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Breast cancer related lymphedema (BCRL) affects many breast cancer survivors and drastically affects their quality of life. There are several surveillance methods for BCRL that are critical at early detection. Prevention of BCRL involves knowledge of alternatives to aggressive axillary surgery, avoidance of axillary surgery, and de-escalation of axillary surgery. There are also techniques to better delineate the anatomy in the axilla to avoid taking nodes that drain the upper extremity. A multidisciplinary approach with medical oncology and radiation oncology can also help avoid unnecessary surgery or radiation that can together strongly increase the risk of BCRL.
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Axila , Linfedema del Cáncer de Mama , Neoplasias de la Mama , Escisión del Ganglio Linfático , Humanos , Femenino , Linfedema del Cáncer de Mama/prevención & control , Linfedema del Cáncer de Mama/etiología , Linfedema del Cáncer de Mama/terapia , Neoplasias de la Mama/cirugía , Escisión del Ganglio Linfático/efectos adversos , Linfedema/etiología , Linfedema/prevención & control , Calidad de Vida , Mastectomía/efectos adversosRESUMEN
Background: Coronavirus disease 19 (COVID-19) has played a pivotal role in changing medical care around the world. During the pandemic, the operating rooms (ORs) were closed to elective surgery. Since breast cancer surgery is not regarded as an emergent procedure, there was an adoption of treatment regimen modification due to delays in treatment. Therefore, a decision was made to bridge early-stage HER2-positive breast cancer patients with neoadjuvant treatment to postpone surgery. Consequently, to reduce the frequency of dosing and the number of visits, as well as avoid steroid premedication, these patients were treated with ado-trastuzumab emtansine (T-DM1) every three weeks as opposed to weekly taxol and herceptin (TH). Case Description: Five patients with early-stage HER2-positive cancer were treated with neoadjuvant T-DM1 3.6 mg/kg IV every three weeks. Three of the five patients developed cancer progression identified by their physical exam and/or imaging. T-DM1 was discontinued, and all three patients underwent immediate surgery. The remaining two patients, 4 and 5, had a complete and partial pathological response, respectively. All five patients received adjuvant therapy after surgery, and currently, none of these patients show evidence of disease on follow-up. Conclusions: Our findings underscore the obstacles and treatment challenges encountered during the COVID-19 pandemic while preventing the spread of the virus and cancer progression. Furthermore, the use of T-DM1 for neoadjuvant treatment remains controversial, particularly when T-DM1 is used as a bridge to surgery during critical times. Perhaps better patient selection or a different drug regimen could have resulted in a better outcome in our study.
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Background: Oncoplastic breast-conserving surgery (OBCS) has demonstrated superior cosmetic outcomes to traditional breast-conserving surgery (BCS) while maintaining oncologic safety. While prior studies have compared OBCS to mastectomy, there is a scarcity of literature on the impact of social determinants of health on outcomes. Furthermore, although traditionally tumors larger than 5 cm and multifocal disease were treated with mastectomy, the literature has now shown OBCS to be safe in treating such disease. As a result, patients with large or multifocal tumors could be eligible for both mastectomy and OBCS, which prompts the need for comparison between the two. Thus, the aim of our study was to compare OBCS and mastectomy with reconstruction using BREAST-Q and oncologic outcome measures, as well as stratify these outcomes based on race, ethnicity, and body mass index (BMI). Methods: A retrospective chart review was performed for 57 patients treated with OBCS and 204 patients treated with mastectomy with reconstruction from 2015 to 2021. Variables including age, race, ethnicity, BMI, insurance status, surgery type, pathology, recurrence, and complications were recorded. Patient-reported outcomes (PROs) were recorded using BREAST-Q pre- and post-operatively. Results: Despite having a higher BMI (P<0.001), OBCS yielded higher "satisfaction with breast" and "satisfaction with outcome" than mastectomy (P=0.02 and P=0.02, respectively). When stratified by race, there were no statistical differences in the PROs between the two surgeries for Hispanic nor African American patients. OBCS had a significantly lower rate of infection and fewer additional surgeries than mastectomy (P=0.004 and P<0.001, respectively). There were no differences in positive margin rate or recurrence rate between the groups. Conclusions: In our study, OBCS yielded better PROs than mastectomy while maintaining oncologic safety and resulting in fewer surgeries and complications. These excellent outcomes in a majority non-Caucasian cohort support the utilization of OBCS for underserved, minority populations. Larger studies evaluating PROs in diverse and uninsured groups are needed to reinforce these conclusions.
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BACKGROUND/OBJECTIVE: Intra-operative radiation therapy (IORT) is a newer partial breast irradiation technique that has been well studied in 2 large randomized trials, the TARGIT-A and ELIOT trials. We initiated our IORT program in 2018 in the context of a registry trial, and aim to report our early results thus far. METHODS: We instituted an IORT practice using Intrabeam® low energy 50kVp x-rays for selected breast cancer cases in 2018. Patients were enrolled on our institutional registry protocol which allowed for IORT in ER + patients with grade 1-2 DCIS ≤ 2.5 cm or invasive disease ≤ 3.5 cm in patients of at least 45 years of age. RESULTS: Between January 2018 and December 2021, 181 patients with clinical stage 0-IIA ER + breast cancer were evaluated. One hundred sixty-seven patients ultimately received IORT to 172 sites. The majority of patients received IORT at the time of initial diagnosis and surgery (160/167; 95.8%). Re-excision post IORT occurred in 16/167 patients (9.6%) due to positive margins. Adjuvant RT to the whole breast +/- LN was ultimately given to 23/167 (13.8%) patients mainly due to positive sentinel LN found on final pathology (12/23; 52%); other reasons were close margins for DCIS (3/23; 13%), tumor size (3/23; 4.3%), and multifactorial (5/23; 17.4%). Five patients (3%) had post-operative complications of wound dehiscence. There were 3 local recurrences (1.6%) at a median follow-up of 27.9 months (range: 0.7- 54.8 months). CONCLUSIONS: IORT has been proven to be a safe and patient-centered form of local adjuvant RT for our population, in whom compliance with a longer course of external beam radiation can be an issue. Long term efficacy remains to be evaluated through continued follow up. In the era of COVID-19 and beyond, IORT has been an increasingly attractive option, as it greatly minimizes toxicities and patient visits to the clinic. TRIAL REGISTRATION: All patients were prospectively enrolled on an institutional review board-approved registry trial (IRB number: 2018-9409).
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Neoplasias de la Mama , COVID-19 , Carcinoma Intraductal no Infiltrante , Femenino , Humanos , Neoplasias de la Mama/radioterapia , Neoplasias de la Mama/cirugía , Neoplasias de la Mama/patología , Carcinoma Intraductal no Infiltrante/patología , Cuidados Intraoperatorios , Mastectomía Segmentaria/métodos , Recurrencia Local de Neoplasia/cirugía , Persona de Mediana EdadRESUMEN
Background: Breast cancer- related lymphedema (BCRL) affects about 3 to 5 million patients worldwide, with about 20,000 per year in the United States. As breast cancer mortality is declining due to improved diagnostics and treatments, the long-term effects of treatment for BCRL need to be addressed. Methods: The American Society of Breast Surgeons Lymphatic Surgery Working Group conducted a large review of the literature in order to develop guidelines on BCRL prevention and treatment. This was a comprehensive but not systematic review of the literature. This was inclusive of recent randomized controlled trials, meta-analyses, and reviews evaluating the prevention and treatment of BCRL. There were 25 randomized clinical trials, 13 systemic reviews and meta-analyses, and 87 observational studies included. Results: The findings of our review are detailed in the paper, with each guideline being analyzed with the most recent data that the group found evidence of to suggest these recommendations. Conclusions: Prevention and treatment of BCRL involve a multidisciplinary team. Early detection, before clinically apparent, is crucial to prevent irreversible lymphedema. Awareness of risk factors and appropriate practice adjustments to reduce the risk aids are crucial to decrease the progression of lymphedema. The treatment can be costly, time- consuming, and not always effective, and therefore, the overall goal should be prevention.
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OBJECTIVE: Complex physical interventions are widely used in physiotherapy, despite doubts over the validity of clinical trial results due to lack of credible shams. Credible shams are critically needed, so too, therefore, is a process by which they can be developed. The authors used a novel methodology to develop and test blinding protocols for dry needling, a complex physical intervention for which blinding is particularly difficult. DESIGN: The research design was a practical three-day workshop influenced by Participatory Action Research, which uses iteration and reflection to solve a problem. PARTICIPANTS: Five multidisciplinary experts (researchers, clinicians, technician, magician) were invited. Healthy volunteers ('recipients', n=17) and accredited physiotherapists (n=6) were recruited to enable testing of blinding strategies. MAIN OUTCOME MEASURES: Primary outcomes were expert opinion on the potential to blind recipients/therapists for (1) individual blinding strategies, and (2) entire blinding protocols. Secondary outcomes included recipient/therapist blinding effectiveness and acceptability. RESULTS: Experts iteratively developed 11 blinding protocols involving 22 blinding strategies. Experts rated 18 of the blinding strategies to 'definitely have potential' and identified four categories: knowledge of the sham, clinical interaction, disinformation, and sensation. Recipient and therapist blinding became more successful as the protocols evolved. CONCLUSIONS: Credible shams capable of simultaneous recipient and therapist blinding have been regarded to be impossible in dry needling. The preliminary success of the devised protocols suggest that our novel approach may be a crucial step in sham development. Improvements in expert rankings and blinding effectiveness as the protocols progressed support the value of this workshop approach.
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Punción Seca , Humanos , Modalidades de FisioterapiaRESUMEN
OBJECTIVES: Dry needling is widely used in physiotherapy. Lack of blinding in clinical trials means that dry needling effects and mechanisms remain unclear, with blinding issues accepted as an unavoidable barrier to better evidence. The authors aimed to overcome this barrier by designing a protocol to double-blind dry needling trials. DESIGN: A prospectively registered randomised experiment tested a novel blinding protocol for blinding effectiveness. SETTING: University physiotherapy clinic. PARTICIPANTS: Therapists (n=15) and asymptomatic volunteers ('recipients') (n=45) were randomly allocated to real and/or sham interventions. INTERVENTIONS: The protocol involved custom-made needles and cognitive and multisensory blinding techniques. MAIN OUTCOME MEASURES: The primary outcome was guesses about allocation. The a priori criterion for successful blinding was ≤50% correct guesses (random chance). Secondary analyses explored blinding patterns using blinding indices. RESULTS: Correct guesses were not different from 50% for therapists [41% (95%CI 30 to 50), n=120 guesses] or recipients [49% (95%CI 38 to 60), n=90 guesses]. Blinding indices supported the primary result but revealed that recipients were better at detecting real dry needling than sham. CONCLUSION: Both therapists and recipients were successfully blinded, which contrasts with the widely held assumption that double-blinding is impossible for needling interventions. The authors recommend that any future trials can, and therefore should, blind therapists. However, secondary analyses revealed that recipients receiving real dry needling were less blinded than sham recipients, which may still create bias in clinical trials and suggests further work is needed to improve recipient blinding. Nonetheless, the current findings offer an opportunity to gain better evidence concerning the effects and mechanisms of dry needling. STUDY REGISTRATION: https://osf.io/rkzeb/.
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Punción Seca , Humanos , Agujas , Modalidades de Fisioterapia , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
Tremendous progress has been made over the past several decades in the treatment of breast cancer. Mortality and recurrence rates continue to decline. Our ability to tailor patient- and tumor-specific treatments has rapidly advanced. The vast majority of our patients can safely have breast conservation. Unfortunately, for many patients, survivorship is burdened by ongoing quality-of-life issues. Most breast cancer patients are asymptomatic at presentation, and the onus is on us to preserve this. Surgery, radiation, and systemic therapy can result in long-term toxicities that can be amplified with multimodality approaches. We must strive to apply minimally effective therapies rather than a maximally tolerated approach. Breast cancer-related lymphedema (BCRL) is a particularly dreaded chronic complication. This review strives to give the reader a better understanding of BCRL and shed light on wisely choosing an integration of treatment modalities that minimizes BCRL risk. Key literature on emerging concepts is highlighted.
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Linfedema del Cáncer de Mama/prevención & control , Neoplasias de la Mama/cirugía , Complicaciones Posoperatorias/prevención & control , Linfedema del Cáncer de Mama/etiología , Neoplasias de la Mama/etiología , Femenino , Humanos , Escisión del Ganglio Linfático/efectos adversos , Ganglios Linfáticos/patología , Complicaciones Posoperatorias/etiologíaRESUMEN
BACKGROUND/AIMS: In clinical trials of physical interventions, participant blinding is often poorly addressed and therapist blinding routinely omitted. This situation presents a substantial barrier to moving the field forward. Improving the success of blinding will be a vital step towards determining the true mechanisms of physical interventions. We used a Delphi approach to identify important elements of shams for physical interventions to maximise the likelihood of participant and therapist blinding in clinical trials. METHODS: Two expert groups were recruited: (1) experts in research methodology and (2) experts in deceptive and/or hypnotic techniques including magic. Magicians were included because they were considered a potentially rich source of innovation for developing credible shams due to their unique skills in altering perceptions and beliefs. Three rounds of survey were conducted, commencing with an open-ended question. Responses were converted to single 'items', which participants rated in the following two rounds using a 9-point Likert scale, categorised as 'Not important' (0-3), 'Depends' (4-6) and 'Essential' (7-9). Consensus was pre-defined as ≥80% agreement within a 3-point category. RESULTS: Thirty-eight experts agreed to participate (research methodology: n = 22; deceptive and/or hypnotic techniques: n = 16), and 30 experts responded to at least one round (research methodology: n = 19; deceptive and/or hypnotic techniques: n = 11). Of 79 items, five reached consensus in the 'Essential' category in both groups, which related to beliefs of participants (n = 3 items), interactions with researchers (n = 1 item) and standardisation of clinical assessments (n = 1 item). Thirteen additional items reached consensus in the 'Essential' category in one group. Experts in research methodology had one additional item reach consensus, related to authentic delivery of study information. The remaining 12 additional items that reached consensus in the deceptive and/or hypnotic techniques group related mainly to therapist attitude and behaviour and the clinical interaction. CONCLUSION: Experts agreed that, for shams to be believable, consideration of cognitive influences is essential. Contrary to the focus of previous shams for physical interventions, replicating the tactile sensation of the active treatment was not considered an essential part of sham development. Therefore, when designing sham-controlled clinical trials, researchers should carefully consider the cognitive credibility of the entire intervention experience, and not just the indistinguishability of the sham intervention itself. The findings provide new guidance to researchers on important contributors to blinding in physical intervention trials.
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Ensayos Clínicos como Asunto/métodos , Modalidades de Fisioterapia , Placebos , Proyectos de Investigación , Adulto , Consenso , Técnica Delphi , Femenino , Humanos , Hipnosis/métodos , Masculino , Persona de Mediana Edad , Método Simple Ciego , Encuestas y CuestionariosRESUMEN
OBJECTIVES: Sham-controlled trials of dry needling, a popular treatment for pain, use a range of methods and theoretical frameworks and most have high risk of bias. Critically, patient blinding is often unsuccessful and therapist blinding has not been attempted. The specific effects of dry needling on pain therefore remain unclear. Our objectives were to identify (1) important elements of active dry needling; (2) important elements of shams for dry needling. DESIGN AND PARTICIPANTS: Two Delphi surveys (to quantify levels of consensus) were undertaken with three expert groups: experts in (1) dry needling, (2) research methodology, and (3) deceptive/hypnotic techniques including magic. Experts in dry needling participated in Delphi 1 and all three groups participated in Delphi 2. Each survey commenced with an open-ended question. Responses were converted to single 'items' suitable for rating on 9-point Likert scales [categorised as 'Not important' (0-3), Depends (4-6), and Essential (7-9)], which participants rated in the following two rounds. Consensus was pre-defined as ≥80% agreement within a 3-point category. RESULTS: In Delphi 1 (n=20 experts), of 80 items, 35 reached consensus in the 'Essential' category, which related to explanations, therapist knowledge/skills, intervention rationale, the setting, and safety. In Delphi 2 (n=53 experts), of 97 items, 15 items reached consensus in the 'Essential' category in all three groups, which related to standardisation/indistinguishability, therapist attributes, expectations/beliefs, vision, protocol, and environment. CONCLUSIONS: Experts placed high importance on the entire intervention experience for active and sham protocols. Cognitive influences that extend beyond mimicking of tactile sensations should be used to create a believable simulation of active dry needling.
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Técnica Delphi , Punción Seca , Placebos , Proyectos de Investigación , Adulto , Femenino , Humanos , Masculino , Persona de Mediana EdadRESUMEN
BACKGROUND: We previously reported that breast conservation was feasible for women with large or irregularly shaped breast cancers when tumor resection was guided by multiple localizing wires. We now report long-term outcomes of multiple-wire versus single-wire localized lumpectomies for breast cancer. PATIENTS AND METHODS: We retrospectively reviewed wire-localized lumpectomies at our institution from May 2000 to November 2006. Rates of ipsilateral in-breast tumor recurrence, metastasis, and subsequent unplanned diagnostic imaging and biopsy were compared between multiple-wire and single-wire cohorts. RESULTS: We identified 112 multiple-wire and 160 single-wire breast cancer lumpectomies that achieved clear margins. Median age was 64 years in the multiple-wire cohort and 57 years in the single-wire cohort. Mean lumpectomy volume was 75 mL in multiple-wire patients and 49 mL in single-wire patients (P = .003). Invasive tumor size, axillary node status, and use of radiation and systemic therapy were similar, but the multiple-wire group had more patients with ductal carcinoma-in-situ only (38% vs. 28%). At 108 months' median follow-up, there was no significant difference in local or distant recurrence rates between multiple-wire and single-wire cohorts. Six (5%) multiple-wire patients and 6 (4%) single-wire patients had local recurrences and 3 (3%) multiple-wire and 5 (3%) single-wire patients developed metastatic disease. Unplanned diagnostic imaging was required for 53 (47%) multiple-wire and 65 (41%) single-wire patients. Subsequent ipsilateral biopsy occurred in 15 (13%) multiple-wire and 19 (12%) single-wire patients. CONCLUSION: Breast-conserving surgery with multiple localizing wires is a safe alternative to mastectomy for breast cancer patients with large mammographic lesions.
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Neoplasias de la Mama/terapia , Carcinoma Ductal de Mama/terapia , Carcinoma Intraductal no Infiltrante/terapia , Mastectomía Segmentaria/métodos , Recurrencia Local de Neoplasia/epidemiología , Adulto , Anciano , Anciano de 80 o más Años , Biopsia/estadística & datos numéricos , Mama/diagnóstico por imagen , Mama/patología , Mama/cirugía , Neoplasias de la Mama/diagnóstico , Neoplasias de la Mama/epidemiología , Neoplasias de la Mama/patología , Carcinoma Ductal de Mama/diagnóstico , Carcinoma Ductal de Mama/epidemiología , Carcinoma Ductal de Mama/patología , Carcinoma Intraductal no Infiltrante/diagnóstico , Carcinoma Intraductal no Infiltrante/epidemiología , Carcinoma Intraductal no Infiltrante/patología , Quimioradioterapia Adyuvante/estadística & datos numéricos , Femenino , Estudios de Seguimiento , Humanos , Mamografía/estadística & datos numéricos , Mastectomía Segmentaria/instrumentación , Persona de Mediana Edad , Recurrencia Local de Neoplasia/diagnóstico , Recurrencia Local de Neoplasia/patología , Recurrencia Local de Neoplasia/prevención & control , Estudios RetrospectivosRESUMEN
BACKGROUND: Blinding of participants and therapists in trials of physical interventions is a significant and ongoing challenge. There is no widely accepted sham protocol for dry needling. PURPOSE: The purpose of this review was to summarize the effectiveness and limitations of blinding strategies and types of shams that have been used in dry needling trials. DATA SOURCES: Twelve databases were searched from inception to February 2016. STUDY SELECTION: Trials that compared active dry needling with a sham that simulated dry needling were included. DATA EXTRACTION: The main domains of data extraction were participant/therapist details, intervention details, blinding strategies, blinding assessment outcomes, and key conclusions of authors. Reported blinding strategies and sham types were synthesized descriptively, with available blinding effectiveness data synthesized using a chance-corrected measurement of blinding (blinding index). DATA SYNTHESIS: The search identified 4894 individual publications with 27 trials eligible for inclusion. In 22 trials, risk of methodological bias was high or unclear. Across trials, blinding strategies and sham types were heterogeneous. Notably, no trials attempted therapist blinding. Sham protocols have focused on participant blinding using strategies related to group standardization and simulation of tactile sensations. There has been little attention given to the other senses or cognitive strategies to enhance intervention credibility. Nonpenetrating sham types may provide effective participant blinding. LIMITATIONS: Trials were clinically and methodologically diverse, which limited the comparability of blinding effectiveness across trials. Reported blinding evaluations had a high risk of chance findings with power clearly achieved in only 1 trial. CONCLUSIONS: Evidence-based consensus on a sham protocol for dry needling is required. Recommendations provided in this review may be used to develop sham protocols so that future protocols are more consistent and potentially more effective.
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Punción Seca , Proyectos de Investigación , Terapias Complementarias , HumanosRESUMEN
PURPOSE: Using in vivo measurements from optically stimulated luminescence dosimeters (OSLDs) to develop and validate a prediction model for estimating the skin dose received by patients undergoing breast intraoperative radiation therapy (IORT). METHODS AND MATERIALS: IORT was performed using INTRABEAM-600 with spherical applicators placed in the lumpectomy cavity. Ultrasound skin bridge measurements were used to determine the applicator-to-skin distance, with OSLDs placed to measure the skin surface dose at the corresponding points. The OSLD response was calibrated for the 50 kVp INTRABEAM-600 output. Models were fit to describe the dose fall-off with increasing applicator-to-skin distance and the best fitting model was chosen for estimating skin dose. RESULTS: Twenty four patients with 25 lumpectomy cavities were included, and the average skin dose recorded was 1.18 Gy ± 0.88 Gy, ranging from 0.17 Gy to 4.77 Gy, with an average applicator-to-skin distance of 19.9 mm ± 5.1 mm. An exponential-plateau model was found to best describe the dose fall-off with a root-mean-square error of 0.73. This model was then validated prospectively using skin dose measurements from five consecutive patients. Validation measurements were well within the 95% prediction limits of the model, with a root-mean-square error of 0.52, showing that the prediction model accurately estimates skin dose using ultrasound skin bridge measurements. CONCLUSIONS: This prediction model constitutes a useful tool for estimating the skin dose received during breast lumpectomy IORT. The model and accompanying 95% confidence intervals can be used to establish a minimum allowable skin bridge distance, effectively limiting the maximum allowable skin dose.
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Braquiterapia/métodos , Neoplasias de la Mama/radioterapia , Dosimetría in Vivo/métodos , Piel/efectos de la radiación , Neoplasias de la Mama/cirugía , Calibración , Femenino , Humanos , Periodo Intraoperatorio , Mastectomía Segmentaria , Persona de Mediana Edad , Modelos Biológicos , Órganos en Riesgo/efectos de la radiación , Dosis de Radiación , Dosificación Radioterapéutica , Radioterapia Adyuvante/métodos , Dosimetría Termoluminiscente/métodos , Ultrasonografía/métodosAsunto(s)
Anticarcinógenos/uso terapéutico , Neoplasias de la Mama/prevención & control , Administración Oral , Anticarcinógenos/efectos adversos , Proteína BRCA1/genética , Proteína BRCA2/genética , Neoplasias de la Mama/genética , Femenino , Heterocigoto , Juramento Hipocrático , Humanos , Mutación , Ensayos Clínicos Controlados Aleatorios como Asunto , Tamoxifeno/administración & dosificaciónRESUMEN
BACKGROUND: Blinding is critical to clinical trials because it allows for separation of specific intervention effects from bias, by equalising all factors between groups except for the proposed mechanism of action. Absent or inadequate blinding in clinical trials has consistently been shown in large meta-analyses to result in overestimation of intervention effects. Blinding in dry needling trials, particularly blinding of participants and therapists, is a practical challenge; therefore, specific effects of dry needling have yet to be determined. Despite this, dry needling is widely used by health practitioners internationally for the treatment of pain. This review presents the first empirical account of the influence of blinding on intervention effect estimates in dry needling trials. The aim of this systematic review was to determine whether participant beliefs about group allocation relative to actual allocation (blinding effectiveness), and/or adequacy of blinding procedures, moderated pain outcomes in dry needling trials. METHODS: Twelve databases (MEDLINE, EMBASE, AMED, Scopus, CINAHL, PEDro, The Cochrane Library, Trove, ProQuest, trial registries) were searched from inception to February 2016. Trials that compared active dry needling with a sham that simulated dry needling were included. Two independent reviewers performed screening, data extraction, and critical appraisal. Available blinding effectiveness data were converted to a blinding index, a quantitative measurement of blinding, and meta-regression was used to investigate the influence of the blinding index on pain. Adequacy of blinding procedures was based on critical appraisal, and subgroup meta-analyses were used to investigate the influence of blinding adequacy on pain. Meta-analytical techniques used inverse-variance random-effects models. RESULTS: The search identified 4,894 individual publications with 24 eligible for inclusion in the quantitative syntheses. In 19 trials risk of methodological bias was high or unclear. Five trials were adequately blinded, and blinding was assessed and sufficiently reported to compute the blinding index in 10 trials. There was no evidence of a moderating effect of blinding index on pain. For short-term and long-term pain assessments pooled effects for inadequately blinded trials were statistically significant in favour of active dry needling, whereas there was no evidence of a difference between active and sham groups for adequately blinded trials. DISCUSSION: The small number and size of included trials meant there was insufficient evidence to conclusively determine if a moderating effect of blinding effectiveness or adequacy existed. However, with the caveats of small sample size, generally unclear risk of bias, statistical heterogeneity, potential publication bias, and the limitations of subgroup analyses, the available evidence suggests that inadequate blinding procedures could lead to exaggerated intervention effects in dry needling trials.
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BACKGROUND: Dedicated Evidence-Based Practice (EBP) courses are often included in health professional education programs. It is important to understand the effectiveness of this training. This study investigated EBP outcomes in entry-level physiotherapy students from baseline to completion of all EBP training (graduation). METHODS: Mixed methods with an explanatory sequential design. Physiotherapy students completed two psychometrically-tested health professional EBP instruments at baseline and graduation. The Evidence-Based Practice Profile questionnaire collected self-reported data (Terminology, Confidence, Practice, Relevance, Sympathy), and the Knowledge of Research Evidence Competencies instrument collected objective data (Actual Knowledge). Focus groups with students were conducted at graduation to gain a deeper understanding of the factors impacting changes in students' EBP knowledge, attitudes, behaviour and competency. Descriptive statistics, paired t-tests, 95% CI and effect sizes (ES) were used to examine changes in outcome scores from baseline to graduation. Transcribed focus group data were analysed following a qualitative descriptive approach with thematic analysis. A second stage of merged data analysis for mixed methods studies was undertaken using side-by-side comparisons to explore quantitatively assessed EBP measures with participants' personal perceptions. RESULTS: Data were analysed from 56 participants who completed both instruments at baseline and graduation, and from 21 focus group participants. Large ES were reported across most outcomes: Relevance (ES 2.29, p ≤ 0.001), Practice (1.8, p ≤ 0.001), Confidence (1.67, p ≤ 0.001), Terminology (3.13, p ≤ 0.001) and Actual Knowledge (4.3, p ≤ 0.001). A medium ES was found for Sympathy (0.49, p = 0.008). Qualitative and quantitative findings mostly aligned but for statistical terminology, participants' self-reported understanding was disparate with focus group reported experiences. Qualitative findings highlighted the importance of providing relevant context and positive role models for students during EBP training. CONCLUSIONS: Following EBP training across an entry-level physiotherapy program, there were qualitative and significant quantitative changes in participants' knowledge and perceptions of EBP. The qualitative and quantitative findings were mainly well-aligned with the exception of the Terminology domain, where the qualitative findings did not support the strength of the effect reported quantitatively. The findings of this study have implications for the timing and content of EBP curricula in entry-level health professional programs.
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Práctica Clínica Basada en la Evidencia , Especialidad de Fisioterapia/educación , Estudiantes del Área de la Salud/psicología , Adolescente , Adulto , Actitud del Personal de Salud , Competencia Clínica , Femenino , Grupos Focales , Humanos , Masculino , Percepción , Evaluación de Programas y Proyectos de Salud , Psicometría , Investigación Cualitativa , Terminología como Asunto , Factores de Tiempo , Adulto JovenRESUMEN
In 2015, the American Society of Breast Surgeons (ASBrS) convened a multidisciplinary consensus conference, the Collaborative Attempt to Lower Lumpectomy Reoperation Rates (CALLER). The CALLER conference endorsed a "toolbox" of multiple processes of care for which there was evidence that they were associated with fewer reoperations. We present an update of the toolbox taking into consideration the latest advances in decreasing re excision rates. In this review, we performed a comprehensive review of the literature from 2015-2018 using search terms for each tool. The original ten tools were updated with the latest evidence from the literature and our strength of recommendation. We added an additional section looking at new tools and techniques that may provide more accurate intraoperative assessment of margins. The updates on the CALLER Toolbox for lumpectomy will help guide surgeons to various resources to aid in the removal of breast cancer, while being aware of cosmesis and decreasing re excision rates.
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BACKGROUND: The majority of reporting guidelines assist researchers to report consistent information concerning study design, however, they contain limited information for describing study interventions. Using a three-stage development process, the Guideline for Reporting Evidence-based practice Educational interventions and Teaching (GREET) checklist and accompanying explanatory paper were developed to provide guidance for the reporting of educational interventions for evidence-based practice (EBP). The aim of this study was to complete the final development for the GREET checklist, incorporating psychometric testing to determine inter-rater reliability and criterion validity. METHODS: The final development for the GREET checklist incorporated the results of a prior systematic review and Delphi survey. Thirty-nine items, including all items from the prior systematic review, were proposed for inclusion in the GREET checklist. These 39 items were considered over a series of consensus discussions to determine the inclusion of items in the GREET checklist. The GREET checklist and explanatory paper were then developed and underwent psychometric testing with tertiary health professional students who evaluated the completeness of the reporting in a published study using the GREET checklist. For each GREET checklist item, consistency (%) of agreement both between participants and the consensus criterion reference measure were calculated. Criterion validity and inter-rater reliability were analysed using intra-class correlation coefficients (ICC). RESULTS: Three consensus discussions were undertaken, with 14 items identified for inclusion in the GREET checklist. Following further expert review by the Delphi panelists, three items were added and minor wording changes were completed, resulting in 17 checklist items. Psychometric testing for the updated GREET checklist was completed by 31 participants (n = 11 undergraduate, n = 20 postgraduate). The consistency of agreement between the participant ratings for completeness of reporting with the consensus criterion ratings ranged from 19 % for item 4 Steps of EBP, to 94 % for item 16 Planned delivery. The overall consistency of agreement, for criterion validity (ICC 0.73) and inter-rater reliability (ICC 0.96), was good to almost perfect. CONCLUSION: The final GREET checklist comprises 17 items which are recommended for reporting EBP educational interventions. Further validation of the GREET checklist with experts in EBP research and education is recommended.
Asunto(s)
Lista de Verificación , Práctica Clínica Basada en la Evidencia/educación , Guías de Práctica Clínica como Asunto , Enseñanza , Adulto , Lista de Verificación/normas , Estudios Transversales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Guías de Práctica Clínica como Asunto/normas , Psicometría , Reproducibilidad de los Resultados , Adulto JovenRESUMEN
PURPOSE: To investigate the magnitude of change in outcomes after repeated exposure to evidence-based practice (EBP) training in entry-level health professional students. METHOD: Using an observational cross-sectional analytic design, the study tracked 78 students in physiotherapy, podiatry, health science, medical radiations, and human movement before and after two sequential EBP courses. The first EBP course was aimed at developing foundational knowledge of and skills in the five steps of EBP; the second was designed to teach students to apply these steps. Two EBP instruments were used to collect objective (actual knowledge) and self-reported (terminology, confidence, practice, relevance, sympathy) data. Participants completed both instruments before and after each course. RESULTS: Effect sizes were larger after the first course than after the second for relevance (0.72 and 0.26, respectively), practice (1.23 and 0.43), terminology (2.73 and 0.84), and actual knowledge (1.92 and 1.45); effect sizes were larger after the second course for sympathy (0.03 and 0.14) and confidence (0.81 and 1.12). CONCLUSIONS: Knowledge and relevance changed most meaningfully (i.e., showed the largest effect size) for participants with minimal prior exposure to training. Changes in participants' confidence and attitudes may require a longer time frame and repeated training exposure.
Objet : Étudier l'ordre de grandeur du changement au niveau des résultats suivant une exposition répétée à la pratique factuelle au cours de la formation des futurs professionnels de la santé au niveau débutant. Méthode : Basée sur un concept d'analyse transversale par observation, l'étude a suivi 78 étudiants en physiothérapie, podiatrie, sciences de la santé, rayonnements médicaux et mouvement humain avant et après deux cours consécutifs sur la pratique factuelle. Le premier visait à produire des connaissances générales et techniques fondamentales sur les cinq étapes de la pratique factuelle. Le deuxième visait à apprendre aux étudiants à appliquer ces étapes. On a utilisé deux instruments relatifs à la pratique factuelle pour réunir des données objectives (connaissances réelles) et autodéclarées (terminologie, confiance, pratique, pertinence, sympathie). Les participants ont rempli les deux questionnaires avant et après chaque cours. Résultats : L'ordre de grandeur de l'effet était plus important après le premier cours qu'après le deuxième pour ce qui est de la pertinence (0,72, 0,26), de la pratique (1,23, 0,43), de la terminologie (2,73, 0,84) et des connaissances réelles (1,92, 1,45). Le changement était plus important après le deuxième cours dans le cas de la sympathie (0,03, 0,14) et dans celui de la confiance (0,81, 1,12). Conclusions : Les connaissances et la pertinence ont changé le plus (c.-à-d., ont montré l'effet le plus important) chez les participants qui avaient une exposition antérieure minime à la formation. Les changements aux niveaux de la confiance et des attitudes des participants peuvent prendre plus de temps et nécessiter une exposition répétée à la formation.
RESUMEN
BACKGROUND: No consensus exists for clear margins for breast-conserving surgery for pure ductal carcinoma in situ (DCIS). We examined the implications of applying a "no ink on tumor" standard for pure DCIS by correlating clear margin width with rates of residual disease. METHODS: Lumpectomies with complete shaved cavity margins (SCMs) for pure DCIS at our institution from 2004 to 2007 were reviewed and patients with microinvasive cancer or multifocal disease requiring multiple wires excluded. Rates of residual disease in shaved margins were determined based on margin status of the main lumpectomy specimen using margin widths of "ink on tumor," ≤1, >1 to <2, and ≥2 mm. RESULTS: Overall, 182 women undergoing lumpectomy for pure DCIS met eligibility criteria. In patients with "ink on tumor" in the main lumpectomy specimen, 88 % had residual disease in the SCMs. Rates of residual disease in SCMs for lumpectomies with margins of <2 mm (but not on ink) were 52 % compared with 13 % for lumpectomies with margins ≥2 mm (p < 0.0005). Multivariate analyses confirmed the association of lumpectomy margin width and residual tumor in shaved cavity margins. Odds of residual disease in the SCM for postmenopausal patients were 74 % less than for pre/perimenopausal women (odds ratio 0.26; confidence interval 0.08-0.82). CONCLUSIONS: Application of a "no ink on tumor" lumpectomy margin standard to patients with DCIS results in a significant increase in the rates of residual disease in cavity margins compared with use of a ≥2-mm margin standard. Use of narrower margins may have important implications for use of adjuvant therapy.