Delphi-consensus weights for ischemic and bleeding events to be included in a composite outcome for RCTs in thrombosis prevention

Background and Objectives

To weight ischemic and bleeding events according to their severity to be used in a composite outcome in RCTs in the field of thrombosis prevention.

Method

Using a Delphi consensus method, a panel of anaesthesiology and cardiology experts rated the severity of thrombotic and bleeding clinical events. The ratings were expressed on a 10-point scale. The median and quartiles of the ratings of each item were returned to the experts. Then, the panel members evaluated the events a second time with knowledge of the group responses from the first round. Cronbach''s a was used as a measure of homogeneity for the ratings. The final rating for each event corresponded to the median rating obtained at the last Delphi round.

Results

Of 70 experts invited, 32 (46%) accepted to participate. Consensus was reached at the second round as indicated by Cronbach''s a value (0.99 (95% CI 0.98-1.00)) so the Delphi was stopped. Severity ranged from under-popliteal venous thrombosis (median = 3, Q1 = 2; Q3 = 3) to ischemic stroke or intracerebral hemorrhage with severe disability at 7 days and massive pulmonary embolism (median = 9, Q1 = 9; Q3 = 9). Ratings did not differ according to the medical specialty of experts.

Conclusions

These ratings could be used to weight ischemic and bleeding events of various severity comprising a composite outcome in the field of thrombosis prevention.     

Quality Indicators for Continuous Monitoring to Improve Maternal and Infant Health in Maternity Departments: A Modified Delphi Survey of an International Multidisciplinary Panel

Objective

Measuring the quality of inpatient obstetrical care using quality indicators is becoming increasingly important for both patients and healthcare providers. However, there is no consensus about which measures are optimal. We describe a modified Delphi method to identify a set of indicators for continuously monitoring the quality of maternity care by healthcare professionals.

Methodology and Main Findings

An international French-speaking multidisciplinary panel comprising 22 obstetricians-gynaecologists, 12 midwives, and 1 paediatrician assessed potential indicators extracted from a medical literature search, using a two-round Delphi procedure followed by a physical meeting. Each panellist rated each indicator based on validity and feasibility. In the first round, 35 panellists from 5 countries and 20 maternity units evaluated 26 indicators including 15 related to the management of the overall population of pregnant women, 3 to the management of women followed from the first trimester of pregnancy, 2 to the management of low-risk pregnant women, and 6 to the management of neonates. 25 quality indicators were kept for next step. In the second round, 27 (27/35: 77%) panellists selected 17 indicators; the remaining 8 indicators were discussed during a physical meeting. The final set comprised 18 indicators.

Conclusion

A multidisciplinary panel selected indicators that reflect the quality of obstetrical care. This set of indicators could be used to assess and monitor obstetrical care, with the goal of improving the quality of care in maternity units.     

Monitoring Vital Signs: Development of a Modified Early Warning Scoring (Mews) System for General Wards in a Developing Country

Objective

The aim of the study was to develop and validate, by consensus, the construct and content of an observations chart for nurses incorporating a modified early warning scoring (MEWS) system for physiological parameters to be used for bedside monitoring on general wards in a public hospital in South Africa.

Methods

Delphi and modified face-to-face nominal group consensus methods were used to develop and validate a prototype observations chart that incorporated an existing UK MEWS. This informed the development of the Cape Town ward MEWS chart.

Participants

One specialist anaesthesiologist, one emergency medicine specialist, two critical care nurses and eight senior ward nurses with expertise in bedside monitoring (N = 12) were purposively sampled for consensus development of the MEWS. One general surgeon declined and one neurosurgeon replaced the emergency medicine specialist in the final round.

Results

Five consensus rounds achieved ≥70% agreement for cut points in five of seven physiological parameters respiratory and heart rates, systolic BP, temperature and urine output. For conscious level and oxygen saturation a relaxed rule of <70% agreement was applied. A reporting algorithm was established and incorporated in the MEWS chart representing decision rules determining the degree of urgency. Parameters and cut points differed from those in MEWS used in developed countries.

Conclusions

A MEWS for developing countries should record at least seven parameters. Experts from developing countries are best placed to stipulate cut points in physiological parameters. Further research is needed to explore the ability of the MEWS chart to identify physiological and clinical deterioration.     

Control of allergic rhinitis and asthma test – a formal approach to the development of a measuring tool

Background

The concurrent management of allergic rhinitis and asthma (ARA) has been recommended by Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines. However, a tool capable of assessing simultaneously the control of upper and lower airways diseases is lacking.

Aim

To describe the studies conducted to design the control of ARA test (CARAT) questionnaire.

Methods

We performed a literature review to generate a list of potentially important items for the assessment of control of ARA. A formal consensus development process, that used an innovative web-based application, was designed – 111 experts in ARA and 60 patients participated. At the final consensus meeting, 25 primary and secondary care physicians formulated the questions and response options. A qualitative feasibility study (n = 31 patients) was conducted to evaluate the comprehensibility of the questionnaire while testing two different designs.

Results

Thirty-four potentially important items were identified. All the steps of the consensus process were completed in 2.5 months. The opinions of experts and patients lead to the formulation of 17 questions. At the feasibility study the instructions and wording problems were corrected and a semi-tabular format was chosen.

Conclusion

A tool to measure the control of allergic rhinitis and asthma was developed using a comprehensive set of methodological steps ensuring the design quality and the face and content validity. Additional validation studies to assess the psychometric properties of the questionnaire have started.     

Development of a Core Set of Outcomes for Randomized Controlled Trials with Multiple Outcomes – Example of Pulp Treatments of Primary Teeth for Extensive Decay in Children

Objectives

Evidence-based comparisons of interventions can be challenging because of the diversity of outcomes in randomized controlled trials (RCTs). We aimed to describe outcomes in RCTs assessing pulp treatments for primary teeth and to develop a core set of component outcomes to be part of composite outcome defining the failure of a pulp treatment.

Methods

We systematically reviewed articles of RCTs comparing pulp treatments for primary molars published up to February 2012. We abstracted all outcomes assessed in each trial, then used a small-group consensus process to group similar outcomes, which were reduced to a composite outcome of failure of a pulp treatment by a 3-round Delphi process involving expert authors and dentists.

Results

We included 47 reports of RCTs in the review, for 83 reported outcomes (median 11 outcomes per RCT). These outcomes were grouped into 24 overarching outcome categories. We contacted 210 experts for the Delphi process and 25% to 30% participated. The process identified the following 5 component outcomes as part of a composite outcome of failure of a pulp treatment: soft-tissue pathology, pain, pathologic mobility, pathologic radiolucency and pathologic root resorption.

Conclusions

RCTs of pulp treatments for primary teeth investigate diverse outcomes. Our consensus process, involving clinicians but no patient, allowed for compiling a core set of component outcomes to define the composite outcome failure of a pulp treatment for primary teeth.     

Establishing a minimum dataset for prospective registration of systematic reviews: an international consultation

Background

In response to growing recognition of the value of prospective registration of systematic review protocols, we planned to develop a web-based open access international register. In order for the register to fulfil its aims of reducing unplanned duplication, reducing publication bias, and providing greater transparency, it was important to ensure the appropriate data were collected. We therefore undertook a consultation process with experts in the field to identify a minimum dataset for registration.

Methods and Findings

A two-round electronic modified Delphi survey design was used. The international panel surveyed included experts from areas relevant to systematic review including commissioners, clinical and academic researchers, methodologists, statisticians, information specialists, journal editors and users of systematic reviews. Direct invitations to participate were sent out to 315 people in the first round and 322 in the second round. Responses to an open invitation to participate were collected separately. There were 194 (143 invited and 51 open) respondents with a 100% completion rate in the first round and 209 (169 invited and 40 open) respondents with a 91% completion rate in the second round. In the second round, 113 (54%) of the participants reported having previously taken part in the first round. Participants were asked to indicate whether a series of potential items should be designated as optional or required registration items, or should not be included in the register. After the second round, a 70% or greater agreement was reached on the designation of 30 of 36 items.

Conclusions

The results of the Delphi exercise have established a dataset of 22 required items for the prospective registration of systematic reviews, and 18 optional items. The dataset captures the key attributes of review design as well as the administrative details necessary for registration.     

Predictors of Recurrent Sickness Absence Due to Depressive Disorders – A Delphi Approach Involving Scientists and Physicians

Background

Depression is a common and highly recurrent mental disorder that is accompanied by poor functioning at home and at work. Not all depressed employees report sick and little is known about variables associated with sickness absence (SA) due to depression. Recurrent SA due to depression tends to marginalize employees from the workforce and exclude them from social participation. Therefore, this study sought group consensus on factors predicting recurrent SA due to depression.

Methodology/principal findings

23 scientists in the field of work and mental health and 23 physicians with expertise in assessing work disability were invited for a Delphi study. Sixty-seven factors retrieved from the literature were scored for their impact on the recurrence of SA due to depression, range 1 (no impact) to 10 (very high impact) in two Delphi rounds. The third Delphi round addressed the assessability and modifiability of elected predictors. Group consensus was defined as 75% agreement. In the first round (response 78%), group consensus was reached on a high impact of 13 factors on recurrent SA due to depression. The second round (response 79%) added another 8 factors with high impact on recurrent SA due to depression. The panelists were of the opinion that stressful life and work events, age at first diagnosis, duration of the last depressive episode, anxiety, lifetime number of depressive episodes, and psychological work demands were readily assessable in consultation with patients. Furthermore, work factors, particularly decision latitude, psychological job demands, and commitment to work, were recognized as modifiable.

Conclusions/significance

Although results have to be validated with further quantitative research, physicians may identify employees at risk of recurrent SA due to depression and may support them to adjust their work aimed at increasing commitment to work and preventing future SA due to depression.     

The Nijmegen Decision Tool for Chronic Low Back Pain. Development of a Clinical Decision Tool for Secondary or Tertiary Spine Care Specialists

Background

In Western Europe, low back pain has the greatest burden of all diseases. When back pain persists, different medical specialists are involved and a lack of consensus exists among these specialists for medical decision-making in Chronic Low Back Pain (CLBP).

Objective

To develop a decision tool for secondary or tertiary spine care specialists to decide which patients with CLBP should be seen by a spine surgeon or by other non-surgical medical specialists.

Methods

A Delphi study was performed to identify indicators predicting the outcome of interventions. In the preparatory stage evidence from international guidelines and literature were summarized. Eligible studies were reviews and longitudinal studies. Inclusion criteria: surgical or non-surgical interventions and persistence of complaints, CLBP-patients aged 18–65 years, reported baseline measures of predictive indicators, and one or more reported outcomes had to assess functional status, quality of life, pain intensity, employment status or a composite score. Subsequently, a three-round Delphi procedure, to reach consensus on candidate indicators, was performed among a multidisciplinary panel of 29 CLBP-professionals (>five years CLBP-experience). The pre-set threshold for general agreement was ≥70%. The final indicator set was used to develop a clinical decision tool.

Results

A draft list with 53 candidate indicators (38 with conclusive evidence and 15 with inconclusive evidence) was included for the Delphi study. Consensus was reached to include 47 indicators. A first version of the decision tool was developed, consisting of a web-based screening questionnaire and a provisional decision algorithm.

Conclusions

This is the first clinical decision tool based on current scientific evidence and formal multidisciplinary consensus that helps referring the patient for consultation to a spine surgeon or a non-surgical spine care specialist. We expect that this tool considerably helps in clinical decision-making spine care, thereby improving efficient use of scarce sources and the outcomes of spinal interventions.     

Determining Possible Professionals and Respective Roles and Responsibilities for a Model Comprehensive Elder Abuse Intervention: A Delphi Consensus Survey

Objective

We have undertaken a multi-phase, multi-method program of research to develop, implement, and evaluate a comprehensive hospital-based nurse examiner elder abuse intervention that addresses the complex functional, social, forensic, and medical needs of older women and men. In this study, we determined the importance of possible participating professionals and respective roles and responsibilities within the intervention.

Methods

Using a modified Delphi methodology, recommended professionals and their associated roles and responsibilities were generated from a systematic scoping review of relevant scholarly and grey literatures. These items were reviewed, new items added for review, and rated/re-rated for their importance to the intervention on a 5-point Likert scale by an expert panel during a one day in-person meeting. Items that did not achieve consensus were subsequently re-rated in an online survey.

Analysis

Those items that achieved a mean Likert rating of 4+ (rated important to very important), and an interquartile range<1 in the first or second round, and/or for which 80% of ratings were 4+ in the second round were retained for the model elder abuse intervention.

Results

Twenty-two of 31 recommended professionals and 192 of 229 recommended roles and responsibilities rated were retained for our model elder abuse intervention. Retained professionals were: public guardian and trustee (mean rating = 4.88), geriatrician (4.87), police officer (4.87), GEM (geriatric emergency management) nurse (4.80), GEM social worker (4.78), community health worker (4.76), social worker/counsellor (4.74), family physician in community (4.71), paramedic (4.65), financial worker (4.59), lawyer (4.59), pharmacist (4.59), emergency physician (4.57), geriatric psychiatrist (4.33), occupational therapist (4.29), family physician in hospital (4.28), Crown prosecutor (4.24), neuropsychologist (4.24), bioethicist (4.18), caregiver advocate (4.18), victim support worker (4.18), and respite care worker (4.12).

Conclusion

A large and diverse group of multidisciplinary, intersectoral collaborators was deemed necessary to address the complex needs of abused older adults, each having important roles and responsibilities to fulfill within a model comprehensive elder abuse intervention.     

Diagnostic utility of musculoskeletal ultrasound in patients with suspected arthritis – a probabilistic approach

Introduction

This study aimed to assess the utility of musculoskeletal ultrasound (MSUS) in patients with joint symptoms using a probabilistic approach.

Methods

One hundred and three patients without prior rheumatologic diagnosis and referred to our clinic for evaluation of inflammatory arthritis were included. Patients were assessed clinically including joint examination, laboratory testing including acute-phase reactants, rheumatoid factor (RF) and anti citrulinated protein antibody (ACPA), and radiographs of hands and feet if clinically indicated. A diagnostic assessment was then performed by the responsible rheumatologist where the probability of a) any inflammatory arthritis and b) rheumatoid arthritis was given on a 5-point scale ranging from 0 to 20% up to 80 to 100% probability. Subsequently, an ultrasound examination of the wrist, metacarpophalangeal (MCP), proximal interphalangeal (PIP) joints 2 to 5 in both hands, metatarsophalangeal (MTP) joints 2 to 5 in both feet and any symptomatic joints was performed and the results presented to the same rheumatologist. The latter then assessed the diagnostic probabilities again, using the same scale.

Results

The rheumatologists’ certainty for presence/absence of inflammatory arthritis and rheumatoid arthritis was increased significantly following ultrasound performance. The proportion of patient for whom diagnostic certainty for inflammatory arthritis was maximal was 33.0% before and 71.8% after musculoskeletal ultrasound (P <0.001). With regard to a diagnosis of RA, the proportions were 31.1% pre-test and 61.2% post-test (P <0.001). MSUS findings agreed with the final diagnosis in 95% of patients.

Conclusion

Musculoskeletal ultrasound, when added to routine rheumatologic investigation, greatly increases the diagnostic certainty in patients referred for the evaluation of inflammatory arthritis. The changes from pre-test to post-test probability quantify the diagnostic utility of musculoskeletal ultrasound in probabilistic terms.     

Agreement among health care professionals in diagnosing case Vignette-based surgical site infections

Objective

To assess agreement in diagnosing surgical site infection (SSI) among healthcare professionals involved in SSI surveillance.

Methods

Case-vignette study done in 2009 in 140 healthcare professionals from seven specialties (20 in each specialty, Anesthesiologists, Surgeons, Public health specialists, Infection control physicians, Infection control nurses, Infectious diseases specialists, Microbiologists) in 29 University and 36 non-University hospitals in France. We developed 40 case-vignettes based on cardiac and gastrointestinal surgery patients with suspected SSI. Each participant scored six randomly assigned case-vignettes before and after reading the SSI definition on an online secure relational database. The intraclass correlation coefficient (ICC) was used to assess agreement regarding SSI diagnosis on a seven-point Likert scale and the kappa coefficient to assess agreement for superficial or deep SSI on a three-point scale.

Results

Based on a consensus, SSI was present in 21 of 40 vignettes (52.5%). Intraspecialty agreement for SSI diagnosis ranged across specialties from 0.15 (95% confidence interval, 0.00–0.59) (anesthesiologists and infection control nurses) to 0.73 (0.32–0.90) (infectious diseases specialists). Reading the SSI definition improved agreement in the specialties with poor initial agreement. Intraspecialty agreement for superficial or deep SSI ranged from 0.10 (−0.19–0.38) to 0.54 (0.25–0.83) (surgeons) and increased after reading the SSI definition only among the infection control nurses from 0.10 (−0.19–0.38) to 0.41 (−0.09–0.72). Interspecialty agreement for SSI diagnosis was 0.36 (0.22–0.54) and increased to 0.47 (0.31–0.64) after reading the SSI definition.

Conclusion

Among healthcare professionals evaluating case-vignettes for possible surgical site infection, there was large disagreement in diagnosis that varied both between and within specialties.     

Development and Validation of a Questionnaire Assessing Fears and Beliefs of Patients with Knee Osteoarthritis: The Knee Osteoarthritis Fears and Beliefs Questionnaire (KOFBeQ)

Objective

We aimed to develop a questionnaire assessing fears and beliefs of patients with knee OA.

Design

We sent a detailed document reporting on a qualitative analysis of interviews of patients with knee OA to experts, and a Delphi procedure was adopted for item generation. Then, 80 physicians recruited 566 patients with knee OA to test the provisional questionnaire. Items were reduced according to their metric properties and exploratory factor analysis. Reliability was tested by the Cronbach α coefficient. Construct validity was tested by divergent validity and confirmatory factor analysis. Test–retest reliability was assessed by the intra-class correlation coefficient (ICC) and the Bland and Altman technique.

Results

137 items were extracted from analysis of the interview data. Three Delphi rounds were needed to obtain consensus on a 25-item provisional questionnaire. The item-reduction process resulted in an 11-item questionnaire. Selected items represented fears and beliefs about daily living activities (3 items), fears and beliefs about physicians (4 items), fears and beliefs about the disease (2 items), and fears and beliefs about sports and leisure activities (2 items). The Cronbach α coefficient of global score was 0.85. We observed expected divergent validity. Confirmation factor analyses confirmed higher intra-factor than inter-factor correlations. Test–retest reliability was good, with an ICC of 0.81, and Bland and Altman analysis did not reveal a systematic trend.

Conclusions

We propose an 11-item questionnaire assessing patients'' fears and beliefs concerning knee OA with good content and construct validity.     

Which Dimensions of Patient-Centeredness Matter? - Results of a Web-Based Expert Delphi Survey

Background

Present models and definitions of patient-centeredness revealed a lack of conceptual clarity. Based on a prior systematic literature review, we developed an integrative model with 15 dimensions of patient-centeredness. The aims of this study were to 1) validate, and 2) prioritize these dimensions.

Method

A two-round web-based Delphi study was conducted. 297 international experts were invited to participate. In round one they were asked to 1) give an individual rating on a nine-point-scale on relevance and clarity of the dimensions, 2) add missing dimensions, and 3) prioritize the dimensions. In round two, experts received feedback about the results of round one and were asked to reflect and re-rate their own results. The cut-off for the validation of a dimension was a median < 7 on one of the criteria.

Results

105 experts participated in round one and 71 in round two. In round one, one new dimension was suggested and included for discussion in round two. In round two, this dimension did not reach sufficient ratings to be included in the model. Eleven dimensions reached a median ≥ 7 on both criteria (relevance and clarity). Four dimensions had a median < 7 on one or both criteria. The five dimensions rated as most important were: patient as a unique person, patient involvement in care, patient information, clinician-patient communication and patient empowerment.

Discussion

11 out of the 15 dimensions have been validated through experts’ ratings. Further research on the four dimensions that received insufficient ratings is recommended. The priority order of the dimensions can help researchers and clinicians to focus on the most important dimensions of patient-centeredness. Overall, the model provides a useful framework that can be used in the development of measures, interventions, and medical education curricula, as well as the adoption of a new perspective in health policy.     

Autologous HIV-1 Clade-B Nef Peptides Elicit Increased Frequency,Breadth and Function of CD8+ T-Cells Compared to Consensus Peptides

Objective

To determine the function and phenotype of CD8⁺ T-cells targeting consensus and autologous sequences of entire HIV-1 Nef protein.

Methods

Multiparameter flow cytometry-based analysis was used to evaluate the responses of two treatment naïve HIV-infected individuals, during primary and the chronic phases of infection.

Results

A greater breadth and magnitude of CD8 IFN-γ responses to autologous compared to clade-B consensus peptides was observed in both subjects. Cross recognition between autologous and consensus peptides decreased in both subjects during progression from primary to chronic infection. The frequencies of TEMRA and TEM CD8⁺ T-cells targeting autologous peptides were higher than those targeting consensus peptides and were more polyfunctional (IFN-γ⁺ Gr-B⁺ CD107a⁺).

Conclusions

Our data indicate superior sensitivity and specificity of autologous peptides. The functional and maturational aspects of “real” versus “cross-recognized” responses were also found to differ, highlighting the importance of a sequence-specific approach towards understanding HIV immune response.     

Frequency of Retinopathy of Prematurity in Premature Neonates with a Birth Weight below 1500 Grams and a Gestational Age Less than 32 Weeks: A Study from a Tertiary Care Hospital in a Lower-Middle Income Country…

Introduction

Retinopathy of prematurity (ROP) is a treatable cause of blindness in neonates. In Pakistan, ROP is often not recognized early because screening and treatment programs are not yet in place in most neonatal units, even in tertiary care hospitals. It is hoped that this report will help inform medical professionals of the magnitude of the problem and help to design appropriate management strategies.

Objectives

The aim was to determine the frequency of ROP in premature and very low birth weight (BW) neonates (BW<1500 g and gestational age (GA) <32 weeks).

Study Design

Cross-sectional study.

Study Setting

Neonatal intensive care unit (NICU) of a tertiary care hospital in Karachi, Pakistan.

Study Duration

From June 2009 to May 2010.

Subjects and Methods

Neonates with a Birth weight (BW) <1500 g and Gestational Age (GA) <32 weeks who were admitted to the NICU and received an eye examination, or were referred for a ROP eye examination as an outpatient, were included in the study. GA was estimated from intrauterine ultrasound findings. Neonates with major congenital malformations, syndromes or congenital cataracts or tumors of the eyes, and those that died before the eye examination or did not attend the out patients department for an eye examination, were excluded. The neonatal eye examination was performed by a trained ophthalmologist at 4 or 6 weeks of age.

Results

Out of 86 neonates, ROP was identified in nine neonates (10.5%) at the first eye examination. ROP was significantly associated with BW (P = 0.037), GA (P = 0.033), and chronological age (P<0.001).

Conclusions

we identified ROP in 10.5% of neonates at first eye examination. Significant associations between ROP and a GA<32 weeks and a BW<1500 g were also observed.we also stress that serial follow-up of neonates at risk for ROP is important when making a final diagnosis.     

Developing an Internationally-Applicable Service Specification for Continence Care: Systematic Review,Evidence Synthesis and Expert Consensus

Background

Global demographic trends suggest that the incidence of both urinary and faecal incontinence will rise in the coming years, bringing significant health and economic implications for both patients and payers. There is limited organisational evidence to guide payers and providers about service configuration which will deliver efficient guideline-compliant, high-quality patient care.

Objectives

To create, using evidence from a systematic review, qualitative data and expert consensus an internationally applicable service specification for continence care.

Method

Evidence was obtained from a systematic and grey literature review of published randomised controlled trials and quasi-experimental studies reporting efficacy of continence service design at the level of the community dwelling patient with either bladder or bowel incontinence, governmental reports and policy frameworks supplemented by data from 47 semi-structured interviews with clinicians, patients, patient-representatives and policy experts from four geographies broadly representative of different healthcare systems.

Results

A number of themes related to current and potential future organisation of continence care were identified from the data. A modular service specification with eight core components was created including case detection, initial assessment and treatment, case co-ordination, caregiver support, community-based support, specialist assessment and treatment, use of containment products, and use of technology. Within this framework important key recommendations are: ensure robust referral pathways, shift assessment for case coordination to nurses specializing in continence care, promote self-management and technology, use comprehensive assessment tools and service performance targets based on outcome and operational measures.

Conclusions

This study has defined practice gaps in the provision of continence services and described eight core components of a service specification for incontinence that commissioners and payers of health and social care could consider using to provide high-quality continence care. A shift towards a community-delivered, nurse-led model appears to be associated with clinical and cost-effective care for people with bladder and bowel incontinence.     

Vacuum-assisted core-needle biopsy as a diagnostic and therapeutic method in lesions radiologically suspicious of breast fibroadenoma

Background

Treatment of breast fibroadenoma remains a subject of clinical discussion. Recommended methods include clinical observation or surgical excision of the lesion. The procedure involves hospitalisation and anaesthesia, leaving a scar on the breast.

Aim

The aim of this study was to present the Centre''s experience in removing lesions radiologically suspicious of fibroadenoma by means of an ultrasound-guided vacuum-assisted core-needle biopsy as an alternative to a classical surgery.

Materials and methods

Between March 2007 and April 2010, 196 ultrasound-guided vacuum-assisted biopsies were performed in the Mammotome Biopsy Laboratory of the 1st Surgical Oncology and General Surgery Department at the Greater Poland Cancer Centre in Poznań. The procedure was delivered to female patients aged 17–91 years (mean 40.8, median 39). Qualified for removal were ultrasound identified lesions described as fibroadenomas.

Results

The average size of excised lesions according to pre-biopsy ultrasound image was 13.53 ± 8.92 mm (median 11 mm, range 4–60 mm). In 184 cases (93.9%), benign lesions were found in the final histopathologic examination. Pre-cancer lesions were found in 10 cases, and invasive lesions in two cases. Overall, after follow-up ultrasound examination, four patients were qualified for subsequent surgical resection of lesions that had been left behind.

Conclusion

Vacuum core-needle biopsy is an effective tool enabling removal of breast fibroadenomas. It combines features of a lesion resection and histopathologic material collection providing an access with minimum invasiveness.     

Agreement among Healthcare Professionals in Ten European Countries in Diagnosing Case-Vignettes of Surgical-Site Infections

Objective

Although surgical-site infection (SSI) rates are advocated as a major evaluation criterion, the reproducibility of SSI diagnosis is unknown. We assessed agreement in diagnosing SSI among specialists involved in SSI surveillance in Europe.

Methods

Twelve case-vignettes based on suspected SSI were submitted to 100 infection-control physicians (ICPs) and 86 surgeons in 10 European countries. Each participant scored eight randomly-assigned case-vignettes on a secure online relational database. The intra-class correlation coefficient (ICC) was used to assess agreement for SSI diagnosis on a 7-point Likert scale and the kappa coefficient to assess agreement for SSI depth on a three-point scale.

Results

Intra-specialty agreement for SSI diagnosis ranged across countries and specialties from 0.00 (95%CI, 0.00–0.35) to 0.65 (0.45–0.82). Inter-specialty agreement varied from 0.04 (0.00–0.62) in to 0.55 (0.37–0.74) in Germany. For all countries pooled, intra-specialty agreement was poor for surgeons (0.24, 0.14–0.42) and good for ICPs (0.41, 0.28–0.61). Reading SSI definitions improved agreement among ICPs (0.57) but not surgeons (0.09). Intra-specialty agreement for SSI depth ranged across countries and specialties from 0.05 (0.00–0.10) to 0.50 (0.45–0.55) and was not improved by reading SSI definition.

Conclusion

Among ICPs and surgeons evaluating case-vignettes of suspected SSI, considerable disagreement occurred regarding the diagnosis, with variations across specialties and countries.     

Development and Validation of a Severity Scale for Leprosy Type 1 Reactions

Objectives

To develop a valid and reliable quantitative measure of leprosy Type 1 reactions.

Methods

A scale was developed from previous scales which had not been validated. The face and content validity were assessed following consultation with recognised experts in the field. The construct validity was determined by applying the scale to patients in Bangladesh and Brazil who had been diagnosed with leprosy Type 1 reaction. An expert categorized each patient''s reaction as mild or moderate or severe. Another worker applied the scale. This was done independently. In a subsequent stage of the study the agreement between two observers was assessed.

Results

The scale had good internal consistency demonstrated by a Cronbach''s alpha >0.8. Removal of three items from the original scale resulted in better discrimination between disease severity categories. Cut off points for Type 1 reaction severities were determined using Receiver Operating Characteristic curves. A mild Type 1 reaction is characterized using the final scale by a score of 4 or less. A moderate reaction is a score of between 4.5 and 8.5. A severe reaction is a score of 9 or more.

Conclusions

We have developed a valid and reliable tool for quantifying leprosy Type 1 reaction severity and believe this will be a useful tool in research of this condition, in observational and intervention studies, and in the comparison of clinical and laboratory parameters.