Towards more credible shams for physical interventions: A Delphi survey.

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.

Changes in physiotherapy students' knowledge and perceptions of EBP from first year to graduation: a mixed methods study.

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.

Implications of New Lumpectomy Margin Guidelines for Breast-Conserving Surgery: Changes in Reexcision Rates and Predicted Rates of Residual Tumor.

BACKGROUND: The 2014 guidelines endorsed by Society of Surgical Oncology, the American Society of Breast Surgeons, and the American Society for Radiation Oncology advocate "no ink on tumor" as the new margin requirement for breast-conserving therapy (BCT). We used our lumpectomy margins database from 2004 to 2006 to predict the effect of these new guidelines on BCT. METHODS: Patients with neoadjuvant therapy, pure ductal carcinoma-in situ, or incomplete margin data were excluded. We applied new ("no ink on tumor") and old (≥2 mm) margin guidelines and compared rates of positive margins, reexcision, and rates of residual disease found at reexcision. RESULTS: A total of 437 lumpectomy surgeries met the eligibility criteria. Eighty-six percent had invasive ductal carcinoma, 12% invasive lobular carcinoma, and 2% invasive ductal carcinoma and invasive lobular carcinoma. Using a ≥2 mm margin standard, 36% of lumpectomies had positive margins compared to 18% using new guidelines (p < 0.0001). Seventy-seven percent of patients with "ink on tumor" had residual disease found at reexcision. Fifty percent of subjects with margins <2 mm had residual disease (p = 0.0013) but would not have undergone reexcision under the new guidelines. With margins of ≥2 mm, residual tumor was seen in the shaved margins of 14% of lumpectomies. Residual tumor was more common in reexcisions for ductal carcinoma-in situ <2 mm from a margin than for invasive cancer (53 vs. 40%), although this was not statistically significant. CONCLUSIONS: Use of new lumpectomy margin guidelines would have reduced reoperation for BCT by half in our patient cohort. However, residual disease was present in many patients who would not have been reexcised with the new guidelines. Long-term follow-up of local recurrence rates is needed to determine if this increase in residual disease is clinically significant.

Should New "No Ink On Tumor" Lumpectomy Margin Guidelines be Applied to Ductal Carcinoma In Situ (DCIS)? A Retrospective Review Using Shaved Cavity Margins.

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.

How Comprehensively Is Evidence-Based Practice Represented in Australian Health Professional Accreditation Documents? A Systematic Audit.

UNLABELLED: PHENONENON: In many developed countries, accreditation documents, which reflect the practice standards of health professions, form the basis for evaluation of education programs for meeting the requirements for registration. The 2005 Sicily statement proposed a 5-step model of training in evidence-based practice (ask, access, appraise, apply, and assess). A key recommendation was that evidence-based practice should be incorporated into entry-level health professional training and registration. No previous research has assessed the extent to which this has occurred. APPROACH: We undertook a systematic audit of the accreditation documents for the registered health professions in Australia. The 11 health professional disciplines included in the audit were medicine, nursing and midwifery, pharmacy, physiotherapy, dentistry, psychology, occupational therapy, optometry, podiatry, osteopathy, and chiropractic. Two investigators independently identified the occurrence of the term evidence that related to "evidence-based practice" and the occurrences of terms related to the 5 steps in the accreditation documents. FINDINGS: Occurrence of the term evidence as it relates specifically to "evidence-based practice" ranged from 0 (pharmacy, dentistry and occupational therapy) to 8 (physiotherapy) in the accreditation documents. Overall, there were 77 occasions when terms relating to any of the 5 steps of evidence-based practice were used across all 11 accreditation documents. All 5 steps were included in the physiotherapy and psychology documents; 4 steps in medicine and optometry; 3 steps in pharmacy; 2 steps each in documents for chiropractic, osteopathy, and podiatry; and 1 step for nursing. There was no inclusion of terms relating to any of the 5 steps in the dentistry and occupational therapy documents. Insights: Terminology relating explicitly to evidence-based practice and to the 5 steps of evidence-based practice appears to be lacking in the accreditation documents for health professions registered in Australia. This is not necessarily reflective of the curricular content or quality, or dedication to evidence-based practice teaching. However, recognition and demand by accreditation bodies for skills in evidence-based practice may act as a driver for education providers to give greater priority to embedding this training in entry-level programs. Consequently, accreditation bodies are powerfully positioned to shape future directions, focus, and boundaries within and across professions. Future international audits of accreditation documents could provide insight into the global breadth of this phenomenon and contribute to closer scrutiny of the representation of evidence-based practice in future iterations of accreditation documents.

Development and validation of the guideline for reporting evidence-based practice educational interventions and teaching (GREET).

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.

Breast Cancer Risk and Follow-up Recommendations for Young Women Diagnosed with Atypical Hyperplasia and Lobular Carcinoma In Situ (LCIS).

BACKGROUND: The risk of breast cancer in young women diagnosed with atypical hyperplasia and (LCIS) is not well defined. The objectives were to evaluate outcomes and to help determine guidelines for follow-up in this population. METHODS: A retrospective review of women under age 35 diagnosed with ADH, ALH, LCIS, and severe ADH from 1987 to 2010 was performed. Patient characteristics, pathology and follow-up were determined from chart review. RESULTS: We identified 58 young women with atypical breast lesions. Median age at diagnosis was 31 years (range 19-34). 34 patients had ADH, 11 had ALH, 8 had LCIS, and 5 had severe ADH. 7 (12%) patients developed breast cancer. The median follow-up was 86 months (range 1-298). Median time to cancer diagnosis was 90 months (range 37-231). 4 cancers were on the same side, 3 were contralateral. 4 were IDC, 1 was ILC, and 2 were DCIS. Cancer was detected by screening mammogram in 4 patients, 2 by clinical exam, and 1 unknown. In the entire cohort, 26 (45%) patients had screening mammograms as part of their follow up, 12 patients had only clinical follow up, and 20 had no additional follow up. 13 patients required subsequent biopsies. CONCLUSION: Young women with atypical breast lesions are at a markedly increased risk for developing breast cancer and should be followed closely. Based on our findings, we recommend close clinical follow-up, MRI starting at age 25 through age 29, and screening mammograms for those over 30 in this high-risk group of patients.

Nipple-Sparing Mastectomy in Irradiated Breasts: Selecting Patients to Minimize Complications.

BACKGROUND: Nipple-sparing mastectomies (NSM) are increasingly common because of their cosmetic advantage. Radiotherapy (RT) has been a relative contraindication to immediate reconstruction because of concerns about increased complications. We aimed to evaluate outcomes of NSM plus immediate reconstruction in irradiated breasts and to determine additional risk factors for complications. METHODS: We retrospectively reviewed NSM with immediate reconstruction from 2007 to 2013 at our institution. Complications were broken down into several categories. Potential risk factors for complications were evaluated. RESULTS: There were 982 NSM: 816 had no RT, 67 had prior RT, and 97 had postmastectomy radiotherapy (PMRT). Compared to breasts with no RT, both prior RT and PMRT increased overall complications (10.2 vs. 21.7 and 17.5%, p = 0.003, 0.03, respectively) and nipple loss (0.9 vs. 4.3 and 4.1%, p = 0.04, 0.02, respectively), while PMRT increased rate of reconstruction failure (2.2 vs. 8.2%, p = 0.003). On multivariate regression analysis, prior RT [odds ratio (OR) 2.53, p = 0.006], PMRT (OR 2.29, p = 0.015), age >55 years (OR 2.03, p = 0.04), breast volume ≥800 cm(3) (OR 1.96, p = 0.04), smoking (OR 2.62, p = 0.001), and periareolar incision (OR 1.74, p = 0.03) were independent risk factors for complications requiring surgical revision. In irradiated breasts, complication rates were 13.4% without further risk factors and 17.5, 50, and 66.7% when 1, 2, and ≥3 additional independent risk factors were present, respectively (p < 0.001). CONCLUSIONS: Although complication rates were higher in irradiated breasts, reconstruction failure and nipple/areola necrosis was infrequent. RT should not be a contraindication to NSM. Preoperative identification of risk factors and appropriate patient selection may reduce complication rates.

Risk factors and predictors of severity score and complications of pediatric hemorrhagic cystitis.

PURPOSE: We retrospectively analyzed our institutional incidence of hemorrhagic cystitis, identified risk factors, and examined associations of risk factors with disease severity and genitourinary complication rates. MATERIALS AND METHODS: We reviewed charts of all consecutive pediatric patients treated from 1986 to 2010. We analyzed demographics, underlying diagnosis and treatment data to assess risk factors for hemorrhagic cystitis. We also correlated disease severity scores with clinical predisposing factors, and performed univariate and multivariate analyses to examine associations between risk factors and outcomes. RESULTS: Hemorrhagic cystitis was observed in 97 of 6,119 children (1.6%), most of whom (75%) had severity scores of II or III. Mean ± SD age was 12.2 ± 6.3 years for patients with hemorrhagic cystitis and 10.5 ± 7 years for patients without hemorrhagic cystitis (p = 0.017). On univariate analysis increased risk of hemorrhagic cystitis was significantly associated with age greater than 5 years, male gender, cyclophosphamide or busulfan chemotherapy, bone marrow or peripheral blood stem cell transplantation, pelvic radiotherapy and underlying diagnoses of rhabdomyosarcoma, acute leukemia and aplastic anemia. On multivariate analysis age greater than 5 years, allogeneic bone marrow or peripheral blood stem cell transplantation and pelvic radiotherapy were significantly associated with increased risk of hemorrhagic cystitis. Older age, late onset hemorrhagic cystitis, positive urine culture for BK virus and bone marrow or peripheral blood stem cell transplantation were associated with greater disease severity. Patients with higher severity scores more frequently experienced bladder perforation, hydronephrosis, overall hemorrhagic cystitis complications, and increased creatinine and blood urea nitrogen levels during followup. CONCLUSIONS: Older age, previous bone marrow or peripheral blood stem cell transplantation and BK virus in the urine are risk factors for hemorrhagic cystitis and are associated with a higher severity score. Higher severity scores are associated with increased rates of genitourinary complications and renal impairment.

A systematic review of how studies describe educational interventions for evidence-based practice: stage 1 of the development of a reporting guideline.

BACKGROUND: The aim of this systematic review was to identify which information is included when reporting educational interventions used to facilitate foundational skills and knowledge of evidence-based practice (EBP) training for health professionals. This systematic review comprised the first stage in the three stage development process for a reporting guideline for educational interventions for EBP. METHODS: The review question was 'What information has been reported when describing educational interventions targeting foundational evidence-based practice knowledge and skills?'MEDLINE, Academic Search Premier, ERIC, CINAHL, Scopus, Embase, Informit health, Cochrane Library and Web of Science databases were searched from inception until October - December 2011. Randomised and non-randomised controlled trials reporting original data on educational interventions specific to developing foundational knowledge and skills of evidence-based practice were included.Studies were not appraised for methodological bias, however, reporting frequency and item commonality were compared between a random selection of studies included in the systematic review and a random selection of studies excluded as they were not controlled trials. Twenty-five data items were extracted by two independent reviewers (consistency > 90%). RESULTS: Sixty-one studies met the inclusion criteria (n = 29 randomised, n = 32 non-randomised). The most consistently reported items were the learner's stage of training, professional discipline and the evaluation methods used (100%). The least consistently reported items were the instructor(s) previous teaching experience (n = 8, 13%), and student effort outside face to face contact (n = 1, 2%). CONCLUSION: This systematic review demonstrates inconsistencies in describing educational interventions for EBP in randomised and non-randomised trials. To enable educational interventions to be replicable and comparable, improvements in the reporting for educational interventions for EBP are required. In the absence of a specific reporting guideline, there are a range of items which are reported with variable frequency. Identifying the important items for describing educational interventions for facilitating foundational knowledge and skills in EBP remains to be determined. The findings of this systematic review will be used to inform the next stage in the development of a reporting guideline for educational interventions for EBP.

A Delphi survey to determine how educational interventions for evidence-based practice should be reported: stage 2 of the development of a reporting guideline.

BACKGROUND: Undertaking a Delphi exercise is recommended during the second stage in the development process for a reporting guideline. To continue the development for the Guideline for Reporting Evidence-based practice Educational interventions and Teaching (GREET) a Delphi survey was undertaken to determine the consensus opinion of researchers, journal editors and educators in evidence-based practice (EBP) regarding the information items that should be reported when describing an educational intervention for EBP. METHODS: A four round online Delphi survey was conducted from October 2012 to March 2013. The Delphi panel comprised international researchers, educators and journal editors in EBP. Commencing with an open-ended question, participants were invited to volunteer information considered important when reporting educational interventions for EBP. Over three subsequent rounds participants were invited to rate the importance of each of the Delphi items using an 11 point Likert rating scale (low 0 to 4, moderate 5 to 6, high 7 to 8 and very high >8). Consensus agreement was set a priori as at least 80 per cent participant agreement. Consensus agreement was initially calculated within the four categories of importance (low to very high), prior to these four categories being merged into two (<7 and ≥7). Descriptive statistics for each item were computed including the mean Likert scores, standard deviation (SD), range and median participant scores. Mean absolute deviation from the median (MAD-M) was also calculated as a measure of participant disagreement. RESULTS: Thirty-six experts agreed to participate and 27 (79%) participants completed all four rounds. A total of 76 information items were generated across the four survey rounds. Thirty-nine items (51%) were specific to describing the intervention (as opposed to other elements of study design) and consensus agreement was achieved for two of these items (5%). When the four rating categories were merged into two (<7 and ≥7), 18 intervention items achieved consensus agreement. CONCLUSION: This Delphi survey has identified 39 items for describing an educational intervention for EBP. These Delphi intervention items will provide the groundwork for the subsequent consensus discussion to determine the final inclusion of items in the GREET, the first reporting guideline for educational interventions in EBP.

Oncoplastic breast-conserving surgery (OBCS) vs. mastectomy with reconstruction: a comparison of outcomes in an underserved population.

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.

Protocol for development of the guideline for reporting evidence based practice educational interventions and teaching (GREET) statement.

BACKGROUND: There are an increasing number of studies reporting the efficacy of educational strategies to facilitate the development of knowledge and skills underpinning evidence based practice (EBP). To date there is no standardised guideline for describing the teaching, evaluation, context or content of EBP educational strategies. The heterogeneity in the reporting of EBP educational interventions makes comparisons between studies difficult. The aim of this program of research is to develop the Guideline for Reporting EBP Educational interventions and Teaching (GREET) statement and an accompanying explanation and elaboration (E&E) paper. METHODS/DESIGN: Three stages are planned for the development process. Stage one will comprise a systematic review to identify features commonly reported in descriptions of EBP educational interventions. In stage two, corresponding authors of articles included in the systematic review and the editors of the journals in which these studies were published will be invited to participate in a Delphi process to reach consensus on items to be considered when reporting EBP educational interventions. The final stage of the project will include the development and pilot testing of the GREET statement and E&E paper. OUTCOME: The final outcome will be the creation of a Guideline for Reporting EBP Educational interventions and Teaching (GREET) statement and E&E paper. DISCUSSION: The reporting of health research including EBP educational research interventions, have been criticised for a lack of transparency and completeness. The development of the GREET statement will enable the standardised reporting of EBP educational research. This will provide a guide for researchers, reviewers and publishers for reporting EBP educational interventions.

Experience with intraoperative radiation therapy in an urban cancer center.

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).

The prevention and treatment of breast cancer- related lymphedema: A review.

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.

Evidence-based practice profiles of physiotherapists transitioning into the workforce: a study of two cohorts.

BACKGROUND: Training in the five steps of evidence-based practice (EBP) has been recommended for inclusion in entry-level health professional training. The effectiveness of EBP education has been explored predominantly in the medical and nursing professions and more commonly in post-graduate than entry-level students. Few studies have investigated longitudinal changes in EBP attitudes and behaviours. This study aimed to assess the changes in EBP knowledge, attitudes and behaviours in entry-level physiotherapy students transitioning into the workforce. METHODS: A prospective, observational, longitudinal design was used, with two cohorts. From 2008, 29 participants were tested in their final year in a physiotherapy program, and after the first and second workforce years. From 2009, 76 participants were tested in their final entry-level and first workforce years. Participants completed an Evidence-Based Practice Profile questionnaire (EBP2), which includes self-report EBP domains [Relevance, Terminology (knowledge of EBP concepts), Confidence, Practice (EBP implementation), Sympathy (disposition towards EBP)]. Mixed model analysis with sequential Bonferroni adjustment was used to analyse the matched data. Effect sizes (ES) (95% CI) were calculated for all changes. RESULTS: Effect sizes of the changes in EBP domains were small (ES range 0.02 to 0.42). While most changes were not significant there was a consistent pattern of decline in scores for Relevance in the first workforce year (ES -0.42 to -0.29) followed by an improvement in the second year (ES +0.27). Scores in Terminology improved (ES +0.19 to +0.26) in each of the first two workforce years, while Practice scores declined (ES -0.23 to -0.19) in the first year and improved minimally in the second year (ES +0.04). Confidence scores improved during the second workforce year (ES +0.27). Scores for Sympathy showed little change. CONCLUSIONS: During the first two years in the workforce, there was a transitory decline in the self-reported practice and sense of relevance of EBP, despite increases in confidence and knowledge. The pattern of progression of EBP skills beyond these early professional working years is unknown.

Prevention of Breast Cancer-Related Lymphedema.

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.

A novel blinding protocol to test participant and therapist blinding during dry needling: a randomised controlled experiment.

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/.

A collaborative experiential problem-solving approach to develop shams for complex physical interventions: a case study of dry needling.

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.