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1.
Hand (N Y) ; : 15589447241235344, 2024 Mar 16.
Article in English | MEDLINE | ID: mdl-38491834

ABSTRACT

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.

2.
J Plast Reconstr Aesthet Surg ; 91: 399-406, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38461624

ABSTRACT

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.


Subject(s)
Logistic Models , Humans , Databases, Factual , Clinical Trials as Topic
3.
RSC Adv ; 14(8): 5351-5369, 2024 Feb 07.
Article in English | MEDLINE | ID: mdl-38348297

ABSTRACT

Owing to the fact that the detection limit of already existing sensor-devices is below 100% efficiency, the use of 3D nanomaterials as detectors and sensors for various pollutants has attracted interest from researchers in this field. Therefore, the sensing potentials of bare and the impact of Cu-group transition metal (Cu, Ag, Au)-functionalized silicon carbide nanotube (SiCNT) nanostructured surfaces were examined towards the efficient detection of NO2 gas in the atmosphere. All computational calculations were carried out using the density functional theory (DFT) electronic structure method at the B3LYP-D3(BJ)/def2svp level of theory. The mechanistic results showed that the Cu-functionalized silicon carbide nanotube surface possesses the greatest adsorption energies of -3.780 and -2.925 eV, corresponding to the adsorption at the o-site and n-site, respectively. Furthermore, the lowest energy gap of 2.095 eV for the Cu-functionalized surface indicates that adsorption at the o-site is the most stable. The stability of both adsorption sites on the Cu-functionalized surface was attributed to the small ellipticity (ε) values obtained. Sensor mechanisms confirmed that among the surfaces, the Cu-functionalized surface exhibited the best sensing properties, including sensitivity, conductivity, and enhanced adsorption capacity. Hence, the Cu-functionalized SiCNT can be considered a promising choice as a gas sensor material.

4.
Plast Surg (Oakv) ; 31(2): 126-131, 2023 May.
Article in English | MEDLINE | ID: mdl-37180341

ABSTRACT

Background: Plastic surgeons treat a large volume of patients with upper limb morbidity resulting from intravenous drug use. The use of motivational interviewing by health care providers has demonstrated effectiveness in eliciting behavioral change, leading to improved health outcomes. This paper aims to explore the concept and process of motivational interviewing and its role in facilitating behavior change in the plastic surgery setting. Methods: The authors reviewed the literature on motivational interviewing in various health care settings. Results: Motivational interviewing, first developed in the field of psychology, has demonstrated effectiveness in facilitating behavior change in various clinical contexts, including brief clinical encounters. Using motivational interviewing guides the patient as they move through the stages of readiness for change in dealing with unhealthy behaviors. The authors demonstrate these techniques in a supplemental instructional video. Conclusions: Motivational interviewing is an evidence-based method for facilitating behavior change. All plastic surgeons should be prepared to use this person-centred counselling method in clinical practice.


Contexte: Les chirurgiens plastiques traitent un grand nombre de patients présentant une morbidité des membres supérieurs liée à l'utilisation de drogues intraveineuses. Le recours à un entretien motivationnel par des prestataires de soins de santé a montré son efficacité pour induire un changement de comportement aboutissant à un meilleur état de santé. Cet article vise à étudier le concept et le processus de l'entretien de motivation, ainsi que son rôle dans la facilitation du changement de comportement dans le cadre de la chirurgie plastique. Méthodes: Les auteurs ont analysé les publications sur les entretiens motivationnels dans différents contextes de soins de santé. Résultats: L'entretien de motivation, tout d'abord développé dans le domaine de la psychologie, a fait la démonstration de son efficacité pour faciliter les changements de comportement dans des contextes cliniques variés, y compris de courtes rencontres cliniques. L'utilisation de l'entretien de motivation guide le patient dans son parcours à travers les stades de préparation pou un changement envers des comportements malsains. Les auteurs démontrent ces techniques dans une vidéo de formation supplémentaire. Conclusions: La technique d'entrevue motivationnelle est une méthode basée sur des faits probants pour faciliter le changement de comportement. Tous les chirurgiens plastiques devraient être préparés à utiliser cette méthode de conseils centrée sur la personne du patient en pratique clinique.

5.
Jpn J Clin Oncol ; 53(6): 489-493, 2023 Jun 01.
Article in English | MEDLINE | ID: mdl-36946321

ABSTRACT

BRIEF ABSTRACT: This is a protocol to assess feasibility of conducting a prospective cohort study comparing local flaps versus skin grafts for surgical excision of skin cancer from the face. INTRODUCTION: Skin cancer is the most common malignancy worldwide and the face is one of the most common locations of occurrence. Surgical excision is the most popular treatment for small lesions of the face. Defects can be reconstructed using local flaps or skin grafts. There is a paucity of literature evaluating outcomes after skin cancer surgery from the patient's perspective using valid measurement tools. The purpose of this study is to assess the feasibility of conducting a prospective observational cohort study. The primary outcomes include recruitment rates, eligibility rate, compliance of intervention and rate of completion of the primary outcome (FACE-Q scales) at 3 months. Secondary outcomes include examining patient characteristic and FACE-Q score differences between local flaps to skin grafts and adverse events. METHODS AND ANALYSIS: This study is a prospective cohort study consisting of an anticipated 30 patients aged ≥18 years. The study population will consist of a consecutive sample of non-melanoma facial skin cancer patients undergoing a skin graft or local flap. Patients will be followed and evaluated with the FACE-Q questionnaire at 2 weeks, 3 months, 6 months and 1 year post-operation. The following criteria will determine success: patients who meet eligibility criteria >70%; recruitment rate >70%; compliance with intervention >90%; rate of completion of full-scale prospective study primary outcome (FACE-Q at 3 months) >80%; retention rate at 6-month follow-up visit >70%. DISCUSSION: The findings of this study will be used to guide the sample size calculation for a future, large-scale prospective study.Trial registration: ClinicalTrials.gov (NCT04842279).


Subject(s)
Skin Neoplasms , Skin Transplantation , Humans , Adolescent , Adult , Prospective Studies , Feasibility Studies , Surgical Flaps/surgery , Skin Neoplasms/surgery , Observational Studies as Topic
6.
Hand (N Y) ; : 15589447231160211, 2023 Mar 23.
Article in English | MEDLINE | ID: mdl-36960481

ABSTRACT

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.

9.
Plast Reconstr Surg ; 150(6): 1202e-1213e, 2022 12 01.
Article in English | MEDLINE | ID: mdl-36103650

ABSTRACT

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.


Subject(s)
Breast Neoplasms , Mammaplasty , Humans , Female , Mastectomy/adverse effects , Breast Neoplasms/surgery , Breast Neoplasms/radiotherapy , Quality of Life , Patient Satisfaction , Mammaplasty/psychology , Sensation
10.
Plast Surg (Oakv) ; 30(3): 233-237, 2022 Aug.
Article in English | MEDLINE | ID: mdl-35990397

ABSTRACT

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.

11.
Healthc Manage Forum ; 35(3): 130-134, 2022 May.
Article in English | MEDLINE | ID: mdl-35389294

ABSTRACT

Public health data have demonstrated disproportionate COVID-19 morbidity and mortality among racialized populations. However, limited hospital data may prevent research into racial disproportionality among inpatients. We conducted a retrospective cross-sectional study of patients admitted with or without COVID-19 to an Ontario tertiary hospital between March and October 2020 to determine the percentage of inpatients with a formal race or ethnicity assessment in their medical record. The COVID-19 group included inpatients with concurrent COVID-19 positivity; the reference group included a random sample of General Medicine inpatients without COVID-19. We reviewed 80 patients with COVID-19 and 80 patients without COVID-19. Formal ethnicity assessments were recorded among 44% of the COVID-19 group and 49% of the reference group. Race and ethnicity data collection was less than 50% among inpatients with and without COVID-19 in one Ontario hospital. Adequate data collection is necessary to study racial health disparities in the hospital setting.


Subject(s)
COVID-19 , COVID-19/epidemiology , Cross-Sectional Studies , Data Collection , Humans , Inpatients , Retrospective Studies
12.
CMAJ Open ; 10(1): E19-E26, 2022.
Article in English | MEDLINE | ID: mdl-35042691

ABSTRACT

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.


Subject(s)
Drug Utilization/statistics & numerical data , Neoplasms , Palliative Care , Suicide, Assisted/statistics & numerical data , Aged , Anesthetics, Intravenous/administration & dosage , Anesthetics, Intravenous/adverse effects , Canada/epidemiology , Cross-Sectional Studies , Drug Dosage Calculations , Female , Humans , Male , Neoplasms/mortality , Neoplasms/therapy , Palliative Care/methods , Palliative Care/statistics & numerical data , Patient Care Management/methods , Time-to-Treatment
14.
Pilot Feasibility Stud ; 7(1): 211, 2021 Nov 30.
Article in English | MEDLINE | ID: mdl-34847957

ABSTRACT

BACKGROUND: Pilot studies are essential in determining if a larger study is feasible. This is especially true when targeting populations that experience stigma and may be difficult to include in research, such as people with HIV. We sought to describe how pilot studies have been used to inform HIV clinical trials. METHODS: We conducted a methodological study of pilot studies of interventions in people living with HIV published until November 25, 2020, using Medline, Embase, and Cochrane Controlled Register of Trials (CENTRAL). We extracted data on their nomenclature, primary objective, use of progression criteria, sample size, use of qualitative methods, and other contextual information (region, income, level, type of intervention, study design). RESULTS: Our search retrieved 10,597 studies, of which 248 were eligible. The number of pilot studies increased steadily over time. We found that 179 studies (72.2%) used the terms "pilot" or "feasibility" in their title, 65.3% tested feasibility as a primary objective, only 2% used progression criteria, 23.9% provided a sample size estimation and only 30.2% used qualitative methods. CONCLUSIONS: Pilot studies are increasingly being used to inform HIV research. However, the titles and objectives are not always consistent with piloting. The design and reporting of pilot studies in HIV could be improved.

15.
Can Fam Physician ; 67(11): 843-849, 2021 11.
Article in English | MEDLINE | ID: mdl-34772714

ABSTRACT

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.


Subject(s)
Breast Neoplasms , Colorectal Neoplasms , Emigrants and Immigrants , Uterine Cervical Neoplasms , Breast Neoplasms/diagnosis , Colorectal Neoplasms/diagnosis , Early Detection of Cancer , Female , Humans , Mass Screening , Ontario/epidemiology , Uterine Cervical Neoplasms/diagnosis , Uterine Cervical Neoplasms/prevention & control
16.
BMJ Open ; 11(10): e039462, 2021 10 25.
Article in English | MEDLINE | ID: mdl-34697107

ABSTRACT

BACKGROUND: To evaluate the definition of HIV virological outcomes in the literature and factors associated with outcomes and missing outcome data. METHODS: We conducted a methodological review of HIV RCTs using a search (2009-2019) of PubMed, Embase and the Cochrane Central Register of Controlled Trials.Only full-text, peer-reviewed, randomised controlled trials (RCTs) that measured virological outcomes in people living with HIV, and published in English were included.We extracted study details and outcomes. We used logistic regression to identify factors associated with a viral threshold ≤50 copies/mL and linear regression to identify factors associated with missing outcome data. RESULTS: Our search yielded 5847 articles; 180 were included. A virological outcome was the primary outcome in 73.5% of studies. 89 studies (49.4%) used virological success. The remaining used change in viral load (VL) (33 studies, 18.3%); virological failure (59 studies, 32.8%); or virological rebound (9 studies, 5.0%). 96 studies (53.3%) set the threshold at ≤50 copies/mL; and 33.1% used multiple measures.Compared with government and privately funded studies, RCTs with industry funding (adjusted OR 6.39; 95% CI 2.15 to 19.00; p<0.01) were significantly associated with higher odds of using a VL threshold of ≤50 copies/mL. Publication year, intervention type, income level and number of patients were not associated with a threshold of ≤50 copies/mL. Trials with pharmacological interventions had less missing data (ß=-11.04; 95% CI -20.02 to -1.87; p=0.02). DISCUSSION: Country source of funding was associated with VL threshold choice and studies with pharmacological interventions had less missing data, which may in part explain heterogeneous virological outcomes across studies. Multiple measures of VL were not associated with missing data. The development of formal guidelines on virological outcome reporting in RCTs is needed.


Subject(s)
HIV Infections , HIV Infections/drug therapy , Humans , Randomized Controlled Trials as Topic , Viral Load
18.
Pilot Feasibility Stud ; 6(1): 164, 2020 Oct 29.
Article in English | MEDLINE | ID: mdl-33292715

ABSTRACT

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.

19.
Shoulder Elbow ; 12(5): 303-314, 2020 Oct.
Article in English | MEDLINE | ID: mdl-33123220

ABSTRACT

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.

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