Reporting Outcomes and Outcome Measures in Digital Replantation: A Systematic Review.

Introduction There is a lack of consensus on what the critical outcomes in replantation are and how best to measure them. This review aims to identify all reported outcomes and respective outcome measures used in digital replantation. Materials and Methods Randomized controlled trials, cohort studies, and single-arm observational studies of adults undergoing replantation with at least one well-described outcome or outcome measure were identified. Primary outcomes were classified into six domains, and outcome measures were classified into eight domains. The clinimetric properties were identified and reported. A total of 56 observational studies met the inclusion criteria. Results In total, 29 continuous and 29 categorical outcomes were identified, and 87 scales and instruments were identified. The most frequently used outcomes were survival of replanted digit, sensation, and time in hospital. Outcomes and measures were most variable in domains of viability, quality of life, and motor function. Only eight measures used across these domains were validated and proven reliable. Conclusion Lack of consensus creates an obstacle to reporting, understanding, and comparing the effectiveness of various replantation strategies.

Reporting Outcomes and Outcome Measures in Cubital Tunnel Syndrome: A Systematic Review.

PURPOSE: Comparison between studies assessing outcomes after surgical treatment of cubital tunnel syndrome (CuTS) has proven to be difficult owing to variations in outcome reporting. This study aimed to identify outcomes and outcome measures used to evaluate postoperative results for CuTS. METHODS: We performed computerized database searches of MEDLINE and EMBASE. Studies with 20 or more patients aged 18 and older who were undergoing medial epicondylectomy, endoscopic decompression, open simple decompression, or decompression with subcutaneous, submuscular, or intramuscular transposition for ulnar neuropathy at the elbow were included. Outcomes and outcome measures were extracted and tabulated. RESULTS: Of the 101 studies included, 45 unique outcomes and 31 postoperative outcome measures were identified. These included 7 condition-specific, clinician-reported instruments; 4 condition-specific, clinician-reported instruments; 8 patient-reported, generic instruments; 11 clinician-generated instruments; and one utility measure. Outcome measures were divided into 6 unique domains. Overall, 60% of studies used condition-specific outcome measures. The frequency of any condition-specific outcome measure ranged from 1% to 37% of included studies. CONCLUSIONS: There is marked heterogeneity in outcomes and outcome measures used to assess CuTS. A standardized core outcome set is needed to compare results of various techniques of cubital tunnel decompression. CLINICAL RELEVANCE: This study builds on the existing literature to support the notion that there is marked heterogeneity in outcomes and outcome measures used to assess CuTS. The authors believe that a future standardized set of core outcomes is needed to limit heterogeneity among studies assessing postoperative outcomes in CuTS to compare these interventions more easily and pool results in the form of systematic reviews and meta-analyses.

Patient-Reported Measurement of Breast Asymmetry Using Archimedes' Principle in Breast Reduction Mammaplasty: A Retrospective Study.

Introduction Breast hypertrophy is a common condition that is often treated with breast reduction surgery. A large percentage of breast hypertrophy patients have notable asymmetry between breasts. Methods The purpose of this study was to investigate a method of measuring breast asymmetry, one that allows patients to determine the asymmetry of their own breasts at home with ease, and to assess its accuracy and role in a surgical practice. A retrospective chart review was conducted, wherein self-measurements of breast asymmetry using a variation of Bouman's technique were compared with the recorded intra-operative resected tissue mass. Results In total, 47 patients with asymmetry were included in the study. The difference between patient-reported measurements and resected breast tissue mass varied from 0 grams to 240 grams. Of the 47 patients, 38% were able to measure their breast difference within a remarkable 10 grams as compared to the resected breast tissue, of which four patients were accurate to less than one gram. The majority (70%) of patients accurately measured their asymmetry within 50 grams, which was determined to be a clinically significant amount based on a survey of plastic surgeons performed for the study. Conclusion The breast measurement technique presented in this study appears to be effective and accurate for most patients with suspected asymmetry undergoing reduction mammaplasty that stands to reduce pre-operative planning time. Patient-reported breast measurement may emerge as a valuable tool in clinical and research pursuits; however, further research on this topic is indicated at this time.

Outcomes and Outcome Measures in Breast Reduction Mammaplasty: A Systematic Review.

BACKGROUND: Reduction mammaplasty remains critical to the treatment of breast hypertrophy. No technique has been shown to be superior; however, comparison between studies is difficult due to variation in outcome reporting. OBJECTIVES: The authors sought to identify a comprehensive list of outcomes and outcome measures in reduction mammaplasty. METHODS: A comprehensive computerized search was performed. Included studies were randomized or nonrandomized controlled trials involving at least 100 cases of female breast hypertrophy and patients of all ages who underwent 1 or more defined reduction mammaplasty technique. Outcomes and outcome measures were extracted and tabulated. RESULTS: A total 106 articles were eligible for inclusion; 57 unique outcomes and 16 outcome measures were identified. Frequency of patient-reported and author-reported outcomes were 44% and 88%, respectively. Postoperative complications were the most frequently reported outcome (82.2%). Quality-of-life outcomes were accounted for in 37.7% of studies. Outcome measures were either condition-specific or generic; frequencies were as low as 1% and as high as 5.6%. Five scales were formally assessed in the breast reduction populations. Clinical measures were defined in 15.1% of studies. CONCLUSIONS: There is marked heterogeneity in reporting of outcomes and outcome measures in the literature. A standardized outcome set is needed to compare outcomes of various reduction mammaplasty techniques.

Reporting Time Horizons in Randomized Controlled Trials in Plastic Surgery: A Systematic Review.

BACKGROUND: Current guidelines for randomized controlled trial reporting do not require authors to justify their choice of time horizon. This is concerning, as the time horizon when an outcome is assessed has important implications for the interpretation of study results, and resources allocated to an investigation. Therefore, this study seeks to examine the standards of time horizon reporting in the plastic surgery literature. METHODS: This is a systematic review of plastic surgery randomized controlled trials published within the past 4 years. The MEDLINE database was searched to yield relevant studies. All studies included were English language, prospective, nonpharmaceutical randomized controlled trials, comparing two plastic surgical interventions. Studies were classified into plastic surgery domains, and information regarding study population, time horizon reporting, and justification of chosen time horizon, was extracted. RESULTS: The search retrieved 720 articles, of which 103 were eligible for inclusion. Time horizons were reported as either a standardized time point at which all patients were assessed, or a follow-up duration range, or were not reported at all. Although most studies (85.4 percent) reported a standardized time horizon, the majority (85.4 percent) failed to provide a valid justification to support their selection of time horizon. CONCLUSIONS: Clinical investigators failed to justify their choice of time horizon in the majority of published randomized controlled trials. To limit heterogeneity, time horizons for given interventions should be standardized to improve validity of outcome assessments, enable future pooling of results, and increase research efficiency.

Users' guide to the surgical literature: how to assess a noninferiority trial.

SUMMARY: A well-planned randomized controlled trial (RCT) is the most optimal study design to determine if a novel surgical intervention is any different than a prevailing one. Traditionally, when we want to show that a new surgical intervention is superior to a standard one, we analyze data from an RCT to see if the null hypothesis of "no difference" can be rejected (i.e., the 2 surgical interventions have the same effect). A noninferiority RCT design seeks to determine whether a new intervention is not worse than a prevailing (standard) one within an acceptable margin of risk or benefit, referred to as the "noninferiority margin." In the last decade, we have observed an increase in the publication of noninferiority RCTs. This article explores this type of study design and discusses the tools that can be used to appraise such a study.

Gynecomastia Classification for Surgical Management: A Systematic Review and Novel Classification System.

BACKGROUND: Gynecomastia is a common deformity of the male breast, where certain cases warrant surgical management. There are several surgical options, which vary depending on the breast characteristics. To guide surgical management, several classification systems for gynecomastia have been proposed. METHODS: A systematic review was performed to (1) identify all classification systems for the surgical management of gynecomastia, and (2) determine the adequacy of these classification systems to appropriately categorize the condition for surgical decision-making. RESULTS: The search yielded 1012 articles, and 11 articles were included in the review. Eleven classification systems in total were ascertained, and a total of 10 unique features were identified: (1) breast size, (2) skin redundancy, (3) breast ptosis, (4) tissue predominance, (5) upper abdominal laxity, (6) breast tuberosity, (7) nipple malposition, (8) chest shape, (9) absence of sternal notch, and (10) breast skin elasticity. On average, classification systems included two or three of these features. Breast size and ptosis were the most commonly included features. CONCLUSIONS: Based on their review of the current classification systems, the authors believe the ideal classification system should be universal and cater to all causes of gynecomastia; be surgically useful and easy to use; and should include a comprehensive set of clinically appropriate patient-related features, such as breast size, breast ptosis, tissue predominance, and skin redundancy. None of the current classification systems appears to fulfill these criteria.

Post-breast surgery pain syndrome: establishing a consensus for the definition of post-mastectomy pain syndrome to provide a standardized clinical and research approach - a review of the literature and discussion.

BACKGROUND: Post-mastectomy pain syndrome (PMPS) is a frequent complication of breast surgery. There is currently no standard definition for this chronic pain syndrome. The purpose of this review was to establish a consensus for defining PMPS by identifying the various elements included in the definitions and how they vary across the literature, determining how these definitions affect the methodological components therein, and proposing a definition that appropriately encompasses all of the appropriate elements. METHODS: We searched PubMed to retrieve all studies and case reports on PMPS, and we analyzed definitions of PMPS, inclusion/exclusion criteria, and methods of measuring PMPS. RESULTS: Twenty-three studies were included in this review. We identified 7 independent domains for defining PMPS: surgical breast procedure, neuropathic nature, pain of at least moderate intensity, protracted duration, frequent symptoms, appropriate location of the symptoms and exacerbation with movement. These domains were used with varying frequency. Inclusion/exclusion criteria and methods for assessing PMPS also varied markedly. CONCLUSION: To prevent future discrepancies in both the clinical and research settings, we propose a new and complete definition based on the results of our review: PMPS is pain that occurs after any breast surgery; is of at least moderate severity; possesses neuropathic qualities; is located in the ipsilateral breast/chest wall, axilla, and/or arm; lasts at least 6 months; occurs at least 50% of the time; and may be exacerbated by movements of the shoulder girdle.

CONTEXTE: Le syndrome douloureux post-mastectomie (SDPM) est une complication fréquente de la chirurgie mammaire. Actuellement, il n'existe aucune définition unique de cette douleur chronique. Le but de la présente revue était donc d'élaborer une définition consensuelle du SDPM en dégageant les différents éléments définitoires, en observant leur variation dans les différentes sources, en déterminant comment ces variations influent sur la méthodologie utilisée, puis en proposant une définition qui met correctement en relation tous les éléments pertinents. MÉTHODES: Nous avons cherché dans PubMed toutes les études et études de cas sur le SDPM. Nous avons ensuite analysé les définitions du syndrome, ses critères d'inclusion et d'exclusion et ses méthodes d'évaluation. RÉSULTATS: La présente revue repose sur 23 études. Nous avons mis en évidence 7 éléments indépendants servant à définir le SDPM : l'intervention de chirurgie mammaire, la nature neuropathique de la douleur, la présence d'une douleur au minimum d'intensité modérée, la persistance des symptômes, leur fréquence élevée, leur localisation ainsi que leur exacerbation due au mouvement. La prise en compte de ces éléments dans les différentes définitions était variable; des variations importantes ont aussi été observées dans les critères d'inclusion et d'exclusion ainsi que dans les méthodes d'évaluation. CONCLUSION: Pour prévenir les différences conceptuelles, autant dans les milieux cliniques que dans les milieux de recherche, nous proposons une définition originale et complète fondée sur les résultats de notre revue. Le SDPM est une douleur qui apparaît à la suite d'une chirurgie mammaire, peu importe sa nature; est au minimum d'intensité modérée; est de nature neuropathique; est localisée dans le sein, la paroi thoracique, l'aisselle ou le bras ipsilatéraux; persiste au moins depuis 6 mois; est présente au moins 50 % du temps; et peut être exacerbée par les mouvements de la ceinture scapulaire.

Users' guide to the surgical literature: how to assess an article about harm in surgery.

CLINICALSCENARIO: You are a new plastic surgeon in the community and you are referred a patient interested in breast reconstruction. The patient is a 35-year-old female school teacher who had a bilateral prophylactic mastectomy 2 years earlier, as she was a BRCA gene carrier. Since she is of a petite build with very little subcutaneous tissue or extra skin in the lower abdomen, you decide that she is not a suitable candidate for an abdomen-based autologous tissue reconstruction. You recommend the technique of tissue expansion and silicone gel implants. She is concerned, however, about the possibility of anaplastic large cell lymphoma (ALCL) developing in her breasts. She read in a magazine recently that ALCL, an unusual form of breast cancer, has been occurring in patients who have breast implants. She is very concerned that she might be at risk and asks for your opinion as to whether she should proceed with the procedure or not.

Assessing accuracy of non-eye care professionals as trainee vision screeners for children.

OBJECTIVE: To determine the level of agreement between non-eye care trainees and a trainer (ophthalmologist) in a vision screening program. DESIGN: Prospective, observational study carried out in 3 phases (Phase I-III). PARTICIPANTS: Study population included 1228 children, aged 6-14 years, at 5 elementary schools in the city of Hamilton. METHODS: In Phase I, 1228 children were screened by the trainee screeners, of which 273 children failed the vision testing. Of these 273 children, 170 consented to enrolment into Phase II and were examined by an ophthalmologist, who confirmed that 105 of these children were true positives. On retesting (Phase III), the ophthalmologist passed 158 of the 163 randomly selected children who passed in Phase I. RESULTS: Overall, trainee screeners had a sample sensitivity of 95.5% and sample specificity of 70.8% in detecting children who should fail vision screening. When we used the positive and negative prediction values obtained, 198 of the 1228 children had vision impairment-providing an estimated prevalence of 16.1%, or 161 children per 1000 population. CONCLUSIONS: Non-eye care professionals can be trained to an acceptable degree of accuracy to perform certain vision screening tests on children. Such screening methods may be a useful approach to address existing gaps in provision of eye care for many Canadian children, thereby ensuring that all children receive timely vision screening.

Users' guide to the surgical literature: how to perform a high-quality literature search.

The article "Users" guide to the surgical literature: how to perform a "literature search" was published in 2003, but the continuing technological developments in databases and search filters have rendered that guide out of date. The present guide fills an existing gap in this area; it provides the reader with strategies for developing a searchable clinical question, creating an efficient search strategy,accessing appropriate databases, and skillfully retrieving the best evidence to address the research question.

Chlamydia Outer Protein (Cop) B from Chlamydia pneumoniae possesses characteristic features of a type III secretion (T3S) translocator protein.

BACKGROUND: Chlamydia spp. are believed to use a conserved virulence factor called type III secretion (T3S) to facilitate the delivery of effector proteins from the bacterial pathogen to the host cell. Important early effector proteins of the type III secretion system (T3SS) are a class of proteins called the translocators. The translocator proteins insert into the host cell membrane to form a pore, allowing the injectisome to dock onto the host cell to facilitate translocation of effectors. CopB is a predicted hydrophobic translocator protein within the chlamydial T3SS. RESULTS: In this study, we identified a novel interaction between the hydrophobic translocator, CopB, and the putative filament protein, CdsF. Furthermore, we identified a conserved PxLxxP motif in CopB (amino acid residues 166-171), which is required for interaction with its cognate chaperone, LcrH_1. Using a synthetic peptide derived from the chaperone binding motif of CopB, we were able to block the LcrH_1 interaction with either CopB or CopD; this CopB peptide was capable of inhibiting C. pneumoniae infection of HeLa cells at micromolar concentrations. An antibody raised against the N-terminus of CopB was able to inhibit C. pneumoniae infection of HeLa cells. CONCLUSION: The inhibition of the LcrH_1:CopB interaction with a cognate peptide and subsequent inhibition of host cell infection provides strong evidence that T3S is an essential virulence factor for chlamydial infection and pathogenesis. Together, these results support that CopB plays the role of a hydrophobic translocator.

Chlamydia pneumoniae CopD translocator protein plays a critical role in type III secretion (T3S) and infection.

Pathogenic Gram-negative bacteria use type III secretion (T3S) to inject effector proteins into the host cell to create appropriate conditions for infection and intracellular replication. Chlamydia spp. are believed to use T3S to infect their host cell, and the translocator proteins are an essential component of this system. Chlamydia pneumoniae contains genes encoding two sets of translocator proteins; CopB and CopD, and CopB2 and CopD2. In this study, we identified novel interactions between CopD and three type III secretion proteins; namely, CopN, CdsN, and CdsF. We identified a CopD putative chaperone binding motif, PxLxxP, within the N-terminal region (CopD amino acids 120-125), which was necessary for interaction with its putative chaperone LcrH_1. Using size exclusion chromatography, we showed that CopD and LcrH_1 formed higher order structures in solution with CopD and LcrH_1 binding in a ratio of 1∶1, which is unique for T3SS translocator proteins. Lastly, we showed that antibodies to CopD reduced C. pneumoniae infectivity by >95%. Collectively, this data suggests that CopD plays a critical role in pathogenesis and likely functions as a hydrophobic translocator of the type III secretion system in Chlamydia pneumoniae.

Multiplex loop-mediated isothermal amplification (M-LAMP) assay for the detection of influenza A/H1, A/H3 and influenza B can provide a specimen-to-result diagnosis in 40 min with single genome copy sensitivity.

BACKGROUND: Rapid isothermal amplification methods have recently been introduced and they offer significant advantages over PCR. OBJECTIVE: To develop a rapid and sensitive M-LAMP assay for the detection of influenza A (H1 and H3) and B that does not require RNA extraction. STUDY DESIGN: We designed six primers targeting the matrix genes of influenza H1 and H3 and the NS1 gene of influenza B and developed a M-LAMP assay using a commercially available Master Mix and a real time fluorometer (Genie II, Optigene, UK) that displays real time amplification, time to positivity and amplicon annealing temperature (Tm). M-LAMP was evaluated against PCR by testing 202 nasopharyngeal (NP) specimens. RESULTS: Optimized M-LAMP was rapid with a mean amplification time of 12 min (compared with 90-120 min for PCR), had an analytical sensitivity of 1 genome equivalent (ge), and could distinguish influenza A including subtypes A/H1 and A/H3 from influenza B by Tm. M-LAMP detected 26/28 influenza A/H1, 27/27 influenza A/H3 and 39/39 influenza B specimens and had a combined sensitivity and specificity for detecting influenza (A and B) of 97.9% (92/94) and 100% (108/108), respectively. The rapid amplification time of LAMP coupled with a novel 10-min specimen preparation procedure consisting of vortexing and heating in M-Swab diluent (Copan Italia) provided a rapid result. CONCLUSIONS: M-LAMP had excellent sensitivity and specificity for detecting influenza A and B in NP specimens and when used together with a rapid specimen processing method provided a specimen-to-result diagnosis in 30 min.

Development of a sensitive loop-mediated isothermal amplification assay that provides specimen-to-result diagnosis of respiratory syncytial virus infection in 30 minutes.

Rapid isothermal amplification methods have recently been introduced, and some of these methods offer significant advantages over PCR. The objective of this study was to develop a rapid and sensitive multiplex loop-mediated isothermal amplification (M-LAMP) assay for the detection of respiratory syncytial virus subgroups A and B (RSV A and B). We designed six primers each for the matrix gene of RSV A and the polymerase gene of RSV B and developed an M-LAMP assay by using a commercially available master mix and a real-time fluorometer (Genie II; Optigene, United Kingdom) that displays real-time amplification, time to positivity, and amplicon annealing temperature (Tm). The M-LAMP was evaluated against PCR by testing 275 nasopharyngeal (NP) specimens. The final optimized M-LAMP assay had a mean amplification time of 14.2 min (compared with 90 to 120 min for PCR) and had an analytical sensitivity of 1 genome equivalent (ge) for both RSV A and B. Using PCR as a comparator, M-LAMP had a sensitivity of 100% (81/81) and specificity of 100% (194/194). We also evaluated a 3- to 10-min specimen processing method involving vortexing with glass beads and heating to 98°C in M-swab medium (Copan Italia, Brescia, Italy) and found that this rapid processing method allowed detection of 37/41 (90.2%) of positives when we used extracted nucleic acid. In summary, the M-LAMP assay had excellent sensitivity and specificity for detecting RSV A and B in NP specimens and, when coupled with a rapid specimen preparation method, could provide a specimen-to-result diagnosis time of 30 min.