Background: To comprehend the results of diagnostic accuracy studies, readers must understand the design, conduct, analysis, and results of such studies. That goal can be achieved only through complete transparency from authors. Objective: To improve the accuracy and completeness of reporting of studies of diagnostic accuracy in order to allow readers to assess the potential for bias in the study and to evaluate its generalizability. Methods: The Standards for Reporting of Diagnostic Accuracy (STARD) steering committee searched the literature to identify publications on the appropriate conduct and reporting of diagnostic studies and extracted potential items into an extensive list. Researchers, editors, methodologists and statisticians, and members of professional organizations shortened this list during a 2-day consensus meeting with the goal of developing a checklist and a generic flow diagram for studies of diagnostic accuracy. Results: The search for published guidelines on diagnostic research yielded 33 previously published checklists, from which we extracted a list of 75 potential items. The consensus meeting shortened the list to 25 items, using evidence on bias whenever available. A prototypical flow diagram provides information about the method of patient recruitment, the order of test execution, and the numbers of patients undergoing the test under evaluation, the reference standard, or both. Conclusions: Evaluation of research depends on complete and accurate reporting. If medical journals adopt the checklist and the flow diagram, the quality of reporting of studies of diagnostic accuracy should improve to the advantage of the clinicians, researchers, reviewers, journals, and the public. *For members of the STARD Group, see Appendix.
Study Design. Literature review and group discussions. Objective. To propose uniform definitions for low back pain episodes to be used in research. Background. Different definitions of episodes have been used in low back pain studies. This hampers comparison of study results. Definitions are proposed for episodes of low back pain, care for low back pain, and work absence because of low back pain. Methods. In a Medline search, we identified about 1200 papers, of which 81 possibly contained a definition of episodes. In group discussions, we decided which definitions to propose and discussed their applicability. Results. We found few definitions in the literature. In the group discussions we decided to define an episode of LBP as a period of pain in the lower back lasting for more than 24 hours, preceded and followed by a period of at least 1 month without low back pain. An episode of care for low back pain was defined as a consultation or a series of consultations for low back pain, preceded and followed by at least 3 months without consultation for low back pain. An episode of work absence due to low back pain was defined as a period of work absence due to low back pain, preceded and followed by a period of at least 1 day at work. Conclusions. In many studies, episodes of low back pain are mentioned without a clear definition. We consider our proposed definitions of episodes to be arbitrary but well considered. We advise that they be tested for use in future research.
The Individual Work Performance Questionnaire (IWPQ), measuring task performance, contextual performance, and counterproductive work behavior, was developed in The Netherlands.To cross-culturally adapt the IWPQ from the Dutch to the American-English language, and assess the questionnaire's internal consistency and content validity in the American-English context.A five stage translation and adaptation process was used: forward translation, synthesis, back-translation, expert committee review, and pilot-testing. During the pilot-testing, cognitive interviews with 40 American workers were performed, to examine the comprehensibility, applicability, and completeness of the American-English IWPQ.Questionnaire instructions were slightly modified to aid interpretation in the American-English language. Inconsistencies with verb tense were identified, and it was decided to consistently use simple past tense. The wording of five items was modified to better suit the American-English language. In general, participants were positive on the comprehensibility, applicability and completeness of the questionnaire during the pilot-testing phase. Furthermore, the study showed positive results concerning the internal consistency (Cronbach's alphas for the scales between 0.79-0.89) and content validity of the American-English IWPQ.The results indicate that the cross-cultural adaptation of the American-English IWPQ was successful and that the measurement properties of the translated version are promising.
Objective To review the evidence on diagnostic accuracy of red flag signs and symptoms to screen for fracture or malignancy in patients presenting with low back pain to primary, secondary, or tertiary care. Design Systematic review. Data sources Medline, OldMedline, Embase, and CINAHL from earliest available up to 1 October 2013. Inclusion criteria Primary diagnostic studies comparing red flags for fracture or malignancy to an acceptable reference standard, published in any language. Review methods Assessment of study quality and extraction of data was conducted by three independent assessors. Diagnostic accuracy statistics and post-test probabilities were generated for each red flag. Results We included 14 studies (eight from primary care, two from secondary care, four from tertiary care) evaluating 53 red flags; only five studies evaluated combinations of red flags. Pooling of data was not possible because of index test heterogeneity. Many red flags in current guidelines provide virtually no change in probability of fracture or malignancy or have untested diagnostic accuracy. The red flags with the highest post-test probability for detection of fracture were older age (9%, 95% confidence interval 3% to 25%), prolonged use of corticosteroid drugs (33%, 10% to 67%), severe trauma (11%, 8% to 16%), and presence of a contusion or abrasion (62%, 49% to 74%). Probability of spinal fracture was higher when multiple red flags were present (90%, 34% to 99%). The red flag with the highest post-test probability for detection of spinal malignancy was history of malignancy (33%, 22% to 46%). Conclusions While several red flags are endorsed in guidelines to screen for fracture or malignancy, only a small subset of these have evidence that they are indeed informative. These findings suggest a need for revision of many current guidelines.
To develop expert consensus on a suite of reporting standards for HRQL outcomes of RCTs.A Task Force of The International Society of Quality of Life Research (ISOQOL) undertook a systematic review of the literature to identify candidate reporting standards for HRQL in RCTs. Subsequently, a web-based survey was circulated to the ISOQOL membership. Respondents were asked to rate candidate standards on a 4-point Likert scale based on their perceived value in reporting studies in which HRQL was a study outcome (primary or secondary). Results were synthesized into draft reporting guidelines, which were further reviewed by the membership to inform the final guidance.Forty-six existing candidate standards for reporting HRQL results in RCTs were synthesized to produce a 40 item survey that was completed electronically by 161 respondents. The majority of respondents rated all 40 items to be either 'essential' or 'desirable' when HRQL was a primary RCT outcome. Ratings changed when HRQL was a secondary study outcome. Feedback on the survey findings resulted in the Task Force generalizing the guidance to include patient-reported outcomes (PROs). The final guidance, which recommends standards for use in reporting PROs generally, and more specifically, for PROs identified as primary study outcomes, was approved by the ISOQOL Board of Directors.ISOQOL has developed a suite of recommended standards for reporting PRO results of RCTs. Improved reporting of PROs will enable accurate interpretation of evidence to inform patient choice, aid clinical decision making, and inform health policy.
The natural course of physical functioning in knee and/or hipOA is highly variable; some patients remain stable, while others improve or worsen. Knowledge on prognostic risk factors related to physical functioning are used to adapt interventions.
Objectives
(1) To systematically summarize the literature from March 2005 to January 2013 on the course of physical functioning and pain in patients with OA of the knee or hip and (2) to provide an overview of prognostic factors of physical functioning and future pain for these patients.
Methods
A search was conducted in PubMed, CINAHL, Embase and Psych-INFO in January 2013. Eligible studies were prospective cohort studies that included participants with knee or hip OA diagnosed with radiographically and/or clinically diagnosed knee or hip OA, or participants with knee or hip pain who were likely to have OA. Outcome measures were measurements that evaluated physical functioning and pain. The included articles were assessed for bias and the results were summarized according to best evidence synthesis.
Results
Of the 9068 studies that were found, 27 articles were included. In patients with knee OA, the average course of physical functioning varied between studies (inconsistent evidence). The same was found for the average course of knee pain in studies with a follow up period shorter than three years. In addition, in patients with hip OA the average course of physical functioning in studies with a follow up period shorter than three years was found to be stable (strong evidence). Because only one study examined the course of physical functioning over a period longer than three years, weak evidence was found for a stable course over 5 years. With regard to prognostic factors, in patients with knee OA strong evidence was found for various prognostic factors for future deterioration in physical functioning i.e. older age, a low to middle education level, higher body mass index, high morbidity count, use of pain medication, greater difficulties with physical functioning at baseline, lower knee extension strength, higher pain intensity, patella-femoral joint compression, lower walking ability, poor mental health and a low vitality. With regard to predictors for future knee pain, a longer symptom duration, bilateral knee symptoms and a higher level of pain at baseline were found to predict future pain in patients with knee OA (strong evidence). In hip OA strong evidence was found that a high morbidity count and a low vitality increase the likelihood of deterioration of physical functioning. No publications were found on prognostic factors for future pain.
Conclusions
The average course of physical functioning and pain in patients with knee OA was found to be variable between studies. In hip OA, the long-term course of physical functioning was found to be stable. In comparison to a previous review stronger evidence was found for a number of variables to be prognostic factors of physical functioning and pain, including demographic factors, clinical factors, knee characteristics and psychosocial factors.
