Estimating the Minimal Clinically Important Difference on the Visual Analogue Scale for Carpometacarpal Thumb Joint Osteoarthritis.

BACKGROUND: The minimal clinically important difference (MCID) is the smallest perceived treatment effect that patients deem clinically significant. There is currently no agreement on an appropriate MCID for the pain visual analogue scale (VAS) in the context of thumb osteoarthritis (OA). METHODS: We approximated MCIDs using a distribution-based approach that pooled standard deviations (SDs) associated with baseline mean values of the pain VAS (0-100 mm). We extracted the data from randomized controlled trials (RCTs) included in a systematic review of adults with long-term OA of the thumb. We excluded RCTs that did not report baseline SD values. The MCIDs were derived at 0.4 and 0.5 SDs of the pooled SD and compared with previously published MCIDs for the pain VAS in OA. RESULTS: A total of 403 patients were pooled from 7 RCTs for the analysis. The mean baseline VAS pain score was 5.6 cm. We derived an MCID of 0.72 cm at 0.4 SDs and 0.91 cm at 0.5 SDs using baseline SDs. We found that MCIDs derived from a distribution-based approach approximated published MCIDs for the VAS for pain for OA in the knee and hip. CONCLUSION: The authors propose that a change of 0.7 to 0.9 cm on the VAS is clinically meaningful in the context of long-term OA of the thumb.

Reporting bias in breast reconstruction clinical trials: Which and when clinical trials get published.

BACKGROUND: Reporting bias refers to the phenomenon in which the reporting of research findings is influenced by the nature of the results. Without the totality of evidence, clinical practice may be misguided. The objective of this work was to examine the extent of reporting bias in clinical trials of breast reconstruction surgery. METHODS: We searched and extracted data from all completed breast reconstruction clinical trials published in ClinicalTrials.gov from database inception to August 2020. Investigators sought to identify published full manuscripts of the registered trials. The primary outcome was classified as positive or nonpositive and trials were classified as industry or nonindustry funded. Time to publication in a peer-reviewed journal was computed and compared using time-to-event analysis. Trial characteristics associated with publication were evaluated using logistic regression. RESULTS: A total of 156 clinical trials were identified, of which, 53 trials were published. The median time to publication was 22 months (IQR, 13-35 months). Industry-funded studies were associated with a longer time to publication (HR = 2.4, p = 0.023) and publication in lower-impact journals (OR = 3.7, p = 0.048). Randomized clinical trials were associated with faster times to publication than nonrandomized studies (aHR = 3.2, p = 0.030). Statistical significance and the effect size were not associated with time to publication. CONCLUSIONS: We found no evidence that industry-funded trials were more likely to report a positive primary outcome. However, industry-funded trials were associated with a longer time to publication and publication in lower-impact journals.

Opioid Consumption After Upper Extremity Surgery: A Systematic Review.

There is currently an overprescription of opioids, which may result in abuse and diversion of narcotics. The aim of this systematic review was to investigate opioid prescription practices and consumption by patients after upper extremity surgery. This review was registered a priori on Open Science Framework (osf.io/6u5ny) and adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A search strategy was performed using MEDLINE, Embase, PubMed, and Cochrane Central Register of Controlled Trials databases (from their inception to October 17, 2021). Prospective studies investigating opioid consumption of patients aged 18 years or older undergoing upper extremity surgeries were included. The Risk of Bias in Nonrandomized Studies of Interventions and Risk of Bias 2.0 tools were used for quality assessment. In total, 21 articles met the inclusion criteria, including 7 randomized controlled trials and 14 prospective cohort studies. This represented 4195 patients who underwent upper extremity surgery. Most patients took less than half of the prescribed opioids. The percentage of opioids consumed ranged from 11% to 77%. There was moderate to severe risk of bias among the included studies. This review demonstrated that there is routinely excessive opioid prescription relative to consumption after upper limb surgery. Additional randomized trials are warranted, particularly with standardized reporting of opioid consumption and assessment of patient-reported outcomes.

Comparing Breast Sensation between Alloplastic and Autologous Breast Reconstruction Patients Using the BREAST-Q Sensation Module.

BACKGROUND: Sensory recovery of the breast is a compelling frontier in comprehensive postmastectomy breast reconstruction. This study uses the BREAST-Q Sensation Module to evaluate the differences in women who underwent an alloplastic versus autologous breast reconstruction. METHODS: Women with a history of breast cancer and postmastectomy breast reconstruction were recruited through the Love Research Army, United States. Participants completed the BREAST-Q Sensation Module, which consists of three scales: Breast Symptoms, Breast Sensation, and Quality of Life Impact. Descriptive statistics and multiple linear regression analyses were used to compare outcomes between women undergoing alloplastic or autologous breast reconstruction. RESULTS: Of 1204 respondents, 933 were included for analysis: 620 (66.5 percent) underwent alloplastic reconstruction and 313 (33.5 percent) underwent autologous reconstruction. The average age and body mass index were 59.2 ± 10.1 years and 26 ± 5 kg/m 2 , respectively. Autologous reconstruction patients scored an average of 6.1 points (95 percent CI, 3.9 to 8.4; p < 0.001) and 5.3 points (95 percent CI, 2.5 to 8.1; p = 0.001) higher on the Breast Symptoms and Quality of Life Impact scales, respectively. No difference (0.0 points, 95 percent CI, -2.9 to 3.0; p = 0.75) was observed for the Breast Sensation scale. Increased time since reconstruction had a positive impact on Breast Symptoms scale scores. Radiotherapy negatively affected scores on both Breast Symptoms and Quality of Life Impact scales. CONCLUSIONS: Autologous breast reconstruction may be associated with fewer abnormal breast sensations and better sensation-related quality of life in comparison to alloplastic reconstruction. This information can be incorporated during preoperative patient counseling when discussing reconstructive options.

Hyaluronidase for Treating Complications Related to HA Fillers: A National Plastic Surgeon Survey.

Background: Hyaluronic acid (HA) fillers have become a popular modality to address changes in the ageing face. There are many described indications of hyaluronidases in aesthetic medicine which include their use in the management of HA-associated complications. To better understand the current practice patterns, we surveyed Canadian plastic surgeons on their use of hyaluronidases. Methods: With the approval of the Canadian Society of Plastic Surgeons, an electronic survey was emailed to members. A total of 350 surveys were distributed and 98 surveys were completed for a response rate of 28%. Results: Approximately half (48%) of the survey respondents used HA fillers in their practice. Skin testing for hypersensitivity reactions was performed by less than 10% of hyaluronidase users. Nearly all respondents used hyaluronidase for filler over-correction (95.5%) and asymmetry (86.4%). Over half of the respondents have used hyaluronidase for inflammatory or infectious nodules and the Tyndall effect. Other reported applications included restoration of vascular compromise, and one respondent reported using hyaluronidase for assisting with haematoma resolution. When compared with the most recent guidelines, there was a wide range of doses used for common side effects and complications. Twenty-four percent of the respondents reported that their hyaluronidase formulation was prepared by a compounding pharmacy, and 20% of respondents who inject HA fillers did not stock hyaluronidase. Conclusion: There are many indications for hyaluronidase in aesthetic plastic surgery. Plastic surgeons should stock hyaluronidase and develop a specific plan in anticipation of adverse events. Although hyaluronidase is commonly used by plastic surgeons for over-correction and asymmetry, the dosages used in aesthetic practice is rather diverse and heterogeneous. When possible, plastic surgeons should perform allergy testing before hyaluronidase use.

Historique: Les agents de comblement à base d'acide hyaluronique (AH) sont devenus populaires pour modifier la face vieillissante. De nombreuses indications sont décrites pour utiliser les hyaluronidases en médecine esthétique, y compris pour la prise en charge des complications liées à l'AH. Pour mieux comprendre les modes de pratique actuels, les chercheurs ont sondé les plasticiens canadiens pour connaître leur utilisation d'hyaluronidases. Méthodologie: Avec l'approbation de la Société canadienne des chirurgiens plasticiens, les membres ont reçu un sondage électronique par courriel. Au total, 350 sondages ont été distribués, et 98 ont été remplis, pour un taux de réponse de 28 %. Résultats: Environ la moitié des répondants au sondage (48 %) utilisent les agents de comblement à base d'AH dans leur pratique. Moins de 10 % d'entre eux effectuaient des tests d'hypersensibilité cutanée. Presque tous les répondants se servaient de l'hyaluronidase pour corriger les surcorrections (95,5 %) et l'asymétrie (86,4 %). Plus de la moitié utilisent l'hyaluronidase pour les nodules inflammatoires ou infectieux et l'effet Tyndall. La restauration d'une atteinte vasculaire était une autre application, et un répondant a déclaré y recourir pour contribuer à la résolution des hématomes. Par rapport aux directives les plus récentes, les doses utilisées étaient très variables pour les effets secondaires et les complications. Ainsi, 24 % des répondants ont déclaré qu'ils obtenaient leur formulation d'hyaluronidase par des préparations magistrales, et 20 % des répondants qui injectent les agents de comblement à base d'AH n'en conservaient pas en stock. Conclusion: Il y a de nombreuses indications pour utiliser l'hyaluronidase en chirurgie plastique. Les plasticiens devraient conserver des provisions d'hyaluronidase et se doter d'un plan détaillé en cas d'événements indésirables. L'hyaluronidase est souvent utilisée par les plasticiens pour corriger les surcorrections et l'asymétrie, mais les dosages utilisés en esthétique sont plutôt diversifiés et hétérogènes. Dans la mesure du possible, les plasticiens devraient effectuer des tests d'allergie avant d'utiliser l'hyaluronidase.

Medications and dosages used in medical assistance in dying: a cross-sectional study.

BACKGROUND: There is little evidence describing the technical aspects of medical assistance in dying (MAiD) in Canada, such as medications, dosages and complications. Our objective was to describe clinical practice in providing MAiD in Ontario and Vancouver, Canada, and explore relations between medications used, time until death and complications. METHODS: We conducted a retrospective cohort study of a sample of adult (age ≥ 18 yr) patients who received MAiD in Ontario between 2016 and 2018, and patients who received MAiD in 1 of 3 Canadian academic hospitals (in Hamilton and Ottawa, Ontario, and Vancouver, British Colombia) between 2019 and 2020. We used de-identified data for 2016-2018 from the Office of the Chief Coroner for Ontario MAiD Database and chart review data for 2019-2020 from the 3 centres. We used multivariable parametric survival analysis to identify relations between medications, dosages and time from procedure start until death. RESULTS: The sample included 3557 patients (1786 men [50.2%] and 1770 women [49.8%] with a mean age of 74 [standard deviation 13] yr). The majority of patients (2519 [70.8%]) had a diagnosis of cancer. The medications most often used were propofol (3504 cases [98.5%]), midazolam (3251 [91.4%]) and rocuronium (3228 [90.8%]). The median time from the first injection until death was 9 (interquartile range 6) minutes. Standard-dose lidocaine (40-60 mg) and high-dose propofol (> 1000 mg) were associated with prolonged time until death (prolonged by a median of 1 min and 3 min, respectively). Complications occurred in 41 cases (1.2%), mostly related to venous access or need for administration of a second medication. INTERPRETATION: In a large sample of patients who died with medical assistance, certain medications were associated with small differences in time from injection to death, and complications were rare. More research is needed to identify the medication protocols that predict outcomes consistent with patient and family expectations for a medically assisted death.

Afrocentric screening program for breast, colorectal, and cervical cancer among immigrant patients in Ontario.

PROBLEM ADDRESSED: Black and immigrant populations across Canada have lower screening rates than Canadian-born white populations, predisposing them to increased cancer morbidity and mortality. Effective interventions are required to increase cancer screening rates among these populations. OBJECTIVE OF PROGRAM: To improve breast, colorectal, and cervical cancer screening rates at TAIBU Community Health Centre, which has a mandate to provide primary health care services to the Black and immigrant community in the greater Toronto area. PROGRAM DESCRIPTION: An Afrocentric quality improvement program was developed and implemented, consisting of provider audits, cancer screening education programs, a patient call-back program, and a mammography promotion day. CONCLUSION: TAIBU Community Health Centre's continuous quality improvement approach was successful in engaging health care providers and patients to increase cancer screening participation sustainably in a racially and socioeconomically diverse setting. Rates of breast, colorectal, and cervical cancer screening offered to eligible patients increased from 17% to 72%, 18% to 67%, and 59% to 70%, respectively, between 2011 and 2018.

More pilot trials could plan to use qualitative data: a meta-epidemiological study.

BACKGROUND: Pilot trials often use quantitative data such as recruitment rate and retention rate to inform the design and feasibility of a larger trial. However, qualitative data such as patient, healthcare provider, and research staff perceptions of an intervention may also provide insights for a larger trial. METHODS: As part of a larger study investigating the reporting of progression criteria in pilot studies, we sought to determine how often pilot studies planned to use qualitative data to inform the design and feasibility of a larger trial and the factors associated with plans to use qualitative data. We searched for protocols of pilot studies of randomized trials in PubMed between 2013 and 2017. RESULTS: We included 227 articles. Only 92 (40.5%; 95% confidence interval [CI] 34.1-47.2) reported plans to collect qualitative data. The factors associated with collecting qualitative data were large studies (defined as sample size ≥ 60; adjusted odds ratio [aOR] 2.77; 95% CI 1.47-5.23; p = 0.002) and studies from Europe (aOR 3.86; 95% CI 1.68-8.88; p = 0.001) compared to North America and the rest of the world. Pilot trials with pharmacological interventions were less likely to plan to collect qualitative data (aOR 0.20; 95% CI 0.07-0.58; p = 0.003). CONCLUSIONS: Qualitative data is not used enough in pilot trials. Large pilot trials, pilot trials from Europe, and pilot trials of non-pharmacological interventions are more likely to plan for qualitative data.

Templating in shoulder arthroplasty - A comparison of 2D CT to 3D CT planning software: A systematic review.

BACKGROUND: Computed tomography (CT) utilizing computer software technology to generate three-dimensional (3D) rendering of the glenoid has become the preferred method for preoperative planning. It remains largely unknown what benefits this software may have to the intraoperative placement of the components and patient outcomes. PURPOSE: The purpose of this systematic review is to compare 2D CT to 3D CT planning in total shoulder arthroplasty. STUDY DESIGN: Systematic review. METHODS: A systematic database search was conducted for relevant studies evaluating the role of 3D CT planning in total shoulder arthroplasty. The primary outcome was component placement variability, and the secondary outcomes were intra- and inter-observer reliability in the context of preoperative planning. RESULTS: Following title-abstract and full-text screening, six eligible studies were included in the review (n = 237). The variability in glenoid measurements between 3D CT and 2D CT planning ranged from no significant difference to a 5° difference in version and 1.7° difference in inclination (p<0.05). Posterior bone loss was underestimated in 52% of the 2D measured patients relative to 3D CT groups. Irrespective of 2D and 3D planning (39% and 43% of cases respectively), surgeons elected to implant larger components than those templated. There was no literature identified comparing differences in time, cost, functional outcomes, complications, or patient satisfaction. CONCLUSION: The paucity of evidence exploring clinical parameters makes it difficult to comment on clinical outcomes using different methods of templating. More studies are required to identify how improved radiographic outcomes translate into improvements that are clinically meaningful to patients.

Postmarket Modifications of High-risk Plastic Surgery Devices.

BACKGROUND: In the United States, high-risk medical devices must be cleared through the premarket approval (PMA) pathway, which requires clinical evidence ensuring safety and efficacy. Approved devices can be modified and reintroduced to market without additional study through the PMA supplemental review track. This study characterizes the changes of high-risk plastic surgery devices once they undergo initial clearance. METHODS: A retrospective, cross-sectional analysis of the Food and Drug Administration (FDA) PMA database. The following data were extracted from the PMA database (January 1, 1980 to December 31, 2018): initial clearance date, device type, the number and type of supplement, supplement reason, and product withdrawal date. Data from the FDA medical device recall database were also extracted and reported. The median number of device modifications and median lifetime of device-years were calculated. RESULTS: There have been 39 original plastic surgery devices approved by the FDA. There was no significant change with respect to initial clearance dates for original devices over time (r = 0.28; P = 0.084). PMA supplement usage has significantly increased with time (rs = 0.9174, P = 0.000). Overall, approved plastic surgery devices have undergone a median of 11 changes (IQR, 3-35). Breast implant devices collectively underwent the most modifications with a median of 28 modifications per device (IQR, 20.25-33.25). CONCLUSIONS: Over the past 2 decades, plastic surgery device manufacturers have significantly increased the use of supplement track review. High-risk plastic surgery devices may undergo frequent minor changes without clinical evidence to support the safety and efficacy of modified versions.

Carpal Tunnel Release without a Tourniquet: A Systematic Review and Meta-Analysis.

BACKGROUND: Open carpal tunnel release is commonly performed with the use of a tourniquet. The combination of local anesthetic and epinephrine with a pneumatic tourniquet helps provide clear visualization during decompression of the median nerve. There has been a rapid expansion of literature challenging the use of tourniquets in open carpal tunnel release. Consequently, the local anesthesia/no tourniquet approach has become increasingly popular. The authors evaluated the outcomes of awake open carpal tunnel release with and without a tourniquet. METHODS: The authors attempted to identify all relevant studies, regardless of language or publication status. A systematic database search for relevant studies was conducted in MEDLINE, EMBASE, EBSCO, and CENTRAL. Included studies compared patients undergoing awake open carpal tunnel release with and without an arm or forearm tourniquet. RESULTS: Eight studies evaluating 765 patients and 866 hands were included. Open carpal tunnel release with the wide awake, local anesthesia, no tourniquet approach resulted in a 2.14 point reduction on the visual analog scale (95% CI, 1.30 to 2.98; p < 0.001). The procedure was 1.82 minutes faster with the use of a tourniquet (95% CI, -3.26 to -0.39; p = 0.01). There were no significant differences between groups in intraoperative blood loss, surgeon perceived difficulty, and complications. CONCLUSION: This systematic review found that tourniquet use causes significantly more pain with no significant clinical benefit as compared with using a wide awake, no tourniquet approach in carpal tunnel decompression.

The reporting of progression criteria in protocols of pilot trials designed to assess the feasibility of main trials is insufficient: a meta-epidemiological study.

INTRODUCTION: Pilot and feasibility trials are conducted to determine feasibility or to collect information that would inform the design of a larger definitive trial. Clear progression criteria are required to determine if a definitive or main trial is feasible and how it should be designed. We sought to determine how often progression criteria are reported and the associated factors. METHODS: We conducted a methodological review of protocols for pilot randomised trials published in three journals that publish research protocols (BMJ Open, Trials, Pilot and Feasibility Studies), using a PubMed search (2013-2017). We extracted bibliometric information including the country in which the study was conducted, source of funding, type of intervention, use of a primary feasibility outcome, sample size reporting, and justification. We used generalised linear models to determine the factors associated with reporting progression criteria. RESULTS: Our search retrieved 276 articles, of which 49 were not eligible. We included 227 articles. Overall, 45/227 (19.8%; 95% confidence interval [CI] 14.8-25.6) reported progression criteria. Protocols published in more recent years were significantly associated with higher odds of reporting progression criteria (adjusted odds ratio [aOR] 1.40; 95% CI 1.03-1.92; p = 0.034). Pilot trials from Europe (aOR 0.19; 95% CI 0.08-0.48; p < 0.001) and the rest of the world (aOR 0.05; 95% CI 0.01-0.18; p < 0.003) compared to North America were significantly associated with lower odds of reporting progression criteria. Journal, source of funding, sample size, intervention type, and having a primary outcome related to feasibility were not significantly associated with reporting progression criteria. CONCLUSION: Progression criteria are not often explicitly stated in protocols of pilot trials leaving room for varied interpretation of findings. The development of formal guidance for progression criteria in protocols of pilot trials is warranted.