PCST) and exercise (PCST/exercise) is more efficacious and cost effective than either treatment alone for knee osteoarthritis (OA).

Severe Nausea and Vomiting in the Evaluation of Nitrous Oxide in the Gas Mixture for Anesthesia II Trial

Background:The Evaluation of Nitrous oxide in the Gas Mixture for Anesthesia II trial randomly assigned 7,112 noncardiac surgery patients to a nitrous oxide or nitrous oxide–free anesthetic; severe postoperative nausea and vomiting (PONV) was a prespecified secondary end point. Thus, the authors evaluated the association between nitrous oxide, severe PONV, and effectiveness of PONV prophylaxis in this setting. Methods:Univariate and multivariate analyses of patient, surgical, and other perioperative characteristics were used to identify the risk factors for severe PONV and to measure the impact of severe PONV on patient outcomes. Results:Avoiding nitrous oxide reduced the risk of severe PONV (11 vs. 15%; risk ratio [RR], 0.74 [95% CI, 0.63 to 0.84]; P < 0.001), with a stronger effect in Asian patients (RR, 0.55 [95% CI, 0.43 to 0.69]; interaction P = 0.004) but lower effect in those who received PONV prophylaxis (RR, 0.89 [95% CI, 0.76 to 1.05]; P = 0.18). Gastrointestinal surgery was associated with an increased risk of severe PONV when compared with most other types of surgery (P < 0.001). Patients with severe PONV had lower quality of recovery scores (10.4 [95% CI, 10.2 to 10.7] vs. 13.1 [95% CI, 13.0 to 13.2], P < 0.0005); severe PONV was associated with postoperative fever (15 vs. 20%, P = 0.001). Patients with severe PONV had a longer hospital stay (adjusted hazard ratio, 1.14 [95% CI, 1.05 to 1.23], P = 0.002). Conclusions:The increased risk of PONV with nitrous oxide is near eliminated by antiemetic prophylaxis. Severe PONV, which is seen in more than 10% of patients, is associated with postoperative fever, poor quality of recovery, and prolonged hospitalization.

Neuraxial block and postoperative epidural analgesia: effects on outcomes in the POISE-2 trial

BACKGROUND We assessed associations between intraoperative neuraxial block and postoperative epidural analgesia, and a composite primary outcome of death or non-fatal myocardial infarction, at 30 days post-randomization in POISE-2 Trial subjects. METHODS 10 010 high-risk noncardiac surgical patients were randomized aspirin or placebo and clonidine or placebo. Neuraxial block was defined as intraoperative spinal anaesthesia, or thoracic or lumbar epidural anaesthesia. Postoperative epidural analgesia was defined as postoperative epidural local anaesthetic and/or opioid administration. We used logistic regression with weighting using estimated propensity scores. RESULTS Neuraxial block was not associated with the primary outcome [7.5% vs 6.5%; odds ratio (OR), 0.89; 95% CI (confidence interval), 0.73-1.08; P=0.24], death (1.0% vs 1.4%; OR, 0.84; 95% CI, 0.53-1.35; P=0.48), myocardial infarction (6.9% vs 5.5%; OR, 0.91; 95% CI, 0.74-1.12; P=0.36) or stroke (0.3% vs 0.4%; OR, 1.05; 95% CI, 0.44-2.49; P=0.91). Neuraxial block was associated with less clinically important hypotension (39% vs 46%; OR, 0.90; 95% CI, 0.81-1.00; P=0.04). Postoperative epidural analgesia was not associated with the primary outcome (11.8% vs 6.2%; OR, 1.48; 95% CI, 0.89-2.48; P=0.13), death (1.3% vs 0.8%; OR, 0.84; 95% CI, 0.35-1.99; P=0.68], myocardial infarction (11.0% vs 5.7%; OR, 1.53; 95% CI, 0.90-2.61; P=0.11], stroke (0.4% vs 0.4%; OR, 0.65; 95% CI, 0.18-2.32; P=0.50] or clinically important hypotension (63% vs 36%; OR, 1.40; 95% CI, 0.95-2.09; P=0.09). CONCLUSIONS Neuraxial block and postoperative epidural analgesia were not associated with adverse cardiovascular outcomes among POISE-2 subjects.

Telephone Coaching to Enhance a Home-Based Physical Activity Program for Knee Osteoarthritis: A Randomized Clinical Trial

To investigate whether simultaneous telephone coaching improves the clinical effectiveness of a physiotherapist‐prescribed home‐based physical activity program for knee osteoarthritis (OA).

Unloading Shoes for Self-management of Knee Osteoarthritis: A Randomized Trial.

Global estimates suggest that knee osteoarthritis affects 10% to 25% of women and 5% to 15% of men aged 60 years or older (1). It results in pain, physical dysfunction, and reduced quality of life and is a leading contributor to global disability (1). In the United States, osteoarthritis is the second most common nonacute reason for seeking medical advice after skin disorders (2). Because it has no cure, advice for self-management is the cornerstone of conservative treatment, along with exercise and weight control (3, 4). Given that abnormal biomechanics are critical to the pathogenesis of knee osteoarthritis (5, 6), clinical guidelines recommend appropriate footwear as part of core treatment (3, 7). However, there is scant evidence from clinical trials to guide footwear choice for this patient group or for any population with chronic musculoskeletal pain. Accordingly, both the European League Against Rheumatism (7) and the U.K. National Institute for Health and Care Excellence (3) have identified footwear trials as a research priority. Furthermore, a U.S. stakeholder panel recently identified evaluating the effectiveness of biomechanical strategies for osteoarthritis as a high-priority evidence gap (8). Abnormal knee load is important in the development and progression of knee osteoarthritis (5, 6) and probably explains why most tibiofemoral osteoarthritis occurs medially (9), given that medial compartment loading is greater than lateral compartment loading during walking (10). Wearing shoes increases medial knee load compared with being barefoot (11, 12), so recent research has focused on developing novel unloading shoes for persons with knee osteoarthritis to reduce medial knee load. Unloading shoes with soles that are stiffer laterally than medially significantly reduce medial knee loads via changes in foot and ankle biomechanics (1316) compared with shoes with conventional soles of uniform stiffness. These types of unloading shoes are now commercially available from footwear retailers (for example, ABEO SMARTsystem [The Walking Company] and GEL-Melbourne OA or GEL-Melo [ASICS]) and are recommended by the manufacturers for persons with knee pain or osteoarthritis. However, whether unloading shoes can reduce pain and physical dysfunction associated with knee osteoarthritis is unclear. In the only randomized, controlled trial (RCT) to date, unloading shoes with soles that were stiffer laterally than medially did not result in between-group differences in the primary pain outcome at 6 months (17) or 1 year (18), but they did lead to more persons achieving a clinically important reduction in pain than the control group (71% vs. 35% at 6 months). Given that persons with generally mild pain and radiographic disease were recruited as well as the considerable dropout rate (30% at 1 year), further clinical trials are required to definitively evaluate unloading shoes for knee osteoarthritis. The aim of this study was to evaluate the efficacy of unloading walking shoes in alleviating knee osteoarthritis symptoms. We hypothesized that unloading shoes would reduce pain and improve physical function after 6 months compared with conventional walking shoes. Methods Design Overview We conducted a 2-group, parallel-group, comparative effectiveness RCT. The protocol has been published (19). The trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12613000851763) and was approved by the Institutional Human Ethics Committee. Participants provided informed consent. Setting and Participants We recruited community-dwelling participants from Melbourne, Australia, between August 2013 and May 2015 via print, radio, television, and social media advertisements and our research database. Participants were included if they were aged 50 years or older, had knee pain on most days in the previous month, reported average pain of at least 4 on an 11-point numerical rating scale (NRS) (with terminal descriptors of no pain and worst pain possible) in the previous week, had radiographic evidence of osteoarthritis (KellgrenLawrence grade 2 [20]), and had definite medial tibiofemoral osteoarthritis on radiography (grade 1 medial osteophytes and grade 1 medial joint space narrowing that was greater than lateral [21]). Exclusion criteria were presence of lateral tibiofemoral osteophytes that were worse than medial (21); intra-articular corticosteroid injection or knee surgery in the prior 3 months; presence of a systemic arthritic condition; prior knee arthroplasty or osteotomy or planned knee surgery in the subsequent 6 months; presence of another condition affecting lower limb function; current or previous (prior 6 months) use of shoe inserts, braces, or customized shoes from a health professional; inability to walk unaided; body mass index of 36 kg/m2 or greater; or self-reported pathology or pain in the ankle or foot. Randomization and Interventions Participants were randomly assigned in random permuted blocks of 6 to 12, stratified by radiographic severity (KellgrenLawrence grade 2, 3, or 4). The randomization schedule was prepared by an independent biostatistician; concealed in consecutively numbered, sealed opaque envelopes by an independent research assistant; and stored in a centrally accessible and locked location. A researcher who was not involved in enrollment or outcome assessment accessed the schedule. Participants were blinded to allocation. Unloading shoes were visually similar to conventional shoes (Appendix Figure), and model names were removed to ensure that the shoes could not be identified. Participants recorded which group they believed they were allocated to (after being fitted with shoes and at 6 months), and the James blinding index was used to assess blinding success (22). Because primary and secondary outcomes were participant-reported, assessors were also blinded. In addition, the research assistant overseeing data entry and the biostatistician were blinded. Appendix Figure. Intervention (unloading) shoes (top) and comparator (conventional) shoes (bottom). Participants were provided a pair of appropriately sized shoes on the basis of their random assignment and were asked to wear them as much as possible every day (4 hours/day) for 6 months and to avoid changing shoes. Participants were provided the shoes at no cost to themselves and were permitted to keep the shoes regardless of whether they completed the trial. For the intervention, we provided black, commercially available unloading walking shoes (GEL-Melbourne OA) (Appendix Figure, top) with triple-density midsoles (stiffer laterally than medially) and mild (5-degree) lateral-wedge insoles attached to the underside of the sock liners. These shoes significantly reduce indirect measures of load across the medial knee compared with conventional recreational shoes (15, 16). For the comparator group, we provided black, commercially available neutral walking shoes (GEL-Odyssey [ASICS]) (Appendix Figure, bottom) that did not contain the specific design features of the unloading shoes. Adherence was measured by self-reported wear of allocated shoes (hours per day), which was recorded in a logbook for 7 consecutive days each month; overall self-reported adherence over 6 months using an 11-point NRS (with the anchors not worn at all and worn completely as instructed); and a shoe-mounted pedometer (Oregon Scientific PE903) for 7 consecutive days during the fourth week of months 2 and 5 to record the number of daily steps in the trial shoes. Outcomes and Follow-up Participants completed self-reported primary and secondary outcome measures at baseline and 6 months, either electronically or on paper at the University of Melbourne. To minimize missing follow-up data, participants were provided a

Nitrous oxide and serious long-term morbidity and mortality in the evaluation of nitrous oxide in the gas mixture for anaesthesia (ENIGMA)-II trial

50AUD gift voucher for returning completed questionnaires at 6 months. Primary outcomes were valid and reliable self-reported pain and physical function measures recommended for knee osteoarthritis clinical trials (23). Overall average pain with walking over the previous week was measured via an 11-point NRS, with terminal descriptors of no pain and worst pain possible and a minimum clinically important difference (MCID) of 1.8 units (24). Difficulty with physical functioning over the previous 48 hours was measured by the function subscale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC, Likert version 3.1) (25), with total scores ranging from 0 (no dysfunction) to 68 (maximum dysfunction) and an MCID of 6 units (26). Both primary outcomes were also assessed at 3 months (secondary time point). Secondary outcomes included knee pain over the previous 48 hours, assessed with the WOMAC pain subscale (25) (also administered at 3 months, with scores ranging from 0 [no pain] to 20 [maximum pain] and an MCID of 18% improvement from baseline [27]); knee stiffness over the previous 48 hours, evaluated with the WOMAC stiffness subscale (25) (also administered at 3 months, with scores ranging from 0 [no stiffness] to 8 [maximum stiffness] and an MCID of 22% improvement from baseline [27]); intermittent and constant knee pain over the previous week, measured by using the Intermittent and Constant Osteoarthritis Pain questionnaire (28) (scores ranging from 0 [no pain] to 100 [maximum pain] and MCIDs of 18.7 and 18.4, respectively [29]); global change in pain and physical function, assessed with 7-point Likert scales (measured at 3 and 6 months, with terminal descriptors of much worse and much better); health-related quality of life, evaluated with the Assessment of Quality of Life 6D scale (AQoL-6D) (30) (scores ranging from 0.04 [lowest quality] to 1.00 [highest quality] and an MCID of 0.06 units [31]); and physical activity over the previous week, assessed with the Physical Activity Scale for the Elderly (32) (scores ranging from 0 [lowest] to >400 [highest]). Adverse effects of treatment (any problem believed by the participan

Interpretation of commonly used statistical regression models.

Background:The Evaluation of Nitrous Oxide in the Gas Mixture for Anaesthesia (ENIGMA)-II trial randomly assigned 7,112 noncardiac surgery patients at risk of perioperative cardiovascular events to 70% N2O or 70% N2 groups. The aim of this follow-up study was to determine the effect of nitrous oxide on a composite primary outcome of death and major cardiovascular events at 1 yr after surgery. Methods:One-year follow-up was conducted via a medical record review and telephone interview. Disability was defined as a Katz index of independence in activities of daily living score less than 8. Adjusted odds ratios and hazard ratios were calculated as appropriate for primary and secondary outcomes. Results:Among 5,844 patients evaluated at 1 yr, 435 (7.4%) had died, 206 (3.5%) had disability, 514 (8.8%) had a fatal or nonfatal myocardial infarction, and 111 (1.9%) had a fatal or nonfatal stroke during the 1-yr follow-up period. Exposure to nitrous oxide did not increase the risk of the primary outcome (odds ratio, 1.08; 95% CI, 0.94 to 1.25; P = 0.27), disability or death (odds ratio, 1.07; 95% CI, 0.90 to 1.27; P = 0.44), death (hazard ratio, 1.17; 95% CI, 0.97 to 1.43; P = 0.10), myocardial infarction (odds ratio, 0.97; 95% CI, 0.81 to 1.17; P = 0.78), or stroke (odds ratio, 1.08; 95% CI, 0.74 to 1.58; P = 0.70). Conclusion:These results support the long-term safety of nitrous oxide administration in noncardiac surgical patients with known or suspected cardiovascular disease.

Safety of sedation for gastrointestinal endoscopy in a group of university-affiliated hospitals: a prospective cohort study.

A review of some regression models commonly used in respiratory health applications is provided in this article. Simple linear regression, multiple linear regression, logistic regression and ordinal logistic regression are considered. The focus of this article is on the interpretation of the regression coefficients of each model, which are illustrated through the application of these models to a respiratory health research study.

Effects of Adding an Internet-Based Pain Coping Skills Training Protocol to a Standardized Education and Exercise Program for People With Persistent Hip Pain (HOPE Trial): Randomized Controlled Trial Protocol

Background. Service models for gastrointestinal endoscopy sedation must be safe, as endoscopy is the most common procedure performed under sedation in many countries. The aim of this prospective cohort study was to determine the patient risk profile, and incidence of and risk factors for significant unplanned events, in adult patients presenting for gastrointestinal endoscopy in a group of university-affiliated hospitals where most sedation is managed by anaesthetists. Methods. Patients aged ≥18 yr presenting for elective and emergency gastrointestinal endoscopy under anaesthetist-managed sedation at nine hospitals affiliated with the University of Melbourne, Australia, were included. Outcomes included significant airway obstruction, hypoxia, hypotension and bradycardia; unplanned tracheal intubation; abandoned procedure; advanced life support; prolonged post-procedure stay; unplanned over-night admission and 30-day mortality. Results. 2,132 patients were included. Fifty percent of patients were aged >60 yr, 50% had a BMI >27 kg m −2, 42% were ASA physical status III-V and 17% were emergency patients. The incidence of significant unplanned events was 23.0% (including significant hypotension 11.8%). Significant unplanned intraoperative events were associated with increasing age, BMI <18.5 kg m −2, ASA physical status III-V, colonoscopy and planned tracheal intubation. Thirty-day mortality was 1.2% (0.2% in electives and 6.0% in emergencies) and was associated with ASA physical status IV-V and emergency status. Conclusions. Patients presenting for gastrointestinal endoscopy at a group of public university-affiliated hospitals where most sedation is managed by anaesthetists, had a high risk profile and a substantial incidence of significant unplanned intraoperative events and 30-day mortality.

Clustering and Residual Confounding in the Application of Marginal Structural Models: Dialysis Modality, Vascular Access, and Mortality

Background Persistent hip pain in older people is usually due to hip osteoarthritis (OA), a major cause of pain, disability, and psychological dysfunction. Objective The purpose of this study is to evaluate whether adding an Internet-based pain coping skills training (PCST) protocol to a standardized intervention of education followed by physical therapist–instructed home exercise leads to greater reductions in pain and improvements in function. Design An assessor-, therapist-, and participant-blinded randomized controlled trial will be conducted. Setting The study will be conducted in a community setting. Participants The participants will be 142 people over 50 years of age with self-reported hip pain consistent with hip OA. Intervention Participants will be randomly allocated to: (1) a control group receiving a 24-week standardized intervention comprising an 8-week Internet-based education package followed by 5 individual physical therapy exercise sessions plus home exercises (3 times weekly) or (2) a PCST group receiving an 8-week Internet-based PCST protocol in addition to the control intervention. Measurements Outcomes will be measured at baseline and 8, 24, and 52 weeks, with the primary time point at 24 weeks. Primary outcomes are hip pain on walking and self-reported physical function. Secondary outcomes include health-related quality-of-life, participant-perceived treatment response, self-efficacy for pain management and function, pain coping attempts, pain catastrophizing, and physical activity. Measurements of adherence, adverse events, use of health services, and process measures will be collected at 24 and 52 weeks. Cost-effectiveness will be assessed at 52 weeks. Limitations A self-reported diagnosis of persistent hip pain will be used. Conclusions The findings will help determine whether adding an Internet-based PCST protocol to standardized education and physical therapist–instructed home exercise is more effective than education and exercise alone for persistent hip pain. This study has the potential to guide clinical practice toward innovative modes of psychosocial health care provision.