Patient-reported outcomes (PROs) are increasingly being used in today's rapidly evolving health care environment. The value of care provision emphasizes the highest quality of care at the lowest ...cost. Quality is in the eye of the beholder, with different stakeholders prioritizing different components of the value equation. At the center of the discussion are the patients and their quantification of outcome via PROs. There are hundreds of different PRO questionnaires that may ascertain an individual's overall general health, quality of life, activity level, or determine a body part-, joint-, or disease-specific outcome. As providers and patients increasingly measure outcomes, there exists greater potential to identify significant differences across time points due to an intervention. In other words, if you compare groups enough, you are bound to eventually detect a significant difference. However, the characterization of significance is not purely dichotomous, as a statistically significant outcome may not be clinically relevant. Statistical significance is the direct result of a mathematical equation, irrelevant to the patient experience. In clinical research, despite detecting statistically significant pre- and post-treatment differences, patients may or may not be able to perceive those differences. Thresholds exist to delineate whether those differences are clinically important or relevant to patients. PROs are unique, with distinct parameters of clinical importance for each outcome score. This review highlights the most common PROs in clinical research and discusses the salient pearls and pitfalls. In particular, it stresses the difference between statistical and clinical relevance and the concepts of minimal clinically important difference and patient acceptable symptom state. Researchers and clinicians should consider clinical importance in addition to statistical significance when interpreting and reporting investigation results.
The evolution of a systematic approach to assessing pertinent investigations is known as evidence-based medicine (EBM). EBM is defined as the conscientious and judicious use of current best evidence ...from clinical care research and integration of clinical expertise in the management of individual patients. There is no doubt that EBM is important but may not give clinically meaningful guidance on topics with clinical equipoise for individual patient care. When EBM has been insufficiently developed for a specific topic, a consensus opinion of experts can be valuable. In principle, there are 2 consensus methods for expert opinion available: the nominal group technique and the Delphi method. The nominal group technique is a structured face-to-face meeting facilitating discussion and allows participants to voice their opinions. The key characteristics of the Delphi method are the use of panel experts to obtain data, no face-to-face discussions, the use of sequential questionnaires, the systematic emergence of a concurrent opinion, use of frequency distributions to identify patterns, and the use of at least 2 rounds with feedback between rounds. We should not dismiss the collective experience of our leading experts, and expert consensus-based evidence should be explored as another tool to improve the quality of treatment for our patients.
Despite improvements in surgical technique and implant longevity, some patients continue to report dissatisfaction after total joint arthroplasty (TJA). As patient satisfaction is increasingly used ...as a quality metric, the objective of this study was to gain better understanding of satisfaction with total joint arthroplasty from the patient perspective.
Five hundred fifty-one primary total hip arthroplasty (THA) and total knee arthroplasty (TKA) with a minimum of 1-year follow-up and were responsive to a satisfaction survey were analyzed. The incidence, predictive factors, and subjective reasoning for patient dissatisfaction were assessed. Univariate and multivariate logistic regression analyses were performed.
Patient satisfaction was 89% for THA and 88% for TKA. Hispanic race was the most significant predictor of dissatisfaction (P = .037). The most common reasons for dissatisfaction after THA were persistent pain (N = 14/34, 41%), functional limitation (N = 12/34, 35%), surgical complication and reoperation (N = 4/34, 12%), staff or quality of care issues (N = 2/34, 6%), and slow recovery (N = 2/34, 6%). The most common reasons for dissatisfaction after TKA were persistent pain (N = 19/46, 41%), functional limitation (N = 12/46, 26%), surgical complication and reoperation (N = 8/46, 17%), staff or quality of care issues (N = 5/46, 11%), and unmet expectations (N = 2/46, 4%).
While persistent pain and functional limitation are the 2 leading reasons for dissatisfaction in both TKA and THA, a subset of patients view satisfaction as an evaluation of the process by which care is delivered. Patient satisfaction is not solely a reflection of surgical outcome and should be interpreted with caution. Potential for incomplete pain relief or full functional recovery should be discussed during preoperative counseling. Empathic care is also important and should be encouraged to enhance the overall patient experience.
The minimal clinically important difference (MCID) is a frequently reported metric for describing within-patient improvement in patient-reported outcome measures (PROMs). It was originally defined by ...Jaeschke et al. as “the smallest difference in score in the domain of interest which patients perceive as beneficial and which would mandate, in the absence of troublesome side effects and excessive cost, a change in the patient’s management.” The latter part of this statement is often omitted, and this results in a loss of the originally intended value through lack of sufficient clinical importance to change management. Other pitfalls in the use of the MCID include that they are population- and condition-specific. As such, MCIDs lack external validity and cannot easily be extrapolated from one study to another. Furthermore, broadly different values can be obtained depending on the calculation method used. This makes the MCID an unhelpful metric when seeking to understand the true efficacy of a given intervention. The Food and Drug Administration recommends anchor-based methodologies (which take into account patient perception), over distribution-based methods (which are purely statistical and do not account for clinical meaningfulness to patients). Regardless, it should be noted that even anchor-based methodologies are susceptible to statistical bias, and measures are apt to be influenced by the regression to mean phenomena, where the value of the preintervention scores and their relationship to postintervention scores can bias estimates of the MCID. Finally, when using MCIDs, one must consider that they are a low bar. This means that patients do not undergo treatment to achieve minimally perceptible clinical improvements; instead, they undergo treatment with the hope of achieving substantial clinical benefit or a patient acceptable symptom state, and so these are more appropriate individual-level metrics to consider when evaluating clinically meaningful outcomes of treatment.
Ceiling effects (CEs) are a major limitation of frequently used patient-reported outcomes measures (PROMs) in the assessment of shoulder function. It is generally considered that a CE may be present ...when the best possible score for a given PROM is achieved by at least 15% of the study population. When a CE occurs, it typically indicates that the scoring criteria are relatively easy and therefore may not reliably capture greater levels of patient function. This is a particular problem with the use of activities of daily living–oriented PROMs in the evaluation of athletic patients because they can still score highly, despite limitations in athletic shoulder function. When a CE is present, it can result in failure to determine the true efficacy of a procedure, limited responsiveness to change, and furthermore if a subsequent comparison of 2 groups of patients is undertaken, it may produce similar results despite meaningful differences between them. It is important to recognize that CEs are common and have important consequences but that careful selection of PROMs adapted to the characteristics of the study population and the specific research question can help to mitigate these issues.
Purpose To conduct a systematic review of the literature in relation to 3 considerations in determining treatment options for patients with acromioclavicular (AC) joint dislocations: (1) operative ...versus nonoperative management, (2) early versus delayed surgical intervention, and (3) anatomic versus nonanatomic techniques. Methods The PubMed database was searched in October 2011 using the single term acromioclavicular and the following search limits: any date, humans, English , and all adult (19+). Studies were included if they compared operative with nonoperative treatment, early with delayed surgical intervention, or anatomic with nonanatomic surgical techniques. Exclusion criteria consisted of the following: Level V evidence, laboratory studies, radiographic studies, biomechanical studies, fractures or revisions, meta-analyses, and studies reporting preliminary results. Results This query resulted in 821 citations. Of these, 617 were excluded based on the title of the study. The abstracts and articles were reviewed, which resulted in the final group of 20 studies that consisted of 14 comparing operative with nonoperative treatment, 4 comparing early with delayed surgical intervention, and 2 comparing anatomic with nonanatomic surgical techniques. The lack of higher level evidence prompted review of previously excluded studies in an effort to explore patterns of publication related to operative treatment of the AC joint. This review identified 120 studies describing 162 techniques for operative reconstruction of the AC joint. Conclusions There is a lack of evidence to support treatment options for patients with AC joint dislocations. Although there is a general consensus for nonoperative treatment of Rockwood type I and II lesions, initial nonsurgical treatment of type III lesions, and operative intervention for Rockwood type IV to VI lesions, further research is needed to determine if differences exist regarding early versus delayed surgical intervention and anatomic versus nonanatomic surgical techniques in the treatment of patients with AC joint dislocations. Level of Evidence Level III, systematic review of Level II and Level III studies and one case series.
Varying concentrations of blood components in platelet-rich plasma preparations may contribute to the variable results seen in recently published clinical studies. The purposes of this investigation ...were (1) to quantify the level of platelets, growth factors, red blood cells, and white blood cells in so-called one-step (clinically used commercial devices) and two-step separation systems and (2) to determine the influence of three separate blood draws on the resulting components of platelet-rich plasma.
Three different platelet-rich plasma (PRP) separation methods (on blood samples from eight subjects with a mean age and standard deviation of 31.6 ± 10.9 years) were used: two single-spin processes (PRPLP and PRPHP) and a double-spin process (PRPDS) were evaluated for concentrations of platelets, red and white blood cells, and growth factors. Additionally, the effect of three repetitive blood draws on platelet-rich plasma components was evaluated.
The content and concentrations of platelets, white blood cells, and growth factors for each method of separation differed significantly. All separation techniques resulted in a significant increase in platelet concentration compared with native blood. Platelet and white blood-cell concentrations of the PRPHP procedure were significantly higher than platelet and white blood-cell concentrations produced by the so-called single-step PRPLP and the so-called two-step PRPDS procedures, although significant differences between PRPLP and PRPDS were not observed. Comparing the results of the three blood draws with regard to the reliability of platelet number and cell counts, wide variations of intra-individual numbers were observed.
Single-step procedures are capable of producing sufficient amounts of platelets for clinical usage. Within the evaluated procedures, platelet numbers and numbers of white blood cells differ significantly. The intra-individual results of platelet-rich plasma separations showed wide variations in platelet and cell numbers as well as levels of growth factors regardless of separation method.
Abstract Within the health care environment, there has been a recent and appropriate trend towards emphasizing the value of care provision. Reduced cost and higher quality improve the value of care. ...Quality is a challenging, heterogeneous, variably defined concept. At the core of quality is the patient's outcome, quantified by a vast assortment of subjective and objective outcome measures. There has been a recent evolution towards evidence-based medicine in health care, clearly elucidating the role of high-quality evidence across groups of patients and studies. Synthetic studies, such as systematic reviews and meta-analyses, are at the top of the evidence-based medicine hierarchy. Thus, these investigations may be the best potential source of guiding diagnostic, therapeutic, prognostic, and economic medical decision making. Systematic reviews critically appraise and synthesize the best available evidence to provide a conclusion statement (a “take-home point”) in response to a specific answerable clinical question. A meta-analysis uses statistical methods to quantitatively combine data from single studies. Meta-analyses should be performed with high methodological quality homogenous studies (Level I or II) or evidence randomized studies, to minimize confounding variable bias. When it is known that the literature is inadequate or a recent systematic review has already been performed with a demonstration of insufficient data, then a new systematic review does not add anything meaningful to the literature. PROSPERO registration and PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines assist authors in the design and conduct of systematic reviews and should always be used. Complete transparency of the conduct of the review permits reproducibility and improves fidelity of the conclusions. Pooling of data from overly dissimilar investigations should be avoided. This particularly applies to Level IV evidence, that is, noncomparative investigations. With proper technique, systematic reviews and meta-analyses have the potential to be powerful investigations that efficiently assist clinicians in decision making.
Recent research has examined the comparative effectiveness of nonoperative treatments for patellar tendinopathy using a network meta-analysis method. This method allows analysis of a network of ...clinical trials individually studying different treatment options in comparison to an eccentric exercise control; however, most treatments have not been compared head to head. Although leukocyte-rich platelet-rich plasma is statistically ranked as the treatment with the highest improvements in pain and function, concerns over the assumption of transitivity (on which network meta-analysis is based) and the lack of connection or comparisons among treatments suggest that future studies comparing treatments head to head are needed.
Patient-Reported Outcomes Measurement Information System (PROMIS) scores have considerable potential to both streamline the collection of outcome data and provide a common set of metrics to compare ...and benchmark patient-reported outcomes after orthopaedic procedures. An analysis of PROMIS scores collected at the preoperative clinical visit and the day of surgery found considerable changes in upper- and lower-extremity physical function, pain interference, and depression. These findings suggest that health status may vary between the day of operative consent and the day of surgery. Given the importance of patient-reported outcomes in clinical research, quality assurance, and value-based health care, the potential for large changes in scores leading up to the procedure warrants attention toward the timing of PROMIS administration to ensure that the health status of the patient-and its variation-is accurately captured.
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