Five nurses made suggestions and 11 rated patient self-management strategies the highest for usefulness. This new template for symptom protocols can be populated with symptom-specific evidence that nurses can use when assessing, triaging, documenting, and guiding patients to manage their-cancer treatment-related symptoms.The study objective was to develop and evaluate a template for evidence-informed symptom protocols for use by nurses over the telephone for the assessment, triage, and management of patients experiencing cancer treatment-related symptoms. Guided by the CAN-IMPLEMENT© methodology, symptom protocols were developed by, conducting a systematic review of the literature to identify clinical practice guidelines and systematic reviews, appraising their quality, reaching consensus on the protocol template, and evaluating the two symptom protocols for acceptability and usability. After excluding one guideline due to poor overall quality, the symptom protocols were developed using 12 clinical practice guidelines (8 for diarrhea and 4 for fever). AGREE Instrument  rigour domain subscale ratings ranged from 8% to 86% . Included guidelines were used to inform the protocols along with the Edmonton Symptom Assessment System questionnaire to assess symptom severity. Acceptability and usability testing of the symptom populated template with 12 practicing oncology nurses revealed high readability ( Adults undergoing cancer treatments often experience distress from treatment-related symptoms , 2. HelpCurrent research is limited to nurse initiated telephone calls to specific oncology patient populations as a follow-up posttreatment to address informational and psychosocial needs, or to monitor for recurrent disease. These types of outgoing telephone-based nursing services have been shown to be feasible and effective for meeting the information needs of patients with specific types of cancer –16. FurtKey elements necessary for quality telephone-based nursing services that minimize risk of litigation include access to protocols to guide the assessment and advice provided, documentation of calls, quality assurance monitoring, and training , 21. HowThe overall aim of this study was to develop and evaluate a template for evidence-informed symptom protocols for use by nurses over the telephone for the assessment, triage, and management of patients experiencing cancer-treatment-related symptoms. For the purposes of this study, a protocol is defined as an agreed upon standardized approach to guide nursing practice. It is based on the best available scientific evidence and formatted for ease of use to fit with usual clinical routines or practices for a specific patient situation.Methods were guided by the CAN-IMPLEMENT© methodology . This fr To determine the evidence required to inform the development of clinical nursing protocols for the assessment, triage, and management of cancer patients experiencing treatment-related symptoms, we first identified five key questions (1) How are symptoms defined? (2) What criteria are used to assess the symptom? (3) How can a patient be risk stratified  based on the symptom assessment findings? (4) How should patients' symptoms be managed ? (5) What followup is required for ongoing symptom monitoring?The search strategy was designed in collaboration with a health sciences librarian (AR-W). Inclusion and exclusion criteria were defined using the PIPOH  framework . Based oCitations were screened for eligibility by two independent reviewers using a three-stage process: titles only, title plus abstract, and full-text screening. Levels one and two were completed by GM and DS to judge the citation as include, exclude, or unsure. All citations rated as include or unsure by at least one reviewer were advanced to the next level. Full text documents were screened for eligibility  and discrepancies were resolved by consensus with the health sciences librarian. Each included guideline was appraised by four independent raters using the AGREE Instrument  . The AGREE Instrument has proven reliability and validity for assessing the quality of clinical practice guidelines . AGREE rFollowing appraisal of identified guidelines and systematic reviews for quality, data was extracted independently by two team members and included: title, publication year, currency survey results, quality appraisal scores, overall recommendation, strengths, limitations, related algorithms/tools, and evidence to answer research questions with level of evidence. A recommendations matrix was populated with the extracted data to allow for comparison across citations .We convened a pan-Canadian panel of 24 stakeholders with a range of expertise in oncology nursing, knowledge translation, CAN-IMPLEMENT© methodology, library sciences, health services research, and electronic systems tools from eight Canadian provinces. Participants were involved in (a) reviewing findings from the systematic literature search, screen, and quality appraisal; (b) reaching consensus on symptom-specific recommendations to include in the protocol; (c) providing iterative feedback as the protocols were developed (via email and in face-to-face meetings). In pairs, participants engaged in role play with the protocols in order to further evaluate their usability and were asked to provide oral feedback during the meeting. A meeting evaluation feedback questionnaire given to participants consisted of eight multiple choice and two open end response type questions pertaining to evaluation of the meeting  and evaluation of the protocols. Specifically, participants were asked whether the protocols provided an accurate reflection of the current scientific knowledge and whether they were willing to use them in practice. Preliminary acceptability and usability testing of the protocols was conducted with oncology nurses from across Canada using a brief survey tool. The tool asked nurses to rate the protocol(s) based on their perceived ease of use, amount of information provided, use of appropriate terms, likelihood to fit with clinical work flow, helpfulness of the various elements provided , and provided space for general comments. The questions were taken from previous surveys used for implementing knowledge tools in clinical practice , 30. TheA total of 412 citations were identified for two cancer-treatment-related symptoms of diarrhea and fever with neutropenia see . After rn = 3) [n = 2) [n = 1) [n = 1) [n = 2) [n = 2) [n = 1) [Diarrhea guidelines were found in peer-reviewed publications (n = 3) –33, Brit [n = 2) , 35, the [n = 1) , and Can [n = 1)  Table 3n = 3 [n  [n = 1) ; and Chi [n = 1) . The feb [n = 2) , 41, pee [n = 2) , 43, and [n = 1)  Table 4n = 3 [n In February 2009, the currency survey checking for updated evidence about diarrhea was completed by all the seven guideline developers and both systematic review authors. Only one guideline  had beenn = 8), AGREE domains were rated higher for clarity of presentation , guideline purpose , and rigour of development   see . There wn = 5), one guideline was not recommended by any raters and was removed from the analysis. For the remaining clinical practice guidelines relevant to fever with neutropenia (n = 4), AGREE domains were rated higher for scope and purpose  and clarity of presentation   see . There whttp://www.cano-acio.ca/triage-remote-protocols  example protocol). The resulting protocol was focused specifically on the symptom and could be combined with general assessment information collected on all patients. The meeting evaluation feedback questionnaire completed by 11 of 16 participants revealed that all participants thought the final symptom protocols would be an accurate reflection of the current scientific knowledge and for those whom it was relevant (n = 7) they would be willing to test the protocols in clinical practice. After trying the protocols in role play exercises, they were revised using plain language to facilitate communication between nurses using the protocol(s) and patients. It was apparent that the protocols required training in their use particularly given that few rated the protocols as self-evidence to use. A set of principles were finalized for creating the symptom protocol template  and two local oncology nurses  convened in Ottawa, Ontario, and reached consensus on the recommendations for symptom-specific protocols based on the current evidence and the protocol format after a review of existing symptom protocols identified in oncology, palliative care, and primary care. The protocol template has five recommendations for the nurse to (a) assess symptom severity, (b) triage patient for symptom management based on highest severity; (c) review medications being used for the symptom, (d) review self-management strategies , and (elate see .n = 6), documentation (n = 4), and triage (n = 2). Nurses were divided on rating the amount of space for entering data . When asked if the protocol would fit with clinical work flow, 8 agreed, 1 disagreed, and 3 did not answer the question. Nurses rated the patient self-management strategies the highest for usefulness of information followed by review of medications, triage of severity, and documenting. Suggestions to improve the protocols that were subsequently acted upon were explaining levels of evidence (changed level of evidence to type of evidence), interpreting assessment, adding more information , and using more plain language . Suggestions to improve the protocols that were not specifically acted upon were the need for protocols that incorporate more than one symptom and adding space to document emotional support. An open space was added for additional comments and could be used to document related emotional issues. General feedback included clear, user-friendly, comprehensive assessment, very thorough yet concise, offers direction without needing to seek more information, and excellent self-care strategies. Nurses liked the tick boxes that could save time from excessive charting, the ease of tool completion while talking, and clear differentiation between mild, moderate, and severe symptoms. Others appreciated the way the protocols linked the evidence for use in practice. Unresolved issues were the need to provide training on how to use the protocols in clinical practice, having electronic applications, and the potential for local adaptation given the different types of resources available across the various ambulatory oncology programs in Canada . Preliminary feedback to establish the protocol's acceptability and usability was obtained from 12 oncology nurses. Nurses rated the amount of information as just right (10 nurses), too much (1), or no answer (1). When asked if terms were appropriate, 10 agreed, 1 disagreed, and 1 gaveno answer. All 12 nurses indicated the font type, size, and icons made readability good. When asked if using the protocol would be self-evident, 5 agreed, 7 disagreed with areas requiring more guidance being the assessment , and not limiting to telephone-based services. Two main limitations were the variable methodological quality of included guidelines and the minimal amount of information that could be used from any one higher quality guideline.There were variable quality ratings for the included guidelines and including guidelines of lower quality may result in the protocols recommending less evidence-based actions. Although we included findings from lower quality guidelines, we did so to indicate consistency across guidelines, with a goal of being transparent about how the information was used . For example, if a specific recommendation was present in a lower quality guideline and higher quality guideline, both documents were cited in order to show consistency across the source documents. Finally, lower quality guidelines were considered useful primarily for formatting and presentation of information within the protocol. Another potential limitation was only including guidelines rather than searching for individual studies. The main reason for doing so was to use a synthesis of evidence that has the potential of increasing the stability of the findings . About h Guided by the CAN-IMPLEMENT© methodology, we developed and evaluated a template for creating clinical nursing symptom protocols to use with patients experiencing symptoms while receiving cancer treatments. This new protocol template which puts evidence into an actionable format is a considerable advancement to the CAN-IMPLEMENT© for point-of-care use of evidence. New protocols created in this initiative provide an evidence-informed and user friendly approach for nurses to systematically assess, triage, document, and if appropriate guide patients in managing their symptoms at home. Furthermore, these types of clinical protocols are consistent with Accreditation Canada's requirements for enhancing safe practices within organizations . However


We hypothesized that mitral valve areas (MVAs) with echocardiography, using 3D planimetry technique  versus pressure half-time technique  in mitral valve repair surgery (MVR) would be different.Patients who had undergone MVR were retrospectively reviewed, and two different observers measured the MVAs using PHT and 3D planimetry technique. The MVAs derived from recorded medical data, using PHT and 3D planimetry technique were abbreviated to MVA-PHT1 and MVA-3D1, and data from the PHT and 3D planimetry techniques by observer A and observer B were determined as MVA-PHT2 and MVA-3D2, and MVA-PHT3 and MVA-3D3, respectively. The MVA derived by post-operative transthoracic echocardiography using the PHT technique was determined as MVA-TTE.2), MVA-3D2 (3.00 ± 0.63 cm2) and MVA-3D3 (2.97 ± 0.88 cm2) were significantly larger than MVA-TTE (2.40 ± 0.59 cm2), but intra-operative MVAs-PHT were not. The biases and precisions were larger, and the correlation coefficients were lower in 3D planimetry technique compared with PHT technique.Intraclass correlation coefficients were 0.90 for the intra-operative PHT technique and 0.78 for the intra-operative 3D planimetry technique. MVA-3D1 (2.91 ± 0.65 cmMVA measured by 3D planimetry technique with TEE at the intra-operative post-MVR period was seemed to be larger than that measured by the PHT technique with TTE at the post-operative period. However, it did not mean that the 3D planimetry technique was inaccurate but needs cautions at determination of MVA using different techniques. Determination of the mitral valve area (MVA) with intra-operative transoesophageal echocardiography (TEE) is essential in evaluating the success of a procedure and predicting outcomes in mitral valve repair surgery (MVR). Accurate assessment of MVA immediately after MVR is also necessary to assess the need for further mitral valve (MV) intervention, or conversion to MV replacement in cases of mitral valve stenosis (MS) or mitral valve insufficiency (MR).Among the various echocardiographic techniques, the 2-dimensional (2D) planimetry technique and pressure half-time (PHT) technique have been widely used for peri-operative determination of the MVA. However, the 2D planimetry technique is not appropriate for measuring the MVA immediately after MVR, due to difficulties in optimizing the 2D plane of the TEE image, which must be perpendicular to MV orifice. The PHT technique is now in wide clinical usage for peri-operative evaluation of mitral valvular disease, because it is easy to perform and obtained during the entire diastolic phase, meaning that it reflects the haemodynamic states, although MVA determined by the PHT technique is not a gold standard technique for determination of MVA after MVR.Real-time 3-dimensional (3D) TEE evaluation has become prominent for MV evaluation, giving a more exact and rapid understanding of the MV and surrounding structures. Several articles reported the efficacy of 3D TEE in the evaluation of the MVA and MV apparatus in MS or MR patients -8. HowevWe hypothesized that MVAs with echocardiography, using intra-operative 3D planimetry versus intra- & post-operative PHT technique in MVR would be different.The aim of the study was to evaluate the MVA determined by intra-operative 3D planimetry at post-MVR periods, compared with intra-operative TEE at post- MVR periods and post-operative transthoracic echocardiography (TTE) using PHT technique in patients undergoing MVR.http://cris.nih.go.kr (KCT0000447), medical records, including TEE and TTE data of patients who had elective MVR due to MS (>moderate) or MR (>moderate) in Konkuk University Medical Center from April 2011 to March 2012, were retrospectively reviewed for demographic, diagnostic, procedural and echocardiographic information. Patients with other concurrent cardiac valvular surgeries, reduced left or right ventricular function (ejection fraction <40%), or post-operative mitral valvular diseases (MS grade > moderate or MR grade > moderate at post-MVR period) were excluded.After a protocol review and approval by the Institutional Review Board of Konkuk University Medical Center, Seoul, South Korea  and registration at Anaesthetic induction and maintenance were performed according to the standard institutional regimen with, remifentanil based anaesthesia with sevoflurane or propofol.-1.m-2; approximately one hour after separation from CPB), MVA derived by PHT technique with TEE (MVA-PHT1) was determined. Three consecutive velocity-time integrals (VTI) of mitral inflow Doppler were traced by placing the sample volume of the pulsed-wave Doppler for MR or continuous-wave Doppler for MS on the tip of the MV leaflets in a mid-oesophageal aortic valve long-axis view. The PHT of the mitral inflow deceleration slope was determined from the stored mitral inflow Doppler VTI, and the MVA was then calculated using the following formula: MVA = 220/PHT  or left ventricle (LV) perspective were acquired. The recorded 3D images were checked whether they contained whole structures of MV including anterior mitral leaflet (AML), posterior mitral leaflet (PML) and mitral valve annulus. If they did not contain the whole structures, the 3D images were re-acquired. The 2D image of the smallest MVA perpendicular to the mitral inflow at the maximal MV opening was acquired by aligning and cropping the acquired 3D images with suitable software . Finally, the MVA was determined by circumferential tracing of the leaflet edges on the reconstructed MV 2D image  weaning and achieving stable haemodynamic state  was applied.For correction of MR, three technical manoeuvers are mainly applied; 1) lifting annuloplasty , 2) artiFor correction of MS, five technical manoeuvres are mainly applied; 1) lifting annuloplasty, 2) maximum commissurotomy, 3) anterior/posterior leaflet extension, 4) restoration of leaflets mobility by thinning and decalcification and 5) subvalvar procedure such as fenestration of fused chordae.2. The sample size of 26 was calculated to detect 20% difference (0.49 cm2) with a power of 0.80 and an α value of 0.05. Statistical analyses were performed with SPSS software .Based on preliminary medical records and echocardiographic data review of 10 MVR cases, the mean and standard deviation (SD) of MVA-PHT1 were 2.47 ± 0.57 cmTo assess inter-observer variability, the MVAs with the PHT and 3D planimetry techniques from TEE, and PHT technique from TTE data were analysed using intraclass correlation coefficient (ICC). Agreements between MVAs derived with PHT technique with TEE and those derived with 3D planimetry with TEE were assessed using the Bland-Altman method , and corp-values were less than 0.05.Comparisons of MVA-PHT, MVA-3D and MVA-TTE were performed using One-way Analysis of Variance and pair-wise multiple comparisons were made using the Tukey method. Additionally, the agreements and correlations between MVA-TTE and the values of MVA derived by PHT technique and 3D planimetry technique with TEE were assessed by the Bland-Altman method and linear regression analysis. Data are expressed as the number of patients or means ± SD . The null hypotheses of no difference were rejected if From April 2011 to March 2012, data for twenty-six of 107 patients’ medical records were analysed. Eighty-one patients were excluded for the following reasons: 57 for examinations only under 2D TEE platform without availability of 3D TEE, 19 for other concurrent valvular surgeries, 4 for low LV function (LV ejection fraction <40%), and 1 for MR grade > moderate at intra-operative post-MVR period. There were no patients with inadequate recorded 3D images for determination of MVA by 3D planimetry technique. Patients’ demographic data and pre-operative diagnosis are summarized in Table N = 4) was 1.14 ± 0.32 cm2 indicating an above moderate degree of MS.LV ejection fraction of these patients by pre-operative TTE evaluation was 62.3 ± 9.6%. The pre-operative mean MVA in MS patients  and 0.78 with intra-operative 3D planimetry technique .2 between MVA-PHT1 and MVA-3D1, 0.46 ± 0.57 cm2 between MVA-PHT2 and MVA-3D2, and 0.35 ± 0.68 cm2 between MVA-PHT3 and MVA-3D3, respectively. The correlation coefficients using linear regression analysis between MVA-PHT and MVA-3D were 0.81  for MVA-PHT1 and MVA-3D1, 0.62  for MVA-PHT2 and MVA-3D2, and 0.74  for MVA-PHT3 and MVA-3D3, respectively  and precisions (standard deviation of mean difference) between MVA-PHT and MVA-3D for agreement analysis were 0.40 ± 0.43 cmThe value of ICC was 0.91with post-operative MVA-TTE.2), MVA-3D2 (3.00 ± 0.63 cm2) and MVA-3D3 (2.97 ± 0.88 cm2)] were larger than MVA-TTE (2.40 ± 0.59 cm2), and there were significant differences , MVA-PHT2 (2.54 ± 0.67 cm2) and MVA-PHT3 (2.62 ± 0.98 cm2)] had no significant difference with MVA-TTE. The biases and precisions for echocardiographic records were 0.12 ± 0.47 cm2 between MVA-PHT1 and MVA-TTE, and 0.52 ± 0.50 cm2 between MVA-3D1 and MVA-TTE. The biases and precisions for observer A were 0.15 ± 0.49 cm2 between MVA-PHT2 and MVA-TTE, and 0.61 ± 0.53 cm2 between MVA-3D2 and MVA-TTE. The biases and precisions for observer B were 0.23 ± 0.57 cm2 between MVA-PHT3 and MVA-TTE, and 0.58 ± 0.58 cm2 between MVA-3D3 and MVA-TTE  between MVA-PHT1 and MVA-TTE, and 0.68  between MVA-3D1 and MVA-TTE. The correlation coefficients for observer A were 0.70  between MVA-PHT2 and MVA-TTE, and 0.62  between MVA-3D2 and MVA-TTE. The correlation coefficients for observer B were 0.85  between MVA-PHT3 and MVA-TTE, and 0.76  between MVA-3D3 and MVA-TTE  because the evaluation is performed using planes in three corresponding perpendicular slice orientations. Lembcke echnique . They suMVA measured by 3D planimetry technique with TEE at intra-operative post- MVR period was larger than that by PHT technique with TTE at post-operative period. However, it did not mean that the 3D planimetry technique was inaccurate but needs cautions at determination of MVA using different techniques.MVA: Mitral valve area; TEE: Transoesophageal echocardiography; MVR: Mitral valve repair surgery; MV: Mitral valve; MS: Mitral valve stenosis; MR: Mitral valve insufficiency; 2D: 2-dimensional; PHT: Pressure half time; 3D: 3-dimensional; TTE: Transthoracic echocardiography; CPB: Cardiopulmonary bypass; MVA-PHT1: Mitral valve area measured as pressure half time technique with transoesophageal echocardiography; VTI: Velocity time integral; MVA-3D1: Mitral valve area measured as 3 dimensional planimetry technique; LA: Left atrium; LV: Left ventricle; AML: Anterior mitral leaflet; PML: Posterior mitral leaflet; MVA-PHT2: Mitral valve area measured as pressure half time technique with transoesophageal echocardiography by observer A; MVA-PHT3: Mitral valve area measured as pressure half time technique with transoesophageal echocardiography by observer B; MVA-3D2: Mitral valve area measured as 3 dimensional planimetry technique by observer A; MVA-3D3: Mitral valve area measured as 3 dimensional planimetry technique by observer B; MVA-TTE: Mitral valve area measured as pressure half time technique with transthoracic echocardiography; SD: Standard deviation; ICC: Intraclass correlation coefficient; CI: Confidence interval; MDCT: Multi-detectors computed tomography.The authors declare that they have no competing interests.WS Kang participated in the design of study protocol, collection of data, statistical analysis of data and description of manuscript. JW Choi participated in the collection of data. JE Kang participated in the collection of data. JW Chung participated in the collection of data. SH Kim participated in the design of study protocol, collection of data, statistical analysis of data and description of manuscript. All authors read and approved the final manuscript.


As clinician educators, we are busy people. We balance the demands of clinical service, administration, management, education and training. We aim to both meet the expectations of and to achieve the best possible outcomes for our patients, service and learners. Unfortunately, we suspect that many of us find that our educational practice comes last. We have to fit teaching and training around our clinical and administration and management responsibilities. And when it comes to our continuing professional development our learning needs as clinicians must come first.But we are clinical educators not because we have to be, it is because we want to be. We read the abstracts of papers which offer tantalizing insights into ways in which we could improve our teaching and training. But can we trust the abstract? We set the paper aside on the ever growing pile of papers we must get round to reading one day. And never do.Of course we have guidelines and systematic reviews to which we could turn. But they are long, heavy in academic detail and unfortunately often heavy to read. And they too get set aside on the pile of papers we must get round to reading one day. And never do.do because there is evidence it works, what you should not do because there is evidence that it does not work or indeed is likely to cause ‘educational harm’ and things which, although they offer potential, we do not know whether they work or not: the ‘Do’s, Don’ts and Don't Knows’ (or ‘D3) of medical education. Initially, we will focus on topics of interest to clinician educators. Each will be written by a small group of authors, authorities in the subject, most of whom are also clinicians. Each D3 will have a short tabulated summary of the Do’s, Don’ts and Don’t Knows’, an indication of the strength of evidence which underpins them and be backed up by an authoritative summary of the underpinning evidence. Our aim is that they will be both accessible to busy clinicians and make a contribution to scholarship: by identifying important ‘Don't Knows’, we hope to stimulate research.In this issue we publish the first of a series of ‘Guidelines for medical education’, which we hope will be different. Our aim is that they will succinctly summarize what you should This is an experimental format which is not yet cast in stone—and may never be. Some guidelines may be underpinned by new systematic reviews while some, because of the wealth of existing reviews, will not be. Our methods of indicating the strength of evidence may evolve. As editors we will learn how to support our authors in producing them. The first D3 addresses giving feedback to learners on their performance . We woulWe aim to publish two each year and we hope you find each D3 accessible, useful and a stimulus for both your educational practice and research. We would value your feedback on the format and the content as we work to make them as useful as possible to you, our readers and colleagues.


Biological evidence with forensic interest may be found in several cases of assault, being particularly relevant if sexually related. Sexual assault cases are characterized by low rates of disclosure, reporting, prosecution, and conviction. Biological evidence is sometimes the only way to prove the occurrence of sexual contact and to identify the perpetrator. The major focus of this review is to propose practical approaches and guidelines to help health, forensic, and law enforcement professionals to deal with biological evidence for DNA analysis. Attention should be devoted to avoiding contamination, degradation, and loss of biological evidence, as well as respecting specific measures to properly handle evidence . Biological evidence must be carefully managed since the relevance of any finding in Forensic Genetics is determined, in the first instance, by the integrity and quantity of the samples submitted for analysis. Biological evidence with forensic interest may be found in several cases of assault, being particularly relevant for sexually related ones. Sexual aggression constitutes a serious social and public health problem that calls for an urgent forensic medical examination (FME), particularly in acute cases, that is, when the elapsed time between the assault and the FME is less than 72 hours, in the generality of cases –6.In these cases a large number of forensic areas are involved  aiming to obtain the proof and elaboration of a final forensic report .From the forensic intervention perspective, despite some published protocols and guidelines, few countries have officially adopted guidelines for evidence management, namely, in acute sexual assault (ASA) cases. Even when guidelines are adopted they may vary within the same country, between different regions and different institutions. However, to standardize the FME of ASA victims and the credibility of forensic practices, which are essential during judicial proceedings, clear guidelines developed by the scientific community are required , 6. ThesThis work will focus on the management of forensic evidence, more specifically the biological samples. Indeed, examiners performing FME in ASA cases must have knowledge and training in collecting and handling evidence, always respecting guidelines and legal obligations. This is true regardless of the value of other forensic procedures  that may be required. Examiners should also be aware of the scope and limitations of laboratory analysis as well as the consequences of contamination or degradation of any evidence . MoreoveBecause of its utility in proving the occurrence of sexual contact and the identification of the suspects, biological evidence for DNA studies is nowadays considered the most important evidence for legal proof in courts of law , 10–12. In this study, we aimed to review and update forensic procedures already implemented in various forensic institutions. These are based on Portuguese and international forensic expertise and evidence gathered through the review of scientific literature and institutional guidelines. However, it is important to note that the application of these guidelines is highly dependent on the available local resources and should be mainly regarded to promote the quality and safety of forensic practices and fill some existing gaps.It is hoped that this work can be a useful tool (not only for forensic practitioners) to help the mission of forensic expertise regarding ASA, promoting the ability of professionals to detect, collect, and properly appraise biological forensic evidence.In every crime against people, as in sexual assault, the contact between the perpetrator and the victim, or his/her environment, or both always leaves evidence which is transferred from the perpetrator to the victim, to the scene, and vice versa , 14, 15.Forensic evidence, in the broadest sense, is any item or information about a suspected crime, which is considered to be relevant to an investigation in order to find the truth of the facts. It may be useful to (1) orient police investigation; (2) provide a reliable identification of the perpetrator; (3) exonerate a suspect or an accused from a crime; (4) support or contradict a victim's, witness', or suspect's statement and, consequently, promote police to conduct further investigations; (5) provide information about the crime scene; and (6) provide proof that attests to the occurrence of the alleged event.Typically crime scene evidence could be found on any place where a criminal offence was committed, on anything worn or carried by the victim during the time the offence or within or on the body of any person associated with the offence.Evidence may be found at the victim's body or clothes, in condoms or bed clothes, or at the crime scene , 16–19. Direct evidence: it establishes the fact without needing further investigations. The most important one is the eyewitness or victim statement; nevertheless, their statement can be prone to many inaccuracies and may be contradicted or supported by other types of evidence  .Circumstantial evidence (or indirect evidence): it needs to be identified and matched with a control or reference sample collected from the victim, suspect, and/or the crime scene or database. Although it is more objective than direct evidence, it must be handled carefully aiming to avoid risk of destruction, contamination, or loss. It is the majority of the evidence analyzed in the forensic laboratories and can be divided into two basic classes. (1) Physical evidence: it includes items of nonbiological origin, such as finger and foot prints, shoe/tire impressions, fibers, paint, soil, dirt, glass, headlamps or arson debris, explosives and gunshot residues, and figured injuries  , 21. TheTwo types of evidence can be considered:The collection of biological evidence for DNA studies is particularly useful in ASA cases to establish the occurrence of sexual contact and to proceed with suspect identification. In fact, the presence of semen on a prepubertal child's body, clothes, or vicinity during the FME usually confirms the diagnosis of the sexual contact and is generally accepted in a court of law as proof , 25, 26.Semen : it is rarely present in oral, anorectal, and vaginal cavities 6, 24, and 72 hours after sexual contact, respectively , 29. In Observation of spermatozoa under an optical microscope , Giemsa, hematoxylin/eosin, and methylene blue/eosin) or by phase contrast microscopy (no stains): these are considered for diagnosis of sexual contact and the concomitant observation of motile spermatozoa allows estimating the time of the assault. However, since these techniques do not lead to the identification of the perpetrator and biological material is lost to perform smears, some authors do not recommend this procedure. The absence of spermatozoa may occur if the suspects are azoospermic or vasectomized or if semen stains are dry , 32. UndSeminal acid phosphatase (AP): this enzyme is present in semen and for positivity, the presence of spermatozoa is not needed since it is a prostatic enzyme. In postpubertal girls' vagina or cervix, the possibility to register elevated AP levels ranges from 24 hours , 29. AP Prostate-specific antigen (PSA): it is a serine protease produced by prostatic epithelial cells found in many tissues . Although PSA is not tissue and gender specific, in ASA cases, the interpretation of the results should not pose a significant problem due to its low concentrations in nonprostatic fluids –38. PSA The following considerations should be taken in order to help forensic examiner to define the best practices in each case and to interpret the findings:α-amylase activity. Nevertheless, it should be taken into account that α-amylase can be present in body fluids other than saliva. This biological material transports epithelial cells from buccal mucosa which contains DNA [Oral fluid: it constitutes the second biological evidence commonly found in ASA cases, often observed by the Phadebas test, which detects ains DNA , 39, 40.Some studies argue that perpetrator's DNA may be detected in the victim's oral cavity up to 1 hour after intense kissing . NeverthHead or pubic hair, and/or epithelial cells of the victim or perpetrator transferred between them during the sexual contact or a fight, should also be collected with utmost care due to the low amount of DNA present , 42–46. The fingernail hyponychium is an isolated area where evidence may accumulate and can provide a valuable source of evidential material for investigation. During the course of a sexual assault, trace amounts of skin , body fluids, hairs, fibers, and vegetation may collect under the nails of either the victim or perpetrator , 43, 47.Other aspects should be considered:Evidence preservation aims to avoid its destruction, contamination, or loss.shower or wash any part of the body, including mouth, hands, and head hair;brush teeth;clean or cut fingernails;comb or cut paint hair;perform vaginal irrigation;urinate, defecate, or vomit ;eat, drink, chew, or smoke;run or perform any kind of sport activities or the same;change, wash, or destroy clothing worn during the event;change or destroy sanitary pads worn during the event;touch the crime scene (including emptying garbage can or flushing the toilet).Moreover in order to prevent DNA degradation, the forensic examiner must correctly select the type of material used for collection and storage  and to avoid direct contact with the samples;to ensure that the room where FME takes place is regularly cleaned before and after patient use;to avoid sneezing, coughing, or talking over the samples;not to drink, eat, and/or smoke when handling samples;to store swabs or other samples separately, ensuring that they are contact-free , particularly in circumstances where reference samples were also collected at the same time ;to avoid contamination with evidence of other body areas, since the specific location of each biological sample is crucial to the investigation ; gloves not to touch the cotton-tipped swabs.For DNA studies, one of the greatest laboratory barriers is the contamination of genetic material from other sources . Contamination may occur during the sexual contact , during the period between the sexual contact and the FME, during the FME, and in the laboratory –53. In oIn many ASA cases, the evidence is recovered in very low amounts. Consequently, two issues must be weighed: the number of swabs to be performed during the collection for each evidence and the pertinence (or not) of doing semen smears for spermatozoa observation under optical microscope.One swab: it is a rapid technique but does not guarantee that the entire evidence is collected for laboratory analysis. It is particularly useful in the presence of evidence with limited quantity. Moreover, if counterproof is required, two situations may be possible: (1) half the cotton swab could be preserved in the laboratory allowing one to perform a new analysis that will begin from extraction of DNA; (2) the entire swab is used in the first forensic analysis (most common situation) and counterproof analysis must be made from DNA previously extracted, ensuring that both analyses begin from the same DNA sample.Two swabs simultaneously: in this case, biological material will be divided into two swabs, which could reduce the success of the laboratory analysis. Furthermore, nothing can guarantee that the two swabs, even used together, have the same evidence quantity, which for some authors seems to be relevant for legal issues. The evidence is rapidly collected and allows the use of the second swab for counterproof , 55, 56.Two swabs successively or “double swab technique”: it is the application of two successive swabs, the first being wet (aiming to collect the majority of the evidence) and the second being a dry swab passed through the same place, the order of the swabs being annotated. This technique aims to collect the largest quantity of evidence available. It is not rapid and there is no guarantee of equality of the two swabs (the second swab may have much lower concentration of the evidence), reducing usefulness in counterproof. In spite of these limitations, this technique has been widely reported in the literature for the collection of various different biological samples  due to good outcomes , 39, 47.The number of swabs performed per body area is important for financial reasons but also due to evidence concentration in each swab. Hochmeister and Ferrel  considerMany variables impact the semen motility and its observation by the examiner does not give a precise estimation of the time of the sexual contact.Due to the increasing number of vasectomized individuals, a semen smear has become a less effective screening tool to prove sexual contact.DNA analysis will be performed in the forensic laboratory regardless of the examiner's findings on a smear.Precious DNA evidence studies may be wasted by preparing a smear.In the majority of cases, semen smears for spermatozoa observation under optical microscope should not be performed, except in very specific circumstances, which should be detailed in the FME report. The following reasons justify their uselessness :Many var kit, its storage, preservation and transportation, and reception by the forensic laboratory, always ensuring the compliance of chain of custody.Good evidence management must properly ensure procedures in the sequence ranging between selecting and collection, packing, sealing, labeling, and insertion into theThe details of the sexual assault history and the physical exam should guide the examiner for evidence collection , 4. DuriSemen is very fluorescent in nature and the fluorescence can be observed on dark as well as light textiles when illuminated with an intense UV light, without the need for using colored goggles. To detect semen the standard Wood's lamp (wavelength 360 nm), often used during SAS examinations, has been shown to be ineffective since several creams and ointments fluoresce in a similar manner to semen . InsteadIn ASA cases, biological fluids collected on cotton-tipped swabs are the most important items of trace evidence. However, all evidence must be collected since, in most cases, it is not possible to collect it later on; even if evidence is still intact, the chain of custody may already be “broken” and evidence will be compromised and therefore should not be analyzed since it will not be admissible in a court of law. For this reason, it is advisable to collect any evidence relevant to the case even though only some samples may be subjected to laboratory analysis , 50.The technique and materials used to collect evidence depend on the type of evidence and its support. For DNA analysis, swabs are usually preferred to collect semen and other fluids, but different techniques exist for hair collection, for example. The presence of inhibitors is another limitation that sometimes examiners have to face . Indeed,For dry surfaces  the swabs should be slightly moistened with 1-2 drops of sterile distilled water, “damp swab.” Phosphate buffered saline (PBS) is also advocated  since it prevents cells rupturing or shriveling up due to osmosis. Therefore, visualization of spermatozoa or vaginal epithelial cells from swabs is more prone to be successful, especially if the number is reduced. PBS does not affect subsequent DNA analysis. The same is not true for certain saline solutions and tap water due to electrolytes content and pH .For mucosa/epithelium  or other wet surfaces, a dry swab should be used.To collect evidence from underneath fingernails, a damp, small, and thin tip swab should be used to be able to reach under the fingernails.Depending on the purpose, swabs of different design, shape, and size are commercially available and should be judiciously selected. Synthetic swabs  are now available and are proved to be more efficient at releasing cells during the extraction  than cotAll collected swabs should be air-dried at room temperature for a minimum of one hour . To acceOther techniques to collect biological evidence  or physical evidence may be used, such as disposable plastic tweezers, combs, or scrapers (the latter for fingernail evidence). All specimens should be collected separately and packaged inside a little paper bag or in a bindle .In case of stains on substrates that can be brought in the laboratory , collection should be performed in the laboratory and not on-site. Clothes or other items should be collected separately in appropriate paper bags .Disposable plastic pipettes may be useful to collect liquid remains and, in this case, the material must be packed in a tube or another suitable container.Tape adapted to evidence collection  could be repetitively applied at the suspected sites and then placed directly in the DNA extraction tube .If a broken fingernail is collected as evidence, the cut should be performed away from the broken area.Reference biological sample from the suspect and the victim should be collected to perform comparative DNA testing and then correctly labeled to avoid confusion with the evidence . An oralIf oral-genital contact is suspected, blood or hair sample may be preferred to act as reference sample since oral sample might be contaminated with the perpetrator's DNA. A blood sample should be collected by venipuncture and deposited onto an appropriate support ). If it is suspected that a blood transfusion or bone marrow transplantation has been performed, the blood sample is not advisable and a hair or oral sample should be collected instead . To collEach evidence must be dried before packaging. If a damp swab or other biological evidence is placed in a plastic or glass container, it will create a favorable environment to the development of bacteria and fungus, thus accelerating the degradation of DNA. If drying is not possible, evidence should be frozen .Paper foldable racks, packages, or bags are preferred for biological evidence instead of plastic or glass containers, since paper allows remaining humidity to evaporate. Plastic or glass containers could be used to package physical evidence.For debris such as hairs, leaves, and fibers, a bindle can be used and then put into a paper package (double packaged).All evidence should be individually sealed.Self-sealing envelopes or suitable adhesive should be used. If the glue is to be moistened, this procedure should be accomplished with tap water or soaked gauze and not saliva, to prevent the contamination of DNA.Evidence should be clearly labeled with at least case number, victim's examiner's names, collection date and time, sample type, evidence number, and the location from which the evidence was collected on the victim's body. Ideally a barcode should be used.The request forms should be carefully filled. In The examiner should put the request form together with samples inside the respective kit before sealing it.Packages should not be stapled and must be signed across the seal in order to detect possible fraud. A biohazard label must be affixed to the package if needed.Each kit should be kept in a suitable and secure place with adequate environmental conditions .The kit should be shipped to the laboratory as soon as possible.Regardless of the transportation means, it is important to ensure that samples are not exchanged/switched from time of collection to receipt in the laboratory.All individuals handling samples must sign appropriate chain of custody report to track documentation regarding date, time, and names.Evidence must be properly labeled and packaged, in order to ensure that evidence is not lost, damaged, or contaminated until handled by the laboratory personnel and to guarantee that reliable results and the chain of custody compliance to evidence be admissible in a court of law. Therefore, all professionals involved need to respect strict procedures , 70, 71 Biological evidence is very important, especially in ASA, since it may prove the existence of sexual contact and lead to the identification of a perpetrator. Knowing and respecting the best practices of evidence management is essential to ensure that evidence (sometimes found in low quantities) is not lost, destroyed, or contaminated and to guarantee reliable results and the admissibility of evidence in the court of law. Carelessness or ignorance of proper handling procedures can result in a sample unsuitable for analysis and in the acquittal of a perpetrator. With this work we intended to summarize and harmonize FME procedures with regard to evidence management for DNA analysis, specifically the selection, collection, packaging, storage, preservation, and transportation of the evidence to the laboratories. Knowing and respecting the good practices of evidence management is essential to ensure that it is not lost, destroyed, or contaminated and to guarantee reliable results and the admissibility of evidence in court of law. Carelessness or ignorance of proper handling procedures for biological evidence can result in an unfit sample for analysis and in the acquittal of the perpetrator. The victim is entitled to a fair judicial decision.Sexual assault history and the physical observation which should guide the examiner for evidence collection .Performing a proper collection, avoiding loss or contamination .Drying under suitable conditions.Individualized packaging.Sealing of containers.Labeling and signing of packages.Correct and complete filling out of forms requesting laboratory analysis.Storing the evidence along with the request form into a kit box or appropriate envelope or bag, guaranteeing the adequate conditions of conservation and security.Sealing of kits.Labeling and signing kits; each kit must be assigned a number and must contain many labels printed with this number.Adequate environmental and secure storage of kits.Delivering to the forensic laboratory all kits and the sealed bag with clothing, accompanied with the chain of custody forms signed by all individuals.Finally, it is important to highlight all steps that any forensic medical expert should be aware of in the management of evidence for DNA analysis:


Predictive biomarkers can be used to identify most suitable treatments for patients. To maximise patient benefit valid predictive biomarkers need to be used and several trial designs have been proposed to achieve this.We aimed to review the evidence considered sufficient by the European Medicines Agency (EMA) for inclusion of a predictive biomarker in a drug indication or contraindication and this required development of a methodology to summarise key information.We reviewed the evidence supporting 49 biomarker-indication-drug combinations (37 different biomarkers and 41 drugs) within EMA licensing. The main issues considered were: biomarker evaluation design, sample size, representativeness of patients in trials, primary outcome type and strength of findings. We developed a novel visual overview of these dimensions in radial plots. We explored whether there were differences in the evidence base depending on authorisation recommendation, disease area, biomarker type and orphan designation.155 studies were identified: one biomarker strategy design, 45 enrichment studies, 37 RCT subgroup analyses and 72 other designs . A median of 2 studies (range: none to 19) supported a biomarker-indication-drug combination. Comparison of evidence depending on factors outlined above will be reported.There was a wide variation in type and quantity of evidence supporting biomarker-indication-drug combinations and the radial plots were a useful means of assessment. Study designs used were not always robust. It was not always clear why certain predictive biomarkers were included in the indication. The role of the biomarker evaluation context seemed important.


Evidence-based guidelines have undergone an incredible transformation over the last number of years. Significant advances include explicit linkages of systematic evidence summaries to the strength and direction of recommendations, consideration of all patient-important factors, transparent reporting of the recommendation generation process including conflict of interest management strategies and the production of clinical practice guidelines which use simple and clear language. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology provides a framework for guideline development and was employed to produce the recently published ATS/ERS/JRS/ALAT update on treatment for idiopathic pulmonary fibrosis (IPF). Herein we discuss the advantages of using an evidence-based approach for guideline development using the IPF process and resultant document as an example. Evidence-based guidelines have undergone intense evolution over the last 15 years . The maiIn 2000, a selected panel of international experts in the field of interstitial lung diseases provided a guideline for the diagnosis and management of IPF . Due to In this commentary, we will discuss the motivation behind this evolution in evidence-based guidelines and the benefits of developing guidelines that are linked to underlying evidence summaries along with explicit assessments of the quality (certainty) of the evidence. We will focus on the utility of GRADE methodology , 9, usedSome believe that the opinion of experts in the field is driven by their understanding of the clinical problem and their accurate interpretation of the underlying literature and therefore such recommendations may be considered, in effect, evidence-based. This approach has gone wrong on many occasions , 12. UsiAnother significant benefit of evidence-based guidelines using GRADE methodology is the formal assessment of certainty in treatment effects . GRADE mandates a systematic and explicit assessment of specific methodological domains in order to evaluate how certain we are in the evidence for each outcome . The cerFor the 2015 IPF treatment guideline, the McMaster University GRADE  team performed comprehensive systematic reviews for each of the 12 clinical questions. These were done in collaboration with clinical experts in the field to ensure proper question development and an experienced information scientist . These sCertainties in evidence assessments were performed by the MacGRADE team and were then reviewed by the entire panel to ensure accuracy and agreement. In each case that the certainty in effect estimates was downgraded, explicit rationale was provided in the evidence profile and in the guideline manuscript. Including the certainty as part of the final recommendation, as we have done for the 2015 IPF evidence-based guideline, helps stakeholders in interpreting the recommendations made by the panel. Recommendations based on higher quality of evidence allow clinicians and patients to be more reassured that this intervention is beneficial. Recommendations based on lower quality of evidence provide caution to stakeholders and recognize the uncertainty that exists regarding the benefits of this intervention.ad hoc approach, GRADE mandates an explicit assessment of these criteria, using the Evidence-to-Decision framework (EtD), with documentation of panel judgements and rationale [Although the estimate of treatment effect and certainty in evidence are important, guideline panelists should also consider other factors when deciding on the strength of recommendations. Elements such as the balance between the desirable and undesirable effects, the resources required, the impact on health equality, the acceptability and the feasibility of treatment must also be considered . As oppoationale , 20, 27.Input from clinical experts in the field is integral and guideline panelists must interpret the evidence summary, the certainty in estimate effects and consider the factors listed above in order to arrive at a direction and strength of recommendation using the EtD. Although some judgements will require an element of subjectivity, GRADE ensures explicit recording of rationale in order to improve transparency and reproducibility. Discussion of the evidence summaries and other EtD criteria for the 2015 IPF guidelines included all panel members, however, in order to help ensure impartiality, only non-conflicted members of the panel were permitted to formulate the recommendations themselves .The final result, using the GRADE process, is a comprehensive, systematic, and explicit evidence-based guideline. Recommendations for the 2015 IPF update were formulated using the common terminology of “we suggest” for conditional  recommendations and “we recommend” for strong recommendations . Strong In summary, guidelines lacking the methodological components described above, especially those on topics with sufficient evidence, while conveying the (unstructured) opinions of clinical experts in the field, have a significant risk of providing biased recommendations that may be then used to guide patient care. With the increasing amount of evidence that has accumulated since the 2000 guidelines, the evolution towards evidence-based guidelines using the methodology described for a complex disease such as IPF is a clear benefit to all and represents a true advance in clinical science and patient-centered healthcare. At the end, what arguments can be made against transparency in guideline development?


Competency profiles for occupational clusters within Canada’s substance abuse workforce (SAW) define the need for skill and knowledge in evidence-based practice (EBP) across all its members. Members of the Senior Management occupational cluster hold ultimate responsibility for decisions made within addiction services agencies and therefore must possess the highest level of proficiency in EBP. The objective of this study was to assess the knowledge of the principles of EBP, and use of the components of the evidence-based decision making (EBDM) process in members of this occupational cluster from selected addiction services agencies in Nova Scotia.A convenience sampling method was used to recruit participants from addiction services agencies. Semi-structured qualitative interviews were conducted with eighteen Senior Management. The interviews were audio-recorded, transcribed verbatim and checked by the participants. Interview transcripts were coded and analyzed for themes using content analysis and assisted by qualitative data analysis software (NVivo 9.0).Data analysis revealed four main themes: 1) Senior Management believe that addictions services agencies are evidence-based; 2) Consensus-based decision making is the norm; 3) Senior Management understand the principles of EBP and; 4) Senior Management do not themselves use all components of the EBDM process when making decisions, oftentimes delegating components of this process to decision support staff.Senior Management possess an understanding of the principles of EBP, however, when making decisions they often delegate components of the EBDM process to decision support staff. Decision support staff are not defined as an occupational cluster in Canada’s SAW and have not been ascribed a competency profile. As such, there is no guarantee that this group possesses competency in EBDM. There is a need to advocate for the development of a defined occupational cluster and associated competency profile for this critical group.The online version of this article (doi:10.1186/1747-597X-9-47) contains supplementary material, which is available to authorized users. Canada’s substance abuse workforce (SAW) is an unregulated profession. At the national level its development is supported by the Canadian Centre on Substance Abuse (CCSA) which provides evidence-based analysis and advice to mobilize collaborative efforts to reduce alcohol and other drug-related harms.Competencies for Canada’s Substance Abuse Workforceell I sit on a number of decision-making bodies around [treatment X] and we do have processes and our goal is consensus” (S14).[t]here is an effort to come to some sort of consensus regarding the decision-making because it is a group process. So there is discussion trying to move folks to that direction, if consensus isn’t achieved then the decision will be put to a vote…Similarly, another participant stated (S3): Theme 3: Senior Management understands the principles of EBP.Arriving at decisions through consensus is compatible with the principles of EBP provided that all components of the EBDM process are inherent to the decision-making, applied comprehensively and through the use of defined skills. […] so research based randomized clinical trials, meta-analyses, Cochrane Reviews, and we try to temper that with the other fields of knowledge, so what are the folks who are actually doing the work saying? What’s the [client] saying?Evidence-based practice is based on two principles: 1) The recognition that scientific evidence alone is insufficient to guide decision making; and 2) Within available sources of evidence, hierarchies exists. The majority of participants demonstrated an understanding of both principles of EBP. The recognition that scientific evidence alone is insufficient to guide a decision is exemplified by one participant who stated (S6): [our manager of research] has done a lot to actually help us learn that when you say ‘evidence’ it’s not a Google search, it’s something from the Cochrane Database or it’s CINAHL, or somewhere a little more reliable when we are actually searching for the evidence.Theme 4: Senior Management themselves do not use all components of the EBDM process when making decisions, often times delegating different components of this process to decision support staff.Recognition of the hierarchy of evidence is present in the following excerpt from one participant discussing the need to gather high quality evidence (S10): While knowledge of the principles of EBP is essential, judicious decision making also requires the comprehensive use of the EBDM process.Participants were asked to describe the process they use to define a problem, or ensure that when developing a question it contains all of the required components needed to inform a subsequent systematic literature search. The majority of participants stated that, at least initially, they were unsure if the question being posed was in fact the right one and that over time the question either changed or became more refined. According to one participant “in a lot of cases you just don’t know if you are asking the right question. For myself, generally something comes to mind that I am wondering about and then I start exploring it” (S7). Another participant explained that “I think the questions evolve, I don’t think you start with a perfect question, but that they evolve as you get more and more information available to you” (S2). Of the 18 participants, one described using a formal process  for defining a researchable question, although this participant did not describe all of the components of that particular process.Some participants discussed the need to consider an outcome when developing a question. For example one participant stated (S2) “I’m thinking of acupuncture, and I don’t know if I am going to get at this or not but the question for acupuncture is “is it effective, does it have good outcomes?” Another stated “obviously you are thinking of an outcome, so I would think ‘this is what I want for my outcome, what do I need to ask, and do, and go through to come up with my question to reach this point?’”(S8).Participants were asked to describe strategies they used to gather evidence, including the sources they might access. Some participants discussed using bibliographic databases  as a source of scientific research literature. Participants frequently indicated they did not use systematic reviews. The majority of participants identified expert opinion as a source of evidence. The majority also indicated that existing policies from other jurisdictions were considered an excellent source. The participants were not asked if they used a process to determine if other jurisdiction’s policies were created using an evidence-based approach. The majority of participants did not identify their own experience as a source of evidence; a minority did not identify the preferences and values of their patient’s/population’s as sources of evidence.I find it difficult because I have never gone beyond, that’s my personal experience [..] I emailed the librarian to ask if she could help me get [this article] because I couldn’t seem to [access] it, and she sent me something back and still I couldn’t get it.In terms of gathering evidence to answer questions or address issues, the majority of participants stated that they did not gather evidence themselves; rather they had staff members perform this function. The majority of participants cited time as one of the reasons that they did not perform their own searches; two participants also added that they were not comfortable with their own skills to perform such a search. One participant described the difficulty encountered with trying to track down the full text version of an article, rather than simply using the abstract (S10): […] we have our decision support person. So we put people in place whose job is to have that expertise, so we would ask them to give us the advice, or well the literature, the evidence, and then we determine from the evidence what our approach [will be].Some participants stated that they had people in positions  to do such work and they trusted that they were experts in that area. According to one participant (S12): When participants were asked how they would evaluate the validity of information gathered as part of their decision-making process, responses varied. Some participants stated that they would look to see if the information came from a recognized source, such as the Centre for Addiction and Mental Health (CAMH) or a well-known journal. Some participants stated that they were not comfortable performing such an evaluation and would rely on the expertise of someone else from within their agency, such as a Research and Statistical Officer, or someone in a decision support role. Some participants stated that the first part they would consider when appraising information would be the methodology. No participant described how he or she would perform such a process (participants were not prompted to do so). When prompted, participants did not acknowledge use of assessment guidelines .A few participants discussed the need to evaluate the specific statistical tests that were employed in a study, though one commented that they did not have the requisite skills to do so “I have taken some statistics courses before but I am certainly not capable of comparing specific statistical analyses against one-another” (S9).[…] I would want to read the research on it, have a look at the outcomes, and I’d want to compare where and who it was implemented with to see if it is compatible with our area and our resources. I’d probably talk to someone who has done the program in another place, make a phone call, talk to staff about it get their views because they are great at finding stuff that I wouldn’t even think about[…].Participants were asked to describe how they applied the results of their evidence gathering to their decision making process. The majority of participants described the consideration of both internal and external evidence when making a decision. According to one participant prior to deciding to implement a new program (S4): When discussing the integration of internal and external evidence participants frequently emphasized the importance placed on scientific research to support decisions.So when I can say ‘OK, this is what the literature says about this; this is what the experts say about this; this is what I read in this or that book; this is what our past experiences with this have been.A few participants identified the need to gather input from relevant high quality literature, expert opinion, clients, and staff, and one individual identified the need to consider previous experiences (S17): […]sometimes it is difficult to translate the best practice to create on the operational side of things simply because you may not always have the resources or capabilities to fully meet the standard that the best practice is setting.The majority of participants also discussed the need to adapt evidence so that it could be applied to their local context. Financial and resource limitations were cited by the majority as significant factors for consideration. According to one participant (S10): Once evidence has been integrated, contextualized and applied to a decision, an evaluation of that decision must be made to determine the outcome as well as areas for future improvement.When asked what methods participants would use to assess the outcome of applied decisions, the majority of the participants stated that they should measure treatment and prevention outcomes, but evaluation is most often based on client satisfaction. Some of the participants acknowledged that these outcomes should be determined in advance to avoid a biased evaluation, but many participants stated that this process does not currently take place.system must be versed in these attributes, competency is particularly important in those working in the Senior Management occupational cluster. Ultimately, it is these individuals who are responsible for decisions, and the hiring of individuals who contribute to decisions, integral to the development and implementation of judicious and evidence-based policies, programs, standards and guidelines that support the treatment and prevention of addiction. The objective of this study was to appraise understanding of the principles of EBP, and investigate the knowledge and use of the components of the EBDM process during their decision making. Results suggest that Senior Management understand the principles of EBP. However, most do not themselves enact all components of the EBDM process during decision making and more than half disclosed a lack of comfort and experience with evaluating existing research. When prompted to describe their decision making process, components of the EBDM process  were not consistently described. An apparent strength of this occupational cluster is their knowledge and described experience with integration of various forms of evidence.The competency profiles ascribed to Canada’s SAW demonstrate a need for understanding the principles of EBP and for possessing skill in all components of the EBDM process . While aThe finding that most participants did not describe all components of the EBDM process might be attributed to the fact that some delegate components of the decision making process  to other staff members. In fact, many participants described decision making as a team process. While this may explain, in part, the absence of description of these components, it highlights an area in need of attention. Individuals identified as providing decision support  are not an occupational cluster of Canada’s SAW and, as such, have no consistently defined roles or expectations. In the absence of competency profiles, there can be no assurance that those providing decision support understand the principles of EBP or use the EBDM process, and therefore it is unknown whether information being provided to Senior Management represents all best available internal and external evidence. Development of the occupational clusters for Canada’s SAW  to incluThe roles and responsibilities of Senior Management are substantial and the need to hire others to search for and appraise evidence may be an acceptable reality. During the hiring process, it would be important to judiciously assess for the ability of a candidate to understand and apply the EBDM process. Such judicious assessment necessitates the interviewer to have competency in the field. In this study some Senior Managers described difficulty in performing selected components of the EBDM process. Therefore, it could be argued that Senior Management may not have the ability to hire or recruit decision support persons with the necessary skills and knowledge.systems of care components. Another contributor to the lack of outcome monitoring may be a lack of resources  available within the addictions prevention and treatment system to support this type of evaluation. Regardless of the reason, in the absence of comprehensive outcome evaluation, systems cannot be considered evidence-based. Furthermore, in the absence of outcome evaluation, applied decisions might result in the provision of ineffective or even harmful practices.A second area potentially in need of attention is in evaluating outcomes of applied decisions. This is a vital step to EBDM enabling the decision maker to assess decisions for effectiveness and/or identification of areas in further need of improvement. It would appear that the most common approach to evaluation in addiction services agencies has been to measure client satisfaction with service delivery and not to evaluate the specific outcomes of programs, services and supports. One possible explanation for this practice is that comprehensive outcomes are often not clearly identified prior to and during the development of Other themes that emerged during the study were the belief that programs, services, policies and standards offered by addictions services agencies are evidence-based and also that decisions are made through consensus. Application of the principles of EBP requires defined skill sets and includes five components: development of a researchable question, development and implementation of an appropriate search strategy, critical appraisal of internal and external evidence, integration of various evidentiary sources, and outcome evaluation. For a decision to be truly evidence-based all of these components must be integrated. The fact that most participants did not describe using all components of the EBDM process, or described challenges with certain components  draws into question some participants' ability to judge addiction services agencies as being evidence-based.Competencies for Canada’s Substance Abuse Workforce, typify the workforce structure of addictions services agencies in Nova Scotia.This study profiles a sample of persons working as Senior Managers in selected jurisdictions of Nova Scotia. Qualitative methodology does not allow generalizabilty and therefore these findings cannot be extrapolated to Senior Management in other jurisdictions within Nova Scotia or Canada. It is of note however that, while no study has examined the educational backgrounds or professional experiences of persons working in addictions services agencies in Nova Scotia, anecdotal evidence suggests that the educational background of the Nova Scotia addictions workforce is similar to that described for Canada . FurtherA recent Canadian study  which usNo other studies have evaluated the knowledge of the principles of EBP or knowledge and use of the components of the EBDM process in Canada’s SAW. To date, studies in the addiction-related field have primarily investigated the implementation and use of evidence-based practices. These studies report a consistent gap, as much as 15 years, between what current research indicates as best practice, and what is practiced in the field , 51–53. The findings from the current study corroborate only one of these variables: participants did discuss a lack of comfort with critical appraisal skills. However, in contest to the other two variables suggested by Dobbins , particiA variety of techniques and procedures exist that can be used to increase the validity of the data in qualitative inquiry , 44. Thesystems.This study has identified the need to consider identification of an additional occupational cluster for Canada’s SAW, one which defines the expectations and competencies of persons specifically hired to provide decision support. It also provides insight into the challenges some Senior Managers face when performing selected components of the EBDM process. These findings were not unexpected. The majority of study participants completed formal education many years prior to the integration of EBP and a formalized EBDM process into curricula of university programs. Furthermore, effective programs for professional development pertaining to EBDM are limited. This study advocates for the provision of professional development training opportunities to support Senior Managers in their EBDM and when hiring decision support staff. Such initiatives will support the continued development of evidence-based Senior management: behavioural competency indicators linked to evidence-based practice.(DOCX 17 KB)Additional file 1:Interview guide.(DOCX 15 KB)Additional file 2:CCSA Copyright Permission Letter.(DOCX 332 KB)Additional file 3:


Class specific deprescribing guidelines could help clinicians taper and stop medications no longer needed or which may be causing more harm than benefit. We set out to develop methodology to create such guidelines using evidence-based methods for guideline development, evidence synthesis and recommendation rating.Using a comprehensive checklist for a successful guideline enterprise, we conducted a national modified Delphi consensus process to identify priorities for deprescribing guidelines, then conducted scoping exercises to identify feasible topics, and sequentially developed three deprescribing guidelines. We selected guideline development team members for clinical expertise; a GRADE member worked with staff to ensure guideline development processes were followed. We conducted or used systematic searches and reviews of deprescribing trials of selected drug classes, reviews or systematic reviews of drug class effectiveness, reviews of reviews of drug class harm and narrative syntheses of contextual questions to inform recommendations and guideline development. Our 8 step process for guideline development included defining scope and purpose, developing a logic model to guide the process and generate key clinical questions, setting criteria for admissible evidence and conducting systematic reviews, synthesizing evidence considering additional contextual information and performing quality estimates, formulating recommendations and providing strength estimations, adding clinical considerations, conducting clinical and stakeholder review and finally updating content pre-publication. Innovative aspects of the guideline development process included synthesizing evidence for outcomes of tapering or stopping medication, and incorporating evidence for medication harm into the recommendation strength rating. Through the development of three deprescribing guidelines  and associated decision-support algorithms, we were able to gradually hone the methodology; each guideline will be published separately.Our methodology demonstrates the importance of searching for short and long-term outcomes, showing the benefits of deprescribing and studying patient preferences. This publication will support development of future deprescribing guidelines. Little deprescribing guidance is available to clinicians and the public. Current deprescribing algorithms –4 are noA companion paper outlines the developmental evaluation method we used to study the development and implementation of the guidelines . ResultsDeprescribing is the planned and supervised process of dose reduction or stopping of medication(s) that may be causing harm or are no longer providing benefit. The goal of deprescribing is to reduce medication burden and harm, while maintaining or improving quality of life. This is particularly important to consider as people age, given changes in pharmacokinetics, pharmacodynamics and physiological reserve . Risks oSmall studies have demonstrated successful deprescribing approaches,  yet haveWe used a comprehensive checklist for a successful guideline enterprise to develop the methods for our deprescribing guidelines.We began by conducting a national modified Delphi consensus process with potential users of the guidelines  to identify priorities for deprescribing guideline development . Particide novo systematic review would be required for the guideline.We conducted scoping exercises to identify three of the top five priority topics for which deprescribing guideline development would be feasible . These iWe established a Guideline Development Team (GDT), including a Methods Committee member for each of three topics–proton pump inhibitors, benzodiazepine receptor agonists and antipsychotics. Each team included a guideline lead, clinical experts  and a staff coordinator. For example, the BZRA guideline included a family physician (1), pharmacists (2), clinical pharmacologist (1), psychiatrists (2), psychologist (1) geriatrician (1) and GRADE methodologist (1). The names and expertise of each GDT member are described in each guideline publication. Guideline leads had clinical expertise with the topic area and experience conducting systematic reviews for guideline development. We identified clinical experts through the Cochrane network, a network of clinicians interested in the Deprescribing initiatives and through identified experts recommending other experts. Clinical and guideline method expertise contributed to the selection of additional guideline team members. We recorded team members’ conflict of interest declarations .Each of the three guideline development teams followed the same process , adaptedEach GDT met either face-to-face and/or by teleconference to determine the target audience, scope and purpose of the guideline. They considered target audiences to be health care professionals involved in the prescribing or monitoring of medication effectiveness and safety within the primary care and long-term care environments. The purpose of each guideline was to provide evidence for the benefits and harms of deprescribing a drug or drug class (including feasibility and safety in terms of not worsening symptoms or causing disease recurrence), evidence of benefit and harm of continuing the drug or drug class, patient preferences and values surrounding deprescribing, resource implications of deprescribing as well as practical guidance on how to implement deprescribing .Each team identified patients for whom the guideline would  and would not  apply, as well as other guidelines recommending a limited duration of treatment for certain indications. While our original intention was to develop guidelines to facilitate deprescribing in the elderly, there was such a paucity of trials in this age group that we therefore expanded the inclusion criteria to include all adults (≥18 years).Population of interest (adults >18), the Intervention (deprescribing), the Comparator (continuation of the medication) and patient-important Outcomes relevant for decision-making (both positive impact and adverse effects of deprescribing) [The Methods Committee developed a generic logic model to illustrate the possible evidence chain of each guideline . The logcribing) . Staff, Each GDT populated a standard template during their initial meeting, then revised a circulated copy of the key PICO question until consensus was reached. Each team considered and ranked the importance for patients and clinicians on the following outcomes: effect on pill burden, patient satisfaction, medication prescription numbers, cost/resource implications, adherence, health care utilization and stabilization, worsening or improvement of a symptom or disease, quality of life and changes in physical or cognitive function.Driven by their clinical experience, each GDT also identified additional contextual questions, for example: What are alternative, safer, effective pharmacological or non-pharmacological options for treatment of the symptom or condition? Are there certain populations that might be more amenable to deprescribing? What tapering strategies and monitoring approaches should be used to safely deprescribe the medication?An expert medical librarian and a systematic review methodologist with experience conducting Cochrane reviews developed the search strategies to assess benefit or harms of deprescribing the drug class  of interest. The research assistants met with one investigator to reconcile the resulting list of studies and resolve any disagreements regarding selection of relevant studies.The librarian conducted a literature search to facilitate an English only review of reviews of harms using the methods outlined by Smith et al.  RelevantThe librarian conducted additional literature searches to provide relevant content for considering other contextual questions . An example search strategy for values and preferences is in All evidence  was synthesized into recommendations using the GRADE Evidence to Recommendations Table  and their own clinical experience to provide guidance on these questions. Sample questions are outlined in A practicing family physician, nurse practitioner and pharmacist (who were not members of the Deprescribing project) provided a clinical review of each guideline using the AGREE II Global Rating Scale  to guidePrior to publication, the GDT incorporated feedback from stakeholders and pilot sites, and updated guideline sections if new relevant evidence was available.deprescribing.org) to house implementation tools . Knowledge translation will be facilitated through social media  and conference presentations/workshops.Dissemination of each guideline is planned via open-access publication and use of a website , using rigorous search and synthesis processes, ensuring clarity of presentation, assessing applicability (through pilot testing in both community and long-term care settings), documenting competing interests and maintaining editorial independence.Consistent with research that demonstrates guidelines are more likely to be implemented when accompanied by guideline implementation tools ,35, eachStrengths of our process included engagement of clinicians in a feedback process using AGREE II, inclusion of all GDT members with an active role in writing sections of the guideline, using the GRADE process to make judgements about directness and values transparent, honing a streamlined process for guideline development and incorporating the development of guideline implementation tools. The research team set out to develop and pilot three guidelines over 30 months. We conducted a developmental evaluation strategy of both the guideline development and implementation processes . ResultsLimitations encountered in our deprescribing guideline development process included the paucity of RCT evidence for deprescribing; this narrowed the choice of topics for guideline development using the GRADE method and highlights an important gap in research that funding agencies should note. Guideline development team members relied on observational evidence for harms data, surveys and interviews for patient preferences data, and expert clinical opinion for clinical considerations pieces when other evidence was unavailable. Our intention was to incorporate frontline patient perspective through interviews with patients in the pilot sites , however, we were unable to recruit sufficient numbers of patients to complete a valid qualitative analysis. Instead, we subsequently incorporated feedback from clinicians who had implemented the guidelines with patients, relying on their perspective to provide proxy patient input. We recognize the limitation with this approach and recommend going forward, that deprescribing guideline developers include representative patient users on guideline development panels from the outset. We recognize this approach is also fraught with challenges  but feelEvidence-based deprescribing involves systematic search, evaluation and synthesis of evidence on benefits and harms to formulate recommendation on tapering or stopping medications. Decisions around deprescribing can be clinically difficult to make. We have developed methodology to create guidelines that synthesize the information needed to support deprescribing decisions. This methodology could be used as a template for future evidence based deprescribing guidelines.Our guidelines take into account evidence of benefit of the medication class, estimations of their harm and evidence of the feasibility and outcomes of deprescribing–the latter two topics representing key innovations in guideline development. The GRADE approach assisted in rating the quality of evidence, particularly for the elderly population subgroup where possible, as well as taking into account patient preferences and resource implications when formulating recommendations. The process fulfills the AGREE II criteria, the current quality standard for guidelines development.S1 Appendix(DOCX)Click here for additional data file.S2 Appendix(DOCX)Click here for additional data file.S3 Appendix(DOCX)Click here for additional data file.S4 Appendix(DOCX)Click here for additional data file.