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Objective To assess the value of a morphine Patient Controlled Intravenous Analgesia (PCIA) after Tonsillectomies (TE). Methods 30 adult patients were treated with oral analgesics (protocol group) and compared to 30 patients treated with a morphine PCIA for the first 3 Postoperative Days (PODs) after TE. Average and maximum pain severities (Numeric Rating Scale – NRS: 0–10) on PODs 1–3, analgesic score, quality of life, patient satisfaction and side effects were defined as outcome measures. Results Average pain severities of the protocol and the PCIA group were of similar magnitude (NRS) (POD1: 4.48 vs. 4.71 [p = 0.68], POD2: 4.75 vs. 4.22 [p = 0.32] and POD3: 4.44 vs. 4.25 [p = 0.71]). Maximum pain intensities on POD1 (p = 0.92), POD2 (p = 0.51) and POD3 (p = 0.36) were also comparable between both groups. Patients with a PCIA consumed significantly more opioids (p = 0.001) without significant more side-effects. Conclusion The PCIA did not provide a superior pain control compared to oral analgesics. In view of the considerable effort and the high opioid consumption, it cannot be recommended as a standardized application for pain control after TE.

International Dermatology Outcome Measures and the American Academy of Dermatology recently agreed on a physician-reported global severity measure to demonstrate quality of care in inflammatory dermatoses.Because patient-reported outcome measures are also important, we aimed to achieve consensus on 1 of these measures for clinical practice.Patients and providers participated in a consensus-building study involving a modified-Delphi technique. Voting was focused on identifying a minimal set of assessments for clinical practice, patient global assessments (PtGAs), Skindex instruments, and final instrument selection for quality improvement.Among 53 stakeholders,70% agreed that identification of patient goals, assessment of treatment harm, and assessment of the adequacy of treatment response were the minimal assessments needed for clinical practice. The most preferred PtGA was a 5-point PtGA (scale 0-4; 0 = clear, 4 = severe) having an optional check-box for worst ever. A new metric to assess change since treatment initiation, which we called a trajectory measure, was proposed. Stakeholders preferred Skindex instruments over PtGAs and a trajectory measure for clinical practice.A small number of patients and caregivers were involved and a consensus was not reached on all items.PtGAs as standalone measures do not adequately capture the patient's assessment of disease severity or the effect of care. The combination of a PtGA with a Skindex instrument or another measure of health-related quality of life might provide a more comprehensive evaluation of patients in clinical practice.

Person-centred care has the potential to improve the patient experience in the intensive care unit (ICU). However, the relationship between person-centred care perceived by critically ill patients and their ICU experience has yet to be determined.The aim of this study was to investigate the relationship between person-centred care and the ICU experience of critically ill patients.This study was a multicentre, cross-sectional survey involving 19 ICUs of four university hospitals in Busan, Korea. The survey was conducted from June 2019 to July 2020, and 787 patients who had been admitted to the ICU for more than 24 hours participated. We measured person-centred care using the Person-Centered Critical Care Nursing perceived by Patient Questionnaire. Participants' ICU experience was measured by the Korean version of the Intensive Care Experience Questionnaire that consists of four subscales. We analysed the relationship between person-centred care and each area of the ICU experience using multivariate linear regression.Person-centred care was associated with 'awareness of surroundings' (β = 0.29, p lt; .001), 'frightening experiences' (β = -0.31, p lt; .001), and 'satisfaction with care' (β = 0.54, p lt; .001). However, there was no significant association between person-centred care and 'recall of experience'.We observed that person-centred care was positively related to most of the ICU experiences of critically ill patients except for recall of experience. Further studies on developing person-centred nursing interventions are needed.

Hallux rigidus is the second most common condition to affect the first ray with an incidence of 2.5% in those above 50 years. Metatarsophalangeal Joint (MTPJ) arthrodesis remains the standard surgery. There are currently no Patient Reported Outcome Measures (PROMS) or functional outcome measures specific to first MTPJ arthrodesis. Finding out what patients can and cannot do after surgery would help surgeons appropriately consent patients and manage expectations pre and post-surgery. A pilot group of 15 patients post arthrodesis agreed on the suitability of the questions developed by the authors. As no further changes were made, a further 35 patients were recruited. Median age was 68 years, 78% were females, and 68% of patients were retired. Median follow-up was 64.5 months. Complete or almost complete pain relief was reported by 92% of patients. No major difficulty was reported by 97% of patients using ladders, 95% of patients driving, 90% of patients standing, 86% of patients wearing shoes without heels. Fifty-seven percent of patients reported extreme difficulty running and 48% percent of patients reported moderate or extreme difficulties wearing shoes with heels. None of the men reported difficulty with shoe wear without heels compared to 18% of women (p=0.01). None of the men reported any difficulty in driving compared to 18% of women (p=0.06). Difficulty in walking was reported in 44% of women compared to 9% of men (p=N/S). Our study is the first to reflect patients’ own long term experiences following first MTPJ arthrodesis. Based on our study, following first MTPJ arthrodesis the majority of patients did not have trouble with pain, walking, standing and driving. More than half of patients did not have trouble wearing shoes without heels; up to a third didn't have trouble wearing heels. More women experienced difficulty compared to men wearing shoes without heels, driving, and walking.

Increased exposure to ultraviolet radiation (UVR) is associated with an increased risk of nonmelanoma skin cancer. Cutaneous surgery can be negatively influenced by UVR, causing delayed wound healing, hyperpigmentation of the scar, and an increased incidence of additional skin cancers. By changing sun protection behavior, these risks can be limited. Therefore, this study evaluates changes in patients' sun protective behavior after Mohs micrographic surgery (MMS). Patients undergoing MMS between December 2017 and November 2019 were included. Patients were asked to complete the FACE-Q Skin Cancer - Sun Protection Behavior checklist before and 3 months and 1 year post-surgery. A total of 125 patients completed the pre-operative and 3-months post-operative checklists, and 89 (71.2%) completed the 1-year post-operative checklist. Reported sun protective behaviors increased post-surgery at all time points (p < 0.001). Patients with a prior history of facial skin cancer demonstrated a larger increase in sun protection behaviors after surgery than patients without a history of facial skin cancer (p = 0.04). Patients with defects located on the ear or scalp demonstrated a lesser increase in sun protection behaviors than patients with defects located in more conspicuous areas as the face (p = 0.02). Our study demonstrates a change in sun protection behavior, with an increase in sun protection behavior over time in patients after MMS. However, more improvement is possible. Targeted counseling can increase sun protection behavior in patients without a history of facial skin cancer and patients with skin cancer located on the ears or scalp.

Background Retrospective auditing identified the need to implement a client centered tool to measure occupational performance and re engagement in activities after burn injury. The Canadian Occupational Performance Measure (COPM) was chosen as it has a broad focus on occupational performance across the lifespan. However, given the time constraints that acute care clinicians work within in a tertiary teaching hospital, a feasibility study was warranted to identify the time to complete the COPM and any potential barriers which may arise in order to evaluate the appropriateness of using this tool. Methods This project was a prospective cohort study. All patients presenting to the ward and the Specialist Burns Outpatient Clinic were consecutively enrolled in this study. Information was collected regarding administration of the COPM including administration time, number of interruptions and reasons for non-completion of the outcome measure e.g. wound dressing procedures, surgery, scheduling conflicts. A survey method was used to explore the perceptions of Occupational Therapy clinicians regarding use of the COPM in clinical practice. Results Over the course of the study period 70 COPM’s were administered. The average time for administration across both settings was 9 min. Individually the average time taken for administration of the COPM with inpatients was 11.21 min, in the outpatient setting 7.85 min. The Survey Monkey questionnaire was emailed to 58 occupational therapy clinicians working at the facility associated with the study. The response rate was 41.4% (24). Discussion Patient reported outcome measures are central to patient centred care which is a core element of health care provision. Results from this study found that the COPM took approximately 9 min to administer, which is suitable within the time constraints of an acute tertiary environment and would be feasible in our setting. Fifty one percent of the participants identified return to work as the activity of daily living most impacted by their burn injury. As burn injuries impact all domains of daily life the use of patient reported outcome measures to direct goal orientated care is imperative. Conclusion This study found that the time to administer the COPM is feasible within the acute tertiary setting. Perceived barriers identified can be overcome with increased knowledge of client centred practice and the importance of goal directed care. The use of patient reported outcome measures in clinical practice empowers consumers to identify what goals they would like to achieve.

INTRODUCTION: Children, adolescents, and young adults (AYAs) with cancer are a special population who are subjected to a number of unique challenges, stressors, and barriers to high-quality psychological care. In a recent systematic review of measurement properties, we found that 5 of 18 identified patient-reported outcome measures (PROMs) had sufficient psychometric properties to justify their use. A next step is to analyze the reliability of these scale scores in a reliability-generalization meta-analysis. METHODS: We conducted a systematic review of three databases for all studies reporting reliability data for previously identified PROMs. Included studies were further required to include patients with cancer, or survivors of cancer, ages 2–39. We next synthesized alpha and test-retest coefficients using best statistical practices, according to prespecified subgroups, where possible. We considered a threshold of 0.7 to represent sufficient evidence of reliability. RESULTS: Seventy-one studies were included. Overall, reliability coefficients for scale and subscale scores exceeded 0.7. Subgroup analyses were limited by incomplete reporting and a lack of sufficient studies for each subgroup; however, where conducted, these subgroup analyses showed significant differences in the reliability of self-reports versus proxy reports and original versus adapted versions of PROMs. DISCUSSION: We recommend better reporting of reliability data in future studies of children and AYAs with cancer. We discourage relying on historical reliability data in different samples and the reporting of only ranges of reliability coefficients for subscales. Our study suggests that significant differences in the reliability of PROMs may be associated with the PROM respondent and the version of the PROM, thus highlighting the need for further investigation.

Objectives To compare patient reported outcome measures (PROMs) between patients who underwent IMN fixation for tibial shaft fractures using an IP or the newer SP approach. Secondary outcomes included fluoroscopic radiation exposure, operative time, and radiographic outcomes. Data sources A systematic literature search of the databases Ovid MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials Study Selection. Study selection Level I to III studies in which patients over the age of 18 with acute tibial shaft fractures who underwent tibial IMN fixation using an IP or SP approach for fracture fixation were assessed for inclusion. Studies with a minimum of 10 patients in each cohort that reported on post-operative patient-reported outcomes with at least six months follow up were included for analysis.Data Extraction and Synthesis: Twelve studies which reported PROMs and compared IP and SP intramedullary nailing of tibial shaft fractures were analyzed. This included 654 patients who underwent IP IMN fixation and 542 patients who underwent SP IMN fixation. A random-effects model for unadjusted/crude study estimates were pooled using inverse variance (IV) weighting for continuous variable analysis. Conclusions This review found a significant improvement in PROM for patients with tibial shaft fractures when the SP IMN technique was utilized. In addition, there was a significant decrease in intraoperative fluoroscopy time consistent with other radiographic findings demonstrating improved start point accuracy and reduction with SP IMN fixation of tibial shaft fractures. Level of evidence Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Objectives To describe the trajectory of recovery following fixation of pilon fractures from baseline to 5 years follow-up. Design Prospective cohort study. Setting Level 1 trauma centre. Patients/participants Patients with pilon fractures (OTA/AO 43.C) treated with open reduction and internal fixation (ORIF). Intervention None. Main outcomes measurements Patient reported outcome measures (PROMs) were measured at baseline, 6 months, 1 year and 5 years using the Short-Form 36 Health Survey Physical and Mental Component Scores (SF-36; PCS, MCS), Short Musculoskeletal Functional Assessment (SMFA), and the Foot and Ankle Outcome Score (FAOS). Results 102 patients were enrolled: mean age was 42.6 years; 69% were males; 88% had an injury severity score (ISS) of 9; 74 patients (73%) completed 1 year follow-up; 40 patients (39%) completed 5 years follow-up. Trajectory of recovery of physical function showed a significant decline between baseline and 6 months, with significant improvement between 6 months and 1 year, and then ongoing but slower improvement between 1 year and 5 years. 64% of patients returned to baseline SF-36 PCS at 5 years. Pain was a persistent issue and remained significantly worse at 5 years when compared to baseline. Psychological wellbeing (SF-36 MCS) did not significantly change from baseline at 5 years. Conclusion Functional recovery following ORIF for pilon fractures was characterized by an initial decrease in function from baseline, followed by an increase between 6 months and 1 year, and then slower but continued increases from 1 year to 5 years. Function did not return to baseline levels, pain was a persistent issue, and mental wellbeing showed no change from baseline at 5 years. This information may be useful when counselling patients.Level of Evidence:Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.

OBJECTIVE Suprasellar meningioma resection via either the transcranial approach (TCA) or the endoscopic endonasal approach (EEA) is an area of controversy and active evaluation. Skull base surgeons increasingly consider patient-reported outcomes (PROs) when choosing an approach. No PRO measure currently exists to assess quality of life for suprasellar meningiomas. METHODS Adult patients undergoing suprasellar meningioma resection between 2013 and 2019 via EEA (n = 14) or TCA (n = 14) underwent semistructured interviews. Transcripts were coded using a grounded theory approach to identify themes as the basis for a PRO measure that includes all uniquely reported symptoms. To assess content validity, 32 patients and 15 surgeons used a Likert scale to rate the relevance of items on the resulting questionnaire and the general Patient-Reported Outcomes Measurement Information System–29 (PROMIS29). The mean scores were calculated for all items and compared for TCA versus EEA patient cohorts by using unpaired t-tests. Items on either questionnaire with mean scores ≥ 2.0 from patients were considered meaningful and were aggregated to form the novel Suprasellar Meningioma Patient-Reported Outcome Survey (SMPRO) instrument. RESULTS Qualitative analyses resulted in 55 candidate items. Relative to patients who underwent the EEA, those who underwent the TCA reported significantly worse future outlook before surgery (p = 0.01), tiredness from medications 2 weeks after surgery (p = 0.001), and word-finding and memory difficulties 3 months after surgery (p = 0.05 and < 0.001, respectively). The items that patients who received a TCA were most concerned about included medication-induced lethargy after surgery (2.9 ± 1.3), blurry vision before surgery (2.7 ± 1.5), and difficulty reading due to blurry vision before surgery (2.7 ± 2.7). Items that patients who received an EEA were most concerned about included blurry vision before surgery (3.5 ± 1.3), difficulty reading due to blurry vision before surgery (2.4 ± 1.3), and problems with smell postsurgery (2.9 ± 1.3). Although surgeons overall overestimated how concerned patients were about questionnaire items (p < 0.0005), the greatest discrepancies between patient and surgeon relevance scores were for blurry vision pre- and postoperatively (p < 0.001 and < 0.001, respectively) and problems with taste postoperatively (p < 0.001). Seventeen meningioma-specific items were considered meaningful, supplementing 8 significant PROMIS29 items to create the novel 25-item SMPRO. CONCLUSIONS The authors developed a disease- and approach-specific measure for suprasellar meningiomas to compare quality of life by operative approach. If demonstrated to be reliable and valid in future studies, this instrument may assist patients and providers in choosing a personalized surgical approach.

BACKGROUND: Thermoablation is an attractive treatment of thyroid nodules for its minimal-invasiveness. It remains unclear whether results and morbidity meet the patients’ expectations. OBJECTIVE: The aim of the presented study is to show data obtained after microwave thyroid ablation from a patients’ perspective. METHODS: Indications and preoperative diagnosis were chosen according to international guidelines. Thermoablation was achieved using a CE certified microwave system. The procedures heeded the published recommendations of the European Federation of Societies for Ultrasound in Medicine and Biology. Follow-up included ultrasound, laboratory parameters and a standardized questionnaire. RESULTS: Thirty patients were enrolled into the study. All patients reported an improvement of complaints following the procedure. Scar formation occurred in 3 cases (10%) with 0.5 ± 1.3 mm length and 0.4 ± 1.0 mm width. No cosmetic, neurological, vocal or pharyngeal complication occurred. Energy required for non-functioning nodules (n= 15, 50%) was 2.56 ± 3.41 kJ/mL, for autonomous adenoma (n= 8, 27%) 0.96 kJ/mL (p< 0.05, t-test). CONCLUSION: The presented data summarize an initial experience in selected patients and resemble excellent patient reported outcome with minimal morbidity. These preliminary data indicate the majority of patients satisfied with the procedure. Further trials will be required to endorse these findings.

The increasing use of patient-reported outcome (PRO) measures is forcing clinicians and health care systems to decide which to select and how to incorporate them into their records and clinical workflows. This overview addresses 3 topics related to these concerns. First, a literature review summarizes key psychometric and practical factors (such as reliability, responsiveness, computer adaptive testing, and interpretability) in choosing PROs for clinical practice. Second, 3 clinical decision support issues are highlighted: gathering PROs, electronic health record effect on providers, and incorporating PROs into clinical decision support design and implementation. Lastly, the salience of crosscutting domains as well as 9 key pragmatic decisions are reviewed. Crosscutting domains are those that are relevant across most medical and mental health conditions, such as the SPADE symptom pentad (sleep problems, pain, anxiety, depression, low energy/fatigue) and physical functioning. The 9 pragmatic decisions include (1) generic vs disease-specific scales; (2) single- vs multidomain scales; (3) universal scales vs user-choice selection; (4) number of domains to measure; (5) prioritization of domains when multiple domains are assessed; (6) action thresholds; (7) clinical purpose (screening vs monitoring); as well as the (8) frequency and (9) logistical aspects of PRO administration.

The Watson Instability Program (WIP1) is current best evidence for conservative management of atraumatic shoulder instability, but it is unknown if this program can be effectively delivered via tele-consultation. The purpose of this longitudinal pre-post intervention study was to determine the effects of the WIP1 on patient-reported outcome measures, scapular position, shoulder strength, and handstand stability in student circus performers with atraumatic shoulder instability when delivered via tele-consultation.Student circus performers aged between 15 and 35 years from the National Institute of Circus Arts were recruited. A 12-week shoulder exercise program was delivered via tele-consultation during the Melbourne, Australia COVID-19 (coronavirus disease 2019) lockdown. The primary outcome measures were the Western Ontario Shoulder Instability Index score and the Melbourne Instability Shoulder Scale score. Secondary outcomes measures included the Orebro Musculoskeletal Pain Questionnaire, the Tampa Scale for Kinesiophobia, and physical assessment measures including strength via handheld dynamometry, scapular position using an inclinometer, and handstand stability via center-of-pressure fluctuation. Patient-reported outcomes were collected at baseline and 6-week, 12-week, 6-month, and 9-month time points, and physical outcomes were measured at baseline and 9-month time points. A repeated-measures mixed model (with effect sizes [ESs] and 95% confidence intervals [CIs]) was used to analyze patient-reported outcomes, handstand data, strength, and scapular measures. Significance was set at P.05.Twenty-three student circus arts performers completed the study. Significant improvements were found in both Western Ontario Shoulder Instability Index scores (effect size [ES], 0.79 [95% CI, 0.31-1.33] at 6 weeks; ES, 1.08 [95% CI, 0.55-1.6] at 12 weeks; ES, 1.17 [95% CI, 0.62-1.78] at 6 months; and ES, 1.31 [95% CI, 0.74-1.95] at 9 months; P.001) and Melbourne Instability Shoulder Scale scores (ES, 0.70 [95% CI, 0.22-1.22] at 6 weeks; ES, 0.83 [95% CI, 0.34-1.37] at 3 months; ES, 0.98 [95% CI, 0.46-1.54] at 6 months; and ES, 0.98 [95% CI, 0.43-1.50] at 9 months; P.001), as well as Orebro Musculoskeletal Pain Questionnaire scores at all follow-up time points. The Tampa Scale for Kinesiophobia scores reached significance at 6 weeks and 12 weeks. Following rehabilitation, we found statistically significant increases in shoulder strength in all positions tested and increased scapular upward rotation measured at end-of-range abduction, as well as during loaded external rotation. The affected arm showed greater instability than the unaffected arm with a significant intervention effect on the affected arm showing a greater consistent anterior-posterior movement pattern.In a group of circus performers with atraumatic shoulder instability, treatment with the WIP1 via telehealth resulted in clinically and statistically significant improvements in shoulder symptoms and function.

Objective To develop an item response theory (IRT)–calibrated, patient-reported outcome measure (the PROMIS Cancer Function Brief 3D Profile) of physical function, including associations with fatigue and social participation, in cancer rehabilitation patients. Design Large-scale field testing, graded response model IRT analyses, and multivariate regression analysis. Setting Six cancer rehabilitation clinics associated with cancer centers across the United States. Participants Adults (N=616) treated in outpatient cancer rehabilitation medicine clinics. Intervention Not applicable. Main Outcome Measures: The PROMIS(r) Cancer Function 3D Profile (including existing items from PROMIS(r) item banks). Results A total of 616 patients completed 21 items in the initial item pool. Nine items were removed because of comparatively lower information that they provide according to the IRT item calibrations, low item-total correlations, or bimodal distributions. The remaining items generated a 12-item short form. Regression analyses determined that the items were responsive to and representative of the patient population across trait ranges and multiple domains and subdomains of function. Conclusions This psychometric investigation supports the use of the PROMIS Cancer Function Brief 3D Profile for evaluating function in outpatient cancer rehabilitation patients.

Background This study investigated the completeness, accuracy, quality and clinical outcomes of the British Orthopaedic Foot and Ankle Society (BOFAS) registry - Ankle Arthrodesis pathway. Methods An observational study using retrospective data derived from the BOFAS registry. Adults aged ≥18 years with a record of undergoing ankle arthrodesis in the UK from 2014 to 31/10/2019 were included. Accuracy of data capture and completeness were explored using means, SD, medians and IQR for continuous variables and frequencies for categorical variables. The pre and post treatment pathway was evaluated by analysing Patient Reported Outcome Measures (PROMs) including MOXF-FQ scores for pain/walking/standing/social interaction; NRS pain; EQ-5D-5L; and EQ-5D-5L-Health VAS at baseline, 6 months, and 12 months. Results Mean age of the study population (n = 186) was 62.3 (±12.9) years and 65% of the study cohort were male. Completeness of data collection was disappointing but variables such as BMI (62.4%) smoking status (82.3%) were reasonably well recorded. PROMs scores were well recorded at baseline but rapidly declined at 6 and 12-months intervals. Reductions in MOXFQ and NRS pain scores by 12 months following surgery were statistically significant (p = 0.001 and p = 0.008), illustrating that most patients demonstrated reductions in pain intensity, improved walking/standing ability, and social interaction. Conclusion These findings illustrate the potential effectiveness of surgery on all outcomes following ankle arthrodesis that merits evaluation in a clinical trial; but also demonstrated the difficulties in obtaining representative data sets. The analyses strongly suggest that with the improvements in data quality greater resources would bring, the BOFAS registry would become a valuable tool.

Purpose To evaluate biologic and esthetic outcomes, as well as the patient-reported outcome measures (PROMs), of full-mouth rehabilitations in patients suffering from generalized erosive and/or abrasive tooth wear following the 3-step technique. Materials and methods Patients who received a minimally invasive full-mouth rehabilitation according to the 3-step technique and who were treated at the University of Geneva and/or in a private practice were considered for inclusion. The minimum service time of the restorations was 12 months. The biologic outcomes were analyzed by assessing pocket probing depth (PPD), Plaque Index (PI), and bleeding on probing (BOP). Furthermore, secondary caries, tooth vitality, and sensitivity to temperature were evaluated using the modified United States Public Health Service (USPHS) criteria. The esthetic outcomes were rated with the White Esthetic Score (WES). Finally, PROMs were evaluated using visual analog scales (VAS). Results A total of 19 patients with 406 restorations (149 direct composite resins, 110 indirect composite resin/ceramic onlays, and 147 composite resin/ceramic veneers) were examined after a mean follow-up of 71.8 ± 28.6 months. Periodontal parameters were good (mPPD = 2.9 ± 0.4; mPI = 0.1 ± 0.2; and mBOP = 0.05 ± 0.1). No secondary caries were found, and no abutment tooth had lost vitality. A total of 36 abutment teeth had moderate sensitivity, but none presented pronounced sensitivity. The rehabilitations exhibited good esthetic outcomes (mWES = 8.4 ± 1.9). Patients reported satisfying esthetic results of their rehabilitations (mean VAS = 9.2 ± 1.6) and considered their treatment as comfortable (mean VAS = 8.2 ± 2.1), while the least favorably rated parameter was the cost of treatment (mean VAS = 4.1 ± 3.2). Conclusion Minimally invasive full-mouth rehabilitations of patients with generalized tooth wear by means of the 3-step technique exhibit very good clinical medium-term results with respect to biologic and objective/subjective esthetic outcomes. The patient satisfaction with this treatment was high.

The aim of this study is to compare functional outcomes and perioperative complications between patients on a selective serotonin reuptake inhibitor (SSRI) and those who are not on an SSRI preoperatively at the time of total joint arthroplasty.A retrospective study was performed on 28,386 patients who received a primary total hip (THA) or knee (TKA) arthroplasty. Patients were compared based on SSRI utilization. We measured patient-reported function and health-related quality of life using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) and the EuroQol-5 Dimensions (EQ-5D-5L) instruments. Chi-squared test was used to compare categorical variables and t-test was used to compare the continuous variables of 2 study groups.Patients on SSRIs have lower preoperative baseline WOMAC and EQ-5D-5L scores than those not using SSRI (P.001). Patient-reported outcomes improved significantly following surgery, but functional outcome scores remained inferior in patients using SSRI. After adjusting for baseline variables, SSRI use in TKA predicted lower EQ-5D-5L scores than non-SSRI users (P = .036) while the WOMAC scores were not different (P = .118). For the THA cohort, SSRI use predicted lower EQ-5D-5L (P = .001) and WOMAC scores than non-SSRI users (P = .008). SSRI use was associated with increased transfusion rate, length of stay, readmission rate, and medical events. About 11.3% of TKA and 13.3% of THA patients stopped using SSRI at 12 months after arthroplasty.Patients using an SSRI show improvement comparable to patients not on an SSRI, but their 12-month functional scores continue to be inferior. SSRI utilization was associated with increased adverse events including needing a blood transfusion.

Background The content validity (appropriateness and acceptability) of patient-reported outcome (PRO) measures for scalp hair loss, eyebrow loss, eyelash loss, nail damage and eye irritation has been demonstrated in adults with alopecia areata (AA) but not adolescents. Objective To explore the content validity of the suite of AA PRO measures and accompanying photoguides in an adolescent sample. Methods Semi-structured, 90-minute, combined concept elicitation and cognitive interviews were conducted face-to-face with adolescents who experienced ≥50% AA-related scalp hair loss. Transcripts underwent thematic and framework analysis. Results Eleven adolescents (age 12-17 years, 55% female, 45% non-Caucasian/white) diagnosed with AA for 5.9 years (mean) participated. Participants had 69.6% scalp hair (mean) and current eyebrow (82%), eyelash loss (82%) and/or nail involvement (36%). Adolescents reported scalp, eyebrow and eyelash hair loss as their top three most bothersome signs/symptoms. Despite mostly accepting their AA, impacts related to visible areas of hair loss were prominent. Participants demonstrated good understanding and appropriate use of the PRO measures, and advocated including hair loss percentages alongside descriptive categories in the Scalp Hair Assessment PRO™. Results confirmed treatment success thresholds established with adults: achievement of ≤20% scalp hair loss, no/minimal eyebrow and eyelash loss, no/a little nail damage and eye irritation (PRO categories 0 or 1). Conclusions The Scalp Hair Assessment PRO™, PRO Measure for Eyebrows™, PRO Measure for Eyelashes™, PRO Measure for Nail Appearance™ and PRO Measure for Eye Irritation™ and accompanying photoguides are fit-for-purpose self-reported measures of AA signs/symptoms that are impactful to adolescents with AA.

Functioning is an important outcome for the management of rheumatoid arthritis (RA). Heterogeneity of respective patient-reported outcome measures (PROMs) challenges direct comparisons between their results. This study aimed to standardize reporting of such PROMs measuring functioning in RA to facilitate comparability.Common-item nonequivalent group design with the Health Assessment Questionnaire (HAQ) as a common scale across data sets from various countries (including the UK, Turkey, and Germany) to establish a common metric was used. Other PROMs included are the physical function items of the Multidimensional HAQ (MDHAQ), the Disabilities of the Arm, Shoulder, and Hand questionnaire, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the World Health Organization Disability Assessment Schedule II (WHODAS II), the Medical Outcomes Study Short Form 36 (SF-36) health survey, and 4 short forms (20, 10, 6, and 4 physical function items) from the Patient-Reported Outcomes Measurement Information System. As the HAQ includes mobility, self-care, and domestic life items, this study focuses on these 3 domains. PROMs were described using standard error of measurement (SEM) and smallest detectable difference (SDD). A Rasch measurement model was used to create the common metric.The range of the SEM was 0.2 (MDHAQ) to 7.4 (SF-36 health survey physical functioning domain). The SDD revealed a range from 9.7% (WOMAC rating scale) to 33.5% (WHODAS physical functioning domain). PROMs co-calibration revealed fit to the Rasch measurement model. A transformation table was developed to allow exchange between PROM scores.Scores between the daily activity PROMs commonly used in RA can now be compared. Factors such as SEM and SDD help to determine the choice of a PROM in clinical practice and research.

Introduction: Children, adolescents, and young adults with cancer are a vulnerable population in whom improvements in psycho-oncology care would be valuable. We previously published a scoping review exploring what is known about positive psychological constructs in this population. A key finding was that evidence-based patient-reported outcome measures (PROMs) were needed to standardize psycho-oncology research. Methods: We undertook a systematic review of measurement properties focused on PROMs in the pediatric and adolescent/young adults (AYAs) with cancer populations. We searched for PROMs that measured at least 1 of 15 previously identified, key positive constructs. This systematic review followed COSMIN guidelines, considered the gold standard manual for systematic reviews of measurement properties. Results: We identified 20 (22 if proxy reports are counted separately) unique PROMs that met inclusion criteria. Of those, only five were recommended for use given the current evidence. The remainder may be used if no alternative exists. Only eight PROMs had any evidence of content validity, considered the most important psychometric property by COSMIN. Many studies were at risk of bias owing to incomplete or suboptimal methods. Discussion: Five PROMs are considered reliable for the pediatric and AYA with cancer populations. A number of PROMs require additional research to ensure their items and instructions are comprehensive, relevant, and comprehensible to children and AYAs. Given the overall lack of research, this review may be considered a starting point for the future refinement of a core set of PROMs to measure positive psychological constructs.

This systematic review aims to provide an update on measurement properties of patient-reported outcome measures for pruritus. A Medline literature search was conducted to update the systematic review published by Schoch et al. in 2017 and to identify new validation studies published between October 2015 and July 2019. The methodological quality of validation studies was assessed based on the COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN) checklist and the measurement properties of patient-reported outcome measures were evaluated. Nineteen new studies were included and added to the 22 studies identified in the previously published review. Evidence from all 41 studies evaluating 38 different measures was summarized. Outcome measures were mapped to one of three constructs where possible: pruritus intensity, pruritus severity, pruritus-specific health-related quality of life. COSMIN rating revealed mixed results with deficiencies in methodological quality of many studies across all constructs. The most appropriate pruritus severity measure was the "Itch Severity Scale". "Itchy Quality of Life" and the disease-specific "Uremic Pruritus in Dialysis Scale" achieved most promising results considering the construct pruritus-specific health-related quality of life. For pruritus intensity, nine measures performed similarly well.

Purpose The purpose of this study was to evaluate the short-term patient-reported outcomes of superior capsular reconstruction (SCR) and identify factors contributing to the success or failure of the procedure at 2 years. Methods A retrospective review was performed on data prospectively collected from the Surgical Outcomes System database. Patient-reported outcomes (PROMs) including American Shoulder and Elbow Surgeons (ASES) score, Single Assessment Numeric Evaluation (SANE) score, visual analog scale for pain, and Veterans RAND 12-Item Health Survey (VR-12) were evaluated at a minimum of 2 years postoperatively and reported using a minimal clinically important difference (MCID) and the percent of maximal possible improvement (MPI). In addition, preoperative and intraoperative variables were evaluated in patients with and without a postoperative improvement in ASES and SANE scores meeting the threshold of MCID. Results Two-year follow-up data were available for 350 patients. Statistically significant improvements were noted in all PROMs at 2-year follow-up. In total, 240 patients (68.8%) achieved an MCID improvement of >17.5 in ASES score, and 185 patients (52.9%) achieved an MCID of >29.8 improvement in the SANE score. Primary SCRs were associated with a higher MPI in the ASES score (60.1% ± 39.8% vs 40.4% ± 47.9%; P = .025) and VR-12 physical score (14.0% ± 13.8% vs 8.0% ± 14.7%; P = .028) compared to revision repairs. Only diabetes was identified as a predictor of SANE score improvement (64.5% vs 62.2%; P = .041). Conclusions SCR is associated with improvement in patient-reported outcomes at short-term follow-up, with 53% to 69% of patients achieving an improvement considered to meet the MCID. Greater improvement is expected when SCR is performed as a primary procedure rather than as a revision procedure for failed rotator cuff repair. Level of Evidence Level III, retrospective comparative study.

OBJECTIVE Patient-reported outcomes (PROs) can provide critical information concerning the impact of a disease on an individual. Mobile technology to collect PRO data in an electronic format (ePRO) allows for frequent assessment in the person's regular environment. The goal of this study was to assess the compliance with a phone application (app) and validate ePRO information in individuals with systemic lupus erythematosus (SLE). METHODS A smartphone app that collects ePRO data from various clinical instruments was developed. Information was collected by both an ePRO and a paper-administered instrument as part of a multicenter randomized interventional clinical trial of patients meeting American College of Rheumatology (ACR) criteria for the classification of SLE. To determine agreement between PRO information collected in the different formats, intraclass correlation coefficients (ICCs), paired Student's t tests, and Bland-Altman plots were evaluated. Compliance and Cronbach's alpha were also assessed as a measure of survey reliability. RESULTS For the 62 subjects from diverse ancestral backgrounds, compliance with ePRO completion was high (more than 75%). Cronbach alpha values for PROs indicated moderate to high survey reliability. The vast majority (73.4%) of ICC values were indicative of good to excellent reliability between measurement methods. Bland-Altman plots verified method agreement, and 87% of pairwise t tests yielded an insignificant difference between information collected with the different administration methods. CONCLUSION The excellent compliance and the high level of consistency between data collected by paper and that collected by electronic methods indicate that the app provides a reliable means of cataloging real-time changes in PROs in SLE patients.

PURPOSE To compare Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) with traditional ("legacy") patient-reported outcome measures (PROMs) in regard to correlations, ease of use, and quality criteria for upper (UE) and lower extremity (LE) orthopaedic conditions. METHODS A systematic search of the PubMed/MEDLINE database was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines to identify published articles that referenced the various PROMIS PF measures. Two authors independently reviewed selected studies. The search returned 857 studies, 85 of which were selected for independent review by 2 authors. Of these, 54 were selected for inclusion. Mixed linear models were performed to assess for differences between legacy PROMs and PROMIS measures. RESULTS The combined sample size of all included studies yielded 6,074 UE and 9,366 LE patients. Overall, PROMIS PF measures demonstrated strong correlations with legacy PROMs among UE (weighted Pearson correlation, 0.624, standard error [SE] = 0.042; weighted Spearman correlation, 0.566, SE = 0.042) and LE patients (weighted Pearson correlation, 0.645, SE = 0.062; weighted Spearman correlation, 0.631, SE = 0.041). PROMIS PF questionnaires completed by UE patients had fewer questions than legacy PROMs (5.9 vs 17.7, P = .0093) and were completed in less time (90.5 vs 223.8 seconds, P = .084). PROMIS PF questionnaires completed by LE patients had fewer questions than legacy PROMs (4.81 vs 15.33, P < .001) and were completed in less time (63.6 vs 203.2 seconds, P = .0063). The differences for the reliability measures were not significant. CONCLUSIONS PROMIS PF scores correlate strongly with commonly used legacy PROMs in orthopaedics, particularly in UE and LE patients. PROMIS PF forms can be administered efficiently and to a broad patient population while remaining highly reliable. Therefore, they can be justified for standardized use among orthopaedic patients with UE and LE conditions, improving the ability to aggregate and compare outcomes in orthopaedic research. LEVEL OF EVIDENCE Level IV, systematic review of Level I-IV evidence.

Introduction Periprosthetic femoral fractures (PFF) are often the reason for revising total hip arthroplasty (RTHA). Converting these fractures into modified extended trochanteric osteotomy (mETO) facilitates stem revision. Modular revision stems are a common choice with good results. We present mid-term outcomes in patients undergoing RTHA for Vancouver B2/B3 PFF using a tapered, fluted modular stem with an mETO approach. Materials and methods A single-center analysis of patients with RTHA for Vancouver B2/B3 PFF using a single modular implant with mETO was performed (2007 – 2019). Clinical outcome (mobility, range of motion, function), radiological outcome (fracture healing, stem subsidence) and patient reported outcome measures (FJS-12, HHS, EQ-5D) were assessed. Results Ninety-seven patients (mean age 78.1 years, BMI 25.8kg/m2, 85.6% B2-fractures) were included; 80 patients had complete clinical and radiological follow-ups. Normal unaided gait without limping was achieved in 38/80 patients. After one year fracture / mETO healing occurred in 74/80 patients; 5.3 years after surgery, the respective FJS-12, HHS and EQ-5D (available in 34 patients) averaged 81.3±30.2, 71.4±18.7 and 0.8±0.2. We documented 7 in-hospital deaths, 18.8% postoperative complications and 13.8% revisions with stem revisions being most commonly for subsequent PFF or subsidence. Conclusion Good clinical and radiological outcomes and rather low complication and revision rates (18.8% and 13.8%) were achieved. FJS-12 showed excellent results in patients undergoing RTHA for Vancouver B2/B3 PFF using a cementless, dual modular titanium revision stem and an mETO approach. Joint awareness was thereby similar to previously reported primary THA results at 5.3 years follow-up.

Context Systematic collection of patient-reported outcomes (PROs) reduces symptom burden and improves quality of life. The ability of older adults to complete PROs, however, has not been thoroughly studied. Objectives To determine whether older adults with advanced cancer received assistance completing PROs, the nature of the assistance, the factors associated with receiving assistance, and how the prevalence of assistance changed over time. Methods Data were obtained from a multisite cluster randomized controlled study of geriatric assessment (Clinicaltrials.gov: NCT02107443). Adults ≥70 years with advanced cancer completed multiple PROs at 4 time points (enrollment, 6 weeks, 3 months, 6 months). Factors associated with receipt of assistance were assessed with bivariate and multivariate analyses. Results The study included 541 adults (range 70-96 years, 49% female, mixed incurable cancer diagnoses). Twenty-eight percent (153/541) received assistance completing PROs. Of these, 42% received assistance from caregivers, 37% from research staff, and 15% from both. Factors associated with receiving assistance included older age [Adjusted Odds Ratio (AOR) 3.71, 95% Confidence Interval (CI) 1.03-13.38], lower education level (3.92, 2.11-7.29), impaired cognition (1.90, 1.23-2.93), impaired functional status (2.16, 1.33-3.52), and impaired hearing (1.38, 1.05-1.80). Eighty percent of individuals who received assistance were identified at study initiation. Receiving assistance decreased over time from 28% to 18%, partially due to drop-outs. Conclusion Over a quarter of older adults with advanced cancer in this study received assistance completing PROs. Completing PROs is a key aspect of many clinical programs and cancer trials; assistance in completing PROs should be offered and provided.

Objective Nonmelanoma skin cancer (NMSC) is one of the most diagnosed cancers in the world, with the number of new occurrences rising every year. Most patients with facial skin cancer experience cancer-related worry. Yet, little is known about their worry during the period after cancer treatment. This study aimed to assess the long-term change of cancer worry after surgical treatment in patients with NMSC. Methods Patients undergoing surgery for facial NMSC between December 2017 and March 2020 were asked to complete the FACE-Q Skin Cancer-Cancer Worry scale before (baseline), 3-month, and 1-year post-surgery. Results A total of 151 patients completed the baseline and 3-month, and 99 (65.6%) the 1-year post-operative survey. A significant decrease in cancer worry score was seen between baseline and 3-month post-surgery (p < 0.001). No difference was found between the 3-month and 1-year post-surgery scores (p = 0.78). Less improvement in cancer worry was seen for patients who had one facial skin cancer in their medical history (p = 0.001) and patients who had a history of facial surgery (p < 0.001). Conclusion Post-surgery patients still experience cancer worry. Therefore, targeted counseling might be of value when coping with cancer-related concerns. Patients with a history of facial NMSC and patients with a history of facial surgery might benefit from additional counseling.

Purpose To compare minimum 2-year follow-up patient-reported outcome scores (PROs) in patients who underwent primary acetabular circumferential and segmental labral reconstruction for irreparable labral tears and femoroacetabular impingement syndrome (FAIS). Methods Data were reviewed from August 2010 to December 2017. Patients with primary labral reconstruction and minimum 2-year follow-up for the modified Harris Hip Score (mHHS), Non-Arthritic Hip Score (NAHS), Hip Outcome Score–Sports Specific Subscale (HOS-SSS), and visual analog scale (VAS) for pain were included. Circumferential and segmental reconstruction were selected in each case based on the extent of the labral pathology. Exclusion criteria were previous ipsilateral hip surgery/conditions, dysplasia, or Tonnis grade >1. Patients were propensity matched 1:1 based on age, sex, and body mass index. Secondary surgeries were reported. The P value was set at Results In total, 144 hips were eligible, and 17 hips were lost to follow-up, leaving 127 hips (88.2%) for analysis. Eighty hips underwent a segmental reconstruction, and 47 hips underwent a circumferential reconstruction. Forty-seven hips with circumferential reconstruction were matched to 47 hips with segmental reconstruction. The average follow-up and age for the segmental and circumferential groups were 29.0 ± 7.8 and 27.9 ± 7.0 months (P = .732) and 43.1 ± 9.4 and 44.7 ± 10.2 years (P = .442) respectively. The segmental and circumferential groups were 48.9% and 51.1% female, respectively. The groups achieved significant and comparable improvement for all PROs and rates of secondary surgeries. No differences were found for achieving the minimal clinically important difference (MCID) and the patient acceptable symptomatic state (PASS). The MCIDs for the segmental and circumferential groups were 76.7% and 77.8% for the mHHS, 64.9% and 77.8% for the HOS-SSS, 71.1% and 68.9% for the VAS, and 68.9% and 73.9% for the NAHS, respectively. The PASSs for the segmental and circumferential groups were 78.3% and 73.3% for the mHHS, 55.3% and 55.0% for the HOS-SSS, and 75.6% and 71.1% for the International Hip Outcome Tool 12, respectively. Conclusions At minimum 2-year follow-up, patients who underwent primary hip arthroscopy for either circumferential or segmental labral reconstruction for irreparable labra and FAIS reported significant improvement and similar postoperative scores for all PROs, with no difference in psychometric outcomes and rate of secondary surgeries. A customized approach, using the extent of the irreparable labral tear, seems to be an appropriate strategy. Level of Evidence Level III, retrospective comparative therapeutic trial.

BACKGROUND: Arthrodesis and metallic hemiarthroplasty are two surgical interventions for the treatment of end-stage osteoarthritis of the first metatarsophalangeal (MTP1) joint. This systematic review and meta-analysis aims to compare the two operations with regards to patient-reported outcomes, pain reduction, complications and revision rates. METHODS: A systematic literature search identified all relevant studies. The methodological quality was assessed using two validated tools. Data of interest were derived and presented. For non-comparative studies, data was assessed for trends, while for comparative studies pooling statistics were performed. RESULTS: A total of 33 studies were included for analysis. The majority of studies (>75%) reported an AOFAS-HMI score greater than 80 points after both metallic hemiarthroplasty and arthrodesis. The lowest VAS pain score was observed after arthrodesis (weighted mean difference -1.58, 95% confidence interval (CI) -2.16 to -1.00 P< 0.00001). Comparable numbers of complications (odds radio 1.48, 95% CI 0.81 to 2.73, P = 0.21, favoring: hemiarthroplasty) and revisions (odds ratio 1.16, 95% CI 0.62 to 2.15 P = 0.64, favoring: hemiarthroplasty) were observed after both interventions. The included non-comparative studies seem to confirm these findings of the comparative studies. CONCLUSION: Metallic hemiarthroplasty and arthrodesis have excellent clinical outcomes and acceptable complication- and revision rates. Arthrodesis seems to be superior in pain reduction, while metallic hemiarthroplasty is a suitable alternative for patients performing activities that requires motion in the first metatarsophalangeal joint.

Objective To estimate the association between discussion of all options (adoption, abortion, and parenting) in pregnancy options counseling and patient-reported experience with counseling. Study Design Patients (n = 316) who received a positive pregnancy test Oct 2018-June 2019 at one of 14 randomly selected clinics in a southern US publicly funded family planning system participated in an anonymous digital survey about their experience with counseling. The survey assessed which options (parenting, adoption, abortion) they discussed with their provider and how they rated their counseling experience using a 20-item scale based on validated measures of patient reproductive health counseling experience. We used Poisson regression to estimate the prevalence ratio for discussing all pregnancy options and rating their provider with a perfect score. Results Approximately 10% of patients reported their provider discussed all options. After adjustment for patient, provider, and clinic characteristics, patients were approximately 80% more likely to rate their counseling as “excellent” on all analyzed scale items when their provider discussed all options compared to when they did not (adjusted prevalence ratio [aPR] = 1.80, 95% CI: 1.43, 2.28). Discussion of all pregnancy options was associated with a more positive patient-reported experience among patients who planned to continue their pregnancy (aPR = 1.82, 95% CI: 1.37, 2.42) and among those who did not (aPR = 1.62, 95% CI: 1.08, 2.44). Patients whose provider had received options counseling training were more likely to report all options were discussed. Conclusion Discussion of all options during pregnancy counseling is associated with a more positive patient experience. These findings indicate patient preference for supportive, nondirective counseling on all pregnancy options. Implications Our study's findings support nondirective discussion of all pregnancy options (including parenting, abortion and adoption) as a best practice, and stand in contrast to regulations that restrict discussion of all options.

Background Distal humerus fractures (DHF) pose a treatment challenge in elderly patients. We sought to systematically review and report the clinical outcomes of the nonoperative approach (e.g., “bag of bones”) for the treatment of these injuries, and the rate of conversion to delayed surgery. Methods A comprehensive review of the literature using the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines was conducted. Studies involving outcomes following nonoperative treatment of DHF in patients >65 years of age were included from 1985 to present. Data regarding patient age, DHF type, nonoperative treatment method, complications, conversion to delayed surgery, range of motion, union rate, and surgeon and patient reported outcome measures were extracted. Results A total of five studies met inclusion criteria (all level IV evidence), yielding a total of 143 patients (mean age: 73.5 years to 87.4 years) with 7.1 months to 55 months of follow-up. The mean Mayo Elbow Performance Index (MEPI) scores were good to excellent across several studies (range 83 - 93.1). Multiple studies reported good range of motion (mean arc of motion: 81 to 106 degrees) and low levels of upper extremity disability (mean Quick Disability of the Arm-Shoulder-Hand (Q-DASH) scores: 31.3 to 38.5) at final follow-up. The rate of conversion to total elbow arthroplasty and operative fixation ranged from 0% to 7.5% and 0% to 5%, respectively. Conclusion Nonoperative management of distal humerus fractures in the elderly seems to be associated with acceptable functional outcomes and low rates of delayed surgery. This information is important for patient counseling and treatment decision-making.

Background There are three patient reported outcome measure instruments (PROMs) that have adequate content validity for breast reconstruction, BREAST-Q, BRECON-31 and EORTC QLQ-BRECON-23, and they all have been robustly validated. The aim of this study was to systematically review scores giving meaning to validated PROMs for breast reconstruction after mastectomy and discuss methods to enable interpretation of them. Methods A systematic review was performed according to the recommendations of PRISMA. Prospero CRD42021255874. Included articles had to meet criteria defined in a SPIDER (Sample, Phenomenon of Interest, Design, Evaluation, Research type). The included studies were critically appraised using the GRADE approach. Results Three articles were finally included in the review: two studies on scores for healthy controls and one on minimally important differences (MIDs), both of BREAST-Q. All of the studies were performed in North America. Only MIDs based on statistical characteristics, and not on what constitutes a relevant change for the patient, exist. The risk of bias was evaluated as very high and moderate, respectively, of inconsistencies as low, of indirectness as high, of imprecisions as low, and of publication bias as probably low. Conclusions The overall certainty of evidence for scores giving meaning to PROMs for breast reconstruction is low (GRADE ƟƟОО). More studies are needed to establish relevant healthy control scores and what constitutes a relevant clinical difference for patient-reported outcome measures for breast reconstruction after mastectomy. Clinical implications of the findings and suggestions for further research are suggested in the article., Highlights • Patient reported outcome measurements have to be clinically interpretable to make sense. • Three articles on scores giving meaning to PROMs for breast reconstruction post-mastectomy exist. • More studies are needed to establish relevant controls and clinical differences in scores. • Clinical implications and suggestions for further research are discussed.

Background and purpose — Total knee replacement (TKR) can be implanted with or without bone cement. It is currently unknown how the functional outcomes compare. Therefore, we compared the patient-reported outcome measures (PROMS) of both fixation methods.Patients and methods — We performed a propensitymatched comparison of 14,404 TKRs (7,202 cemented and 7,202 cementless) enrolled in the National Joint Registry and the English National PROMs collection programme. Subgroup analyses were performed in different age groups (1) < 55 years; (2) 55–64 years; (3) 65–74 years; (4) ≥ 75 years.Results — The 6-month postoperative Oxford Knee Score (OKS) was significantly (p < 0.001) higher for cemented TKR (35, SD 9.7) than cementless TKR (34, SD 9.9). The OKS was also significantly higher for the cemented TKR in all age groups, except the 55–64-year group. A significantly higher proportion of cemented TKRs had an excellent OKS (≥ 41) compared with cementless (32% vs. 28%, p < 0.001) and a lower proportion of poor (< 27) scores (19% vs. 22%, p = 0.001). This was also observed for all age subgroups. Therewere no significant differences in EQ-5D points gained postoperatively between the groups respectively (0.31 vs. 0.30, p = 0.1).Interpretation — Cemented TKRs had a greater proportion of excellent OKS scores and lower proportion of poor scores both overall and across all age groups. However, the absolute differences are small and below the minimally clinically important difference, making both fixation types acceptable. Currently the vast majority of TKRs are cemented and the results from this study suggest that this isappropriate.

Background and purpose — Knowing how to interpret values obtained with patient reported outcome measures (PROMs) is essential. We estimated the substantial clinical benefit (SCB) and patient acceptable symptom state (PASS) for Forgotten Joint Score 12 (FJS) and explored differences depending on methods used for the estimates. Patients and methods — The study was based on 195 knee arthroplasties (KA) performed at a university hospital. We used 1 item from the Knee injury and Osteoarthritis Outcome Score domain quality of life and satisfaction with surgery, obtained 1-year postoperatively, to assess SCB and PASS thresholds of the FJS with anchor-based methods. We used different combinations of anchor questions for SCB and PASS (satisfied, satisfied with no or mild knee difficulties, and satisfied with no knee difficulties). A novel predictive approach and receiver-operating characteristics curve were applied for the estimates. Results — 70 and 113 KAs were available for the SCB and PASS estimates, respectively. Depending on method, SCB of the FJS (range 0–100) was 28 (95% CI 21–35) and 22 (12–45) respectively. PASS was 31 (2–39) and 20 (10–29) for satisfied patients, 40 (31–47) and 38 (32–43) for satisfied patients with no/mild difficulties, and 76 (39–80) and 64 (55–74) for satisfied patients with no difficulties. The areas under the curve ranged from 0.82 to 0.88. Interpretation — Both the SCB and PASS thresholds varied depending on methodology. This may indicate a problem using meaningful values from other studies defining outcomes after KA. This study supports the premise of the FJS as a PROM with good discriminatory ability in patients undergoing KA.

Summary Background With the experience-based hypothesis of low donor site morbidity (DSM) for free flaps from the distal femur, this cohort study aimed to evaluate the DSM according to objective and reproducible criteria. Methods One hundred and fifty-six patients who had a flap harvest from either the medial or lateral femoral condyle region between 2005 and 2017 were included. A retrospective chart review was performed for all patients. In total, 97 patients were available for a follow-up examination. Outcomes were assessed according to objective (Knee Society Score; Larson Knee Score; OAK Score; 0–100 points), patient-reported (IKDC Score; KOOS Score; 0–100 points), and radiologic criteria (Kellgren and Lawrence Score; MRI Osteoarthritis Knee Score). Results The median follow-up time was 1,529 days (range: 248–4,810). The mean Knee Society Score (94.8 ± 10.1), Larson Knee Score (94.5 ± 10.1), and OAK Score (95.5 ± 6.6) showed nearly unimpaired knee function. The overall patient-reported DSM was low (IKDC Score: 86.7 ± 17.4; KOOS Score: 89.3 ± 17.1). Osteochondral (OC) flaps had a significantly higher DSM, regardless of the donor site. Bone flaps did not show any relevant radiologic morbidity in the Kellgren and Lawrence Score. Besides the procedure-associated cartilage lesions at the OC donor sites, MRI Osteoarthritis Knee Score did not show any significant presence of further knee pathologies in the bilateral MRI Scans. The obvious cartilage lesions did not have a relevant impact on the knee function of most patients. Conclusion The DSM for bone and soft-tissue flaps from the femoral condyle region is negligible. OC flaps are associated with a significantly higher DSM, although a clinically relevant impact on knee function was not evident in the majority of patients.

Objective Healthcare experiences, quality of life and psychosocial needs of patients with Neuroendocrine tumours (NETs) will be assessed to identify differences between NET sub-groups and inform the design of supportive care services. Methods This study constitutes phase one of a three-phase mixed-methods multi-site study with NET patients (n = 123). Demographic, clinical and patient reported outcome questionnaire data was collected. Results No differences in patient reported outcomes were found beyond symptoms of diarrhoea and flushing between NET sub-groups. For combined NET patients, the majority reported negative experiences in their understanding of the explanation of what was wrong with them (67%); receiving written information about their cancer (69%), their family/carer receiving all the information required to care for them (61%); and the usefulness of information about NETs online (66%). NET patients reported at least one moderate-to-high need for disease specific information (63%). Medium- to large-sized differences in quality of life subscales were also observed with the functioning group reporting more anxiety compared to population norms. Conclusions There is a need to improve the current provision of information for people with NETs. Practice implications These findings will inform the design and development of an informational resource to facilitate improved understanding for patients with NETs.

Purpose This study aimed to determine whether continual electronic patient-reported outcome (ePRO) measurements at home can capture the fluctuations in health-related quality of life (HRQOL) scores between visits. Methods We performed a randomized controlled trial to compare the scores obtained by standard practice (paper-based measurements in the hospital) to scores by continuous measurement of ePRO at home. Metastatic cancer patients were randomly assigned to either the paper-based ( n = 50) or the ePRO group ( n = 52). EQ-5D-5L and EORTC QLQ C-30 scores were obtained on 3 different chemotherapy days in the paper-based group. Meanwhile, scores were obtained on the chemotherapy day and on days 3, 7, 10, and 14 in the ePRO group during 2 cycles. The first hypothesis of our study was that both scores at the same time points would be equivalent despite different measurement frequency, place, or mode of measurement. The second hypothesis was that PRO score–adjusted time would be different between the groups. For equivalence, the endpoint was the mean EQ-5D-5L index value on the chemotherapy day before the outpatient treatment. Only if equivalence was shown, quality-adjusted life-days (QALDs) were considered using all the data. Results The adjusted mean difference in the EQ-5D-5L index was determined to be −0.013 (95% confidence interval [CI]: −0.049 to 0.022); the 95% CI did not exceed the equivalence margin. Similarly, the mean difference in global health status (2.28 [95% CI: −2.55 to 7.11]) also showed equivalence. However, the QALD by EQ-5D-5L was significantly lower in the ePRO group by 1.36 per 30 d (95% CI: −2.22 to −0.51; P = 0.0021). Conclusions Continual measurements of the HRQOL at home by ePRO may yield more detailed profiles of the HRQOL.

Background: Patient reported outcome measures (PROMs) such as health status (HS) and quality of life (QOL) are frequently used interchangeably while they represent different outcomes. Whether a discrepancy exists in patients with intermittent claudication (IC) in changes over time between HS and QOL is unclear. This study aimed to investigate the strength and the direction of the association between HS and QOL over time in patients with IC that underwent supervised exercise therapy (SET).Material and methods: Patients were part of the ELECT multi-center prospective cohort study. One goal of this study was to obtain data on HS and QOL at different time intervals of patients with IC that underwent SET. HS (VascuQOL-6) and QOL (WHOQOL-BREF) were completed at baseline, 3 months, and 6 months follow up. Pearson's correlation coefficients and the associated common variances (R2) were calculated to measure the strength and the direction of the association between HS and QOL in changes between baseline and follow-up moments.Results: In total, 177 patients were included in data analyses. Only changes in physical QOL and overall QOL had a small correlation with changes over time in HS, at both 3- and 6 months follow up (respectively R2=.14; P < 0.001 and R2 = 0.12; P < 0.001 for physical QOL and R2 = 0.18; P < 0.001 and R2 = 0.13; P < 0.001 for overall QOL).Conclusions:This study showed that HS and QOL provide different outcomes in patients with IC that underwent SET. Future studies should be aware of these differences before PROMs are being incorporated as an outcome measure in clinical studies.

Background The aim of this study was to investigate which factors patients considered to be important for determining the degree of cosmetic satisfaction with regards to perceived body image after previous breast-conserving therapy (BCT). Methods Outcomes considered relevant by the patients were first identified using interviews. A questionnaire based on this group input was then devised and added to the physician-based Sneeuw questionnaire. Next, a quantitative study using this questionnaire was conducted in Dutch patients treated at least 6 months earlier for (non-) invasive breast cancer by BCT. Exclusion criteria were: previous mastectomy or BCT of the contralateral breast, BCT with nipple resection, metastatic disease, local recurrence or (previous) plastic breast surgery. Descriptive statistics were used throughout. Results A total of 149 patients (aged 36–87 years) completed the questionnaire. From this focus group input, the top three factors in overall importance (important or very important) for satisfaction were: ‘wearability of bra’ (67%), ‘breast sensitivity’ (59%) and ‘asymmetry’ (51%). Younger patients ( 55 years). Time since BCT did not significantly influence the rating of relevant factors. Conclusion Patients consider ‘wearability of bra’, ‘breast sensitivity’ and ‘asymmetry’ as the most important factors when assessing their satisfaction with regards to cosmetic outcome and body image. These factors should be addressed in routine clinical practice during (pre) counseling.

Background: The use of the reverse shoulder arthroplasty (RSA) for cuff tear arthropathy (CTA) has increased within the last decades, but there is still limited information about the long-term outcome and how it performs in comparison with hemiarthroplasty (HA). The aim of this study was to compare the long-term patient-reported outcomes of RSA and HA for CTA. Methods: We included all patients with CTA, who according to the Danish Shoulder Arthroplasty Registry, underwent either HA or RSA between 2006 and 2010. Patients who were alive were sent the Western Ontario Osteoarthritis of the Shoulder (WOOS) questionnaire in 2020. One hundred twenty (65%) patients returned a complete questionnaire. The linear regression model was used to compare RSA and HA. Sex, age, and previous surgery were included in the multivariable model. Results: Forty-two HAs and 78 RSAs were evaluated with a mean follow-up time of 11.5 and 10.6 years, respectively. The mean WOOS score was 66.7 for HA and 71.7 for RSA. The difference of 5.0 was neither statistically significant nor clinically important (95% confidence interval: -4.3 to 14.2, P = .17), nor were there any significant risk of a worse WOOS score for sex, age, or previous surgery. Conclusion: To our knowledge, this is the first study to compare the long-term patient-reported outcomes of HA and RSA for CTA. Our results indicate that RSA is a reliable and durable treatment option for CTA with good long-term results. Based on this observational study, it is not possible to make safe estimates about the effect of RSA compared with HA, but similar to RSA, HA was associated with relatively good long-term results.

Intestinal fibrosis is a common complication of inflammatory bowel disease (IBD) that is usually the consequence of chronic inflammation. Although the currently available anti-inflammatory therapies have had little impact on intestinal fibrosis in Crohn’s disease (CD), increased understanding of the pathophysiology and the development of therapies targeting fibrogenic pathways hold promise for the future. One of the critical challenges is how reduction or reversal of intestinal fibrosis should be defined and measured in the setting of clinical trials and drug approval. The International Organization for Inflammatory Bowel Disease (IOIBD) organized a workshop in Amsterdam, The Netherlands, on December 19(th) and 20(th), 2018 in an attempt to review the current knowledge of the biological background, diagnosis, treatment of intestinal fibrosis and clinical trial endpoints. Basic and clinical scientists discussed the pathophysiology of intestinal fibrosis, the current status of biomarkers and imaging modalities in stenosing CD, and recent clinical studies in this area. Researchers from outside of the IBD field presented advances in the understanding of fibrotic processes in other organs, such as the skin, liver and lungs. Lastly, the design of clinical trials with antifibrotic therapy for IBD was discussed, with priority on patient populations, patient reported outcomes (PROs) and imaging. This report summarizes the key findings, discussions and conclusions of the workshop.

Objectives: The aim of the study was to describe the longitudinal development of health-related quality of life (HRQOL) and fatigue in children with chronic intestinal failure (CIF) on home parenteral nutrition (PN) and compare these children to the general population. Methods: Prospective, observational study conducted over 7 years in patients suffering from CIF receiving home PN from 2 tertiary hospitals in the Netherlands. Every 6 months, parents (if child

Introduction The KLIK Patient Reported Outcome Measures (PROM) portal (www.hetklikt.nu) has been implemented since 2011 in clinical practice in over 20 Dutch hospitals. Patients and/or parents complete PROMs before the outpatient consultation and answers are subsequently discussed by clinicians during consultation. This study aims to provide insight into patients’ and parents’ perspective on the use of the KLIK PROM portal in order to optimize its implementation in pediatric clinical practice. Methods Patients (12–19 years) and parents (of children 0–19 years) from the Emma Children’s Hospital were invited to participate. A mixed-method design was used; (1) Focus groups were held and analyzed using thematic analysis in psychology, (2) a questionnaire was sent out and analyzed using descriptive statistics. Results (1) Eight patients and 17 parents participated. Patients mentioned that KLIK has an attractive layout. However, PROMs were sometimes considered irrelevant and repetitive. Parents valued that KLIK provides insight into their child’s functioning, but they were not satisfied with the extent to which PROMs were discussed by clinicians. (2) 31 patients and 130 parents completed the questionnaire. Overall, patients and parents reported a satisfaction score of 7.9/10 and 7.3/10, respectively. 81% of patients and 74% of parents indicated that KLIK is easy to use. Conclusion Patients and parents are generally satisfied with KLIK, however, points of improvement were mentioned. These are currently being addressed by e.g., upgrading the KLIK website, implementing PROMIS item banks in KLIK to reduce irrelevancy and repetitiveness of PROMs, and implementation strategies to improve the discussion-rate. In this way, implementation of the KLIK PROM portal can be further optimized, with the ultimate goal to improve quality of care.

Background\ud Urolithiasis has a significant impact on patients’ health-related quality of life (HRQoL).\ud Objective\ud To develop a core patient-reported outcome measure (PROM) using modern psychometric methods to quantify the impact of urolithiasis and different treatments.\ud Design, setting, and participants\ud Adult patients with urinary calculi, attending urology departments, covering all index categories and treatment spectrum, participated during different development phases. The pilot instrument was created from potential items (phases 1 and 2) within the conceptual framework. The instrument was pretested (phase 3) and then underwent psychometric evaluation in two parts (phases 4 and 5).\ud Outcome measurements and statistical analysis\ud The validity and reliability of the new PROM were assessed using Rasch measurement theory (RUMM 2030 statistical software) and traditional analyses.\ud Results and limitations\ud In total, 683 patients (median age 51 yr, range 18–92 yr) participated during different phases. The initial 60-item draft (five scales) was completed by 212 patients (phase 4). A revised 25-item draft was produced after removal of unstable items. In the second field test, the revised version was evaluated by 369 patients. This led to the final Urinary Stones and Intervention Quality of Life (USIQoL; 15 items) with summated logit scores. The PROM includes three scales: pain with physical health (six items), psychosocial health (seven items) and work performance (two items). Lower scores indicate better outcomes. Results demonstrate that USIQoL is reliable (r ≥ 0.8) and internally consistent (α ≥ 0.7), and has good construct validity (good hypothesised correlations, r > 0.3) and satisfactory sensitivity to change (p < 0.01). All scales demonstrated unidimensionality with good item fit and person separation indices. A limitation is that USIQoL was developed in the English language within the UK population.\ud Conclusions\ud USIQoL is a short, unidimensional, valid, and reliable PROM for assessing the HRQoL impact of urinary calculi and treatments. It is expected to serve as a core PROM across the entire spectrum of urolithiasis.\ud Patient summary\ud Kidney stones are a common condition for which various treatment options are available. The condition and treatments have a significant impact on a patient’s quality of life. This can be measured objectively using a valid and reliable patient-reported outcome measure (PROM) developed using modern methods. We have developed a PROM that provides helpful and accurate measurement useful for all stakeholders.

Objective: To assess the benefits and harms associated with biopsychosocial rehabilitation in patients with inflammatory arthritis and osteoarthritis (OA). Methods: We performed a systematic review and meta-analysis. Data were collected through electronic searches of Cochrane CENTRAL, MEDLINE, Embase, PsycInfo, and CINAHL databases up to March 2019. Trials examining the effect of biopsychosocial rehabilitation in adults with inflammatory arthritis and/or OA were considered eligible, excluding rehabilitation adjunct to surgery. The primary outcome for benefit was pain and total withdrawals for harm. Results: Of the 27 trials meeting the eligibility criteria, 22 trials (3,750 participants) reported sufficient data to be included in the quantitative synthesis. For patient-reported outcome measures, biopsychosocial rehabilitation was slightly superior to control for pain relief (standardized mean difference [SMD] −0.19 [95% confidence interval (95% CI) −0.31, –0.07]), had a small effect on patient global assessment score (SMD –0.13 [95% CI –0.26, –0.00]), with no apparent effect on health-related quality of life, fatigue, self-reported disability/physical function, mental well-being, and reduction in pain intensity ≥30%. Clinician-measured outcomes displayed a small effect on observed disability/physical function (SMD −0.34 [95% CI −0.57, −0.10]), a large effect on physician global assessment score (SMD −0.72 [95% CI −1.18, −0.26]), and no effect on inflammation. No difference in harms existed in terms of the number of withdrawals, adverse events, or serious adverse events. Conclusion: Biopsychosocial rehabilitation produces a significant but clinically small beneficial effect on patient-reported pain among patients with inflammatory arthritis and OA, with no difference in harm. Methodologic weaknesses were observed in the included trials, suggesting low-to-moderate confidence in the estimates of effect.

Interest in patient-related outcome information is a prerequisite for patient-centered care, which has increasingly been recognized as an ethical imperative in modern health care. Patient-reported outcomes assess aspects of a patient's health status coming directly from the patient. Patient-reported outcome measures (PROMs) intent to profoundly change the face of modern health-care delivery. PROMs are increasingly used by clinicians to guide and audit routine care and are already firmly embedded in clinical research. These important patient-centered measures are likely to have a growing impact on physiotherapists all over the world. Patient-reported outcome research findings will increasingly guide policymakers and clinicians in providing evidence-based treatment. In addition, the routine clinical use of PROMs may allow physiotherapists to more effectively track treatment impact, thus aiding the development of optimal management strategies. The Chartered Society of Physiotherapy encourages as well as promotes at every level that physiotherapists must demonstrate measurable improvements in the clinical outcomes of their patients as part of daily practice. The use of PROMs to measure health status in routine practice has some distinct advantages over the traditional research-based outcome measures, as they may directly facilitate change behavior for patients, clinicians, managers, and policymakers. Widespread adoption of PROMs across physiotherapy is, therefore, something for the profession to embrace as it has the potential to empower patients, support clinical decision-making, and drive forward quality improvement. Thus, this article aim towards highlighting the importance and usage of PROMs in clinical physiotherapy practice.

Purpose: Advances in the diagnosis and treatment of prostate cancer have increased the patients’ stress level and decreased the quality of life. A variety of instruments are currently available to evaluate patients with prostate cancer. However, only a few tools are available to assess Korean patients, and therefore we demonstrated a linguistic validation of Korean Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP).Methods: EPIC-CP was translated into Korean and the linguistic validation was evaluated. The evaluation process includes permission for translation, forward translation, reconciliation, backward translation, cognitive debriefing, and proofreading. Two bilingual translators independently translated the original questionnaire, discussed the feasibility and naturalness of initial translation, followed by revision to the reconciled version. Another translator then performed a backward translation into English. Ten patients with prostate cancer completed the translated questionnaire and performed cognitive debriefing.Results: The original EPIC-CP was translated into 2 Korean versions. The different wording in both versions and the ordinary words in the initial translations were changed considering the nuances and meanings of medical terms. During the backward translation, the panels made slight changes to clarify the meaning and nuances of the translated questionnaire. During cognitive debriefing, 10 patients answered the questionnaire and offered their opinions regarding comprehensibility and naturalness. Most patients agreed that the translation was comprehensible in general.Conclusions: Our study provides a successful linguistic validation of the EPIC-CP questionnaire. The translation is a helpful diagnostic tool to ensure the quality of life of patients with prostate cancer attending crowded clinics.

Purpose: The aim of this study was to evaluate the prevalence of bowel/bladder dysfunction in multiple sclerosis (MS) and its associations with cognitive impairment.Methods: We prospectively enrolled 150 MS patients. Patients were administered the Symbol Digit Modality Test (SDMT), the Neurogenic Bowel Dysfunction Score (NBDS), and the Actionable Bladder Symptom Screening Tool (ABSST). The associations between bowel/bladder dysfunction and cognitive function were assessed through hierarchical regression models using the SDMT and clinicodemographic features as independent variables and NBDS and ABSST scores as dependent variables.Results: The prevalence of bowel/bladder deficits was 44.7%, with 26 patients (17.3%) suffering from bowel deficits and 60 patients (40%) from bladder deficits. The total NBDS and ABSST scores were correlated with the SDMT (β=-0.10, P

Misconceptions about visible skin diseases are widespread, and patients often face discrimination and stigmatization due to their condition. The associated negative health and psychosocial consequences of stigmatization in skin diseases have prompted an increase in research activity in recent times, resulting in a wide variety of assessment measures. This study aimed at aggregating and evaluating evidence of psychometric properties and methodological quality of published measures to assess stigma in visible skin diseases. Studies assessing stigmatization in visible skin diseases were searched in four databases (Medline, PsycINFO, Web of Science and Embase) until February 2021. The review followed PRISMA guidelines. Papers regarding development and/or validation of measures were identified by two independent researchers. Inclusion criteria were defined as follows: (i) quantitative studies in (ii) populations with skin diseases using (iii) questionnaires explicitly assessing (iv) perceived or public stigmatization or discrimination available in (iv) English or German language. The COnsensus-based Standards of health Measurement INstruments (COSMIN) checklist was used to evaluate their psychometric properties and risk of bias. 35 studies using 21 instruments were identified. Twenty instruments focused on assessing the perceived reality of those affected by visible skin diseases, while public stigma was only assessed by two instruments. Twelve scales could be recommended for use, while nine instruments had the potential to be recommended after further studies have assessed their quality. Some limitations are to be noted. Only studies in English and German were included. Research on self-constructed instruments can lead to new validated instruments, but they were not included in the review at this point. Several validated instruments could be recommended for use. Future research is needed regarding the assessment of stigma across different visible skin diseases, in children and adolescents, and in the general public.

Implant loss due to infection is the most devastating complication of implant-based breast reconstruction. The use of negative pressure wound therapy with instillation(NPWTi) for salvage of infected implant-based breast reconstructions has shown promising results allowing early reinsertion of a new implant as an alternative to the current management with delayed reinsertion. This study compares the patient-reported outcome and cost implication of NPWTi to the current management.Twenty cases of infected breast implants treated with NPWTi(V.A.C. VERAFLO™ Therapy), followed by early reinsertion of new implants were compared to 20 cases that had delayed reinsertion(non-NPWTi). Patient satisfaction was evaluated using the BREAST-Q questionnaire. The average cost per patient was calculated using total operative expense, cost of inpatient stay, investigations, antibiotics, and outpatient visits.Treatment with NPWTi allowed earlier reinsertion of a new implant (NPWTi: 10.3 ± 2.77days vs. non-NPWTi: 247.45±111.28days, p0.001). Patients in the NPWTi group reported higher satisfaction. The average cost per patient for NPWTi and non-NPWTi was £14,343.13±£2,786.70 and £8,920.31±£3,005.73, respectively(p0.001). All patients treated with NPWTi had one admission and spent 11.9 ± 4.1days as inpatients, while non-NPWTi patients had 2.1 ± 0.3 admissions(p0.001) and spent 7.1 ± 5.8days(p0.004) as inpatients. Patients treated with NPWTi had more procedures (NPWTi:3.35±0.81 Vs. non-NPWTi:2.2 ± 0.41, p = 0.006); however, three non-NPWTi cases required flap reconstruction.Patients treated with NPWTi reported higher satisfaction, received a new and earlier implant, and had fewer admissions and outpatient visits; however, they incurred higher average costs, longer inpatient stays, and underwent more procedures. Early implant reinsertion preserves skin envelope; hence avoiding additional cost and stress related to further major autologous reconstruction.