The Quality Improvement Review Board: An Innovative Approach to Oversight of Projects That Do Not Meet Criteria of Human Subject Research.

This article describes the development of an institutional quality improvement review board (QIRB) as an effective and efficient method for reviewing and overseeing institutional quality improvement (QI) initiatives. QI projects involve the systematic collection and analysis of data and the implementation of interventions designed to improve the quality of clinical care and/or educational programs for a distinct population in a specific setting. QI projects are fundamentally distinct from human subjects research (HuSR); however, the differences between them are subtle and highly nuanced. Determining whether a project meets the definition of QI or qualifies as HuSR, thus requiring institutional review board (IRB) review, can be confusing and frustrating. Nevertheless, this distinction is highly consequential due to the heavy regulatory requirements involved in HuSR and IRB oversight. Making the correct determination of a project's regulatory status is essential before the project begins. Project leaders may not realize that their work meets the definition of HuSR and, therefore, might conduct the project without appropriate IRB review. Therefore, best practices dictate that project leaders should not decide which type of institutional review is appropriate for their projects. In addition, when QI project teams attempt to disseminate the results of their work, documentation of formal review and approval is generally required by peer-reviewed journals and professional organizations. However, institutional review mechanisms are rarely available. Projects that do not meet the definition of HuSR fall outside the purview of IRBs and most institutions do not have an alternative review body. This creates frustration for both project leaders and IRB administrators. Apart from IRB review, a separate process for reviewing QI projects offers several benefits. These include (1) relieving the burden on busy IRB staff; (2) promoting scholarly activity; (3) protecting the institution, project leaders, and participants from HuSR conducted outside of appropriate IRB review; and (4) promoting rigorous QI methods.

The role of Doctor of Nursing Practice programs' mission, vision, and values statements in the development of students' professional identity: A qualitative study.

OBJECTIVES: The effectiveness of university and program mission, vision, and values statements in shaping Doctor in Nursing Practice (DNP) programs' curricula and their students' professional identity is insufficiently understood. DESIGN: This qualitative research project explored how these statements inform DNP program curricula and contribute to the development of the professional identity of students SETTING: Three DNP programs in the U.S. American Midwest participated in this research. PARTICIPANTS: Participants included students, alumni, and faculty from these three programs. METHODS: 33 semi-structured interviews were conducted. The transcriptions were analyzed, using the Grounded Theory approach, and the results were interpreted in light of the statements of participating programs. RESULTS: While a wide range of themes related to interviewees' professional identity was identified, it became apparent that students' professional identity is centered on (1) being citizens engaged in social, democratic, and political processes, (2) building caring relationships and communities, and (3) addressing health inequities. Such priorities are explicitly aligned with the statements of participating programs. CONCLUSIONS: The results (1) highlight the potential of statements to foster students' development of a professional identity as DNPs and (2) underscore that this identity is aligned with nursing programs' specific mission and values.

Clinical Practice Guideline for Best Practice Management of Pediatric Patients by Chiropractors: Results of a Delphi Consensus Process.

Objective: To build upon existing recommendations on best practices for chiropractic management of children by conducting a formal consensus process and best evidence synthesis. Design: Best practice guide based on recommendations from current best available evidence and formal consensus of a panel of experienced practitioners, consumers, and experts for chiropractic management of pediatric patients. Methods: Synthesis of results of a literature search to inform the development of recommendations from a multidisciplinary steering committee, including experts in pediatrics, followed by a formal Delphi panel consensus process. Results: The consensus process was conducted June to August 2022. All 60 panelists completed the process and reached at least 80% consensus on all recommendations after three Delphi rounds. Recommendations for best practices for chiropractic care for children addressed these aspects of the clinical encounter: patient communication, including informed consent; appropriate clinical history, including health habits; appropriate physical examination procedures; red flags/contraindications to chiropractic care and/or spinal manipulation; aspects of chiropractic management of pediatric patients, including infants; modifications of spinal manipulation and other manual procedures for pediatric patients; appropriate referral and comanagement; and appropriate health promotion and disease prevention practices. Conclusion: This set of recommendations represents a general framework for an evidence-informed and reasonable approach to the management of pediatric patients by chiropractors.

RTA1 Is Involved in Resistance to 7-Aminocholesterol and Secretion of Fungal Proteins in Cryptococcus neoformans.

Cryptococcus neoformans (Cn) is a pathogenic yeast that is the leading cause of fungal meningitis in immunocompromised patients. Various Cn virulence factors, such as the enzyme laccase and its product melanin, phospholipase, and capsular polysaccharide have been identified. During a screen of knockout mutants, the gene resistance to aminocholesterol 1 (RTA1) was identified, the function of which is currently unknown in Cn. Rta1 homologs in S. cerevisiae belong to a lipid-translocating exporter family of fungal proteins with transmembrane regions and confer resistance to the antimicrobial agent 7-aminocholesterol when overexpressed. To determine the role of RTA1 in Cn, the knock-out (rta1Δ) and reconstituted (rta1Δ+RTA1) strains were created and phenotypically tested. RTA1 was involved in resistance to 7-aminocholesterol, and also in exocyst complex component 3 (Sec6)-mediated secretion of urease, laccase, and the major capsule component, glucuronoxylomannan (GXM), which coincided with significantly smaller capsules in the rta1Δ and rta1Δ+RTA1 strains compared to the wild-type H99 strain. Furthermore, RTA1 expression was reduced in a secretory 14 mutant (sec14Δ) and increased in an RNAi Sec6 mutant. Transmission electron microscopy demonstrated vesicle accumulation inside the rta1Δ strain, predominantly near the cell membrane. Given that Rta1 is likely to be a transmembrane protein located at the plasma membrane, these data suggest that Rta1 may be involved in both secretion of various fungal virulence factors and resistance to 7-aminocholesterol in Cn.

Chiropractic program changes facilitated by the European Council on Chiropractic Education Accreditation reports.

OBJECTIVE: The European Council on Chiropractic Education (ECCE) currently accredits 10 programs throughout Europe and South Africa. It is assumed that ECCE evaluation activities lead to changes to the chiropractic programs but no systematic evaluation as to whether this is true, and the extent of changes has previously been done. The purpose of this study was to obtain feedback from program heads as to whether ECCE evaluation reports facilitated changes/improvements to their programs and to identify their reported changes. METHODS: This was a mixed methods audit study using questionnaires with 2 sections. Closed statements requesting the degree of change to each section of the "Standards" based on ECCE evaluation reports (substantial, some, none) were analyzed using frequencies. Written responses identifying the specific changes made based on previous evaluation reports were evaluated independently by 3 researchers using a modified "thematic analysis" approach. RESULTS: All 10 accredited programs responded. Seven of the 10 programs (70%) reported "some" or "substantial" changes to ≥ 6 sections of the ECCE Standards. The most common section with reported changes was "Educational Program" (8 of 10). "Educational Resources" had the largest number of programs reporting "substantial changes" (4) and was the second most common section to have reported changes. The main themes identified emphasized changes in "infrastructure, equipment and faculty," "increasing evidence-based practice," and "instilling a research culture in faculty and students." CONCLUSION: ECCE accreditation processes facilitate changes to the chiropractic programs, particularly in the areas of improved infrastructure and faculty, research, and evidence-based practice.

Is there any benefit to adding students to the European council on chiropractic education evaluation teams and general council? An audit of stakeholders.

Background: The European Council on Chiropractic Education (ECCE) is currently the only chiropractic specific accrediting body in the world to include students as equal members on Council and accreditation evaluation teams. Therefore, the purpose of this study is to evaluate feedback from four ECCE stakeholder groups regarding the effectiveness of chiropractic students on ECCE General Council and evaluation teams. Methods: This was a mixed-methods audit using questionnaires including closed statements requesting level of agreement and open-ended statements requesting written responses. The proportion of responses falling into the five categorical options for level of agreement was calculated for each questionnaire using descriptive statistics. The analysis of the two statements per questionnaire requiring written responses used a modified 'thematic analysis' approach. Three researchers independently identified themes from the written responses. They then met to agree the final themes for each statement. Results: The response rates for the four questionnaires ranged from 87 to 100%. Feedback regarding 'Student members on General Council' was the least positive with 65% neutral or negative regarding 'students being prepared for meetings'. Feedback from stakeholders regarding use of students on evaluation teams was universally positive, ranging from 82.4-100% Strongly Agreeing or Agreeing with each closed statement.Themes were identified for each open statement. The unique contribution students make to evaluation teams was most common. General Council feedback identified 'lack of student preparation' and 'the short time period of student membership' as important themes. Conclusions: This study demonstrates the unique and positive contributions chiropractic students make to accreditation evaluation teams. The results were less positive concerning students on ECCE General Council due to the lack of specific training for their roles and the short time-frame of their membership. Therefore, the ECCE has created training workshops and expanded the time period for students on Council in order to address these issues.

Maternal Report of Outcomes of Chiropractic Care for Infants.

OBJECTIVE: The purpose of this study was to investigate the report by mothers of their infants' condition before and after a trial of care provided by registered chiropractic clinicians in addition to ratings of satisfaction, cost of care, and reports of any adverse events or side effects. A second purpose was to report the demographic profile of infants who presented for care to 16 chiropractic clinics in the United Kingdom. METHODS: This observational study prospectively collected reports by mothers of their infants' demographic profiles and outcomes across several domains of infant behavior and their own mental state using the United Kingdom Infant Questionnaire. Participating registered chiropractors were recruited through the Royal College of Chiropractors annual meeting in January 2016, and 15 clinics and the Anglo-European College of Chiropractic University College teaching clinic volunteered to participate. RESULTS: In all, 2001 mothers completed intake questionnaires and 1092 completed follow-up forms. Statistically significant (P < .05) improvements were reported across all aspects of infant behavior studied, including feeding problems, sleep issues, excessive crying, problems with supine sleep position, infant pain, restricted cervical range of motion, and time performing prone positioning. Maternal ratings of depression, anxiety, and satisfaction with motherhood also demonstrated statistically significant improvement (P < .05). In total, 82% (n = 797) reported definite improvement of their infants on a global impression of change scale. As well, 95% (n = 475) reported feeling that the care was cost-effective, and 90.9% (n = 712) rated their satisfaction 8 or higher on an 11-point scale. Minor self-limiting side effects were reported (5.8%, n = 42/727) but no adverse events. CONCLUSION: In this study, mothers reported that chiropractic care for their infants was effective, safe, and cost-effective. Although the observational design makes it impossible to determine efficacy, the study's findings indicate that, on average, the changes observed by mothers were positive and may be clinically relevant.

Demographic Profile of Chiropractors Who Treat Children: A Multinational Survey.

OBJECTIVE: The purpose of this study was to survey the demographic profile and educational background of chiropractors with pediatric patients on a multinational scale. METHODS: A multinational online cross-sectional demographic survey conducted over a 15-day period in July 2010. The survey was electronically administered via chiropractic associations in 17 countries, using SurveyMonkey for data acquisition, transfer, and descriptive analysis. RESULTS: The response rate was 10.1%, and 1498 responses were received from 17 countries on 6 continents. Of these, 90.4% accepted pediatric cases. The average practitioner was male (61.1%) and 41.4 years old, had 13.6 years in practice, and saw 107 patient visits per week. Regarding educational background, 63.4% had a bachelor's degree or higher in addition to their chiropractic qualification, and 18.4% had a postgraduate certificate or higher in pediatric chiropractic. CONCLUSION: This is the first study about chiropractors who treat children from the United Arab Emirates, Peru, Japan, South Africa, and Spain. Although the response rate was low, the results of this multinational survey suggest that pediatric chiropractic care may be a common component of usual chiropractic practice on a multinational level for these respondents.

Caring in the Margins: A Scholarship of Accompaniment for Advanced Transcultural Nursing Practice.

Nurses must learn essential skills based in transcultural nursing to address issues of equity and social justice. The development of a model for nursing practice for an urban nurse-led drop-in center for individuals experiencing marginalization provides an opportunity for student nurses to learn transcultural nursing skills that shifts care from acknowledging the need of others to accompanying others on their health journey. The practice model provides the opportunity for undergraduate and graduate nursing students at Augsburg University to de-emphasize tasks and build relationships. Students learn to listen to others' stories and acknowledge their struggles in the margins. Four stages of nursing practice skills, acknowledging others' needs, attending to their struggles, affirming strengths, and ultimately accompanying others, are taught and experienced. At the core of the nursing practice model is the concept of "hospitality." The nursing practice model serves as guide for student nurses to learn to suspend disbeliefs, withhold judgment, and ultimately reduce stereotypes and stigma to offer a safe space for individuals living in the margins seeking care. The future of nursing requires essential knowledge, skills, and attitudes that shift care from need-based care to accompaniment to address health inequities and provide culturally appropriate care.

The Citizen Nurse: An Educational Innovation for Change.

BACKGROUND: Nursing education needs to provide the necessary tools for students to develop leadership skills and to practice civic agency to create meaningful change in the shifting health care field. This article focuses on facilitating a student's role in becoming a citizen nurse through curricular modifications. METHOD: Through an ongoing partnership, nursing faculty and community organizers implemented a year-long pilot project to discover the deeper insights into the role of a citizen nurse and to analyze the skills students need to be effective agents of change. Pilot lectures and workshops were held throughout the academic year, and curricular changes were implemented. RESULTS: Based on input from pilot class experiences, student reflections, and faculty workshop feedback, the decision to implement ongoing curricular changes was made by the department. CONCLUSION: The development of citizen nurses in nursing education will pave the way for praxis embedded in meaningful work with just solutions, enhancing the agency of all involved in promoting health and well-being. [J Nurs Educ. 2017;56(4):247-250.].

Parent Reports of Exclusive Breastfeeding After Attending a Combined Midwifery and Chiropractic Feeding Clinic in the United Kingdom: A Cross-Sectional Service Evaluation.

This service evaluation investigated an interdisciplinary allied professional health care strategy to address the problem of suboptimal breastfeeding. A clinic of midwives and chiropractors was developed in a university-affiliated clinic in the United Kingdom to care for suboptimal feeding through a multidisciplinary approach. No studies have previously investigated the effect of such an approach. The aim was to assess any impact to the breastfeeding dyad and maternal satisfaction after attending the multidisciplinary clinic through a service evaluation. Eighty-five initial questionnaires were completed and 72 (85%) follow-up questionnaires were returned. On follow-up, 93% of mothers reported an improvement in feeding as well as satisfaction with the care provided. Prior to treatment, 26% of the infants were exclusively breastfed. At the follow-up survey, 86% of mothers reported exclusive breastfeeding. The relative risk ratio for exclusive breastfeeding after attending the multidisciplinary clinic was 3.6 (95% confidence interval = 2.4-5.4).

3D Plant cell architecture of Arabidopsis thaliana (Brassicaceae) using focused ion beam-scanning electron microscopy.

PREMISE OF THE STUDY: Focused ion beam-scanning electron microscopy (FIB-SEM) combines the ability to sequentially mill the sample surface and obtain SEM images that can be used to create 3D renderings with micron-level resolution. We have applied FIB-SEM to study Arabidopsis cell architecture. The goal was to determine the efficacy of this technique in plant tissue and cellular studies and to demonstrate its usefulness in studying cell and organelle architecture and distribution. • METHODS: Seed aleurone, leaf mesophyll, stem cortex, root cortex, and petal lamina from Arabidopsis were fixed and embedded for electron microscopy using protocols developed for animal tissues and modified for use with plant cells. Each sample was sectioned using the FIB and imaged with SEM. These serial images were assembled to produce 3D renderings of each cell type. • RESULTS: Organelles such as nuclei and chloroplasts were easily identifiable, and other structures such as endoplasmic reticula, lipid bodies, and starch grains were distinguishable in each tissue. • DISCUSSION: The application of FIB-SEM produced 3D renderings of five plant cell types and offered unique views of their shapes and internal content. These results demonstrate the usefulness of FIB-SEM for organelle distribution and cell architecture studies.

Risk factors associated with breast lymphedema.

BACKGROUND: The development of breast lymphedema (BLE) after breast/axillary surgery is poorly characterized. We prospectively evaluated clinical and surgical factors associated with development of BLE. METHODS: Patients undergoing unilateral breast-conserving surgery were prospectively enrolled preoperatively and followed for development of BLE. To augment the number of patients with BLE for evaluation of risk factors, postoperative patients identified in the clinic with signs and symptoms of BLE were also enrolled. Logistic regression with Firth's penalized likelihood bias-reduction method was used for univariate and multivariate analysis. RESULTS: Of 144 women, 124 were enrolled preoperatively (38 of whom developed BLE), and 20 women with BLE were enrolled postoperatively. Any type of axillary surgery was the strongest factor associated with BLE (odds ratio, 134; 95 % confidence interval, 18 to >1,000). All 58 BLE events occurred in women with axillary surgery as compared with no events in the 46 patients without axillary surgery (p < 0.0001). Among 98 women who underwent axillary surgery, BLE did not occur more often after axillary lymph node dissection versus sentinel lymph node biopsy (p = 0.38) and was not associated with total number of nodes removed (p = 0.52). In multivariate analysis, factors associated with the development of BLE in the axillary surgery subgroup included baseline BMI (p = 0.004), incision location (p = 0.009), and prior surgical biopsy (p = 0.01). CONCLUSIONS: Risk of BLE is primarily related to performance of any axillary surgery but not the extent of axillary surgery or number of lymph nodes removed. Other factors associated with BLE were increased body mass index, incision location, and prior surgical excisional biopsy.

Students' perceptions of holistic nursing care.

AIM: This qualitative study aimed to investigate the trends and perceptions related to the provision of spiritual care for patients. BACKGROUND: Holistic nursing integrates the body, mind, and spirit into care. However, nursing students from a traditional program, an RN-BSN program, and a graduate nurse practitioner program voiced discomfort with providing such spiritual care. METHOD: The study was a retrospective review of a convenience sample of journal entries about specific questions of how and when three groups of students developed ideas and concepts about spirituality. RESULTS: Students embraced the idea of spirituality connected to their experiences. As students developed as registered nurses, their manner of including spirituality mirrored Benner's model. CONCLUSION: Additional education is needed for professional nurses concerning spirituality and the provision of spiritual care in a holistic manner.

Use of complementary and alternative medicine by children in Europe: published data and expert perspectives.

INTRODUCTION: Few data document the use of complementary and alternative medicine (CAM) in Europe, with even fewer investigating use by children. METHODS: A narrative, non-systematic review of CAM use in Europe was performed by combining data from published surveys with expert perspectives. Limitations created by a lack of representative studies, varying definitions of CAM use, and what qualifies as CAM in different countries was partially overcome by integrating local experts to summarise information available only in the national language and provide their perspectives about CAM availability, quality, use and popularity in their countries using a semi-structured questionnaire. Local and international published surveys were summarised, and the prevalence of CAM use was extrapolated. RESULTS: Data from 20 European countries were available, representing 69% of the European population. Some data about CAM use by the general population were available for 90% of the examined countries, whereas peer-reviewed published surveys were available for only 60%. We extrapolated that 56% (range: 10-90%, adjusted for population size) of the European population in general had used CAM at least once in the past year. Surveys in CAM use by children were available for 55% of the investigated countries. The extrapolated prevalence of CAM use by children in Europe was 52% (range: 5-90%, adjusted for population size). Paediatric CAM experts reported an increasing awareness for and use of CAM in healthcare institutions. CONCLUSION: This precursor for further surveys indicates that CAM appears to be popular not only among adults in Europe, but also for children. Development of a pan-European definition of CAM use and CAM therapies are required to achieve surveys comparable between European countries. Additionally, more research investigating the efficacy and potential adverse effects of CAM therapies is needed because of increasing CAM use by children in Europe.

Randomized controlled trial to reduce bacterial colonization of surgical drains after breast and axillary operations.

OBJECTIVE: To determine whether bacterial colonization of drains can be reduced by local antiseptic interventions. BACKGROUND: Drains are a potential source of bacterial entry into surgical wounds and may contribute to surgical site infection after breast surgery. METHODS: After institutional review board approval, patients undergoing total mastectomy and/or axillary lymph node dissection were randomized to standard drain care (control) or drain antisepsis (treated). Standard drain care comprised twice daily cleansing with alcohol swabs. Antisepsis drain care included (1) a chlorhexidine disc at the drain exit site and (2) irrigation of the drain bulb twice daily with dilute sodium hypochlorite (Dakin's) solution. Culture results of drain fluid and tubing were compared between control and antisepsis groups. RESULTS: Overall, 100 patients with 125 drains completed the study with 48 patients (58 drains) in the control group and 52 patients (67 drains) in the antisepsis group. Cultures of drain bulb fluid at 1 week were positive (1+ or greater growth) in 66% (38/58) of control drains compared with 21% (14/67) of antisepsis drains (P = 0.0001). Drain tubing cultures demonstrated more than 50 colony-forming units in 19% (8/43) of control drains versus 0% (0/53) of treated drains (P = 0.004). Surgical site infection was diagnosed in 6 patients (6%)--5 patients in the control group and 1 patient in the antisepsis group (P = 0.06). CONCLUSIONS: Simple and inexpensive local antiseptic interventions with a chlorhexidine disc and hypochlorite solution reduce bacterial colonization of drains. Based on these data, further study of drain antisepsis and its potential impact on surgical site infection rate is warranted (ClinicalTrials.gov Identifier: NCT01286168).

Manipulative therapies for infantile colic.

BACKGROUND: Infantile colic is a common disorder, affecting around one in six families, and in 2001 was reported to cost the UK National Health Service in excess of £65 million per year (Morris 2001). Although it usually remits by six months of age, there is some evidence of longer-term sequelae for both children and parents.Manipulative therapies, such as chiropractic and osteopathy, have been suggested as interventions to reduce the severity of symptoms. OBJECTIVES: To evaluate the results of studies designed to address efficacy or effectiveness of manipulative therapies (specifically, chiropractic, osteopathy and cranial manipulation) for infantile colic in infants less than six months of age. SEARCH METHODS: We searched following databases: CENTRAL (2012, Issue 4), MEDLINE (1948 to April Week 3 2012), EMBASE (1980 to 2012 Week 17), CINAHL (1938 to April 2012), PsycINFO (1806 to April 2012), Science Citation Index (1970 to April 2012), Social Science Citation Index (1970 to April 2012), Conference Proceedings Citation Index - Science (1990 to April 2012) and Conference Proceedings Citation Index - Social Science & Humanities (1970 to April 2012). We also searched all available years of LILACS, PEDro, ZETOC, WorldCat, TROVE, DART-Europe, ClinicalTrials.gov and ICTRP (May 2012), and contacted over 90 chiropractic and osteopathic institutions around the world. In addition, we searched CentreWatch, NRR Archive and UKCRN in December 2010. SELECTION CRITERIA: Randomised trials evaluating the effect of chiropractic, osteopathy or cranial osteopathy alone or in conjunction with other interventions for the treatment of infantile colic. DATA COLLECTION AND ANALYSIS: In pairs, five of the review authors (a) assessed the eligibility of studies against the inclusion criteria, (b) extracted data from the included studies and (c) assessed the risk of bias for all included studies. Each article or study was assessed independently by two review authors. One review author entered the data into Review Manager software and the team's statistician (PP) reviewed the chosen analytical settings. MAIN RESULTS: We identified six studies for inclusion in our review, representing a total of 325 infants. There were three further studies that we could not find information about and we identified three other ongoing studies. Of the six included studies, five were suggestive of a beneficial effect and one found no evidence that manipulative therapies had any beneficial effect on the natural course of infantile colic. Tests for heterogeneity imply that there may be some underlying difference between this study and the other five.Five studies measured daily hours of crying and these data were combined, suggesting that manipulative therapies had a significant effect on infant colic - reducing average crying time by one hour and 12 minutes per day (mean difference (MD) -1.20; 95% confidence interval (CI) -1.89 to -0.51). This conclusion is sustained even when considering only studies with a low risk of selection bias (sequence generation and allocation concealment) (MD -1.24; 95% CI -2.16 to -0.33); those with a low risk of attrition bias (MD -1.95; 95% CI -2.96 to -0.94), or only those studies that have been published in the peer-reviewed literature (MD -1.01; 95% CI -1.78 to -0.24). However, when combining only those studies with a low risk of performance bias (parental 'blinding'), the improvement in daily crying hours was not statistically significant (MD -0.57; 95% CI -2.24 to 1.09).One study considered whether the reduction in crying time was clinically significant. This found that a greater proportion of parents of infants receiving a manipulative therapy reported clinically significant improvements than did parents of those receiving no treatment (reduction in crying to less than two hours: odds ratio (OR) 6.33; 95% CI 1.54 to 26.00; more than 30% reduction in crying: OR 3.70; 95% CI 1.15 to 11.86).Analysis of data from three studies that measured 'full recovery' from colic as reported by parents found that manipulative therapies did not result in significantly higher proportions of parents reporting recovery (OR 11.12; 95% CI 0.46 to 267.52).One study measured infant sleeping time and found manipulative therapy resulted in statistically significant improvement (MD 1.17; 95% CI 0.22 to 2.12).The quality of the studies was variable. There was a generally low risk of selection bias but only two of the six studies were evaluated as being at low risk of performance bias, three at low risk of detection bias and one at low risk of attrition bias.One of the studies recorded adverse events and none were encountered. However, with only a sample of 325 infants, we have too few data to reach any definitive conclusions about safety. AUTHORS' CONCLUSIONS: The studies included in this meta-analysis were generally small and methodologically prone to bias, which makes it impossible to arrive at a definitive conclusion about the effectiveness of manipulative therapies for infantile colic.The majority of the included trials appeared to indicate that the parents of infants receiving manipulative therapies reported fewer hours crying per day than parents whose infants did not, based on contemporaneous crying diaries, and this difference was statistically significant. The trials also indicate that a greater proportion of those parents reported improvements that were clinically significant. However, most studies had a high risk of performance bias due to the fact that the assessors (parents) were not blind to who had received the intervention. When combining only those trials with a low risk of such performance bias, the results did not reach statistical significance. Further research is required where those assessing the treatment outcomes do not know whether or not the infant has received a manipulative therapy.There are inadequate data to reach any definitive conclusions about the safety of these interventions.

Efficacy of chiropractic manual therapy on infant colic: a pragmatic single-blind, randomized controlled trial.

OBJECTIVE: The purpose of this study was to determine the efficacy of chiropractic manual therapy for infants with unexplained crying behavior and if there was any effect of parental reporting bias. METHODS: Infants with unexplained persistent crying (infant colic) were recruited between October 2007 and November 2009 at a chiropractic teaching clinic in the United Kingdom. Infants younger than 8 weeks were randomized to 1 of 3 groups: (i) infant treated, parent aware; (ii) infant treated, parent unaware; and (iii) infant not treated, parent unaware. The primary outcome was a daily crying diary completed by parents over a period of 10 days. Treatments were pragmatic, individualized to examination findings, and consisted of chiropractic manual therapy of the spine. Analysis of covariance was used to investigate differences between groups. RESULTS: One hundred four patients were randomized. In parents blinded to treatment allocation, using 2 or less hours of crying per day to determine a clinically significant improvement in crying time, the increased odds of improvement in treated infants compared with those not receiving treatment were statistically significant at day 8 (adjusted odds ratio [OR], 8.1; 95% confidence interval [CI], 1.4-45.0) and at day 10 (adjusted OR, 11.8; 95% CI, 2.1-68.3). The number needed to treat was 3. In contrast, the odds of improvement in treated infants were not significantly different in blinded compared with nonblinded parents (adjusted ORs, 0.7 [95% CI, 0.2-2.0] and 0.5 [95% CI, 0.1-1.6] at days 8 and 10, respectively). CONCLUSIONS: In this study, chiropractic manual therapy improved crying behavior in infants with colic. The findings showed that knowledge of treatment by the parent did not appear to contribute to the observed treatment effects in this study. Thus, it is unlikely that observed treatment effect is due to bias on the part of the reporting parent.

A prospective study of breast lymphedema: frequency, symptoms, and quality of life.

Although lymphedema of the arm is a well-known complication of breast and axillary surgery, breast lymphedema has received scant attention. We sought to prospectively characterize breast lymphedema's incidence, associated symptoms, clinical course, and impact on quality of life. Subjects were enrolled prospectively from a consecutive sample of patients undergoing non-mastectomy breast procedures (excisional biopsy or wide local excision ± lymph node removal) and followed for signs and symptoms of lymphedema in the operated breast. Symptoms and distress were serially assessed with 11-point linear analog scales. Breast lymphedema was diagnosed independent of symptoms, based on the distribution and degree of edema and erythema. One hundred twenty-four women were followed for a median of 11 months, and breast lymphedema was diagnosed in 38 (31%) women. Breast lymphedema was more frequent after breast surgery with axillary node removal (49%) compared to breast surgery alone (0%), p < 0.0001. Breast lymphedema involved multiple quadrants in most women and was characterized by edema in 100% and erythema in 79%. Patients with breast lymphedema were significantly more likely than women without breast lymphedema to report symptoms of breast heaviness (65% vs 22%, p < 0.0001), redness (62% vs 29%, p = 0.0006), and swelling (59% vs 22%, p < 0.0001), but symptom-associated distress was low overall. Three of 32 breast lymphedema patients with clinical follow-up developed chronic edema. Breast lymphedema occurs in approximately one-half of women who undergo breast surgery with axillary node removal. The condition is characterized by diffuse skin edema and erythema as well as self-reported symptoms with a low level of distress.

Prognostic significance of subgroup classification for infant patients with crying disorders: A prospective cohort study.

INTRODUCTION: Few convincing treatment options have been identified for the excessively crying infant. One explanation may be a lack of identification of patient subgroups. This study used a clinically plausible categorization protocol to subgroup infants and compared changes in symptoms between these subgroups during treatment. METHODS: An observational cohort design was employed. All infants presenting with excessive infant crying between July 2007 and March 2008 were categorized into three subgroups, (A) infant colic, (B) irritable infant syndrome of musculoskeletal origin (IISMO) and (C) inefficient feeding crying infants with disordered sleep (IFCIDS) based on history and physical findings. Mothers completed questionnaires which rated their own and their child's characteristics prior to and at the end, of a course of manual therapy. Independent associations between infant subgroups and changes in continuous outcomes (crying, stress, sleep, and consolability) were assessed. Multivariable analysis of covariance was used to identify and control for potential confounders. RESULTS: A total of 158 infants were enrolled. There was no significant difference in demographic profile between groups or any significant difference in infant crying or level of maternal stress at the start. Only the putative subgroups were significantly associated with differences in outcomes. In general, colic babies improved the most in consolability and crying. CONCLUSION: Babies with excessive crying should not be viewed as a homogenous group. Treatment outcomes may be improved by targeting appropriate subgroups prior to treatment.