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1.
Aesthet Surg J ; 2024 May 22.
Artigo em Inglês | MEDLINE | ID: mdl-38775083

RESUMO

A clinical practice guideline (CPG) recommended not to use drains in breast reduction. This CPG was based on 3 randomized controlled trials (RCTs). The objective of this review was to double-check the methodological quality of the three RCTs. These RCTs were critically appraised using a) the Users' guide to RCT assessment for methodological quality, b) the CONSORT guideline for reporting quality, and c) the Cochrane risk of bias tool 2 (RoB 2) for risk of bias. Weaknesses were identified in all assessments for the three RCTs. Items with the poorest adherence in the User's guide to RCT included: "Were patients stratified?", "Was follow-up complete?", and "Were all clinically important outcomes considered?". The overall adherence to the CONSORT Reporting Checklist across all studies was moderate with 40.0%, 62.1% and 48.3% adherence. All 3 RCTs had a similar low to moderate risk of bias, with no areas with a high risk of bias. None of the studies took into consideration a single critical outcome (such as major hematoma) and the outcome's minimally important difference as the basis for the sample size and power calculation of the study. All three RCTs additionally lacked clear reporting of treatment effect sizes or precision of estimates. Our re-examination of the evidence questions the recommendation of the CPG. We believe that the recommendation should have been "we remain uncertain whether drains in breast reduction have a salutary effect". As such, we recommend that a methodologically robust RCTs be conducted to answer this question.

2.
Aesthet Surg J ; 43(9): NP674-NP686, 2023 08 17.
Artigo em Inglês | MEDLINE | ID: mdl-37162009

RESUMO

BACKGROUND: The FACE-Q Aesthetics module is a validated patient-reported outcome measure (PROM) that evaluates perspectives on facial aesthetic treatments. Improper administration and poor study methodology can compromise the validity and interpretation of this PROM. OBJECTIVES: This systematic review sought to evaluate the administration and scoring of the FACE-Q Aesthetics scales within the literature. METHODS: A search of Ovid Medline, Embase, Cochrane, and Web of Science was performed on December 20, 2022, with the assistance of a health-research librarian (CRD42022383676). Studies that examined facial aesthetic interventions using the FACE-Q Aesthetics module as a primary or secondary outcome measure were included for analysis. RESULTS: There were 114 studies included. The Face Overall (n = 52, 45.6%), Psychological (n = 45, 39.4%), and Social (n = 43, 37.7%) scales were most frequently reported. Errors in FACE-Q administration were identified in 30 (26.3%) studies. The most common error was the presentation of raw ordinal scores rather than the converted Q score (n = 23). Most studies reported a time horizon for their primary analysis (n = 76, 66.7%); however, only 4 studies provided a rationale for this selection. Sample size calculations for the primary outcome were rarely performed (n = 9, 7.9%). CONCLUSIONS: There continues to be limitations in PROM administration and the quality of articles that report FACE-Q Aesthetic scale data. The authors suggest that future investigators using the FACE-Q refer to the User's Guide regarding administration and scoring of this scale, report a rationale for the study time horizon, and provide an a priori sample size calculation for the primary outcome of interest.


Assuntos
Qualidade de Vida , Humanos , Estética , Psicometria
5.
J Hand Surg Am ; 40(1): 8-14, 2015 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-25534832

RESUMO

PURPOSE: To measure the desirable health outcome, termed utility, and the expected quality-adjusted life years (QALYs) gained with hand composite tissue allotransplantation (CTA) using hand amputee patients and the general public. METHODS: Using the standard gamble (SG) and time trade-off (TTO) techniques, utilities were obtained from 30 general public participants and 12 amputee patients. The health utility and net QALYs gained or lost with transplantation were computed. A sensitivity analysis was conducted to account for the effects of lifelong immunosuppression on the life expectancy of transplant recipients. Higher scores represent greater utility. RESULTS: Hand amputation mean health utility as measured by the SG and TTO methods, respectively, was 0.72 and 0.80 for the general public and 0.69 and 0.70 for hand amputees. In comparison, hand CTA mean health utility was 0.74 and 0.82 for the general public and 0.83 and 0.86 for amputees. Hand CTA imparted an expected gain of 0.9 QALYs (SG and TTO) in the general public and 7.0 (TTO) and 7.8 (SG) QALYs in hand amputees. A loss of at least 1.7 QALYs was demonstrated when decreasing the life expectancy in the sensitivity analysis in the hand amputee group. CONCLUSIONS: Hand amputee patients did not show a preference toward hand CTA with its inherent risks. With this procedure being increasingly adopted worldwide, the benefits must be carefully weighed against the risks of lifelong immunosuppressive therapy. This study does not show clear benefit to advocate hand CTA.


Assuntos
Transplante de Mão , Mãos/cirurgia , Anos de Vida Ajustados por Qualidade de Vida , Adolescente , Adulto , Amputação Cirúrgica , Amputados , Técnicas de Apoio para a Decisão , Feminino , Transplante de Mão/efeitos adversos , Nível de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Medição de Risco , Resultado do Tratamento , Adulto Jovem
6.
Hand (N Y) ; : 15589447231222517, 2024 Jan 20.
Artigo em Inglês | MEDLINE | ID: mdl-38243708

RESUMO

Trigger finger release (TFR) is a common hand surgery, historically performed using a tourniquet. Recently, wide-awake local anesthesia no tourniquet (WALANT) has gained popularity due to ostensible advantages such as improved patient pain, satisfaction, lower rate of complications, and decreased cost. This systematic review compares outcomes of WALANT for TFR with local anesthesia with a tourniquet (LAWT). MEDLINE, Embase, CINAHL, Web of Science, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov were searched. All English-language peer-reviewed randomized and observational studies assessing TFR in adults were included. Quality of evidence was assessed with the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system. Eleven studies (4 randomized controlled trials, 7 observational) including 1233 patients were identified. In the WALANT group, pain on injection was statistically nonsignificantly lower (mean difference [MD]: -1.69 points, 95% confidence interval [CI] = -4.14 to 0.76, P = .18) and postoperative pain was statistically lower in 2 studies. Patient and physician satisfaction were higher and analgesic use was lower in WALANT. There were no significant differences between groups for functional outcomes or rates of adverse events. Preoperative time was longer (MD: 26.43 minutes, 95% CI = 15.36 to 37.51, P < .01), operative time similar (MD: -0.59 minutes, 95% CI = -2.37 to 1.20, P = .52), postoperative time shorter (MD: -27.72 minutes, 95% CI = -36.95 to -18.48, P < .01), and cost lower (MD: -52.2%, 95% CI = -79.9% to -24.5%) in WALANT versus LAWT. The GRADE certainty of evidence of these results ranges from very low to low. This systematic review does not confirm superiority of WALANT over LAWT for TFR due to moderate to high risk of bias of included studies; further robust trials must be conducted.

7.
Hand (N Y) ; : 15589447231225271, 2024 Jan 24.
Artigo em Inglês | MEDLINE | ID: mdl-38265010

RESUMO

No formal review of qualitative research in hand surgery has been previously performed. The primary objective of this study was to evaluate the reporting quality of hand surgery qualitative research with the Standards for Reporting Qualitative Research (SRQR), a 21-item checklist. The secondary objectives were to describe qualitative research in hand surgery by domain, determine differences in reporting quality based on use of a reporting guideline, publication of SRQR and journal of publication, and to identify important outcomes in hand surgery conditions. Fifty-five studies were included from MEDLINE, Embase, PsycINFO, and Emcare. The median SRQR score was 16. The lowest reported sections were context, data collection methods, and data analysis. Qualitative research was found in multiple domains of hand surgery. There was a significant difference between papers that used a reporting guideline and studies published after the publication of the SRQR. Clinical/medical/basic science journals had the highest median SRQR score. Outcomes identified were pain for carpal tunnel syndrome and pain, function, unintentional harm, recurrence, and recovery time for Dupuytren disease. To further improve reporting quality in hand surgery qualitative research, we recommend that investigators ensure they provide rationale for their methodology and become familiar with the SRQR guidelines.

8.
J Plast Reconstr Aesthet Surg ; 95: 231-238, 2024 Jun 07.
Artigo em Inglês | MEDLINE | ID: mdl-38936334

RESUMO

BACKGROUND: The test-retest (TRT) reliability of FACE-Q Aesthetic scales is yet to be assessed. The aim of this study was to establish the TRT reliability of 17 FACE-Q Aesthetic scales and determine the smallest detectable change (SDC) that can be identified using these scales. METHODS: Data were collected from an online international sample platform (Prolific). Participants ≥20 years old, who had been to a dermatologist or plastic surgeon for a facial aesthetic treatment within the past 12 months were asked to provide demographic and clinical information and complete an online REDcap survey consisting of 17 FACE-Q Aesthetic scales. Participants were asked if they would be willing to complete the survey again in 7 days. Only the participants who reported no important change in the scale construct and completed the retest within 14 days were included. RESULTS: A total of 342 unique participants completed the TRT survey. The mean age of the sample was 36.6 (±11.5) years, and 82.4% were female. With outlier data removed, all FACE-Q scales demonstrated an intraclass correlation coefficient >0.70 indicating "good" TRT reliability. The standard error of measurement for the included scales ranged from 3.37 to 11.87, corresponding to a range of SDCgroup from 0.95 to 3.23 and SDCind from 9.34 to 32.91. CONCLUSION: All included FACE-Q scales demonstrated sufficient TRT reliability and stability overall after the outlier data were removed. Moreover, the authors calculated the values for the SDC for these scales.

9.
Aesthet Surg J ; 33(2): 189-200, 2013 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-23388642

RESUMO

BACKGROUND: There is ongoing debate over which surgical technique is the safest for brow elevation. OBJECTIVES: The authors outline complication rates for a variety of open and endoscopic browlift techniques based on the results of a literature review. METHODS: The following databases were searched to capture relevant studies: MEDLINE, EMBASE, CINAHL, LILACS, Web of Science, Cochrane Libraries, controlled-trials.com, and clinicaltrials.gov. Eighty-two studies met the inclusion criteria. Assuming between-study heterogeneity due to the limitations and biases inherent to case series, a random-effects model was used to calculate weighted proportions. Pooled weighted proportions with 95% confidence intervals were determined. RESULTS: All open and endoscopic procedures are associated with a variety of complications. Unacceptable scarring and paresthesia are the most common complications among all surgical browlifts. For anterior hairline incision with subcutaneous dissection, alopecia occurred in 8.5% of patients, paresthesia in 5.4%, unacceptable scarring in 2.1%, and skin necrosis in 1.8%. For coronal incision with subgaleal dissection, unacceptable scarring occurred in 3.6% of patients, hematoma in 0.5%, and infection in 0.2%. Endoscopic techniques with subperiosteal dissection had the highest complication rates: 6.2% for paresthesia, 3.6% for asymmetry, 3.0% for alopecia, and 2.7% for lagophthalmos. CONCLUSIONS: Although complication rates vary with respect to incision site and plane of dissection, endoscopic techniques are associated with a larger variety of complications than open approaches. The findings should be interpreted with caution due to the limitations inherent to a case series. A well-designed comparative study is needed to evaluate the "true" rate of complications among the various browlift techniques.


Assuntos
Endoscopia/efeitos adversos , Complicações Pós-Operatórias/epidemiologia , Ritidoplastia/efeitos adversos , Cicatriz/epidemiologia , Cicatriz/etiologia , Endoscopia/métodos , Humanos , Parestesia/epidemiologia , Parestesia/etiologia , Complicações Pós-Operatórias/etiologia , Rejuvenescimento , Ritidoplastia/métodos
10.
Plast Surg (Oakv) ; 31(3): 306-310, 2023 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-37654536

RESUMO

Credible clinical research is a precondition of evidence-based surgery. If clinical research is not conducted and reported properly, such research can be unreliable, unclear, and misleading. Our journal, Plastic Surgery, aims to improve its quality and thus enhance interest, submissions, and readership. To do so, we must ensure that the articles published in our journal align with these goals. This article guides future clinical research contributors, how to design, conduct and report valuable and reliable research. Readers are informed how to choose a title and keywords that properly reflect the content of the article. The proper organization of a manuscript, and the information that goes into each section is described. Valuable tools like the EQUATOR Network Guidelines, the FINER Criteria and the PICOT Format are described for the reader. These resources help formulate a proper research question and ensure transparency in reporting. Commonly used study designs, and the research questions they answer are presented. This ensures that those engaged in research are choosing the right study design for their research. We outline the statistical information that should be presented in the Methods section and differentiate between the content that should be found in the Results and Discussion sections. As Plastic Surgery strives to publish high-quality, reliable research, it is by the standards presented in this article that we will judge all manuscripts submitted for publication.


Une recherche clinique crédible est une condition préalable à une chirurgie basée sur des données probantes. Si la recherche clinique n'est pas menée et rapportée correctement, cette recherche peut être non fiable, peu claire et trompeuse. Notre journal, Plastic Surgery a pour objectif d'améliorer sa qualité et par conséquent d'améliorer l'intérêt, les soumissions et le lectorat. Pour y parvenir, nous devons nous assurer que les articles qui y sont publiés sont conformes à ces objectifs. Le présent article vise à guider les futurs contributeurs à la recherche clinique sur la façon de concevoir, mener et rapporter une recherche de valeur et fiable. Les lecteurs sont informés sur comment choisir un titre et des mots-clés qui sont le reflet correct du contenu de l'article. La bonne organisation d'un manuscrit et l'information entrant dans chaque section sont décrites. Des outils intéressants tels que les lignes directrices du réseau EQUATOR, les critères FINER et le format PICOT sont décrits pour le lecteur. Ces ressources aident à formuler une question de recherche appropriée et à assurer la transparence dans la présentation des résultats. Les plans d'études souvent utilisés et les questions auxquelles la recherche répond sont présentés. Cela garantit à ceux qui s'engagent dans la recherche qu'ils choisissent le bon plan d'étude pour leur travail. Nous soulignons les renseignements statistiques qui devraient figurer dans la section Méthodes en les distinguant des résultats qui devraient se trouver dans les sections Résultats et Discussion. Alors que Plastic Surgery s'efforce de publier une recherche fiable et de grande qualité, c'est en fonction des normes présentées dans cet article que nous jugerons tous les manuscrits soumis pour publication.

11.
Plast Surg (Oakv) ; 31(4): 401-407, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37915342

RESUMO

Background: Valuable research requires contribution from many experts; however, the "et al." truncation often keeps all individuals from being acknowledged. The adoption of a new citation rule (list all authors up to 30, followed by et al.) would allow more authors to be acknowledged. The purpose of this study was to (1) explore the citation styles of the top 10 Plastic Surgery, Surgery, and Medical journals and (2) compare the number of extra pages required, and the number of additional authors acknowledged when the "new rule" is implemented. Methods: The top 10 journals in Plastic Surgery, Surgery, and Medicine were identified. The citation styles used in each of the journals were reviewed and the reference list from a recently published article was extracted. The original reference list was used to create an Extended Reference List using the new rule. Results: Most journals implemented "et al." when seven or more authors were listed. Ten articles required additional pages to accommodate the Extended Reference List. When the "et al." truncation was introduced after 30 authors, there was an almost 100% chance of all authors being included. The adoption of this rule rarely resulted in the need for additional pages, especially within Plastic Surgery. Conclusions: In a time of electronic publishing, where constraints such as article and journal page length should not be important factors, all authors should be recognized. The use of the "et al." truncation should be discouraged by all individuals involved in the production and publication of research. Scenario You are asked by the Editor-in-Chief of your specialty's journal to review an article in your area of expertise. You gladly accept the task. One of the questions you are required to answer in your review is whether the authors of the submitted manuscript have missed any important articles in their references. As you are the recognized expert in this field, you glance at the references to see if a key article you published 3 years earlier has been included. The first author of that article was a junior resident in your service and the research was done under your supervision. To their credit, the authors included the said article, but you are dismayed that the reference does not include your name. It includes only the names of the first three authors, all junior residents in your service. Your name, and the names of many others, are lost in the et al. truncation.


Contexte: Une recherche intéressante nécessite la contribution de nombreux experts; cependant, le raccourci « et coll. ¼ empêche souvent la reconnaissance de toutes les personnes. L'adoption d'une nouvelle règle de référencement (énumérer tous les auteurs jusqu'à 30, suivi de et coll.) permettrait de reconnaître davantage d'auteurs. L'objectif de cette étude était de 1) explorer les styles de référence des 10 principaux journaux de chirurgie plastique, chirurgie et médecine, et 2) comparer le nombre de pages supplémentaires requises et le nombre d'auteurs supplémentaires identifiés quand la « nouvelle règle ¼ est appliquée. Méthodes: Les 10 principaux journaux de chirurgie plastique, chirurgie et médecine ont été identifiés. Les styles de référencement utilisés dans chacun de ces journaux ont été revus et la liste des références d'un article récemment publié a été extraite. La liste de références originale a servi à créer une liste de références étendue selon la nouvelle règle. Résultats: La majorité des journaux a utilisé « et coll. ¼ quand 7 auteurs ou plus étaient cités. Dix articles ont nécessité des pages supplémentaires pour accueillir la liste de références étendue. Quand le raccourci « et coll. ¼ était introduit avec le seuil de 30 auteurs, il y avait pratiquement 100 % de chances d'avoir inclus tous les auteurs. L'adoption de cette règle a rarement entraîné le besoin de pages supplémentaires, en particulier dans Plastic Surgery. Conclusions: À l'époque de l'édition électronique où des contraintes telles que la longueur d'un article et le nombre de pages ne devraient pas être des facteurs importants, tous les auteurs devraient être reconnus. L'utilisation du raccourci « et coll. ¼ devrait être découragée par tous ceux qui sont impliqués dans la production et la publication de recherches.

12.
Plast Surg (Oakv) ; 31(3): 236-246, 2023 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-37654529

RESUMO

Purpose: There is a lack of scientific consensus on the best arthroplasty implant option for proximal interphalangeal joint (PIPJ) arthritis, due to diversity in outcome reporting and measurement methods. The development of a standardized core outcome set (COS) and standard outcome measures could mitigate this issue. This study catalogs the reported outcomes and outcome measures found in PIPJ arthroplasty studies, which can be used in the first step of developing a COS. Methods: A database search of MEDLINE, EMBASE, and Web of Science (January 1, 2010, to March 10, 2021) was performed to retrieve studies that reported outcomes of the 3 most common primary PIPJ arthroplasty implants: silicone, pyrocarbon, and metal-polyethylene. The primary objectives of this study include reported outcomes and outcome measures. Secondary objectives include clinimetric properties of outcome measures, study design, and implant types. Results: Fifty articles met inclusion criteria. Of the included studies, 41 (82%) were case series, 8 (16%) were cohort studies, and 1 (2%) was a randomized control trial. Thirty-three unique outcomes were identified. Fifteen (46%) outcomes were clinician-reported and 26 (79%) were patient-reported. Eighteen unique outcome measures were identified. Of the outcome measures, 15 (83%) were patient-reported, 1 (6%) was clinician-reported, and 2 (11%) were reported by both patients and clinicians. Conclusions: Substantial heterogeneity was found in reported outcomes and outcome measures across studies evaluating PIPJ arthroplasty, impeding knowledge translation. The development of a COS for PIPJ arthroplasty is necessary to help compare and pool data across studies, and advance scientific knowledge.


Objectif: Il manque de consensus scientifique sur la meilleure option d'arthroplastie pour l'arthrite de l'articulation interphalangienne proximale (IPP) en raison de la diversité des résultats décrits et des méthodes de mesure. L'élaboration d'un ensemble standardisé de résultats de base et de mesures standardisées des résultats pourrait contribuer à limiter ce problème. Cette étude dresse un catalogue des résultats rapportés et des mesures de résultats trouvés dans les études sur l'arthroplastie des IPP; celui-ci peut servir de première étape à l'élaboration d'un ensemble standardisé de résultats de base. Méthodes: Une recherche a été menée dans les bases de données MEDLINE, EMBASE et Web of Science sur la période du 1er janvier 2010 au 10 mars 2021 pour extraire les études qui rapportaient des résultats avec les 3 implants pour arthroplastie des IPP les plus souvent utilisés : silicone, pyrocarbone et métal-polyéthylène. Les objectifs principaux de cette étude incluent les résultats rapportés et les mesures des résultats. Les objectifs secondaires sont, notamment, les propriétés clinimétriques des mesures des résultats, la conception des études et les types d'implants. Résultats: Cinquante articles satisfaisaient les critères d'inclusion. Parmi les études incluses, 41 (82%) étaient des séries de cas, 8 (16%) étaient des études de cohortes et 1 (2%) était un essai randomisé. Trente-trois résultats uniques ont été identifiés. Quinze résultats (46%) étaient rapportés par le clinicien et 26 (79%) ont été déclarés par les patients. Dix-huit mesures uniques de résultats ont été identifiées. Parmi les mesures de résultats, 15 (83%) ont été déclarées par les patients, 1 (6%) a été déclarée par un clinicien et 2 (11%) ont été déclarées à la fois par les patients et les cliniciens. Conclusions: Une hétérogénéité importante a été constatée dans les résultats rapportés et dans les mesures de résultats dans les études évaluant l'arthroplastie des IPP, entravant leur traduction en connaissances utiles. L'élaboration d'un ensemble standardisé de résultats de base s pour les IPP est nécessaire pour comparer et regrouper les données entre les études et donc pour faire avancer les connaissances scientifiques.

13.
J Plast Reconstr Aesthet Surg ; 85: 72-85, 2023 10.
Artigo em Inglês | MEDLINE | ID: mdl-37473643

RESUMO

BACKGROUND: Patient-reported outcome measures (PROMs) quantify patient perspectives to measure outcomes that matter to patients. The aim of this study was to assess the reporting of appropriateness and quality of PROM selection in plastic surgery randomized controlled trials (RCTs). METHODS: MEDLINE, Embase, and CENTRAL were searched from January 1, 2000, to June 5, 2022, to identify published RCTs within the plastic surgery literature. Included studies were categorized as follows: 1) a clearly defined patient-reported primary outcome; 2) a primary outcome could be inferred; or 3) no clear or implied primary outcome. The Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) database was consulted to assess the available literature on the PROMs. RESULTS: There were 130 plastic surgery RCTs identified. Of the 43 studies with a clear or inferred primary outcome, the percentage of studies that commented with supporting references on the PROM's appropriateness for the population, disease/condition, and outcome were 20.9% (n = 9/43), 18.6% (n = 8/43), and 27.9% (n = 12/43), respectively. The percentage of studies that commented on the PROM's validity, reliability, and responsiveness with supporting references were 34.9% (n = 15/43), 14.0% (n = 6/43), and 11.7% (n = 5/43), respectively. There were 21 unique PROMs identified; 28.6% (n = 6/21) were available in the COSMIN database. CONCLUSION: The majority of plastic surgery RCTs assessing patient-reported primary outcomes lack transparency surrounding PROM selection and quality. We recommend investigators conducting plastic surgery clinical research report explicitly why they used a particular PROM and support its appropriateness and psychometric properties with supporting references. Finally, they should familiarize themselves with the COSMIN initiative.


Assuntos
Procedimentos de Cirurgia Plástica , Cirurgia Plástica , Humanos , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Medidas de Resultados Relatados pelo Paciente
14.
EClinicalMedicine ; 65: 102283, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37877001

RESUMO

Background: Interventional trials that evaluate treatment effects using surrogate endpoints have become increasingly common. This paper describes four linked empirical studies and the development of a framework for defining, interpreting and reporting surrogate endpoints in trials. Methods: As part of developing the CONSORT (Consolidated Standards of Reporting Trials) and SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) extensions for randomised trials reporting surrogate endpoints, we undertook a scoping review, e-Delphi study, consensus meeting, and a web survey to examine current definitions and stakeholder (including clinicians, trial investigators, patients and public partners, journal editors, and health technology experts) interpretations of surrogate endpoints as primary outcome measures in trials. Findings: Current surrogate endpoint definitional frameworks are inconsistent and unclear. Surrogate endpoints are used in trials as a substitute of the treatment effects of an intervention on the target outcome(s) of ultimate interest, events measuring how patients feel, function, or survive. Traditionally the consideration of surrogate endpoints in trials has focused on biomarkers (e.g., HDL cholesterol, blood pressure, tumour response), especially in the medical product regulatory setting. Nevertheless, the concept of surrogacy in trials is potentially broader. Intermediate outcomes that include a measure of function or symptoms (e.g., angina frequency, exercise tolerance) can also be used as substitute for target outcomes (e.g., all-cause mortality)-thereby acting as surrogate endpoints. However, we found a lack of consensus among stakeholders on accepting and interpreting intermediate outcomes in trials as surrogate endpoints or target outcomes. In our assessment, patients and health technology assessment experts appeared more likely to consider intermediate outcomes to be surrogate endpoints than clinicians and regulators. Interpretation: There is an urgent need for better understanding and reporting on the use of surrogate endpoints, especially in the setting of interventional trials. We provide a framework for the definition of surrogate endpoints (biomarkers and intermediate outcomes) and target outcomes in trials to improve future reporting and aid stakeholders' interpretation and use of trial surrogate endpoint evidence. Funding: SPIRIT-SURROGATE/CONSORT-SURROGATE project is Medical Research Council Better Research Better Health (MR/V038400/1) funded.

15.
Plast Reconstr Surg ; 149(3): 453e-464e, 2022 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-35196683

RESUMO

BACKGROUND: Economic evaluations can inform decision-making; however, previous publications have identified poor quality of economic evaluations in surgical specialties. METHODS: Study periods were from January 1, 2006, to April 20, 2020 (methodologic quality) and January 1, 2014, to April 20, 2020 (reporting quality). Primary outcomes were methodologic quality [Guidelines for Authors and Peer Reviewers of Economic Submissions to The BMJ (Drummond's checklist), 33 points; Quality of Health Economic Studies (QHES), 100 points; Consensus on Health Economic Criteria (CHEC), 19 points] and reporting quality (Consolidated Health Economic Evaluation Standards (CHEERS) statement, 24 points). RESULTS: Forty-seven hand economic evaluations were included. Partial economic analyses (i.e., cost analysis) were the most common (n = 34; 72 percent). Average scores of full economic evaluations (i.e., cost-utility analysis and cost-effectiveness analysis) were: Drummond's checklist, 27.08 of 33 (82.05 percent); QHES, 79.76 of 100 (79.76 percent); CHEC, 15.54 of 19 (81.78 percent); and CHEERS, 20.25 of 24 (84.38 percent). Cost utility analyses had the highest methodologic and reporting quality scores: Drummond's checklist, 28.89 of 35 (82.54 percent); QHES, 86.56 of 100 (86.56 percent); CHEC, 16.78 of 19 (88.30 percent); and CHEERS, 20.8 of 24 (86.67 percent). The association (multiple R) between CHEC and CHEERS was strongest: CHEC, 0.953; Drummond's checklist, 0.907; and QHES, 0.909. CONCLUSIONS: Partial economic evaluations in hand surgery are prevalent but not very useful. The Consensus on Health Economic Criteria and Consolidated Health Economic Evaluation Standards should be used in tandem when undertaking and evaluating economic evaluation in hand surgery.


Assuntos
Análise Custo-Benefício/métodos , Mãos/cirurgia , Procedimentos de Cirurgia Plástica/economia , Garantia da Qualidade dos Cuidados de Saúde/métodos , Punho/cirurgia , Análise Custo-Benefício/normas , Humanos , Garantia da Qualidade dos Cuidados de Saúde/normas , Procedimentos de Cirurgia Plástica/normas
16.
Plast Surg (Oakv) ; 30(2): 144-150, 2022 May.
Artigo em Inglês | MEDLINE | ID: mdl-35572080

RESUMO

Background: Predatory journals promise high acceptance rates and quick publication in exchange for a processing fee. As these journals aim to maximize profits, they neglect traditional mechanisms used to ensure a high-quality publication. Unsolicited email invitations are a characteristic of predatory journals that often inundate the inboxes of surgeons. The objective of this study is to use these emails to identify potentially predatory journals in the area of surgery and plastic surgery. Methods: Unsolicited email requests from surgery-related journals were collected over a 3-month period. Journals were evaluated using a modified version of the Rohrich and Weinstein checklist. The average number of "predatory" criteria met by these potentially predatory journals (PPJs) was compared to that of the top open-access plastic surgery journals which were assumed to be non-predatory for the purposes of this study. Results: In total, 437 unsolicited email requests were received. Of these, 92 emails, representing 57 PPJs, were eligible for inclusion. On average, the PPJs met 5 of the 12 "predatory" criteria, compared to less than 1 in the comparison group. Approximately 96% of these emails, or the respective websites, contained obvious spelling or grammatical mistakes; 98% of these emails came from journals not listed on Scopus, Directory of Open Access Journals (DOAJ), and/or Web of Science. Conclusions: Of the journals that sent unsolicited emails, 98% met 2 or more criteria and were deemed to be predatory. If a journal contains grammatical mistakes and is not listed on Scopus, DOAJ, and/or Web of Science, authors should be cautious.


Historique: Les revues prédatrices promettent un taux d'acceptation élevé et une publication rapide en échange de frais de traitement. Puisque ces revues cherchent à optimiser leurs profits, elles omettent les mécanismes habituels garantissant la qualité d'une publication. Les courriels d'invitation non sollicités sont caractéristiques des revues prédatrices, qui inondent souvent la boîte d'accueil des chirurgiens. La présente étude visait à utiliser ces courriels pour repérer d'éventuelles revues prédatrices en chirurgie et en plasturgie. Méthodologie: Les chercheurs ont amassé les courriels non sollicités de revues liées à la chirurgie sur une période de trois mois. Ils ont évalué les revues à l'aide d'une version modifiée de la liste de Rohrich et Weinstein. Ils ont comparé le nombre moyen de critères « de prédation ¼ de ces éventuelles revues prédatrices (ÉRP) à celui de revues de plasturgie en libre accès considérées comme non prédatrices pour les besoins de la présente étude. Résultats: Au total, 437 courriels non sollicités ont été reçus. De ce nombre, 92 courriels, représentant 57 ÉRP, étaient admissibles. En moyenne, les ÉRP respectaient cinq des 12 critères « de prédation ¼, par rapport à moins de un dans le groupe comparatif. Environ 96 % de ces courriels ou des sites Web s'y rapportant contenaient des erreurs orthographiques ou grammaticales évidentes, et 98 % de ces courriels provenaient de revues ne figurant pas dans Scopus, Directory of Open Access Journals (DOAJ) ou Web of Science. Conclusions: Parmi les revues qui envoyaient des courriels non sollicités, 98% respectaient au moins deux critères et étaient considérées comme prédatrices. Les auteurs devraient faire preuve de prudence lorsqu'une revue renferme des erreurs grammaticales et ne figure pas dans Scopus, DOAJ ou Web of Science.

17.
Plast Reconstr Surg ; 149(6): 1224e-1233e, 2022 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-35436246

RESUMO

SUMMARY: In 1906, George Bernard Shaw criticized the medical profession for its lack of science and compassion. Since then, advances in both medical and surgical subspecialties have improved quality of patient care. Unfortunately, the reporting of these advances is variable and is frequently biased. Such limitations lead to false claims, wasted research dollars, and inability to synthesize and apply evidence to practice. It was hoped that the introduction of evidence-based medicine would improve the quality of health care and decrease health dollar waste. For this to occur, however, credible "best evidence"-one of the components of evidence-based medicine-is required. This article provides a framework for credible research evidence in plastic surgery, as follows: (1) stating the clinical research question, (2) selecting the proper study design, (3) measuring critical (important) outcomes, (4) using the correct scale(s) to measure the outcomes, (5) including economic evaluations with clinical (effectiveness) studies, and (6) reporting a study's results using the Enhancing the Quality and Transparency of Health Research, or EQUATOR, guidelines. Surgeon investigators are encouraged to continue improving the science in plastic surgery by applying the framework outlined in this article. Improving surgical clinical research should decrease resource waste and provide patients with improved evidence-based care.


Assuntos
Procedimentos de Cirurgia Plástica , Cirurgiões , Cirurgia Plástica , Análise Custo-Benefício , Medicina Baseada em Evidências , Humanos
18.
J Plast Reconstr Aesthet Surg ; 75(2): 579-585, 2022 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-34785160

RESUMO

PURPOSE: With the increase in the aging population, the level of frailty has become an important metric for assessing preoperative patient risk. Although medical and surgical specialties continue to adopt and standardize the use of frailty instruments, few studies within the plastic surgery literature have utilized such instruments to predict poor postoperative outcomes. The purpose of this article is two-fold: (1) to provide a comprehensive review of the existing frailty instruments and (2) to summarise the existing evidence regarding the role of pre-operative frailty assessments on peri­operative morbidity and mortality in plastic surgery. METHODS: This systematic review was registered a priori on the Open Science Framework (https://osf.io/vfzw8). A computerized database search of Ovid MEDLINE, EMBASE, and Cochrane was performed from database inception to December 13, 2020. All articles that examined the effect of preoperative patient frailty on perioperative morbidity and mortality outcomes following plastic surgery interventions were included for data extraction. RESULTS: From the 11 studies included in this review, ten unique frailty instruments were identified. The modified Frailty Index (mFI) and the Fried Frailty Index (FFI) were the most commonly reported frailty measurement tools; however, the FRAIL scale was the only outcome measure identified to be valid, reliable, and responsive to change. Regardless of the frailty measure used, nearly all studies reported that worse surgical outcomes were associated with a higher patient frailty score. CONCLUSION: There is a strong association between higher frailty scores and worse postoperative outcomes in plastic surgery. The FRAIL scale is a clinimetrically sound frailty instrument that should be used in all patients to assess perioperative risk in plastic surgery.


Assuntos
Fragilidade , Procedimentos de Cirurgia Plástica , Cirurgia Plástica , Idoso , Fragilidade/complicações , Fragilidade/diagnóstico , Fragilidade/epidemiologia , Humanos , Avaliação de Resultados em Cuidados de Saúde , Complicações Pós-Operatórias/epidemiologia , Fatores de Risco
19.
Hand (N Y) ; : 15589447221128982, 2022 Oct 31.
Artigo em Inglês | MEDLINE | ID: mdl-36314350

RESUMO

BACKGROUND: In surgery for Dupuytren disease (DD), palmar fascia specimens are routinely submitted for pathological evaluation. The purpose of this study was to determine the rate of discordant diagnosis and the value of, and costs associated with, routine pathological analysis of palmar fascia tissue extracted in surgery for clinically diagnosed DD. METHODS: All pathology reports for in-house palmar fascia specimens obtained in surgery for clinically diagnosed DD (time period: January 2001 to December 2020) were retrieved from one academic institution. All specimens were classified by a hierarchical free-text string matching algorithm (HFTSMA) and searched for evidence of malignancy. The primary outcome was percentage of concordant, discrepant, and discordant diagnoses. Secondary outcomes included anatomical location and costs. The HFTSMA was used to capture the anatomical location. Costs included professional, laboratory processing, and ancillary fees based on the Ontario Schedule of Benefits. RESULTS: The search retrieved 1323 pathology reports, with 1480 palmar fascia specimens, from 1078 individual patients. By diagnosis, 96.1% of specimens (1422/1480) were concordant (fibromatosis), 3.9% (58/1480) were discrepant (scarring/fibrosis, benign fascia/connective tissue, or other benign findings), and 0% (0/1480) were discordant. The most common location was ring finger (n = 381, 48.7%). Ancillary testing was minimal. The cost per palmar fascia specimen was estimated to be CAD $34.57. The institutional costs were approximately CAD $2558.18/year. CONCLUSIONS: Routine pathological examination of specimens in cases of clinically diagnosed DD does not yield additional clinically important findings and may not warrant their costs.

20.
J Plast Reconstr Aesthet Surg ; 74(11): 2846-2855, 2021 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-34272177

RESUMO

INTRODUCTION: Volume Replacement (VR-OBCS) and Volume Displacement Oncoplastic Breast Conserving Surgery (VD-OBCS) are commonly used in the management of breast cancer. Many studies summarize the individual postoperative outcomes of these two procedures; however, there is a lack of research that compares outcomes of these approaches. This review summarizes the available VR and VD-OBCS literature in terms of oncological, cosmetic, and clinical outcomes. METHODS: An online literature search (MEDLINE, EMBASE, PubMed, and CINAHL) was performed. Studies were included if they were written in English, had more than 10 adult (18+) female patients who underwent VR-OBCS or VD-OBCS, and reported at least one well-described oncological, clinical, or cosmetic outcome RESULTS: Thirty-three studies (26 VR-OBCS and 7 VD-OBCS) were included in this review; VR-OBCS studies were separated based on the use of latissimus dorsi (LD) flaps. Studies utilizing VR-OBCS with LD flaps reported the highest rate of all oncological outcomes; VR-OBCS studies without LD flaps reported the lowest. Rates of hematoma, seroma, and wound dehiscence were highest in VR-OBCS with LD flaps; partial flap loss and fat necrosis were highest in VR-OBCS without LD flaps and infection was highest in VD-OBCS studies. Inconsistencies in methodology (cosmetic outcome measures, outcome definitions, and time horizons) were found in all procedural groups. CONCLUSION: Differences in outcomes for both OBCS procedures may be due to the heterogeneity of patient populations. "Doers" and "Users" of breast oncoplastic research should consider tumor size, laterality of tumor, breast size, measurement scales, and defensible time horizons before the application of a study's conclusions.


Assuntos
Neoplasias da Mama/cirurgia , Mastectomia Segmentar/métodos , Estética , Feminino , Humanos , Mamoplastia/métodos , Tamanho do Órgão , Complicações Pós-Operatórias
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