BACKGROUND: Ongoing lower extremity long-bone nonunion is a devastating condition and associated with substantial patient morbidity. There is limited evidence regarding physical and mental function after surgical management of lower extremity nonunions. The purpose of this study was to assess general physical and mental health and lower extremity specific physical function of patients that underwent surgery for a lower extremity long-bone nonunion.
METHODS: One-hundred and twenty-four adult patients who underwent successful surgical management for a lower extremity long-bone nonunion between June 2002 and December 2021 were evaluated at an average follow-up of 8.6 years (interquartile range [IQR]: 4 - 12). General physical and mental health was assessed with the Short-Form 12 (SF-12) physical (PCS) and mental (MCS) component summaries, and lower extremity specific physical function with the Lower Extremity Functional Scale (LEFS). Multivariable linear regression was performed to identify variables that were independently associated with outcomes.
RESULTS: The median LEFS was 50 (IQR: 37 - 63) and the median SF-12 PCS was 43 (IQR: 33 - 52), which are both lower than normative population scores (LEFS: 77 and PCS: 51, p < 0.0001). The median SF-12 MCS was 50, which was comparable to the normative population score of 51 (p < 0.0001). The number of previous surgeries before the index nonunion treatment (p = 0.018 and p = 0.041) and the number of revision surgeries after the index nonunion treatment (p = 0.022 and p = 0.041) were associated with lower LEFS and SF-12 PCS scores.
CONCLUSIONS: At an average of 8.6 years after lower extremity nonunion surgery that led to bone healing, patients continue to report lower general and lower extremity specific physical functioning compared to the normative population. The number of surgical attempts to obtain definitive healing was associated with compromised physical function scores. Mental health scores may return close to normative population scores. These results can be used to inform patients and guide treatment strategies and healthcare policies.

Background: Overhead athletes frequently perform rapid and powerful throwing overhead strokes in positions at the extreme range of motion, increasing the risk of upper limb injury. The Kerlan-Jobe Orthopedic Clinic (KJOC) Shoulder and Elbow Score has shown to be a valid and reliable questionnaire that can be used for the assessment of the functional status of the upper limb of patients involved in highly demanding overhead sports. The KJOC has been translated into several other languages however, a Greek version of the KJOC is not available yet. Methods: The KJOC will be cross-culturally adapted into Greek following international guidelines. At least 100 overhead athletes with or without shoulder or elbow complaints will be recruited and asked to fill in the Greek version of the KJOC twice and the Disabilities of Arm, Shoulder and Hand Questionnaire (DASH) once. The internal consistency and the test-retest reliability will be examined using Cronbach\'s alpha and the intraclass correlation coefficient (ICC), respectively. The standard error of measurement (SEM) and the minimum detectable change (MDC) will be calculated and possible ground or ceiling effects will be also examined. Convergent validity will be evaluated with the Greek DASH using Pearson\'s correlation. Results: The results of this study will be presented in an article to be published later. Conclusions: This report describes the process of translation and cross cultural adaptation of the Greek version of the KJOC. We believe a study protocol will assist researchers in the field to improve the reporting of similar studies and as a result improve the quality of their studies.

BACKGROUND: We aimed to evaluate the validity and reliability of the Turkish version of the Patient-Reported Impact of Spasticity Measure (PRISM-TR).
METHODS: Expert opinions and the forward-back translation method were used for linguistic validation. Cronbach α and test-retest analysis were performed for reliability analysis. Correlations between the PRISM-TR and the Modified Ashworth Scale (MAS), the Numerical Rating Scale (NRS), and the Expanded Disability Status Scale (EDSS) were assessed.
RESULTS: A total of 206 individuals with multiple sclerosis (MS; 139 women; mean age, 47.7 ± 11.3 years; mean EDSS score, 5.2 ± 1.5) who had not had a relapse in the previous 3 months were included in the study. Test-retest correlation coefficients were high for all subdimensions of the scale (0.95-0.99). All Cronbach α values for the PRISM-TR subdimensions, except for Positive Impact, were likewise quite high (0.85-0.94). PRISM-TR subscale scores were correlated with MAS, NRS, and EDSS scores (P < .001).
CONCLUSIONS: PRISM-TR is a valid and reliable scale for use with Turkish individuals with MS. It is simple to use in the clinic and can be helpful in detecting patients\' spasticity early in the disease course.

OBJECTIVE: Acute respiratory tract infections (ARTIs) are a heterogenous group of diseases. Often, it is difficult to obtain a precise diagnosis in general practice but also difficult to determine when the patient is recovered. The lack of a precise definition of recovery after ARTI complicates scientific research aiming to optimize diagnostics and compare treatments. The study aimed to define cutoff points to determine the end of an ARTI as a proxy for recovery in patients diagnosed with ARTI in general practice using a validated patient-reported outcome instrument; The ARTI Questionnaire (ARTIQ).
METHODS: A total of 259 participants was divided in 2 groups-1 with ARTI and 1 without. Histograms and area under the curve were calculated for each of the 5 dimensions within the ARTIQ to evaluate the discriminative effect. For the most discriminative dimensions receiver operating comparison curves were performed to determine relevant cutoff points for having or not having ARTI symptoms and serve as a proxy for recovery in clinical research.
RESULTS: The highest discriminative effect was found in 2 dimensions: \"physical-upper airways\" and \"physical-lower airways.\" When combining these dimensions, the area under the curve was 0.97. Sensitivity, specificity, and predictive values were calculated for selected cutoff points.
CONCLUSIONS: Cutoff points serving as proxy for recovery from ARTI using a patient-reported outcome were identified. The specific cutoff point for a certain research project must be selected considering the specific clinical situation of interest.

BACKGROUND: The role that preoperative Satisfaction with Breast plays in a patient\'s postoperative course after postmastectomy breast reconstruction (PMBR) is not understood. The aim of this study is to understand the impact of the preoperative score on postoperative outcome as an independent variable.
METHODS: We examined patients who underwent PMBR between 2017 and 2021 and who completed the BREAST-Q Satisfaction with Breasts at 1 year postoperatively. Two multiple linear regression models (Model 1 with the preoperative Satisfaction with Breasts score and Model 2 without the preoperative score), likelihood ratio tests, simple t-statistics, and sample patient dataset to predict the 1 year score were performed. Multiple imputation was used to account for missing preoperative scores.
RESULTS: Overall, 2324 patients were included. Model 1 showed that the preoperative score is significantly associated with the postoperative score (β = 0.09, 95% confidence interval 0.04-0.14; p < 0.001). Comparing Model 1 and Model 2 demonstrated that including preoperative Satisfaction with Breasts in a regression significantly improves model fit (test statistic = 10.04; p = 0.0021). Using the absolute value of the t-statistics as a measure of variable importance in linear regression, the importance of the preoperative score was quantified as 3.39-more important than neoadjuvant radiation, mastectomy weight, body mass index, bilateral prophylactic mastectomy, and race, but less than adjuvant radiation, reconstruction type, and psychiatric diagnoses.
CONCLUSIONS: Preoperative Satisfaction with Breasts scores are an important independent predictor of postoperative satisfaction after PMBR. Just as vital sign and work-up are carefully documented before surgery, preoperative scores should be collected to pre-emptively gauge patients\' satisfaction and optimize postoperative outcomes.

OBJECTIVE: To provide an updated summary of published anchor-based Minimum Important Difference (MID) estimates for the EQ-5D index (EQ index) and visual analogue scale (EQ VAS) scores and identify factors influencing those estimates.
METHODS: We systematically searched eight electronic databases from January 1990 to March 2023. We examined the association of baseline score, type of score change (improvement/worsening), data source, value set, disease/condition, treatment type (surgical/non-surgical), and type of anchor (clinical vs self-rated) with MID estimates for the EQ-5D-3L and EQ-5D-5L indices, and EQ VAS. Significant variables were used to develop prediction formulas for MID by testing both linear and non-linear regression models.
RESULTS: Of 6,786 records reviewed, 47 articles were included for analysis. MID ranges for improved scores were -0.13-0.68 (EQ-5D-3L), 0.01-0.41 (EQ-5D-5L), and 0.42-23.0 (EQ VAS). Surgical intervention and lower baseline scores were associated with higher MIDs for both the EQ indices but not for EQ VAS. The non-linear logarithmic model outperformed the linear model in predicting the MIDs. MIDs based on deteriorated scores were insufficient for quantitative synthesis (mean: -0.02 for EQ-5D-3L; -0.04 for EQ-5D-5L; and -6.5 for EQ VAS).
CONCLUSIONS: This review revealed that the MID of EQ-5D index scores varies with baseline score and treatment type, indicating that use of a uniform MID may not be appropriate. We recommend using baseline score-adjusted and treatment type-specific EQ-5D MIDs, and call for more MID research, particularly in the context of assessing deterioration in health using this widely used generic health-status instrument.

OBJECTIVE: The positive impact of implant interventions on dental patient-reported outcomes is an essential parameter of treatment effectiveness. This study assessed the 2-year changes in patient satisfaction and oral health-related quality of life (OHRQoL) of edentulous patients treated with a four mini implant mandibular overdenture (IOD) METHODS: The study was planned as a 2 × 2 factorial randomized clinical trial that tested two surgical approaches (flapped or flapless) and two loading protocols (immediate and delayed) using a titanium-zirconium mini implant (Straumann Mini Implant System®) and a PEEK retentive system (Straumann® Optiloc® Retentive System). Outcome measures (OHIP-Edent scores and the McGill Denture Satisfaction questionnaire) were assessed before treatment and at the 3-, 6-, 12-, and 24-month follow-ups. The Friedman test and multiple regression using Generalized Estimating Equations (GEE) were used for data analysis, considering the per-protocol (PP) and intention-to-treat (ITT) approaches RESULTS: Seventy-four patients were randomized to the study groups. No implant failure occurred during the study period. Marked improvement in all post-treatment periods compared to baseline were observed for the two outcomes. No significant effect of patient\'s gender, age, and surgical protocol on the study outcomes. The effect of treatment provision was significant for the two outcomes in the PP and ITT approaches (p < 0.001). A barely significant positive effect of the immediate loading was observed for OHIP-Edent in the PP approach (p = 0.020) CONCLUSION: IOD treatment significantly improved patient-reported outcomes measures, with sustained benefits over the two years of overdenture use, and can be considered a promising treatment option in for the edentulous mandible.

BACKGROUND: Cognitive behavioral therapy (CBT) has been successfully utilized in improving mental health (MH) and quality of life (QoL) in the general population, regardless of age. Cancer, which is most frequently diagnosed in older adults, is a debilitating illness that has a detrimental and long-lasting effect on patients\' MH and QoL. While numerous studies have demonstrated CBT\'s efficacy, little evidence exists for its role in older cancer patients. This study, using MH and QoL metrics, evaluates the effectiveness of CBT for older adult cancer patients.
METHODS: Focusing on MH and QoL and an average age of over 60 years old, a final analysis was performed on 17 clinical trials with a total of 124 effect sizes, including 3073 participants receiving CBT. \"Metaphor\" and \"Robumeta\" packages in R Statistical Software (version 4.2.2) were used for analysis, which included robust variance estimation (RVE) in intercept-only meta-regression, and univariate meta-regression for moderator analysis.
RESULTS: With 17 clinical trials and 124 effect sizes, our results show that CBT moderately improves MH and QoL in cancer patients d = 0.19, 95% CI 0.0166-0.364, p < 0.0399. The delivery format was shown to be a strong moderator of CBT effectiveness with interpersonal technological interventions combined with pre-programmed segments having a very strong treatment effect size (d = 1.7307, 95% CI 1.5244-1.937, p < 0.001).
CONCLUSIONS: The use of CBT in older adult cancer patients statistically improves MH and QoL, with delivery format and stages of treatment having important roles. Tech-only interpersonal interventions combined with pre-programmed CBT provide an avenue for targeting older adult cancer patients.

BACKGROUND: Symptom assessment is the key factor in determining disease status and optimal management of exocrine pancreatic insufficiency (EPI). There is a need for a standardized patient-reported outcome (PRO) questionnaire to assess symptoms in patients diagnosed with EPI. The purpose of this qualitative study was to increase understanding of the EPI symptom experience from the patients\' perspective, and to develop and evaluate the content validity of the EPI Symptom Questionnaire (EPI-SQ) in US patients with EPI.
METHODS: Concept elicitation interviews (Phase I) were conducted to understand the symptom experience in patients with a clinical diagnosis of EPI (i.e., fecal pancreatic elastase value of ≤ 200 mcg/g based on most recent value) due to chronic pancreatitis or pancreatectomy. The EPI-SQ was developed based on the data extracted from Phase I interviews and feedback from clinical experts. Next, separate cognitive interviews (Phase II) were conducted to evaluate participants\' understanding of the instructions, items, response scales, and recall periods of the instrument.
RESULTS: During Phase I interviews (n = 21), 19 participants (90%) reported abdominal pain as the most frequent EPI symptom and lifestyle changes were the most frequently endorsed impacts (n = 18; 86%). Phase II results indicated that all participants (n = 7) felt the 12-item EPI-SQ was relevant to their symptom experience and that they understood the items, instructions, and response options as intended.
CONCLUSIONS: The qualitative data from this study support the content validity of the EPI-SQ in measuring EPI symptom severity in US patient populations diagnosed with EPI.

BACKGROUND: The epidemiology data and global burden of diabetic foot disease underscores the need for effective prevention strategies, which requires an early diagnosis. Patient-reported outcome measures are instruments based on a simple format, which favours their application. Currently, there is an absence of instruments with a broad enough scope to capture the diverse aspects involved in diabetic foot disease.
OBJECTIVE: To develop a questionnaire for the assessment of patients with diabetic foot disease and carry out an analysis of its validity and reliability.
METHODS: The study was developed in two stages. Stage 1: the Delphi Panel was composed of 22 experts. The questionnaire is made up of 25 questions selected, after three rounds, from an initial sample of 68 questions. Stage 2: A validation study was performed. With a sample of 273 subjects, an exploratory factor analysis and an analysis of internal consistency, items response, and validity were carried out using the Diabetes Quality of Life, SF-12v2, Foot Function Index and EuroQol EQ5D questionnaires. Measurements of error and sensitivity to change were also analyzed.
RESULTS: A 25-item questionnaire (DiaFootQ) was developed. It comprised two dimensions: 1) lifestyle and function; and 2) footwear and foot self-care. Sample (n=273) mean age was 69.77 years (±11.08). The internal consistency of DiafootQ was α=0.916, and item response values were ICC=0.862-0.998. External validity correlation levels ranged from r=0.386 to r=0.888.
CONCLUSIONS: DiaFootQ was developed. Integrating the main aspects involved in diabetic foot disease could help to detect more accurately the risk or severity of these patients. DiaFootQ is a well-structured, valid, and reliable tool whose use should be promoted in clinical and research settings.