Inclusion of Social and Structural Determinants of Health to Advance Understanding of their Influence on the Biology of Chronic Disease.

Social Determinants of Health (SDOH) consider social, political, and economic factors that contribute to health disparities in patients and populations. The most common health-related SDOH exposures are food and housing insecurity, financial instability, transportation needs, low levels of education, and psychosocial stress. These domains describe risks that can impact health outcomes more than health care. Epidemiologic and translational research demonstrates that SDOH factors represent exposures that predict harm and impact the health of individuals. International and national guidelines urge health professionals to address SDOH in clinical practice and public health. The further implementation of these recommendations into basic and translational research, however, is lagging. Herein, we consider a precision health framework to describe how SDOH contributes to the exposome and exacerbates physiologic pathways that lead to chronic disease. SDOH factors are associated with various forms of stressors that impact physiological processes through epigenetic, inflammatory, and redox regulation. Many SDOH exposures may add to or potentiate the pathologic effects of additional environmental exposures. This overview aims to inform basic life science and translational researchers about SDOH exposures that can confound associations between classic biomedical determinants of disease and health outcomes. To advance the study of toxicology through either qualitative or quantitative assessment of exposures to chemical and biological substances, a more complete environmental evaluation should include SDOH exposures. We discuss common approaches to measure SDOH factors at individual and population levels and review the associations between SDOH risk factors and physiologic mechanisms that influence chronic disease. We provide clinical and policy-based motivation to encourage researchers to consider the impact of SDOH exposures on study results and data interpretation. With valid measures of SDOH factors incorporated into study design and analyses, future toxicological research may contribute to an evidence base that can better inform prevention and treatment options, to improve equitable clinical care and population health. © 2022 Wiley Periodicals LLC.

A Standard Set of Value-Based Patient-Centered Outcomes and Measures of Overall Health in Adults.

BACKGROUND: The definition of population-specific outcomes is an essential precondition for the implementation of value-based health care. We developed a minimum standard outcome set for overall adult health (OAH) to facilitate the implementation of value-based health care in tracking, comparing, and improving overall health care outcomes of adults across multiple conditions, which would be of particular relevance for primary care and public health populations. METHODS: The International Consortium for Health Outcomes Measurement (ICHOM) convened an international panel (patients, clinicians, and topic experts). Following the development of a conceptual framework, a modified Delphi method (supported by public consultations) was implemented to identify, in sequence, the relevant domains, the best instruments for measuring them, the timing of measurement, and the relevant adjustment variables. FINDINGS: Outcomes were identified in relation to overall health status and the domains of physical, mental, and social health. Three instruments covering these domains were identified: PROMIS Scale v1.2-Global Health (10 items), WHO Wellbeing Index (5 items), and the WHO Disability Assessment Schedule 2.0 (12 items). Case-mix variables included a range of sociodemographic and biometric measures. Yearly measurement was proposed for all outcomes and most case-mix variables. INTERPRETATION: The ICHOM OAH Standard Set has been developed through consensus-based methods based on predefined criteria following high standards for the identification and selection of high-quality measures The involvements of a wide range of stakeholders supports the acceptability of the set, which is readily available for use and feasibility testing in clinical settings.

Turning Feed-forward and Feedback Processes on Patient-reported Data into Intelligent Action and Informed Decision-making: Case Studies and Principles.

INTRODUCTION: The collection of patient-reported outcomes (PROs) in routine clinical practice provides opportunities to "feed-forward" the patient's perspective to his/her clinical team to inform planning and management. This data can also be aggregated to "feedback" population-level analytics that can inform treatment decision-making, predictive modeling, population-based care, and system-level quality improvement efforts. METHODS AIDING INTERPRETATION AND ACTING ON RESULTS: Three case studies demonstrate a number of system-level features which aid effective PRO interpretation: (1) feed-forward and feedback information flows; (2) score interpretation aids; (3) cascading measurement; (4) registry-enabled learning health care systems; and (5) the maturational development of information systems. DISCUSSION: The case studies describe the developmental span of feed-forward PRO programs-from simple to mature applications. The Concord Hospital (CH) Multiple Sclerosis Neurobehavioral Clinic exemplifies a simple application in which PRO data are used before and during clinic visits by patients and clinicians to inform care. The Dartmouth-Hitchcock (D-H) Spine Center exemplifies a mature program which utilizes population-level analytics to provide decision support by predicting outcomes for different treatment options. The Swedish Rheumatology Quality (SRQ) Registry epitomizes an exceptional application which has spread to multiple systems across an entire country. KEY POINTS: Feed-forward and feedback PRO information systems can better inform, involve, and support clinicians, patients and families, and allow health systems to monitor and improve system performance and population health outcomes. Ideal systems have the capability for multilevel analyses at patient, system, and population levels, and an information technology infrastructure that is linked to associated workflows and a supportive practice culture. As systems mature, they progress beyond the ability to describe and inform towards higher level capabilities including prediction and decision support. Finally, there is additional promise for the integration of patient-reported information that is adjusted (or weighted) by preferences and values to guide shared decision-making and inform individualized precision health care in the future.

Implementation of Patient-Reported Outcomes in Routine Medical Care.

There is increasing interest to integrate collection of patient-reported outcomes (PROs) in routine practice to enhance clinical care. Multiple studies show that systematic monitoring of patients using PROs improves patient-clinician communication, clinician awareness of symptoms, symptom management, patient satisfaction, quality of life, and overall survival. The general approach includes a brief electronic survey, administered via the Web or an app or an automated telephone system, with alerts to clinicians for concerning or worsening issues. Patients have generally been asked to self-report on a regular basis (remotely between visits and/or at visits), with reminders prompting patients to self-report that are sent via email, text, or automated phone message. More recently, care management pathways for patients and clinicians have been triggered by PRO system alerts. PRO systems may be free-standing, integrated into electronic health record systems or patient portals, or native functionality of an electronic health record. Despite potential benefits, there are challenges with integrating PROs into practice for monitoring patient status, as there are with any modifications to existing clinical processes. These challenges range from administrative to technical to workflow. A session at the 2018 ASCO Annual Meeting was dedicated to the implementation of PROs in clinical practice. The session focused on practical examples of PRO implementations, with honest reflections on barriers and strategies that may be generalizable to other systems looking to implement PROs. Panelists for that session are the authors of this paper, which describes their respective experiences implementing PROs in practice settings.

Breast Cancer and Reconstruction: Normative Data for Interpreting the BREAST-Q.

BACKGROUND: The BREAST-Q is a patient-reported outcome instrument used to evaluate outcomes in patients undergoing breast cancer surgery and reconstruction. Normative values for the BREAST-Q breast cancer modules have not been established, limiting data interpretation. METHODS: Participants were recruited by means of the Army of Women, an online community of women (with and without breast cancer), to complete Mastectomy, Breast Conserving Therapy, and Reconstruction preoperative BREAST-Q scales. Inclusion criteria were women aged 18 years or older without a history of breast surgery or breast cancer. Analysis included descriptive statistics, a linear multivariate regression, and a comparison of the generated normative data to previously published BREAST-Q findings. RESULTS: The BREAST-Q was completed by 1201 women. The mean patient age was 54 ± 13 years, mean body mass index 26 ± 6 kg/m, and 38 percent (n = 455) had a bra cup size of D or greater. Mean ± SD scores for BREAST-Q scales were as follows: Satisfaction with Breasts (58 ± 18), Psychosocial Well-being (71 ± 18), Sexual Well-being (56 ± 18), Physical Well-being-Chest (93 ± 11), and Physical Well-being Abdomen (78 ± 20). Women with a body mass index of 30 kg/m or greater, cup size of D or greater, age younger than 40 years, and annual income less than $40,000 reported lower scores. Comparing normative scores to published data in breast cancer patients, Satisfaction with Breasts scores were higher after autologous reconstruction and lower after mastectomy; Sexual Well-being scores were lower after mastectomy and breast conserving therapy; and Physical Well-being Chest scores were lower after mastectomy, breast conserving therapy, and reconstruction. CONCLUSION: These are the first published normative scores for the BREAST-Q breast cancer modules and provide a clinical reference point for the interpretation of data.

Understanding the Health Burden of Macromastia: Normative Data for the BREAST-Q Reduction Module.

BACKGROUND: The BREAST-Q Reduction module evaluates outcomes in reduction mammaplasty. However, there are currently no published normative scores, limiting the interpretation of BREAST-Q data. METHODS: The BREAST-Q Reduction module was administered via the Army of Women, an online community of women (with and without breast cancer) engaged in breast-cancer related research. Normative data were generated from women aged 18 years and older, without a history of breast cancer or breast surgery. Data analysis was performed using descriptive statistics and a linear multivariate regression. Generated normative data were compared to published BREAST-Q Reduction findings. RESULTS: The preoperative version of the BREAST-Q Reduction module was completed by 1206 women. Participant mean age was 55 ± 13 years, mean body mass index was 27 ± 6 kg/m, and 40 percent (n = 481) had a bra cup size ≥ D. Mean normative scores were as follows: Satisfaction with Breasts, 57 ± 16; Psychosocial Well-being, 68 ± 19; Sexual Well-being, 55 ± 19; and Physical Well-being, 76 ± 11. Normative scores were lower in women with body mass index ≥ 30 and bra cup size ≥ D. In comparison to normative Army of Women scores, published BREAST-Q scores for women undergoing reduction mammaplasty were lower (worse) for preoperative patients and higher (better) for postoperative patients. CONCLUSION: These new Army of Women normative data provide insights into breast-related satisfaction and well-being in women not pursuing breast reduction, giving new clinical context to better understand the health burden of macromastia, and to demonstrate the value of reduction mammaplasty in certain patients.

Normative Data for Interpreting the BREAST-Q: Augmentation.

BACKGROUND: The BREAST-Q is a rigorously developed, well-validated, patient-reported outcome instrument with a module designed for evaluating breast augmentation outcomes. However, there are no published normative BREAST-Q scores, limiting interpretation. METHODS: Normative data were generated for the BREAST-Q Augmentation module by means of the Army of Women, an online community of women (with and without breast cancer) engaged in breast-cancer related research. Members were recruited by means of e-mail; women aged 18 years or older without a history of breast cancer or breast surgery were invited to participate. Descriptive statistics and a linear multivariate regression were performed. A separate analysis compared normative scores to findings from previously published BREAST-Q augmentation studies. RESULTS: The preoperative BREAST-Q Augmentation module was completed by 1211 women. Mean age was 54 ± 24 years, the mean body mass index was 27 ± 6 kg/m, and 39 percent (n = 467) had a bra cup size of D or greater. Mean scores were as follows: Satisfaction with Breasts, 54 ± 19; Psychosocial Well-being, 66 ± 20; Sexual Well-being, 49 ± 20; and Physical Well-being, 86 ± 15. Women with a body mass index of 30 kg/m or greater and bra cup size of D or greater had lower scores. In comparison with Army of Women scores, published BREAST-Q augmentation scores were lower before and higher after surgery for all scales except Physical Well-being. CONCLUSIONS: The Army of Women normative data represent breast-related satisfaction and well-being in women not actively seeking breast augmentation. These data may be used as normative comparison values for those seeking and undergoing surgery as we did, demonstrating the value of breast augmentation in this patient population.

Benefits and Risks of Prophylaxis for Deep Venous Thrombosis and Pulmonary Embolus in Plastic Surgery: A Systematic Review and Meta-Analysis of Controlled Trials and Consensus Conference.

UNLABELLED: The goal of this consensus conference, sponsored by the American Association of Plastic Surgeons, was to perform a systematic review and meta-analysis of controlled trials to examine both the benefits and risks of venous thromboembolism prophylaxis in plastic surgery patients. The panel sought to assess the safety and effectiveness of recognized venous thromboembolism prophylaxis strategies, including variation in anesthetic management, use of elastic compression stockings or intermittent pneumatic compression, and use of chemoprophylaxis. The authors also sought to examine effectiveness and safety of prophylaxis in patients risk-stratified by procedure type or 2005 Caprini score. The panel met face to face in March of 2015 to perform an exhaustive review of the existing literature. The panel subsequently created consensus recommendations using the GRADE criteria. Important directions for future research were also identified. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, V.

Evidence-based medicine: reduction mammaplasty.

LEARNING OBJECTIVES: After reading this article, the participant should be able to: 1. Accurately state the indications for breast imaging prior to breast reduction; 2. List the modifiable risk factors in a woman considering breast reduction. 3. Use perioperative antibiotics in an evidence based fashion. 4. Identify factors that are associated with higher rates of perioperative complications. 5. Describe the risks and benefits of breast infiltration with epinephrine. 6. Describe the pros and cons of using drains following breast reduction. 7. Describe the incidence of invasive breast cancer in surgical specimens compared to autopsy specimens. 8. Identify common questionnaires that can be used to track short and long-term outcomes following breast reduction. 9. List at least three current practices that are now evolving and changing based on evidence based medicine. SUMMARY: This paper is designed to summarize key evidence based steps in the care of women undergoing reduction mammaplasty. In addition, the authors identify gaps between how plastic surgeons practice breast reduction and what the best evidence supports. The article was prepared to accompany practice-based assessment with ongoing surgical education for the Maintenance of Certification Program of the American Board of Plastic Surgery.

The usefulness of patient-reported measures for clinical practice.

BACKGROUND: The authors assessed the diagnostic potential of commonly used patient-reported measures, namely, the Boston Carpal Tunnel Questionnaire (function and symptom severity), QuickDASH (a shortened version of the Disabilities of the Arm, Shoulder and Hand questionnaire), and the Short Form-8. METHODS: Measure scores were extracted retrospectively from the records of 262 patients (397 hands) and compared using analysis of variance to determine statistical differences among diagnoses assigned by the same surgeon at the time of visit. Patients were grouped into one of two diagnostic groups: those with Dupuytren disease and those with carpal tunnel, osteoarthritis, and tenosynovitis conditions. Logistic regression analysis was performed, and a receiver operating characteristic curve was used in data analysis. RESULTS: Analysis of variance showed statistical differences among the five diagnoses for each patient-reported measure. Results showed that Dupuytren disease was significantly different from the other diagnoses. Carpal tunnel, osteoarthritis, and tenosynovitis conditions were statistically associated with higher Boston Carpal Tunnel Questionnaire function and symptom severity and QuickDASH scores compared with Dupuytren disease. Lower physical and mental summary Short Form-8 scores were associated with the carpal tunnel, osteoarthritis, and tenosynovitis conditions. QuickDASH scores of 25 or higher and Boston Carpal Tunnel Questionnaire symptom severity scores and function scores of 2.5 or higher and of 2 or higher, respectively, are the best patient-reported measure threshold values for distinguishing between the two diagnostic groups. CONCLUSIONS: The QuickDASH and Boston Carpal Tunnel Questionnaire patient-reported measures have diagnostic potential. Establishing threshold values for predicting a diagnostic group may prove to be a useful tool for referring providers. CLINICAL QUESTION/LEVEL OF EVIDENCE: Diagnostic, IV.

Evidence-based practices for thromboembolism prevention: summary of the ASPS Venous Thromboembolism Task Force Report.

In July of 2011, the American Society of Plastic Surgeons Executive Committee approved the Venous Thromboembolism Task Force Report. The report includes a summary of the scientific literature relevant to venous thromboembolism and plastic surgery along with five evidence-based recommendations. The recommendations are divided into two sections: risk stratification and prevention. The risk stratification recommendations are based on the 2005 Caprini Risk Assessment Module, which has been validated in the scientific literature as an effective tool for risk-stratifying plastic and reconstructive surgery patients based on individual risk factors for 60-day venous thromboembolism. The three prophylaxis recommendations are dependent on an individual patient's 2005 Caprini Risk Assessment Module score.

Harmonic scalpel versus electrocautery in breast reduction surgery: a randomized controlled trial.

BACKGROUND: The authors hypothesized that the Harmonic Scalpel (Ethicon Endo-Surgery, Cincinnati, Ohio) might outperform electrocautery in bilateral breast reduction surgery, possibly resulting in (1) shorter operative times, (2) lower postoperative fluid drainage rates, and (3) reduced postoperative pain scores. METHODS: Thirty-one patients were evaluated in a matched-pair design, with random (blinded) assignment of one side to the Harmonic Scalpel, with the other side defaulting to electrocautery. Main outcome measures were: (1) resection/hemostasis time, (2) drainage volume, and (3) postoperative pain. The authors also compared the learning curves, operative time versus specimen weights, complications, and costs for the devices. RESULTS: There was a statistically significant (but not clinically significant) difference between the median times for the Harmonic Scalpel (33 minutes) and electrocautery (31 minutes) (p=0.02). There was no statistical difference in drainage scores, and pain scores were equivalent. The analysis of specimen weight versus resection/hemostasis time showed no correlation. There were more complications on the breasts reduced with the Harmonic device, but due to the small sample size, the complication results were not statistically significant. Start-up costs for the devices were comparable, but the per-procedure cost for the Harmonic device was considerably higher. CONCLUSIONS: The Harmonic Scalpel is roughly equivalent to electrocautery in breast reduction surgery in terms of resection/hemostasis time, serous drainage, and postoperative pain. Though the Harmonic device may be excellent for other surgical procedures, its high cost suggests that surgeons and institutions can confidently forgo its use in breast reduction surgery. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

A cost, profit, and efficiency analysis of performing carpal tunnel surgery in the operating room versus the clinic setting in the United States.

BACKGROUND: Carpal tunnel surgery (CTS) can be performed in the clinic or operating room with similar outcomes. Our goals were to perform a total cost comparison, profit analysis, and assess efficiency of CTS in each setting. METHODS: A detailed cost analysis for all CTSs at a tertiary care academic center was done for the year 2007. We calculated the net revenues and profit margins for single endoscopic port and open CTS performed in each setting in the year 2007. For efficiency analysis, we assumed that the time saved by performing a procedure in the more efficient setting could accumulate and permit additional CTSs. This would be the opportunity cost of performing CTS in the less efficient setting. RESULTS: In general, the operating room was a costlier setting than the clinic. The total cost per case when performing single-port endoscopic CTS was more than double ($2273 vs. $985) when performed in the operating room versus the clinic. For open CTS, the operating room was more than 4 times as expensive than the clinic ($3469 vs. $670). For single endoscopic port cases, profits gained were greater than double in the clinic versus the operating room ($2710 vs. $1139). For open CTS, clinic cases had a profit margin per case of $1186; however, procedures in the operating room incurred a loss of $650 per case. The block time allowed for CTS in the clinic was 30 and 60 minutes in the operating room. To value this efficiency, we used the profit margin of CTS performed in the clinic ($2710) and divided it by the 30 minutes it took to perform. This provided us with a multiplier of $90/min. We multiplied the 30 minutes saved when operating in the clinic by the $90/min to give us an opportunity cost of $2700. CONCLUSION: Performing either single endoscopic port or open CTS in the operating room is more expensive and less efficient than in the clinic setting.

A detailed analysis of level I evidence (randomized controlled trials and meta-analyses) in five plastic surgery journals to date: 1978 to 2009.

BACKGROUND: Evidence-based medicine is the synthesis of clinical expertise, best available clinical evidence, and patient values to provide optimal health outcomes. A scant number of randomized controlled trials exist in the plastic surgery literature. The authors sought to analyze the level I studies (randomized controlled trials and meta-analyses) in five leading plastic surgery journals to date to understand the distribution of primary categories of study, primary outcomes, age breakdown, degree of quality, and the trend in publication rates. METHODS: PubMed/MEDLINE was searched by leaving entry field empty and applying the following limitations: randomized controlled trials and meta-analysis, English, all ages, all dates, humans and animals, Plastic and Reconstructive Surgery, Annals of Plastic Surgery, British Journal of Plastic Surgery, Aesthetic Plastic Surgery, and Journal of Plastic, Reconstructive & Aesthetic Surgery. RESULTS: Three hundred nine publications were included in the analysis. There was a steady increase in the number of level I studies from 1978 to 2009. Thirty-eight percent were double-blinded, 31 percent were single-blinded, 20 percent were not blinded, and 8 percent were meta-analyses. Cosmetic was the most common category. Cost and efficiency were primary outcomes in only 2.6 and 4.2 percent, respectively. Power analysis was performed 15.5 percent of the time, and randomization technique was reported in only 39 percent of the studies. CONCLUSIONS: Level I studies in plastic surgery continue to increase in number; however, most are not randomized or blinded, do not have power analyses, and do not consider cost. Future studies should be designed to produce high-quality evidence and should address cost and comparative effectiveness.

Evaluation of a new wound closure device for linear surgical incisions: 3M Steri-Strip S Surgical Skin Closure versus subcuticular closure.

BACKGROUND: Technological innovations are often adopted before scientific comparison to an accepted standard. The authors' study compared suture with a new coaptive film device, 3M Steri-Strip S Surgical Skin Closure, on linear incisions. METHODS: Patients undergoing Wise-pattern breast reduction or abdominal procedures had paired incisions randomly assigned to Steri-Strip S or suture closure. Key outcome measures were closure time, patient comfort, and scar quality at 6 months by patients and surgeons using a new scar evaluation tool, visual assessment of linear scars. Statistical differences between the two closure techniques were assessed by Wilcoxon signed rank test. RESULTS: Of 59 patients, eight were excluded from randomization (a surgeon judged Steri-Strip S to be a nonviable closure technique for mismatched wound edges). Fifty-one patients (breast, n = 24; abdomen, n = 27) were randomized. Operative time with Steri-Strip S for breast was 2.0 minutes (SD = 1.1) versus suture closure at 4.6 minutes (SD = 1.5; p < 0.001). Similarly, Steri-Strip S versus suture for the abdomen was faster (p < 0.001; 4.9 minutes, SD = 2.3 versus 10.1 minutes, SD = 3.4). Comfort scores did not differ between closures [5.8 (SD = 2.7) versus 6.9 (SD = 2.0), respectively, on breast (p = 0.142) and 7.7 (SD = 1.8) versus 7.7 (SD = 2.3) on abdomen (p = 0.903)]. Complication rates did not differ between closure types. Patients' visual assessment of linear scars rating of breasts was 3.8 (SD = 2.9) for Steri-Strip S and better at 2.6 (SD = 2.9) for suture (p = 0.008). One surgeon rated breast Steri-Strip S scars worse than suture scars (4.3 versus 3.7; p = 0.014). For abdominal scars, there was no difference in the patient or surgeon ratings. CONCLUSIONS: Steri-Strip S permits faster wound closure than suture. On the basis of patient reports of comfort and scar quality, surgeons increase efficiency and maintain quality with the use of Steri-Strip S on abdominal wounds but not on breast wounds.

Visual assessment of linear scars: a new tool.

BACKGROUND: Existing scar evaluation tools are based on verbal descriptions and used primarily for burn scar assessment. To evaluate linear scars, the authors developed a new tool called the visual assessment of linear scars. This study was designed to determine whether patients and surgeons rated scars similarly and to test the intrarater and interrater reliability of the surgeons' ratings. METHODS: At 6 months postoperatively, 51 patients used the visual assessment of linear scars tool to rate each of their own surgical scars (two scars for abdominal; six scars for breast), and two surgeons used the visual assessment of linear scars tool to rate the patients' scar photographs. A post hoc two-sample t test was used to determine whether the raters' scar means were significantly different from each other. Spearman correlation was used to determine the intrarater and interrater reliability. RESULTS: There was no difference in the mean scar ratings between the surgeons; however, both surgeons had significantly higher mean ratings than the patients (a higher score is a worse-appearing scar). Intrarater reliability for the surgeons was large (rho > 0.5) and interrater reliability between the surgeons was also large (rho = 0.53) but borderline. CONCLUSIONS: The visual assessment of linear scars tool was developed to create a simple, straightforward method of assessing the overall appearance of the postsurgical linear scar, keeping in mind that the patient's perspective might differ from that of a surgeon or researcher. Both patients and surgeons found the ratings easy to perform, and the results showed that patients might rate their scars' appearance more favorably than the surgeons. The visual assessment of linear scars is a reliable tool with two plastic surgeons' rating of repeated photographs.

Surgery versus non-surgical therapy for carpal tunnel syndrome: a randomised parallel-group trial.

BACKGROUND: A previous randomised controlled trial reported greater efficacy of surgery than of splinting for patients with carpal tunnel syndrome. Our aim was to compare surgical versus multi-modality, non-surgical treatment for patients with carpal tunnel syndrome without denervation. We hypothesised that surgery would result in improved functional and symptom outcomes. METHODS: In this parallel-group randomised controlled trial, we randomly assigned 116 patients from eight academic and private practice centres, using computer-generated random allocation stratified by site, to carpal tunnel surgery (n=57) or to a well-defined, non-surgical treatment (including hand therapy and ultrasound; n=59). The primary outcome was hand function measured by the Carpal Tunnel Syndrome Assessment Questionnaire (CTSAQ) at 12 months assessed by research personnel unaware of group assignment. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00032227. FINDINGS: 44 (77%) patients assigned to surgery underwent surgery. At 12 months, 101 (87%) completed follow-up and were analysed (49 of 57 assigned to surgery and 52 of 59 assigned to non-surgical treatment). Analyses showed a significant 12-month adjusted advantage for surgery in function (CTSAQ function score: Delta -0.40, 95% CI 0.11-0.70, p=0.0081) and symptoms (CTSAQ symptom score: 0.34, 0.02-0.65, p=0.0357). There were no clinically important adverse events and no surgical complications. INTERPRETATION: Symptoms in both groups improved, but surgical treatment led to better outcome than did non-surgical treatment. However, the clinical relevance of this difference was modest. Overall, our study confirms that surgery is useful for patients with carpal tunnel syndrome without denervation. FUNDING: NIH/NIAMS 5P60AR048093 and the Intramural Research Program of the NIH Clinical Center.

Using evidence to minimize the cost of trigger finger care.

PURPOSE: Critics of U.S. health care cite both underuse and overuse of resources. With more than one third of Americans paying for medical care out of pocket, optimizing the cost-benefit ratio of care is a high priority. Clinical trials have established the success of the different treatment options for patients who present with trigger finger. The economic impact of these differing strategies has not been established. The aim of this study was to perform a cost-minimization analysis to identify the least costly strategy for effective treatment of trigger finger using existing evidence in the literature. METHODS: Five strategies for the treatment of trigger finger were identified: (1) a steroid injection followed by surgical release for failure or recurrence, (2) a steroid injection followed by a second injection for failures or recurrence, followed by definitive surgery if needed, (3) 3 steroid injections before definitive surgery if needed, (4) surgical release, and (5) percutaneous release with definitive open surgery if needed. To reflect the costs, we used 2 sources of data: our institution's billing charges to private payers and our institution's reimbursements from Medicare. A literature review identified median success rates of the different treatment strategies. We conducted a series of analyses to evaluate the effect of varying individual costs and success rates. RESULTS: The second strategy is the least costly treatment of those considered in this study. The most costly treatment, surgical release, costs between 248% and 340% more than the second strategy. For surgical or percutaneous release to cost less than the second strategy, the surgical billing charge would need to be lower than $742 for private payers or less than $305 of Medicare reimbursement. CONCLUSIONS: Trigger finger is a common problem with many acceptable treatment algorithms. Management of trigger finger with 2 steroid injections before surgery is the least costly treatment strategy. TYPE OF STUDY/LEVEL OF EVIDENCE: Decision Analysis II.