An apprasial on two articles one is qualitative and one is systematic.

nursing project and need a sample draft to help me learn.

Use the information below to help you know which section of the article to use to answer questions in the template:
Introduction and its subsections have the purpose or WHY the study was done.
Methods section and its subsections contain HOW the study was done.
Results, Discussion, and Conclusions section will have WHAT was found.
Each section of the template is required to be completed as this assignment builds on your Evidence-Based Practice Project. Each template has a citation that must be submitted in APA format. Answers to questions in Synopsis sections are required (see template examples in your book). Each question must have an answer of 1-2 full sentences in length per question. Credibility section Yes/No answers are also required. The Comments area is also required and should be at least 1-3 sentences noting how this article relates to your nursing issue topic from week 3 and what you thought was significant.
My topic has been on Venous Thromboembolism
attached below is the documents which need to be filled out and the pdf articles which are to be used
Requirements:
Log inGo to: ▸Go to: ▸Go to: ▸Go to: ▸Open in a separate windowGo to: ▸Go to: ▸Go to: ▸Go to: ▸Go to: ▸Go to: ▸Open in a separate windowOpen in a separate windowGo to: ▸Go to: ▸Journal List > Res Pract Thromb Haemost > v.5(6); 2021 Aug > PMC8435525As a library, NLM provides access to scientiÞc literature. Inclusion in an NLM database does not implyendorsement of, or agreement with, the contents by NLM or the National Institutes of Health.Learn more: PMC Disclaimer | PMC Copyright NoticeRes Pract Thromb Haemost. 2021 Aug; 5(6): e12593.Published online 2021 Sep 12. doi: 10.1002/rth2.12593PMCID: PMC8435525PMID: 34532630The use of qualitative methods in venous thromboembolism researchJackeline Hernandez‐Nino, MD,Mary Thomas, MD, MPH,Andreia B. Alexander, MD, PhD, MPH,Mary A. Ott,MD, MA,and Jeffrey A. Kline, MD▸ Author information ▸ Article notes ▸ Copyright and License information PMC DisclaimerAssociated Data▸ Supplementary MaterialsAbstractIntroductionQualitative research has been increasingly used in health care research to allow in‐depth insights andunderstanding of patientsÕ lived experiences for poorly understood phenomena. The psychological stressmechanisms underlying fear, dyspnea, and pain after venous thromboembolism (VTE) remain poorlyunderstood. However, novice VTE researchers may not be familiar with the process of undertakingqualitative research.ObjectiveThe aim of this article is to describe the planning, methodology and execution of qualitative methods,using the example of patientsÕ lived experiences during and after the diagnosis of VTE. We discusschallenges and solutions in implementing qualitative research methods in health care research.MethodsPatients were recruited from the emergency department and clinic using in‐person and phone contact. Weused both in‐person and video format to interview 24 patients. Interviews were guided by a set ofquestions to be explored but conducted to elucidate unique thoughts and opinions from patients.ResultsFor recruitment, Òcold‐callingÓ was found to be largely unsuccessful. Many patients have preexistingdiagnoses of anxiety and depression. Video interviews were found to be at least as effective as in‐personinterviews. Interviews revealed unique post‐VTE experiences from all participants, with a wide range ofimpact on quality of life. Themes that were most common included perceptions of physiciancommunication, fear of recurrence, and concerns of death.ConclusionA qualitative research approach can reveal individual experiences and psychosocial impact in patientsdiagnosed with VTE, which allow the researchers to better comprehend the complexity of thisphenomenon and its impact in health care.Keywords: challenges, methods, psychological stress, qualitative research, solutions, venousthromboembolismEssentialsHealth care researchers may not be familiar with starting a qualitative study.Qualitative research was used to explore lived experiences in patients with blood clots.This provides a detailed account of the planning and execution of a qualitative project.Challenges and solutions are described to guide new researchers.1. INTRODUCTIONDespite the increasing acceptance of qualitative methods in health care research, qualitative methods havebeen slow to impact research and medical practice related to venous thromboembolism (VTE).Qualitative research, through detailed descriptions and open‐ended approaches, offers a differentapproach to identify what is important for patients and to improve health care experiences. It allowsresearchers to reach areas that cannot be measured by quantitative research. For patients with VTE,overutilization of emergency departments (EDs) is an example of a signiÞcant health care problem withhigh Þnancial and human costs that could beneÞt from qualitative approaches.Qualitative research involves collecting and analyzing nonnumerical data to understand humanexperiences, conveyed by the expression of opinions, behaviors, concepts, beliefs, attitudes, andinteractions with other humans. Qualitative methods allow access to in‐depth insights and understandingof real‐world problems from the patient perspective and are particularly helpful when little is knownabout a topic, when quantitative results are unexpected, or when a problem, like overuse of EDs, provesto be persistent and recalcitrant to interventions. Qualitative methods do not require an a priorihypothesis, or preidentiÞcation of variables, making them ideal when a health services topic is poorlyunderstood. Qualitative methods are an important tool for health care, as they can identify the impact ofsocial determinants such as sex, education, poverty, race, or religion on the conduct and outcomes ofresearch.Over the past decade, there has been increasing attention to the quality and rigor of qualitative studies inhealth research generally, including methodological guidelines for qualitative health research. Checklistshave been published to improve the reporting of research methods, coding, analysis, and results, as wellas the interpretation of qualitative work, which allow a structured and reproducible critique of qualitativeresearch (checklist for the current manuscript is provided in supplemental information). Missing,however, from existing methods literature are detailed examples of how qualitative research methods canbe applied and discussions of challenges, solutions, and adaptations.Using the case of venous thromboembolism (VTE) research, we describe a qualitative approach tounderstand patientsÕ lived experiences of VTE. The purpose of this article is to describe the applicationof qualitative methods, as well as challenges and solutions, in implementing qualitative research on healthcare topics. We Þrst provide a detailed account of the planning and execution of a qualitative project and,second, describe challenges and solutions for future researchers selecting qualitative methods.2. DISEASE MODEL: VTEThe target condition for this work is VTE, deÞned as deep vein thrombosis (DVT), pulmonary embolism(PE), or both. VTE affects >600,000 individuals in the United States each year, causing considerablemorbidity and mortality. About 5% to 15% of patients with VTE have a recurrence in the Þrst year ifanticoagulation therapy is discontinued after 3 to 6 months. By 10 years, approximately 40% of patientswith unprovoked VTE will have experienced a recurrence, increasing risks for complications andmortality.In addition to the risk of recurrence, ≈30% of PE survivors develop substantial ongoing reductions inmental and physical health that greatly impair their quality of life. If DVT is included, thenumber affected at least doubles, in part because of the impact of the postthrombotic syndrome, a chronicconsequence of DVT characterized by leg swelling, pain, edema, venous ectasia, and skin induration.Persistent symptoms likely amplify fears of recurrence, and these fears, coupled with concerns aboutside effects of anticoagulants used to treat the condition, contribute to a lifelong cognitive and healthburden. It is thought that persistent symptoms and fears may play a causative role in frequent ED visits.These visits can result in unnecessary testing that requires ionizing radiation, are costly (both Þnanciallyand personally), and do not change plans of care. This low‐value use of the ED contributes to the highlong‐term economic burden of VTE.Accordingly, this qualitative study was undertaken with the belief that qualitative methods can provide anopportunity for a better in‐depth understanding of how and why the diagnosis of VTE may impactindividuals and their use of the health care system.3. QUALITATIVE RESEARCH DESIGNA qualitative method, in‐depth individual interviews, was selected to allow for richly detailed data aboutthe lived experiences of patients diagnosed with VTE and the psychosocial impact of VTE on patients.This approach was selected because there is little known about patientsÕ lived long‐term experience ofVTE, and in‐depth individual interviews (similar to other qualitative approaches) allowed our team togenerate an explanation of a process of health care usage shaped by the views of a number of participantson this particular phenomenon. For patients with VTE, limited prior research has described their goals,fears, expectations, values, concerns and anxiety. This qualitative analysis allows us to describethe lived reality that consists of peopleÕs individual experiences and how individuals interpret thoseexperiences. Using textual data from interviews, the aim of this research was to generate explanations andtheories on how individuals with VTE use health services.We chose to use additional quantitative measures to more accurately describe participantsÕ severity ofVTE and comorbid conditions, such as anxiety, posttraumatic stress disorder, and postthromboticsyndrome, and quality of life after VTE. Quantitative self‐administered surveys were administeredimmediately after the interview. The addition of quantitative measures to this primarily qualitative studyallowed us to compare patientsÕ experiences with more objective measures of disease severity andcomorbidities.4. SAMPLING AND RECRUITMENT METHODSPurposive sampling was used to identify participants. Purposive sampling is a nonprobability samplingapproach in which informants are selected to capture a range of experiences and characteristics. Ideally,informants will be willing to share their experiences and have good communication skills and the abilityto reßect upon their experiences. For this study, we sought a range of ages, varied types and severity ofVTE (PE only, PE and DVT, or DVT only). We also sought participants who had a wide variety of healthcare experiences, including those who were discharged home from the ED or had more intensivetreatment (eg, reperfusion therapy), and those representing a wide range of VTE recurrences, time sincediagnosis, and ED visits. See Table 1 for participant information.TABLE 1Clinical characteristics of participantsAbbreviations: DVT, deep vein thrombosis; PE, pulmonary embolism; VTE, venous thromboembolism.To capture a range of patient experiences, in particular recurrence and ED usage, we used severaldifferent recruitment approaches. We Þrst used databases from a university hospital anticoagulation clinic(>50% patients with DVT only), a registry kept of patients treated with multidisciplinary pulmonaryresponse team, as well as patients who participated in other VTE research studies by our group. We alsoused the electronic medical record (First Net; Cerner Corp., North Kansas City, MO, USA) to surveypatients presenting to the IU Health Methodist and Eskenazi Hospital ED in Indianapolis to identifypotential participants who were diagnosed with VTE at least 6 months prior. Participants were betweenthe ages of 18 and 70 years who had experienced a symptomatic VTE as a DVT, PE, or both at least 6months prior to the interview. Participants were excluded if they had a diagnosis of active cancer orknown history of mental illness or other psychological diagnosis before the VTE with the exception of adiagnosis of anxiety or depression. This study was approved by a local institutional review board (IRB).This study was conducted in compliance with the ethical standards of the responsible institution onhuman subjects as well with the Helsinki Declaration.The main challenge for the sampling and recruitment was the time and effort required to screen and enrollparticipants. To complete the 24 interviews, the Þrst author (JHN) reviewed 620 charts from the differentVTE study databases for inclusion, exclusion, and sampling criteria. The time required for this screeningprocess ranged from a few minutes (eg, when age was found to be an exclusion criterion) to 90 minutes(when the participants had a contradictory past medical history or unclear psychiatric history). Toexpedite this process, the participants with contradictory or unclear medical history were ßagged to do amore detailed assessment of the exclusion criteria during the phone call. Ultimately, 160 participants metthe criteria. After the participant met the inclusion criteria, the study personnel or the principalinvestigator (PI) then initiated phone calls to inquire about interest in participating. The time spent onphone calls varied from 1 minute (when calls were not answered, or the number was not in service) to30 minutes (to explain the study to the participant and schedule the interview).The second challenge was the original exclusion criterion of history of mental illness. The diagnosis ofanxiety and depression excluded the majority of otherwise eligible patients. Simultaneously,documentation of mental health disorders was inconsistent and often incomplete, requiring PIinvestigation of unexplained International ClassiÞcation of Diseases codes in the absence of adocumented formal psychiatric or even primary care mental health evaluation. As a solution, wechanged our original exclusion criteria of history of mental illness to known history of mental illness orother psychological diagnosis prior to VTE diagnosis with the exception a diagnosis of anxiety ordepression. This change in the exclusion criteria increased the number of participants eligible to becalled; however, these protocol changes only modestly helped the rate of recruitment because ofpervasive problems with telephonic recruitment.We were able to obtain a waiver from the IRB for recruitment but found that the Òcold‐callÓ telephonecontact method proved to be highly inefficient. Approximately 14% of telephone numbers haddisconnected service. An additional 51% of participants were unable to be reached. In 75% of these cases,the caller left at least one voice message and never received a call back. Nineteen percent answered theÞrst phone call and asked to be called another time but did not answer the subsequent call. Fifteen percentrefused to participate in the study. The remaining 6% of calls were never answered or the voicemail wasfull.Additional opportunity cost resulted from 27% of scheduled interviews who failed to show, with only twoof those participants completing the interview after rescheduling. In an attempt to improve outcomes,every participant was called at least three times on different days, at different times. A minimum of threecalls were made to numbers not obviously disconnected with an average of six to seven calls per patient.Despite strenuous effort and protocol modiÞcations, the recruitment effort required 9 months to completeinterviews with the Þrst 15 participants. After the coronavirus disease 2019 (COVID‐19) pandemicbegan, and state and local stay‐at‐home public health orders began, the number of participants whoanswered the phone calls increased, and within 2 months, 13 individuals agreed to participate. Because ofthe convenience of virtual interviews, we were able to retain a higher proportion of participants, and ninecompleted interviews. However, two participants were unable to complete the interview due to lack ofaccess to computer, smartphone or internet, and two participants did not answer the day of the interview.One of them was reached later again but declined to complete the interview due to being admitted to thehospital, and the second participant never answered the calls to be rescheduled.5. SAMPLE SIZEQualitative sample size is determined by thematic saturation rather than mathematical calculation.Thematic saturation is the point at which the interviewer has uncovered the full range of perspectives inthe population interviewed, and subsequent interviews no longer uncover new ideas. It is dependent upona variety of factors, including the purposive sampling approach and the diversity of perspectives in thepurposive sample. We had originally planned on 30 interviews. However, with a total of 24 interviews,we felt that we achieved thematic data saturation, based on repetition of statements and themes.6. STUDY PROCEDURESThe initial design of the study was to interview all participants face to face to facilitate the developmentof rapport between the interviewer and interviewee, reduce distractions, and allow the interviewer to readthe participantÕs body language.However, to adapt to the public health orders related to COVID‐19, interviews were switched to a webconferencing platform (Zoom; Zoom Video Communications, San Jose, CA, USA) after the Þrst 15interviews. We adapted the same structure, identical format, and verbal instructions for COVID‐19Ðadapted video interviews and tracked the duration and content of these video interviews to compare toface‐to‐face interviews. The duration of the interview remained identical after the transition from face‐to‐face interviews to a web conferencing platform (Zoom). Overall, the web conferencing offered logisticaladvantages. The access to geographically remote participants, the reduction on travel expenses forparticipants and interviewer, and savings on setup cost were key advantages.Nonetheless, we identiÞed a few challenges with the web conferencing platform. Two participants wereunable to be enrolled because they did not have access to the necessary technology(Internet/smartphone/computer). The ability to establish a natural, relaxed conversation and observe bodylanguage was signiÞcantly reduced with two participants who used a cellphone for the video call. Thiswas largely because the participants were holding the cell phone in their hands throughout the interview,which focused the camera only on their face and took away the ability to observe nonverbal cues. Finally,one participant who had never participated in a videoconference seemed distracted by the process. Thiswas evidenced by the participantÕs inability to focus on the verbal conversation and requiring frequentredirection throughout the interview. The participant seemed Þxated on the video display, often Þxing thehair and asking whether the interviewer could see and hear well.For the face‐to‐face interviews, participants were interviewed individually in a quiet and private officewith no others present, not bright lights and neutral background to avoid distractions. A ÒDo Not DisturbÑInterview in ProcessÓ sign was placed outside the door to minimize interruptions. When the interviewwas done by a web conferencing platform, the interviewer used the same place and the participants wereasked to be in a location that would ensure privacy and prevent interruptions.Two audio recorders were used during each interview to ensure that the interview was recordedcompletely and accurately and to allow the PI to focus during the interview. None of the interviewsrequired a repeat session. All interviews were transcribed verbatim by a professional transcriptionist.None of the transcripts were returned to the participants.Most interviews lasted 75 minutes and were followed by completion of Þve questionnaires: GeneralizedAnxiety Disorder Scale, Posttraumatic Stress Disorder Checklist, Pulmonary Embolism Quality of Lifequestionnaire, Villalta Scale for Diagnosing Post‐Thrombotic Syndrome, and the Concerns AboutRecurrence ScaleÑVTE.7. INTERVIEWER CHARACTERISTICSIn qualitative work, we found it important to be attentive to the interviewer characteristics as well as theinterviewer‐interviewee relationships. In this study, the interviewer had no prior clinical relationship withany of the 24 participants. We felt that it was important for the interviewer to not be the patientÕs medicalprovider because we wanted patients to be free to express negative as well as positive experiences withthe health care system and to not feel pressured to participate. However, we did feel that it was importantfor the interviewer to have prior knowledge on the topic (in this case VTE) and research expertise. Theinterviewer was a female internal medicine physician, has both clinical care and research experience withVTE, as well as both clinical and qualitative interview experience.8. INTERVIEW GUIDE DEVELOPMENTInterview guides for qualitative research range from completely unstructured to highly structured. Weopted to use a semistructured approach, in which all participants were asked the same main questions, butthe interviewer followed up with different probing questions, depending on the answer to the mainquestion. The use of a semistructured approach enabled us to cover all pertinent areas but also allowedparticipants to bring up topics we had not previously considered and to provide a high degree of detail.Our preliminary interview guide was developed on the basis of pertinent information gathered from areview of the literature. Then, the interviewer conducted three pilot interviews to test the guide.These pilot interviews allowed us to reÞne existing questions. Questions that did not work well weredropped, and questions were added on the basis of participant feedback. We set up our questions toencourage participants to tell their story. In contrast to questions that allow short or single‐word answers,a storytelling approach allowed a more detailed narrative. The use of a semistructured guide enabledßexibility to ask questions that incorporated new information and to follow new ideas as they came up inthe interview.9. INTERVIEW PROCESSWhile the goal of the qualitative interview is to feel like a conversation, the emphasis is on activelistening. At the beginning of the interviews, the roles were clariÞed: The participant was counseled thatthe interviewer would ask questions but mostly listen and the interviewee should do the majority of thetalking. The interviewer stated that the interview was intended to be conversational with no expectationof right or wrong answers.The interview structure started with asking the participants to describe the time when they werediagnosed with VTE. We deliberately asked the interviewee to tell us their ÒstoryÓ of VTE both to serveas a warm‐up for the interviewee because of its ease and allow for often unexpected details that comefrom storytelling. Probing questions were used to elicit details of the story.The interviewer then inquired about the participantÕs knowledge of VTE to compare his or her knowledgeat the time of the diagnosis with his or her current knowledge. As the interview progressed, theinterviewer posed more challenging questions involving life‐changing aspects due to the diagnosis,concerns and fears about the diagnosis, and coping mechanisms and emotional support, which alsopresented challenges to the interviewer.A strength and a challenge in qualitative interviewing is the ability of the interviewer to identify andexplore discrepancies in the participantÕs stories. For example, when participants were asked aboutmental health after VTE diagnosis, most participants denied having any anxiety, worry, or concern afterthe diagnosis; however, the same participants described signs of anxiety, fears, concerns, and worriesafter the diagnosis throughout the interview. In these situations, the interviewer would ask the samequestion using more neutral words, avoiding words clearly aligned with mental health, such as anxiety,worry, depression, or stress, in attempt to overcome their reluctance to endorse anxiety or worry about thedisease. For example, the interviewer might ask: ÒWhat comes to your mind?; or ÒWhat do you thinkwhen you start having shortness of breath or chest pain or leg pain?Ó; or ÒTell me about changes in yourlife after the blood clots.Ó This discrepancy was more prevalent with male participants, and wehypothesized that this might be related to the perceived stigma of a mental health diagnosis.A second challenge in qualitative interviews on health services is that often informants do not know basicknowledge about their own health care condition. This raises both practical and ethical concerns. In asuccessful qualitative interview, the interviewer and interviewee build a relationship of trust, and whenthere is that level of trust, interviewees are often more willing to make themselves vulnerable anddisclose lack of knowledge or ask for assistance in understanding their conditions when they would nothave otherwise. In our study, a subset of participants had questions about their disease or treatment duringthe interview. While the goal of qualitative interviews is for the participant to express their feelings,perceptions, and decisions based on their current knowledge, a competing obligation is to resolvemisinformation that may negatively affect a personÕs health. In our study, the interviewer addressed thesequestions when all research procedures (interview and questionnaires) were completed to prevent theanswer from inßuencing the participantÕs opinions/beliefs during the interview. For example, theinterviewer might say, ÒI am going to table your question for now, but we will come back to it at the endof the interviewÑis that OK with you?Ó.All interviews ended with the interviewer asking if the participants had any experiences or informationrelated to VTE to share that had not been asked. This was done to make sure the participants had theopportunity to share anything that may have been missed in the interview but also to reiterate the value oftheir opinion. The majority of participants felt everything they wanted to discuss was covered in theinterview.10. CODING AND ANALYSISAll the transcripts were reviewed by the investigator for accuracy and completeness and then uploadedinto NVivo software (QSR International, Melbourne, Australia). NVivo allowed for an organized andstructured approach to the coding process as it facilitated categorization and comparison of the codes fordata analysis.Using two or more independent coders, or Òdouble coding,Ó is one way to improve validity. Some morestructured qualitative approaches involve calculating interrater reliability. However, in exploratoryqualitative research, such as our study, discussion is more frequently used to resolve differences.Inductive coding is deriving codes from the data. Deductive codes are predeÞned codes that come fromprevious research. The form of coding used should Þt the goals of the research. In our study, codes weredeveloped in several phases by two authors (JHN and MT) using a blended approach of deductive andinductive codes. This approach kept the coding process open to interesting new data while remainingconnected to the scarce data currently available on this topic. Initial deductive codes were drawn from areview of the literature. However, some of those codes were adjusted as novel and potentially importantinformation was elicited. The majority of the codes were developed through an inductive approach whilecoding participantsÕ transcripts, which allowed the codes to remain accurate and relevant, representingthe reality of the participants as opposed to the beliefs of the researchers.The Þrst phase of code development used a descriptive approach, which identiÞed emerging issues andconcepts surrounding the participantsÕ experiences. The second phase involved constructing patterns inthe data. This process consisted of identifying and reÞning the codes by groups and subdividing similarand unrelated codes and creating and relabeling categories. In the last phase, the results were furtheranalyzed to determine how the new categories and subcategories were interrelated with one another.An important analytic step is the development of a codebook. In qualitative work, codebooks organizecodes (themes or concepts) and typically include codes, subcodes, a deÞnition of the code, and examplefrom the transcript and a description of when to use it or not use it (inclusion/exclusion criteria for thecodes). DeÞnitions for codes were developed by reviewing all corresponding coded text. Similar codeswere combined, and infrequent codes were dropped. Inclusion and exclusion criteria were developed aftercomparing codes to prevent overlap. Once a draft of the codebook was developed, it was applied to theremaining transcripts and revamped when new codes were developed. The codebook underwent Þverevisions before both authors agreed on a satisfactory version. See Table 2 for an example of thecodebook.TABLE 2Codebook exampleIn our project, all transcripts were independently coded by two authors (JHN and MT). An important partof qualitative work is the explicit recognition of what the interviewers/coders brings to the table. Thecoders Þlter data through their own experiences, creating interpretations of the data. In our study, onecoder was a practicing physician, while the other was a fourth‐year medical student. This was an explicitchoice, so that the coders would understand the medical information and the difference betweennecessary care and overuse. Some argue that qualitative researchers should be outsiders, unconnectedwith the phenomena under evaluation, and that only an outsider can be sufficiently impartial. However,we argue that, whether insider or outsider, the interviewer always brings a speciÞc lens to the interview.Instead, the goals should be an explicit acknowledgment of oneÕs perspective and self‐awareness on thepart of the interviewer.For the Þrst six transcripts, both coders met in person to review and code transcripts together. The codersspent ≈15 hours analyzing the Þrst transcript, learning to navigate NVivo, initiating the development ofthe codebook, creating new codes and discussing consistency of judgments between coders. Coding timeprogressively decreased with each transcript. As the coders became more familiar with NVivo, morecodes were developed and readily available for application to each transcript and few differences betweencoders arose. After transcript six, both coders independently reviewed and coded each transcript. Then,the coders began online meetings (via Zoom) to establish consensus on the codes, formulate a generaldescription of the analysis, and to discuss emerging themes for each transcript. For codes identiÞed laterin the coding process, earlier transcripts were reanalyzed for the novel codes. Differences among coderswere resolved by discussion. If the coders could not come to consensus, a third person (JAK) provided athird opinion to help reach a Þnal decision.A myriad of qualitative analytic approaches exist, ranging from a straightforward thematic analysis tomore complex methods such as grounded theory or phenomenology. We chose to use content analysisbecause little is known about the psychosocial experiences during and after the diagnosis with VTE. Thisanalysis will help identify patterns and common topics in the data. The identiÞcation of speciÞccomponents of patientsÕ experiences with VTE will inßuence the care and support of patients with VTE.Excerpts of transcripts, key themes (also called higher‐order codes) were developed by grouping andanalyzing similar codes. The relationship among these themes were examined to create a model of thepatient experience. Patterns were identiÞed within the data that conveyed a collective experience.However, multiple models emerged from the data in part, owing to differing patient experiences and inpart to different author perspectives. Preliminary models were tested against subsequently analyzedtranscripts and revised to create a Þnal model of patient experiences of VTE.Some of the themes that we found associated with the lived experiences of patients diagnosed with VTEand the psychosocial impact of VTE on patients were (i) increased anxiety/stress after communicationwith health care provider, (ii) fear of recurrence, and (iii) concerns of death.Increased anxiety/stress after communication with health care provider. Our results suggest that healthcare providers can unintentionally communicate with patients with VTE in way that fails to inform themabout their disease process, and cause harm by unnecessarily escalating fear and concerns, which lead toongoing anxiety. See Table 3 for patient quotes.TABLE 3ThemesFear of recurrence. Most of the participants that we interviewed had increased fears that the blood clotmay return, described as a fear that is Òalways in the back of my mind.Ó This fear was triggered mostly byphysical signs/symptoms and was associated with increased anxiety. Patients with unprovoked VTE seemto have higher levels of anxiety due to the unknown cause for the VTE. It is noteworthy that theseparticipants seem to have higher reliance on medication because they considered the medication as aÒlifesaver.Ó See Table 3 for patient quotes.Concerns of death. Participants express concerns of death at different stages. Some of them reported thisconcern at the time of the VTE diagnosis and during the acute treatment; some realized later that theycould have died; and some patients had a constant feeling of threat to their life, with the idea that theÒnext oneÓ will be fatal. See Table 3 for patient quotes.11. FINAL THOUGHTSÑQUALITY, TRANSPARENCY, AND VALIDITYIn quantitative research, the goal is to have a generalizable sample. In qualitative research, the goal shouldbe transparency in sample selection. With transparency in purposive sampling, the question is notwhether qualitative results can be broadly applied to the whole population but whether the researchershave been transparent enough in the detail about sampling and research procedures that a reader feels thatOTHER FORMATSPubReader| PDF (435K)ACTIONSCiteCollectionsSHARE RESOURCESAn oScial website of the United States government Advanced Search | User GuideFemale (n = 15) (%)Male (n = 9) (%)Total (n = 24) (%)Age, y<506 (25)4 (16.5)10 (41.5)>509 (37.5)5 (21)14 (58.5)RaceBlack6 (25)2 (8.5)8 (33.5)White9 (37.5)7 (29)16 (66.5)Marital statusMarried6 (25)6 (25)12 (50)Single3 (12.5)1 (4)4 (16.5)Divorced3 (12.5)1 (4)4 (16.5)In relationship/not married3 (12.5)1 (4)4 (16.5)Time since VTE diagnosis, y<24 (16.5)5 (21)9 (37.5)>211 (46)4 (16.5)15 (62.5)Received thrombolysisYes2 (8.5)3 (12.5)5 (21)ThemesDeÞnitionWhen to useWhen not to useExamplesConcerns ofdeathPatients describe theirfear of death at the timeof diagnosis of VTEand/or their continuedfear of deathPatient reports aconcern about thepossibility of dying as aresult of VTEPatient describesconcerns about death asa result of treatmentÒI guess my biggest fearis that I just walkaround one day, grow aclot, and drop deadÓÒMy biggest fear isdying from itÓOther concernsPatient describes otherconcerns (different thandeath) directly related toVTEAny other concernsdeveloped after andsecondary to thediagnosis of VTE(incomplete resolutionof VTE, effects onfamily)Patient describesconcerns abouttreatment, effects oftreatment, recurrence,or deathÒThe scariest part forme was I wasn’t sure ifit (clot) would likemove to the babyÓÒI was worried about it(clot) movingÓIncreasedstress aftercommunicationwith healthcare providerPatient discussed thenegative impact thatverbal communicationabout VTE with theirhealth care provider hadPatient reported thattheir stress or anxietylevel increased due tocommunication aboutVTE with their healthPatient discussesnonverbalcommunication thatincreased stress (facialexpressions, gestures,ÒWhen somebody tellsyou are the mostinteresting patient in theemergency room, thatÕsprobably not a goodThemes and stories about patientsÕ VTE lived experiences1. Increased anxiety by physician communicationPatient 6ÒSo, I was worried about, and the way they made it sound, it was like you cut yourself, even ifyouÕre brushing your teeth and your gums start bleeding, go to the hospital. IÕm like, so I wasanxious about that, nervous, especially at work, but I told everybody I was working with if Istarted bleeding get me to the hospital. But so, I was just nervous. I didnÕt know. I didnÕtunderstand fully what could happen.ÓPatient 7ÒI was very uneasy. Because I feel like IÕm a project at that point, and theyÕre not really sure whatÕsgoing on with me. It was kind of unnerving, I guess for me, because IÕm like you guys, literally, Iwas so dangerous 10 minutes ago I wasnÕt allowed to walk to the restroom by myself, but now IÕmhealthy enough that I can go home? All within a 4‐hour time span or whatever that is. So it was alittle scary for me.Ó2. Fear of recurrencePatient 12Here’s how you know Search in PMCSearch PMC Full-Text Archive 1 2 1 3 112345, 678, 91011, 12, 13, 141516, 1718, 192017, 21, 22, 234242516, 22, 23262728   Similar articlesCited by other articlesLinks to NCBI Databases
Go to: ▸Go to: ▸Go to: ▸Go to: ▸Go to: ▸Go to: ▸have been transparent enough in the detail about sampling and research procedures that a reader feels thatresults can be applied to their own population. In additional to transparency, further validity assessmentsinclude the following: (i) acknowledgement of the researcher perspective; (ii) participant checks orpresenting the data to participants to see if they feel that it reßects their reality; and (iii) triangulation orusing two or more different types of data to see if results are similar.This report provides methodologic guidance for the implementation of individual qualitative interviewsto capture patientsÕ lived experience of a medical diagnosis associated with overuse of ED resources. Ourgoal in providing details on study design, sampling, interviewing, and analysis is to make qualitativeresearch accessible to quantitative researchers.RELATIONSHIP DISCLOSUREJAK: Johnson & Johnson 39039039VTE4002, PÞzer/BMS CV185‐56, National Institutes ofHealth/National Heart, Lung, and Blood Institute (NIH/NHLBI) U34 HL144374, NIH/NHLBIUM1HL113203‐01, NIH/NHLBI. K12HL133310. JHN: NIH/NHLBI. K12HL133310. MT, ABA, andMAO declare no conßicts of interest.AUTHOR CONTRIBUTIONSJH conceived of the study and designed the work, collected data, performed data analysis andinterpretation, drafted the article, and provided Þnal approval of the version to be published. MTcollected data, performed data analysis and interpretation, and provided Þnal approval of the version to bepublished. AA performed data analysis and interpretation, offered critical revision of the article, andprovided Þnal approval of the version to be published. MO performed data analysis and interpretation,offered critical revision of the article, and provided Þnal approval of the version to be published. JKconceived of the study and designed the work, performed data analysis and interpretation, offered criticalrevision of the article, and provided Þnal approval of the version to be published.Supporting informationSupplementary MaterialClick here for additional data Þle.ACKNOWLEDGMENTSThe authors thank Kate Pettit, MS, project management specialist at the Emergency Department, IndianaUniversity School of Medicine, Indianapolis. Indiana, for her expertise and assistance in all managementand technical support.NotesHernandez‐Nino J, Thomas M, Alexander AB, Ott MA, Kline JA. The use of qualitative methods invenous thromboembolism research. Res Pract Thromb Haemost. 2021;5:e12593. 10.1002/rth2.12593[CrossRef] [Google Scholar]Handling Editor: Dr Suzanne Cannegieter.Funding informationFunding was provided by the National Institutes of Health/National Heart, Lung, and Blood Institute K12emergency care research training program grant # 133310REFERENCES1. Tuckerman J, Kaufman J, Danchin M. How to use qualitative methods for health and health services research. J PaediatrChild Health. 2020;56(5):818‐820. [PubMed] [Google Scholar]2. Babitsch BBC, Borgetto B, Ciupitu‐Plath CC. Health Care Utilization: Insights from Qualitative Research. In: Janssen C,Swart E, von Lengerke T, eds. Health Care Utilization in Germany. Springer. Health Care Utilization: Insights fromQualitative Research. 2014:87‐97. 10.1007/978-1-4614-9191-0_6 [CrossRef] [Google Scholar]3. Pathak V, Jena B, Kalra S. Qualitative research. Perspect Clin Res. 2013;4(3):192. [PMC free article] [PubMed] [GoogleScholar]4. Moser A, Korstjens I. 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AdvertisementConsider SARCLISA + Kd at Þrst relapse1 >Important Safety InformationCONTRAINDICATIONSSARCLISA is contraindicated inpatients with severe hypersensitivityto isatuximab-irfc or to any of itsAll ContentUmbrella Alt TextCartSign InENTER SEARCH HEREISSUESLATEST ARTICLESGUIDELINESCOLLECTIONSAUTHOR CENTERABOUTVolume 4, Issue 12June 23 2020Previous ArticleNext ArticleAdvertisementPotential Articles of InterestView MetricsCited ByWeb Of Science (8)Google ScholarEmail AlertsArticle Activity AlertContinuous Publishing AlertNew Journal Content AlertAdvertisementSubjects:Topics:Total of 9 studies,13-21 5126 patients.DD, D-dimer; NR, not reported.*Pathways labeled by letter available with diagrams in supplemental Material 1.Total of 3 studies,22-24 500 patients.*Pathways labeled by letter available with diagrams in supplemental Material 1.SR, systematic review.SYSTEMATIC REVIEW| JUNE 22, 2020Systematic review and meta-analysis of outcomes in patients with suspecteddeep vein thrombosis Blood Adv (2020) 4 (12): 2779Ð2788.https://doi.org/10.1182/bloodadvances.2020001558Split-ScreenAbstractAfter deep vein thrombosis (DVT) is diagnosed, prompt evaluation and therapeutic intervention are ofparamount importance for improvement in patient-important outcomes. We systematically reviewed patient-important outcomes in patients with suspected DVT, including mortality, incidence of pulmonary embolism (PE)and DVT, major bleeding, intracranial hemorrhage, and postthrombotic sequelae. We searched the CochraneCentral Register of Controlled Trials, Ovid Medline, Embase for eligible studies, references lists of relevantreviews, registered trials, and relevant conference proceedings. Two investigators screened and abstracted data.Nine studies with 5126 patients were included for lower extremity DVT. Three studies with 500 patients wereincluded for upper extremity DVT. Among patients with lower extremity DVT, 0.85% (95% confidence interval[CI], 0% to 2.10%) and 0% developed recurrent DVT and PE, respectively, at 3 months. Among patients withupper extremity DVT, 0.49% (95% CI, 0% to 1.16%) and 1.98% (95% CI, 0.62% to 3.33%) developed recurrent DVTand PE, respectively, at 3 months. No major bleeding events were reported for those anticoagulated, which islower than in other systematic reviews. For both upper and lower extremity DVT, low pretest probability patientswith a negative D-dimer had a comparable incidence of VTE at 3 months (∼1%) as patients with a negativeultrasound (US). At higher pretest probabilities, negative US testing with or without serial US appears to be thesafer option. In this review, we summarized the outcomes of patients evaluated by various diagnostic pathways.In most instances, there was significant limitation due to small population size or lack of direct evidence ofeffects of using a specific pathway. This systematic review was registered at PROSPERO as CRD42018100502.Health Services and Outcomes, Systematic Review, Thrombosis and Hemostasisdeep vein thrombosis, deep venous thrombosis of upper extremity, venous thromboembolism, leg,hemorrhage, fibrin fragment d substance, intracranial hemorrhagesIntroductionThe annual incidence of deep vein thrombosis (DVT) in the general population is 48 per 100 000 and can beassociated with significant morbidity and mortality.1 Prompt evaluation and expeditious therapeutic interventionwhen DVT is confirmed is of paramount importance for optimal patient management. Various strategies arecurrently used for the evaluation of suspected DVT. The first step involves determining the pretest probability(PTP) of DVT, either formally using a clinical decision rule or informally through clinical judgment, prior todiagnostic testing. Following this, options for diagnostic tests include compression ultrasound (US) with orwithout Doppler US of the proximal leg veins (duplex US), whole-leg US, serial US, and D-dimer assays. Thesetests can be used alone or in sequence, depending on the pre-test probability.While the diagnostic pathway is an important consideration in determining the optimal strategy for theevaluation of suspected DVT, this review focuses on patient-important outcomes. These outcomes assess theconsequences of missed or incorrect diagnoses when anticoagulant treatments are mistakenly withheld oradministered unnecessarily. Anticoagulant treatment of DVT is associated with risks of bleeding, with majorbleeding (bleeding requiring red cell transfusion or intervention to stop bleeding or bleeding into a critical area,such as intracranial hemorrhage) being the most clinically relevant. Missed diagnoses can be associated with anincreased risk of recurrent DVT, development of pulmonary embolism (PE), and postthrombotic syndrome. Weconducted a systematic review and meta-analysis to evaluate the outcomes of patients with suspected DVTevaluated by various diagnostic pathways to determine the frequency of such outcomes. This systematic reviewwas performed in conjunction with upper and lower extremity DVT test accuracy reviews that evaluated optimaldiagnostic pathways based on PTP to inform an overall guideline on management of venous thromboembolism,detailed further in ÒMethods.Ó2-4 MethodsDetermining outcomes of interestThis systematic review was undertaken for the purposes of informing the American Society of HematologyGuidelines on Management of Venous Thromboembolism, specifically diagnosis of venous thromboembolism(VTE). The review process began with a multidisciplinary panel coordinated by the American Society ofHematology Venous Thromboembolism Guideline Coordination Committee consisting of physicians with clinicaland research expertise on the guideline topic, methodologists with expertise in evidence appraisal and guidelinedevelopment, and patient representatives. These panel members developed clinical questions of interestregarding the diagnosis of VTE. The process is briefly described below; however, for detailed information, referto the original guideline publication.2 After the primary questions were developed, the panel chairs developed diagnostic pathways that were refinedthrough an iterative process with input from the panel (supplemental Material 1). The diagnostic strategies forDVT are based on the PTPs for individual patients, which provide an estimate of the expected prevalence of DVTat a population level. PTP can be determined using validated clinical decision rules, such as the Wells criteria.5 The original Wells criteria divided outpatients into 3 categories (low, intermediate, and high), and thedichotomized Wells criteria divided patients into 2 categories (unlikely and likely). In patients with suspectedlower extremity DVT, the guideline assumed the prevalence in patients with low, intermediate, and high PTP tobe 10%, 25% to 35%, and >50%, respectively. In patients with suspected upper extremity DVT using theConstans score,6 the guideline assumed the prevalence in patients with unlikely and likely PTP to be 10% and40%, respectively. Therefore, when possible, outcomes were also further classified by PTP.The panel then selected outcomes of interest for each question a priori, following the approach described indetail elsewhere.7 The panel brainstormed all possible outcomes and then rated their relative importance fordecision making following the Grading of Recommendation, Assessment, Development and Evaluation (GRADE)approach.8 During this rating process, the panel used definitions of the outcomes (Òmarker statesÓ) that weredeveloped for these guidelines by the McMaster Grading of Recommendations, Assessment, Development andEvaluation (GRADE) Center. Rating outcomes by their relative importance can focus attention on thoseoutcomes that are considered most important and help to resolve or clarify potential disagreements. The panelrated the following outcomes as critical for decision making across the DVT diagnosis questions: all-causemortality, mortality from VTE, development of PE, development of DVT, development of recurrent DVT,development of postthrombotic sequelae, major bleeding, and intracranial hemorrhage; in addition to thediagnostic accuracy outcomes (false positive [FP], false negative [FN], true positive [TP], and true negative [TN]test results).Data sources and searchesWe conducted this systematic review in accordance with a prespecified registered protocol available on theInternational Prospective Register of Systematic Reviews (PROSPERO; registration number CRD42018100502).We reported the results according to preferred reporting items for systematic reviews and meta-analyses(PRISMA) guidelines.9 The primary source of information was obtained from the studies that were included forthe analysis of test accuracy, represented in Figure 1 and discussed in a separate paper.3,4 The secondarysource included studies identified as having potential information for outcomes when the initial search wascompleted, regardless of whether the study contained test accuracy information. The final source was anyadditional studies suggested by experts in the field or other guidelines.Figure 1.VIEW LARGEDOWNLOAD PPTFlowchart of the article selection process for included studies.We performed an electronic search of CENTRAL (until May 2019), Ovid Medline (from 1976 to May 2019), andEMBASE (from 1974 to May 2019). A methodological filter was applied to limit retrieval of studies with data fortest accuracy (prospective studies, cross-sectional studies, cohort studies, or abstracts and conference postersafter 2014, limited to humans); a detailed search strategy provided in supplemental Material 2. We also reviewedthe reference lists of relevant articles and reviews.Study selectionWe used the following eligibility criteria for the outcomes studies:Study design.Prospective studies, cross-sectional studies, cohort studies from January 1974 to May of 2019, or abstracts andconference posters after 2014 were used.Participants.All adult patients (age ≥18 years) suspected of having a symptomatic first or recurrent DVT were included.Outcomes.Studies assessing all-cause mortality, mortality from VTE, development of PE or DVT, development of recurrentDVT, or postthrombotic sequelae, major bleeding, and intracranial hemorrhage in patients with suspected first orrecurrent episode of symptomatic DVT were included.Language.We included studies published in any language.Publication status.We reviewed all published and unpublished studies. Abstracts with relevant information were also reviewed.Exclusion criteria.Studies that did not assess or provide information on the outcomes of interest (eg, narratives, letters to editorwithout primary data), abstracts before 2014, duplicate populations, and studies with missing or incompleteoutcomes results were excluded.We used the following eligibility criteria for the studies with test accuracy information3,4 :Study design.Prospective studies, cross-sectional studies, cohort studies from January 1974 to May 2019, or abstracts andconference posters after 2014 were included.Participants.All adult patients (age ≥18 years) suspected of having a symptomatic first or recurrent DVT were included.Outcomes.Studies assessing test accuracy of whole leg US, compression US, serial US, and high-sensitivity quantitative D-dimer (Vidas, STA Liatest, TinaQuant, Innovance, and HemoSIL) to diagnose a first or recurrent symptomaticDVT were included.Language.We included studies published in any language.Publication status.We reviewed all published and unpublished studies. Abstracts with relevant information were also reviewed.Exclusion criteria.We excluded studies that did not assess test accuracy or had missing data (eg, narrative reviews, letters to theeditor without primary data), abstracts before 2014, duplicate populations, and studies that included <100patients, patients who were asymptomatic, pregnant, had superficial venous thrombosis, had atrial fibrillation, orwere in the pediatric age group (age <18 years or if >80% of the population was <18 years or if mean age ofgroup was <25 years). We also excluded studies using impedance plethysmography, Doppler US withoutcompression, US of calf veins without examination of proximal veins, contrast computed tomography for upperextremity DVT, unacceptable reference standards (D-dimer alone, impedance plethysmography), as well asstudies that did not use a standard D-dimer cutoff for lower extremity DVT or used D-dimer assays that are nolonger in use or not highly sensitive for lower extremity DVT (SimpliRed, MDA, Asserachrom, Dimertest I,Enzygnost, Fibrinostika FbDP, Acculot, Wellcotest, and Minutex).Two investigators (M. Bhatt or C.B., and Parth Patel.) independently screened the search results for articlesbased on title or title and abstract. Each of the investigators then independently assessed the eligibility of eacharticle by using a pilot-tested, standardized form with written instructions. Disagreements were resolved by athird investigator (Payal Patel).Data extraction and quality assessmentTwo investigators (Parth Patel or M. Bhatt, and Payal Patel) independently extracted data using a pilot-tested,standardized form. Results of data extraction were then compared, and any discrepancy was resolved bydiscussion. A third reviewer additionally reviewed all study extractions and assessments (R.A.M.). When thesame results were presented in >1 publication, we included the publication with the most complete results. Ifresults were incomplete or unclear, we contacted study authors for additional information. We collected thefollowing information from each study: study characteristics (author name, year of publication, country,language, number of centers, number of countries, and inclusion and exclusion criteria), patient characteristics(number, patients completing follow up, age, and comorbidities), diagnostic tests used and comparisoncharacteristics (how the test was performed and interpreted), codiagnostic test(s) used, and outcomes. Wecollected information about funding sources, conflict-of-interest statements, consent, and ethics approval.Data synthesis and analysisThe outcomes information from each study was combined quantitatively from different studies and reviews.Information was abstracted with respect to those diagnostic pathways determined to be of interest by the panelin the primary test accuracy systematic review (Tables 1 and 2). The data were further stratified by PTP andpatients anticoagulated (TP/FP) compared with those not anticoagulated (TN/FN). This information wascompared with the information abstracted from additional resources such as systematic reviews, treatmentguidelines that reviewed outcomes, a targeted search of general outcomes studies, and a survey of panelopinion (Table 3; supplemental Material 4).10-12 Table 1.Outcomes in patients with suspected lower extremity DVT from test accuracy studiesTable 2.Outcomes in patients with suspected upper extremity DVT from test accuracy studiesTable 3.Outcomes in patients with suspected lower extremity DVT from various sourcesTestaccuracyresultsConsequencesResults frompublished SR10 Results fromtreatmentguideline11 Targeted search ofoutcomes studies12 PanelsurveyresultsTP Mortality: all cause NR 2.0% (6 mo) 6% (3 mo) 8.8% (1 y) Mortality: from DVT at 3-12mo 0.4% (PEmortality, 3 mo) NR 0% (3 mo) 4.3% (1 y) Recurrence of DVT onanticoagulation at 3-12 mo 3.8% (3 mo) 1.3% (6 mo) 4.6% (3 mo) 5.6% (1 y) Development of PE NR 1.0% (6 mo) 1.0% (3 mo) 5.8% (1 y) Major bleeding NR 2.1% (6 mo) 3.1% (3 mo) 4.2% (1 y) Fatal major bleeding NR 0.2% (6 mo) NR NR Hemorrhagic stroke NR NR NR 2.0 (ICH; 1y) FP Mortality: all cause NR NR NR NR Major bleeding NR 2.1% (6 mo) 3.1% (3 mo) 4.2% (1 y) Fatal major bleeding NR 0.2% (6 mo) NR NR TN Mortality: from DVT at 3-12mo NR NR 0% NR FN Mortality: all cause NR NR NR 18.4% (1 y) Mortality: from DVT at 3-12mo NR NR NR 10.5% (1 y) Recurrence of DVT on at 3-12mo NR NR NR 11.0% (1 y) ResultsSearch resultsAmong the 15 435 nonduplicate records identified from the electronic database search, 320 full-text articles wereretrieved after title and abstract screening. After exclusion of articles that were not relevant, a total of 12 studieswere included.13-24 A summary of the outcomes is presented below with detailed abstraction available insupplemental Material 3.Lower extremity DVT.Patients diagnosed with DVT and initiated on anticoagulation had an overall mortality of 6.79% (14/206, 95%confidence interval [CI], 3.36% to 10.23%), 0% (0/476) mortality from VTE at 3 months, 0% (0/471) incidence ofPE at 3 months, 0.85% (4/471, 95% CI, 0% to 2.10%) recurrent DVT at 3 months, 0% (0/326) incidence ofpostthrombotic sequelae, 0% (0/326) major bleeding events, and 0% (0/326) intracranial hemorrhage. Therewere no important differences between the various diagnostic pathways (Table 1).For patients with negative diagnostic testing who did not receive anticoagulant treatment, outcome informationmust be interpreted with respect to PTP and the diagnostic algorithm assessed. For patients with a low PTP oflower extremity DVT, negative proximal compression US alone had an overall VTE rate of 1.70% (15/844, 95% CI,0.89% to 2.67%) at 3 months, comparable to the 1.03% (2/338, 95% CI, 0% to 1.41%) of patients with negative D-dimer. The rate is reduced to 0.74% (9/1212, 0.74%; 95% CI, 0.26% to 1.23%) in patients discharged from eitherinitial negative proximal compression US or initial positive proximal compression US with subsequent negativeserial US (Table 1).In patients with intermediate or high PTP, the differences are more important. Patients with intermediate PTPand negative compression US have a VTE rate of 1.65% (6/363, 1.65%; 95 CI, 0.34% to 2.96%) at 3 monthscompared with 0.68% (1/148, 0.68%; 95% CI, 0% to 2.0%) for negative whole leg US and 4.08% (2/49, 4.08%;95% CI, 0% to 9.62%) for negative D-dimer. This may indicate that D-dimer has an increased FN rate in thispopulation. The rate of VTE for patients with negative serial US after initial proximal compression US in theintermediate PTP population was determined to be 1.11% (2/180, 1.11%; 95% CI, 0% to 2.64%). This may indicateadding serial US may improve accuracy of proximal compression US to make it comparable to that of whole legUS. Finally, in patients with high PTP, negative compression US had a 13.8% (4/29, 13.8%; 95% CI, 1.24% to26.34%) incidence of VTE at 3 months. We did not identify test accuracy studies with outcomes reported onserial US testing for high PTP patients.Upper extremity DVT.Patients discharged with anticoagulation had an overall mortality of 1.03% (9/870; 95% CI, 0.36% to 1.71%), 0%(0/412) mortality from upper extremity DVT at 3 months, 0% (0/441) mortality from PE at 3 months, 1.98%(8/405; 95% CI, 0.62% to 3.33%) incidence of PE at 3 months, 0.49% (2/410, 95% CI, 0% to 1.16%) incidence ofrecurrent upper extremity DVT at 3 months, and 0% (0/58) incidence of postthrombotic sequelae at 3 months(Table 2).For patients discharged without treatment due to negative diagnostic test results, outcome information must beinterpreted with respect to PTP and the diagnostic algorithm assessed. For the population with an unlikelyprobability of upper extremity DVT, the overall VTE rate was 0.98% (2/204; 95% CI, 0% to 2.33%) at 3 monthsfor patients with a negative D-dimer, while the overall VTE rate was 1.65% (3/182; 95% CI, 0% to 3.49%) inpatients with negative US. The rate is reduced to 0.56% (1/180; 95% CI, 0% to 1.64%) in patients with negativeUS followed by negative serial US. In patients with likely PTP, those with a negative US have a VTE rate of 4.20%(5/119; 95% CI, 0.59% to 7.80%) at 3 months compared with 1.19% (1/84; 95% CI, 0% to 3.50%) in patients withnegative serial US testing (Table 2).Additional sources of data.This information was compared with the information abstracted from additional resources such as suggestedsystematic reviews, treatment guidelines that reviewed outcomes, a targeted search of general outcomesstudies, and a survey of panel opinion (Table 3; supplemental Material 4).Lower extremity DVT.Patients discharged with anticoagulation had an all-cause mortality of 2.0% at 6 months from a VTE treatmentguideline, 6% at 3 months from a targeted search of outcomes studies, and 8.8% at 1 year from a survey of thepanel members. Mortality from DVT was reported at 0% at 3 months from a targeted search of outcomesstudies and 4.3% at 1 year from a survey of panel members. Major bleeding was reported at 2.1% at 6 monthsfrom the VTE treatment guideline, 3.1% at 3 months from a targeted search of outcomes studies, and 4.2% at 1year from a survey of panel members.For patients discharged without treatment due to negative diagnostic test results, all-cause mortality was notreported in multiple sources, with a panel survey reporting 18.4% at 1 year. Mortality from DVT reported at 0% ina targeted search of outcome studies and not reported in the remainder of sources. Recurrence of DVT wasreported by panel survey at 11.0% at 1 year, with no report from remainder of sources. Findings are summarizedin Table 3.Upper extremity DVT.Patients discharged with anticoagulation had an all-cause mortality of 22% at 3 months based on a targetedsearch of outcomes studies and 14% at 1 year by panel survey results. Mortality from DVT was reported at 10.4%at 1 year by a survey of panel members, with no reporting by other sources. Major bleeding was reported at 6.0%at 3 months by a targeted search of outcomes studies and 4.0% at 1 year by panel survey results.For patients discharged without treatment due to negative diagnostic test results, there were no outcomesreported by a published systematic review, VTE treatment guideline, or targeted search of outcomes studies. Allreports were from a survey of panel members with all-cause mortality 12.5% at 1 year, mortality from DVT 9.5%at 1 year, and recurrence of DVT 19.25% at 1 year. Findings are summarized in supplemental Material 4.DiscussionThere are a variety of diagnostic tests that can be used in the diagnosis of suspected DVT, and these tests canbe used in isolation or in combination in a diagnostic pathway to rule in or exclude a diagnosis. This review isone of the first to provide a systematic overview of patient-important outcomes in patients with suspected DVT,both overall and associated with different diagnostic strategies. The findings can assist decision-makers toestimate impacts on patients, they can assist researchers in identifying gaps and plan for adequately poweredstudies with outcomes beyond diagnostic accuracy.For both upper and lower extremity DVT, low-PTP patients with negative D-dimer had a lower incidence of VTEat 3 months than patients with negative US. This suggests that D-dimer is comparable to US in lower PTPpatients and can be used to rule out lower extremity DVT in this population. At higher PTP, it may be safer to godirectly to US testing rather than starting with D-dimer for both lower and upper extremity DVT. Serial USprovides additional benefit. Patients deemed to have DVT, a population composed of TPs and FPs, receivedanticoagulant treatment often without major bleeding events in the studies included in this review. The lack ofmajor bleedings may relate to the fact that identified studies primarily focused on test accuracy of VTE and thusare typically shorter in duration. Therefore, these studies may not have adequately captured bleeding outcomesand bleeding rates may be underreported. This contrasts with findings from a treatment guideline and targetedsearch of outcomes studies listed in Table 3, which reported that lower extremity DVT had 2.1% and 3.1% risk ofmajor bleeding events, respectively. Similarly, a targeted search of outcome studies on upper extremity DVTreported a 6.0% risk for major bleeding events (supplemental Material 4). Based on our data, patients with upperextremity DVT had a 0.49% (95% CI, 0% to 1.16%) and 1.98% (95% CI, 0.62% to 3.33%) risk of developingrecurrent DVT and PE, respectively, at 3 months. Patients with lower extremity DVT had a 0.85% (95% CI, 0% to2.10%) and 0% risk of developing recurrent DVT and PE, respectively, at 3 months.This review has several strengths. The comprehensive search makes it unlikely that relevant studies weremissed. All steps, including initial screening, study selection, and data abstraction, were performedindependently in duplicate to minimize any potential biases. Additionally, we did not limit our review by languageand we translated nonÐEnglish articles. We analyzed sources of bias and explored reasons for diversity in thepublished literature. Outcomes were stratified by PTP and diagnostic pathway used to assist in decision-makingcapacity. When compared with other systematic reviews, which typically reviewed consecutive patients withDVT or PE in the Registry Informatizado de la Enfermedad TromboEmb—lica (RIETE), outcomes were reportedwithout stratification.25,26 There are a few limitations of the present review. The sample size of the patients from the test accuracy studieswere often too small to accurately assess outcomes. In addition, when outcomes are reported in accuracystudies, they generally focus on the safety among these who were designated as negative; thus, outcomes areprimarily reported in patients with negative testing. The bleeding risks in patients with positive testing andtreatment with anticoagulation may not have been scrutinized to the same degree. Furthermore, diagnosticaccuracy studies are not typically designed to capture outcomes, unlike therapeutic studies. Therefore,definitions of outcomes, methods of measurements, and duration of follow-up may not have been clear orconsistent across studies. This may lead to under- or overreporting of events. Finally, in most instances, therewas no direct evidence that assessed the effect of using one diagnostic pathway versus another on patientoutcomes or directly comparing the accuracy of different diagnostic pathways. In some circumstances wherethe diagnostic pathway of interest was evaluated, details regarding the specific number of patients for eachPathway*PTPStudiesAll-causemortalityMortalityfrom VTEat 3 moIncidence ofPE at 3 moIncidence ofDVT at 3 moOverall VTE at3 moPostthromboticsyndromeAnticoagulated (TP/FPpopulation)  B Low PositivecompressionUS 0/18 (0%) 0/18 (0%) 0/18 (0%) 0/18 (0%) 0/18 (0%) 0/18 (0%)  A, E Low PositivecompressionUS alone orpositiveserial USafter initialcompressionUS 7/84 (8.33%;95% CI,2.42%-14.24%) 0/84 (0%) 0/79 (0%) 4/79 (5.06%;95% CI,0.23%-9.90%) 4/79 (5.06%;95% CI,0.23%-9.90%) 0/14 (0%)  H Low Positive DD→ positiveUS 5/80 (6.25%;95% CI,0.95%-11.55%) 0/80 (0%) 0/80 (0%) 0/80 (0%) 0/80 (0%) NR  G Low Positive DD NR 0/202(0%) 0/202 (0%) 0/202 (0%) 0/202 (0%) 0/202 (0%)  B High PositivecompressionUS 2/24 (8.33%;95% CI,0%-19.39%) 0/24 (0%) 0/24 (0%) 0/24 (0%) 0/24 (0%) 0/24 (0%)  G High Positive DD NR 0/68 (0%) 0/68 (0%) 0/68 (0%) 0/68 (0%) 0/68 (0%) Overall positive for DVT and initiated onanticoagulation 6.79%; 95% CI,3.36%-10.23%(14/206) 0%(0/476) 0% (0/471) 0.85% 95% CI,0%-2.10%)(4/471) 0.85%; 95% CI,0%-2.10%)(4/471) 0% (0/326) Not anticoagulated(TN/FN population)  B Low NegativecompressionUS 10/612 (1.63%;95% CI0.63%-2.64%) 0/884(0%) 5/884(0.57%; 95%CI,0.07%-1.06%) 10/884 (1.13%;95% CI,0.43%-1.83%) 15/884 (1.70%;95% CI,0.89%-2.67%) 0/277 (0%)  A, E Low NegativecompressionUS ornegativeserial USafter initialcompressionUS 8/426 (1.88%;95% CI,0.59%-3.17%) 0/1212(0%) 3/1212(0.25%; 95%CI,0%-0.53%) 6/1212 (0.50%;95% CI,0.10%-0.89%) 9/1212 (0.74%;95% CI,0.26%-1.23%) 0/91 (0%)  G Low NegativeDD 0/120 (0%) 0/338(0%) 0/338 (0%) 2/338 (1.03%;95% CI0%-1.41%) 2/338 (1.03%;95% CI0%-1.41%) 0/120 (0%)  H Low Positive DD→ negativecompressionUS NR 0/85 0/85 (0%) 0/85 (0%) 0/85 (0%) NR  B Intermediate NegativecompressionUS NR 0/363(0%) 2/363(0.55%; 95%CI,0%-1.31%) 4/363 (1.10%;95% CI0.03%-2.18%) 6/363 (1.65%;95% CI,0.34%-2.96%) NR  A Intermediate Negativewhole legUS 2/154 (1.30%;95% CI,0%-2.18%) 0/148(0%) 0/148 (0%) 1/148 (0.68%;95% CI,0%-2.0%) 1/148 (0.68%;95% CI,0%-2.0%) NR  G Intermediate NegativeDD 0/49 (0%) 0/49 (0%) 0/49 (0%) 2/49 (4.08%;95% CI0%-9.62%) 2/49 (4.08%;95% CI0%-9.62%) NR  I Intermediate Positive DD→ negativewhole legUS NR NR 0/464 (0%) 13/464 (2.80%;95% CI,1.30%-4.30%) 13/464 (2.80%;95% CI,1.30%-4.30%) NR  C, D Intermediate NegativecompressionUS →negativeDD 4/598 (0.67%;95% CI,0.02%-1.32%) 0/679(0%) 0/679 (0%) 1/679 (0.15%;95% CI,0%-0.44%) 1/679 (0.15%;95% CI,0%-0.44%) NR  D Intermediate NegativecompressionUS →positive DD→ negativeserial US 1/83 (1.20%;95% CI,0%-3.55%) 1/180(0.56%;95% CI,0%-1.64%) 2/180 (1.11%;95% CI;0%-2.64%) 0/180 (0%) 2/180 (1.11%;95% CI;0%-2.64%) NR  B High NegativecompressionUS 0/25 (0%) 0/25 (0%) 0/29 (0%) 4/29 (13.8%;95% CI1.24%-26.34%) 4/29 (13.8%;95% CI1.24%-26.34%) 0/29 (0%)  G High NegativeDD 0/11 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%) 0/11 (0%) Pathway*PTPStudiesMortality: allcauseMortality:from UEDVT at 3moPE at 3 moMortality:from PE at 3moUE DVT at 3moOverall VTEat 3 moAnticoagulated(TP/FPpopulation)  E Unlikely PositiveDD 2/203 (0.99%;95% CI,0%-2.34%) 0/112(0%) 0/112 (0%) 0/112 (0%) 0/112 (0%) 0/112 (0%)  F Unlikely PositiveDD →PositiveUS 2/203 (0.99%;95% CI,0.37%-2.34%) 0/37(0%) 0/37 (0%) 0/37 (0%) 0/37 (0%) 0/37 (0%)  A Likely PositiveUS 10/261 (3.83%;95% CI,1.50%-6.16%) 0/144(0%) 8/137 (5.84%;95% CI,1.91%-9.76%) 0/173 (0%) 2/142 (1.41%;95%CI,0%-3.34%) 10/142 (7.04%;95% CI,2.83%-11.25%)  D Likely PositiveUS orNegativeUS →positiveDD →positiveserialUS 5/203 (2.46%;95% CI,0.33%-4.59%) 0/119(0%) 0/119 (0%) 0/119 (0%) 0/119 (0%) 0/119 (0%) Overall positivefor DVT andinitiated onanticoagulation 1.03%;95% CI,0.36%-1.71%(9/870) 0%(0/412) 1.98%; 95%CI,0.62%-3.33%(8/405) 0%(0/441) 0.49%; 95%CI, 0%-1.16%(2/410) 2.44%; 95%CI,0.95%-3.93%(10/410) 0% (0/58) NR Notanticoagulated(TN/FNpopulation)  E Unlikely NegativeDD 0/117 (0%) 0/204(0%) 0/204 (0%) 0/204 (0%) 2/204 (0.98%;95% CI,0%-2.33%) 2/204 (0.98%;95% CI,0%-2.33%)  A Unlikely NegativeUS 0/182 (0%) 0/182(0%) 0/182 (0%) 0/182 (0%) 3/182(1.65%;95%CI,0%-3.49%) 3/182(1.65%;95% CI,0%-3.49%)  B Unlikely NegativeUS →andnegativeserialUS 0/180 (0%) 0/180(0%) 0/180 (0%) 0/180 (0%) 1/180 (0.56%;95% CI,0%-1.64%) 1/180 (0.56%;95% CI,0%-1.64%)  F Unlikely NegativeDD orPositiveDD →negativeUS 2/203 (0.99%;95% CI,0%-2.34%) 0/162(0%) 0/162 (0%) 0/162 (0%) 0/162 (0%) 0/162 (0%)  A Likely NegativeUS 10/261 (3.83%;95% CI,1.50%-6.16%) 0/119(0%) 0/119 (0%) 0/119 (0%) 5/119 (4.20%;95% CI,0.59%-7.80%) 5/119 (4.20%;95% CI,0.59%-7.80%)  D Likely NegativeUS →positiveDD →negativeserialUS 5/203 (2.46%;95% CI,0.33%-4.59%) 0/84(0%) 0/84 (0%) 0/84 (0%) 1/84 (1.19%;95% CI,0%-3.50%) 1/84 (1.19%;95% CI,0%-3.50%) Payal Patel,Parth Patel,Meha Bhatt,Cody Braun,Housne Begum,Robby Nieuwlaat,Rasha Khatib,Carolina C. Martins,Yuan Zhang,Itziar Etxeandia-Ikobaltzeta,Jamie Varghese,Hani Alturkmani,Waled Bahaj,Mariam Baig,Rohan Kehar,Ahmad Mustafa,Rakesh Ponnapureddy,Anchal Sethi,Merrill Thomas,David Wooldridge,Wendy Lim,Shannon M. Bates,Eddy Lang,GrŽgoire Le Gal,Marc Righini,Wojtek Wiercioch,Holger J. SchŸnemann,Reem A. MustafaArticle historyShare Tools PDFSystematic review and meta-analysis of outcomesin patients with suspected pulmonary embolismParth Patel et al., Blood Advances, 2021Diagnosis of deep vein thrombosis of the lowerextremity: a systematic review and meta-analysisof test accuracyMeha Bhatt et al., Blood Advances, 2020American Society of Hematology 2020 guidelinesfor management of venous thromboembolism:treatment of deep vein thrombosis and pulmonaryembolismThomas L. Ortel et al., Blood Advances, 2020Disease profile and plasma neutralizing activity ofpost-vaccination Omicron BA.1 infection in Tianjin,China: a retrospective studyHong Zheng et al., Cell Research, 2022Long-Term Use of Insomnia Medications: AnAppraisal of the Current Clinical and ScientificEvidencePhyllis C. Zee et al., Journal of Clinical Medicine,2023The MDM2Ðp53 Antagonist Brigimadlin (BI907828) in Patients with Advanced or MetastaticSolid Tumors: Results of a Phase Ia, First-in-Human, Dose-Escalation Study Patricia LoRusso et al., Cancer Discovery, 2023Powered byPDFHelp
AdvertisementCurrent IssueLatest ArticlesCollectionsCommunity ConversationsBlood Advance TalksAll IssuesNewsroomCopyrightPermissionsSubmit to Blood AdvancesAlertsContact UsOrder ReprintsAdvertising in Blood AdvancesAuthorsTwitterAmerican Society of Hematology/2021 L Street NW, Suite 900/Washington, DC 20036/TEL +1 202-776-0544/FAX +1 202-776-0545ASH PublicationsAmerican Society of Hematology BloodBlood AdvancesHematology, ASH EducationProgramASH Clinical NewsASH-SAPThe HematologistASH HomeResearchEducationAdvocacyMeetingsPublicationsASH StoreThe full-text version of this article contains a data supplement.the diagnostic pathway of interest was evaluated, details regarding the specific number of patients for eachpathway were not provided. Additionally, in many instances, the review was limited to the outcomes reported inthe studies that differed from the prioritized outcomes by the guideline panel. To combat this limitation, theoriginal guideline publication did compare test accuracy of diagnostic tests in sequence to individual diagnostictests alone (ie, D-dimer followed by computed tomography in contrast to D-dimer alone), further characterizedby PTP into low, intermediate, and high PTP. The final recommendations for a diagnostic pathway were based oninformation provided in this review on patient-centered outcomes and based on information provided in the testaccuracy review.2-4 In addition to these reviews, the panel considered information on the overall certainty in theevidence, including certainty in the diagnostic test accuracy results, patientsÕ values and preferences, balance ofdesirable and undesirable effects, resource implications, feasibility, acceptability, and equity considerations.AcknowledgmentsThis systematic review was conducted to support the development of the American Society of Hematology 2018guidelines for management of venous thromboembolism: diagnosis of venous thromboembolism. The entireguideline development process was funded by the American Society of Hematology. Through the McMasterGRADE Center, some researchers received salary (Payal Patel, C.B., M. Bhatt, W.W., Parth Patel, H.B., and J.V.) orgrant support (R.A.M. and H.J.S.), and others participated to fulfill requirements of an academic degree orprogram or volunteered their time.AuthorshipContribution: Payal Patel contributed to study design, search strategy, study selection, data extraction, statisticalanalysis, and drafting the report; Payal Patel, M. Bhatt, C.B., H.B., R.N., and Parth Patel contributed to studydesign, study selection, data extraction, statistical analysis, and critical revision of the report; R. Khatib, C.C.M.,Y.Z., I.E.-I., J.V., H.A., W.B., M. Baig, R. Kehar, A.M., R.P., A.S., M.T., and D.W. contributed to study selection, dataextraction, and statistical analysis of data; and W.W., W.L., S.M.B., E.L., G.L.G., M.R., H.J.S., and R.A.M. contributedto the study design, interpretation of the results, and critical revision of the report.Conflict-of-interest disclosure: The authors declare no competing financial interests.Correspondence: Reem A. Mustafa, Division of Nephrology and Hypertension, Department of Medicine,University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS; e-mail: rmustafa@kumc.edu.References1.Silverstein MD, Heit JA, Mohr DN, Petterson TM, OÕFallon WM, Melton LJ III. Trends in the incidence ofdeep vein thrombosis and pulmonary embolism: a 25-year population-based study. Arch Intern Med.1998;158(6):585-593.Google ScholarCrossref PubMed 2.Lim W, Le Gal G, Bates S, et al. American Society of Hematology 2018 Guidelines for Management ofVenous Thromboembolism: Diagnosis of Venous Thromboembolism. Blood Adv. 2018;2(22):3226-3256.ArticleGoogle ScholarCrossref PubMed 3.Bhatt M, Braun C, Patel P, et al. Diagnosis of deep vein thrombosis of the lower extremity: a systematicreview and meta-analysis of test accuracy. Blood Adv. 2020;4(7):1250-1264.ArticleGoogle ScholarCrossref PubMed 4.Patel P, Braun C, Patel P, et al. Diagnosis of deep vein thrombosis of the upper extremity: a systematicreview and meta-analysis of test accuracy. Blood Adv. 2020;4(11):2516-2522.ArticleGoogle ScholarCrossref PubMed 5.Wells PS, Anderson DR, Rodger M, et al. Evaluation of D-dimer in the diagnosis of suspected deep-veinthrombosis. N Engl J Med. 2003;349(13):1227-1235.Google ScholarCrossref PubMed 6.Constans J, Salmi LR, Sevestre-Pietri MA, et al. A clinical prediction score for upper extremity deepvenous thrombosis. Thromb Haemost. 2008;99(1):202-207.Google ScholarCrossref PubMed 7.Guyatt GH, Oxman AD, Kunz R, et al. GRADE guidelines: 2. Framing the question and deciding onimportant outcomes. J Clin Epidemiol. 2011;64(4):395-400.Google ScholarCrossref PubMed 8.Guyatt G, Oxman AD, Akl EA, et al. GRADE guidelines: 1. Introduction-GRADE evidence profiles andsummary of findings tables. J Clin Epidemiol. 2011;64(4):383-394.Google ScholarCrossref PubMed 9.Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. J Clin Epidemiol.2009;62(10):e1-e34.Google ScholarCrossref PubMed 10.Douketis J, Kearon C, Bates S, Duku E, Ginsberg J. Risk of fatal pulmonary embolism in patients withtreated venous thromboembolism. JAMA. 1998;279(6):458-462.Google ScholarCrossref PubMed 11.Witt D, Nieuwlaat R, Clark N, et al. American Society of Hematology 2018 guidelines for management ofvenous thromboembolism: optimal management of anticoagulation therapy. Blood Adv.2018;2(22):3257-3291.ArticleGoogle ScholarCrossref PubMed 12.Kearon C. Natural history of venous thromboembolism. Circulation. 2003;107(23 suppl 1):I22-I30.Google ScholarPubMed 13.Anderson DR, Wells PS, Stiell I, et al. Thrombosis in the emergency department: use of a clinicaldiagnosis model to safely avoid the need for urgent radiological investigation. Arch Intern Med.1999;159(5):477-482.Google ScholarCrossref PubMed 14.Bernardi E, Prandoni P, Lensing AW, et al; The Multicentre Italian D-dimer Ultrasound StudyInvestigators Group. D-dimer testing as an adjunct to ultrasonography in patients with clinicallysuspected deep vein thrombosis: prospective cohort study. BMJ. 1998;317(7165):1037-1040.Google ScholarCrossref PubMed 15.Birdwell BGR, Raskob GE, Whitsett TL, et al. The clinical validity of normal compression ultrasonographyin outpatients suspected of having deep venous thrombosis. Ann Intern Med. 1998;128(1):1-7.Google ScholarCrossref PubMed 16.Birdwell BG, Raskob GE, Whitsett TL, et al. Predictive value of compression ultrasonography for deepvein thrombosis in symptomatic outpatients: clinical implications of the site of vein noncompressibility.Arch Intern Med. 2000;160(3):309-313.Google ScholarCrossref PubMed 17.Cornuz J, Ghali WA, Hayoz D, Stoianov R, Depairon M, Yersin B. Clinical prediction of deep venousthrombosis using two risk assessment methods in combination with rapid quantitative D-dimer testing.Am J Med. 2002;112(3):198-203.Google ScholarCrossref PubMed 18.Legnani C, Cini M, Scarvelis D, Toulon P, Wu JR, Palareti G. Multicenter evaluation of a new quantitativehighly sensitive D-dimer assay, the Hemosil D-dimer HS 500, in patients with clinically suspected venousthromboembolism. Thromb Res. 2010;125(5):398-401.Google ScholarCrossref PubMed 19.Luxembourg B, Schwonberg J, Hecking C, et al. Performance of five D-dimer assays for the exclusion ofsymptomatic distal leg vein thrombosis. Thromb Haemost. 2012;107(2):369-378.Google ScholarCrossref PubMed 20.Schutgens RE, Esseboom EU, Haas FJ, Nieuwenhuis HK, Biesma DH. Usefulness of a semiquantitativeD-dimer test for the exclusion of deep venous thrombosis in outpatients. Am J Med. 2002;112(8):617-621.Google ScholarCrossref PubMed 21.Wells PSA, Anderson DR, Rodger M, et al. Evaluation of D-dimer in the diagnosis of suspected deep-veinthrombosis. N Engl J Med. 2003;349(13):1227-1235.Google ScholarCrossref PubMed 22.Kleinjan A, Di Nisio M, Beyer-Westendorf J, et al. Safety and feasibility of a diagnostic algorithmcombining clinical probability, d-dimer testing, and ultrasonography for suspected upper extremity deepvenous thrombosis: a prospective management study. Ann Intern Med. 2014;160(7):451-457.Google ScholarCrossref PubMed 23.Prandoni P, Polistena P, Bernardi E, et al. Upper-extremity deep vein thrombosis. Risk factors, diagnosis,and complications. Arch Intern Med. 1997;157(1):57-62.Google ScholarCrossref PubMed 24.Sartori M, Migliaccio L, Favaretto E, et al. D-dimer for the diagnosis of upper extremity deep andsuperficial venous thrombosis. Thromb Res. 2015;135(4):673-678.Google ScholarCrossref PubMed 25.Mu–oz FJ, Mismetti P, Poggio R, et al; RIETE Investigators. Clinical outcome of patients with upper-extremity deep vein thrombosis: results from the RIETE Registry. Chest. 2008;133(1):143-148.Google ScholarCrossref PubMed 26.Arcelus JI, Caprini JA, Monreal M, Su‡rez C, Gonz‡lez-Fajardo J. The management and outcome of acutevenous thromboembolism: a prospective registry including 4011 patients. J Vasc Surg.2003;38(5):916-922.Google ScholarCrossref PubMed Author notes© 2020 by The American Society of HematologySupplemental dataSupplement File 1- pdf fileCopyright ©2023 by American Society of HematologyPrivacy Policy Cookie Policy Terms of Use Contact Us
APPENDIX E
Appraisal Guide
Findings of a Qualitative Study
Citation:
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
Synopsis
What experience, situation, or subculture does the researcher seek to understand?
Does the researcher want to produce a description of an experience, a social process, or an event, or is the goal to generate a theory?
How was data collected?
How did the researcher control his or her biases and preconceptions?
Are specific pieces of data (e.g., direct quotes) and more generalized statements (themes, theories) included in the report?
What are the main findings of the study?
Credibility
Is the study published in a source
that required peer review?  Yes   No   Not clear
Were the methods used appropriate
to the study purpose?  Yes   No   Not clear
Was the sampling of observations or
interviews appropriate and varied
enough to serve the purpose of the study?  Yes   No   Not clear
*Were data collection methods
effective in obtaining in-depth data?  Yes   No   Not clear
Did the data collection methods
avoid the possibility of oversight,
underrepresentation, or
overrepresentation from certain
types of sources?  Yes   No   Not clear
Were data collection and analysis
intermingled in a dynamic way?  Yes   No   Not clear
*Is the data presented in ways that
provide a vivid portrayal of what was
experienced or happened and its
context?  Yes   No   Not clear
*Does the data provided justify
generalized statements, themes,
or theory?  Yes   No   Not clear
Are the findings credible?  Yes All   Yes Some   No
Clinical Significance
*Are the findings rich and informative?  Yes   No   Not clear
*Is the perspective provided
potentially useful in providing
insight, support, or guidance
for assessing patient status
or progress?  Yes   Some  No  Not clear
Are the findings
clinically significant?  Yes All   Yes Some   No
* = Important criteria
Comments
___________________________________________________________________________
___________________________________________________________________________
APPENDIX C
Appraisal Guide
Conclusions of a Systematic Review with Narrative Synthesis
Citation:
____________________________________________________________________________
____________________________________________________________________________
____________________________________________________________________________
Synopsis
What organization or persons produced the systematic review (SR)?
How many persons were involved in conducting the review?
What topic or question did the SR address?
How were potential research reports identified?
What determined if a study was included in the analysis?
How many studies were included in the review?
What research designs were used in the studies?
What were the consistent and important across-studies conclusions?
Credibility
Was the topic clearly defined?  Yes   No   Not clear
Was the search for studies and other
evidence comprehensive and unbiased?  Yes   No   Not clear
Was the screening of citations for
inclusion based on explicit criteria?  Yes   No   Not clear
*Were the included studies assessed
for quality?  Yes   No   Not clear
Were the design characteristics and
findings of the included studies displayed
or discussed in sufficient detail?  Yes   No   Not clear
*Was there a true integration (i.e., synthesis) of the findings—not
merely reporting of findings from
each study individually?  Yes   No   Not clear
*Did the reviewers explore why differences
in findings might have occurred?  Yes   No   Not clear
Did the reviewers distinguish between
conclusions based on consistent findings
from several good studies and those
based on inferior evidence (number or quality)?  Yes   No   Not clear
Which conclusions were supported by
consistent findings from two or more
good or high-quality studies? List
____________________________________________________________________________
____________________________________________________________________________
____________________________________________________________________________
Are the conclusions
credible?  Yes All   Yes Some   No
Clinical Significance
*Across studies, is the size of the
treatment or the strength of the
association found or the
meaningfulness of qualitative findings
strong enough to make a difference
in patient outcomes or experiences of care?  Yes   No   Not clear
Are the conclusions relevant to the
care the nurse gives?  Yes   No   Not clear
Are the conclusions
clinically significant?  Yes All   Yes Some   No
Applicability
Does the SR address a problem,
situation, or decision we are addressing in our setting?  Yes   No   Not clear
Are the patients in the studies or a
subgroup of patients in the studies
similar to those we see?  Yes   No   Not clear
What changes, additions, training, or
purchases would be needed to implement
and sustain a clinical protocol based
on these conclusions? Specify and list
____________________________________________________________________________
____________________________________________________________________________
Is what we will have to do to implement
the new protocol realistically achievable
by us (resources, capability, commitment)?  Yes   No   Not clear
How will we know if our patients are
benefiting from our new protocol? Specify
____________________________________________________________________________
____________________________________________________________________________
Are these conclusions
applicable to our setting?  Yes All   Yes Some   No
Should we proceed to design
a protocol incorporating
these conclusions?  Yes All   Yes Some   No
* = Important criteria
Comments
____________________________________________________________________________
____________________________________________________________________________

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