Female non-obstetric urogenital fistula repair: long-term patient-reported outcomes and a scoping literature review.

OBJECTIVE: To investigate long-term and patient-reported outcomes, including sexual function, in women undergoing urogenital fistula (UGF) repair, addressing the lack of such data in Western countries, where fistulas often result from iatrogenic causes. PATIENTS AND METHODS: We conducted a retrospective analysis at a tertiary referral centre (2010-2023), classifying fistulas based on World Health Organisation criteria and evaluating surgical approaches, aetiology, and characteristics. Both objective (fistula closure, reintervention rates) and subjective outcomes (validated questionnaires) were assessed. A scoping review of patient-reported outcome measures in UGF repair was also performed. RESULTS: The study included 50 patients: 17 (34%) underwent transvaginal and 33 (66%) transabdominal surgery. History of hysterectomy was present in 36 patients (72%). The median (interquartile range [IQR]) operating time was 130 (88-148) min. Fistula closure was achieved in 94% of cases at a median (IQR) follow-up of 50 (16-91) months and reached 100% after three redo fistula repairs. Seven patients (14%) underwent reinterventions for stress urinary incontinence after transvaginal repair (autologous fascial slings). Patient-reported outcomes showed median (IQR) scores on the International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) of 5 (3-7) for filling symptoms, 1 (0-2) for voiding symptoms and 4.5 (1-9) for incontinence symptoms. The median (IQR) score on the ICIQ Female Sexual Matters Associated with Lower Urinary Tract Symptoms Module (ICIQ-FLUTSsex) was 3 (1-5). The median (IQR) ICIQ Satisfaction (ICIQ-S) outcome score and overall satisfaction with surgery item score was 22 (18.5-23.5) and 10 (8.5-10), respectively. Higher scores indicate higher symptom burden and treatment satisfaction, respectively. Our scoping review included 1784 women, revealing mixed aetiology and methodological and aetiological heterogeneity, thus complicating cross-study comparisons. CONCLUSIONS: Urogenital fistula repair at a specialised centre leads to excellent outcomes and high satisfaction. Patients with urethrovaginal fistulas are at increased risk of stress urinary incontinence, possibly due to the original trauma site of the fistula.

Application of Patient-Reported Outcome Measurements in Adult Tumor Clinical Trials in China: Cross-Sectional Study.

BACKGROUND: International health policies and researchers have emphasized the value of evaluating patient-reported outcomes (PROs) in clinical studies. However, the characteristics of PROs in adult tumor clinical trials in China remain insufficiently elucidated. OBJECTIVE: This study aims to assess the application and characteristics of PRO instruments as primary or secondary outcomes in adult randomized clinical trials related to tumors in China. METHODS: This cross-sectional study identified tumor-focused randomized clinical trials conducted in China between January 1, 2010, and June 30, 2022. The ClinicalTrials.gov database and the Chinese Clinical Trial Registry were selected as the databases. Trials were classified into four groups based on the use of PRO instruments: (1) trials listing PRO instruments as primary outcomes, (2) trials listing PRO instruments as secondary outcomes, (3) trials listing PRO instruments as coprimary outcomes, and (4) trials without any mention of PRO instruments. Pertinent data, including study phase, settings, geographic regions, centers, participant demographics (age and sex), funding sources, intervention types, target diseases, and the names of PRO instruments, were extracted from these trials. The target diseases involved in the trials were grouped according to the American Joint Committee on Cancer Staging Manual, 8th Edition. RESULTS: Among the 6445 trials examined, 2390 (37.08%) incorporated PRO instruments as part of their outcomes. Within this subset, 26.82% (641/2390) listed PRO instruments as primary outcomes, 52.72% (1260/2390) as secondary outcomes, and 20.46% (489/2390) as coprimary outcomes. Among the 2,155,306 participants included in these trials, PRO instruments were used to collect data from 613,648 (28.47%) patients as primary or secondary outcomes and from 74,287 (3.45%) patients as coprimary outcomes. The most common conditions explicitly using specified PRO instruments included thorax tumors (217/1280, 16.95%), breast tumors (176/1280, 13.75%), and lower gastrointestinal tract tumors (173/1280, 13.52%). Frequently used PRO instruments included the European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire-30, the visual analog scale, the numeric rating scale, the Traditional Chinese Medicine Symptom Scale, and the Pittsburgh Sleep Quality Index. CONCLUSIONS: Over recent years, the incorporation of PROs has demonstrated an upward trajectory in adult randomized clinical trials on tumors in China. Nonetheless, the infrequent measurement of the patient's voice remains noteworthy. Disease-specific PRO instruments should be more effectively incorporated into various tumor disease categories in clinical trials, and there is room for improvement in the inclusion of PRO instruments as clinical trial end points.

Patient-Reported Outcomes after Laser Ablation for Bladder Tumours Compared to Transurethral Resection-A Prospective Study.

The standard procedure for diagnosis and treatment of bladder tumours, transurethral resection of bladder tumour (TURBT), is associated with a complication rate of up to 26% and potentially has severe influence on patient-reported outcomes (PRO). Outpatient transurethral laser ablation (TULA) is an emerging new modality that is less invasive with a lower risk of complications and, thereby, possibly enhanced PRO. We collected PRO following transurethral procedures in treatment of bladder tumours to evaluate any clinically relevant differences in symptoms and side effects. This prospective observational study recruited consecutive patients undergoing different bladder tumour-related transurethral procedures. Patients filled out questionnaires regarding urinary symptoms (ICIQ-LUTS), postoperative side effects, and quality of life (EQ-5D-3L) at days 1 and 14 postoperatively. In total, 108 patients participated. The most frequently reported outcomes were postoperative haematuria and pain. Patients undergoing TURBT reported longer lasting haematuria, a higher perception of pain, and a more negative impact on quality of life compared to patients undergoing TULA. TURBT-treated patients had more cases of acute urinary retention and a higher need for contacting the healthcare system. Side effects following transurethral procedures were common but generally not severe. The early symptom burden following TURBT was more extensive than that following TULA.

Multilevel Social Determinants of Patient-Reported Outcomes in Young Survivors of Childhood Cancer.

In this study, the social determinants of patient-reported outcomes (PROs) in young survivors of childhood cancer aged <18 years are researched. This cross-sectional study investigated social determinants associated with poor PROs among young childhood cancer survivors. We included 293 dyads of survivors receiving treatment at St. Jude Children's Research Hospital who were <18 years of age during follow-up from 2017 to 2018 and their primary caregivers. Social determinants included family factors (caregiver-reported PROs, family dynamics) and county-level deprivation (socioeconomic status, physical environment via the County Health Rankings & Roadmaps). PROMIS measures assessed survivors' and caregivers' PROs. General linear regression tested associations of social determinants with survivors' PROs. We found that caregivers' higher anxiety was significantly associated with survivors' poorer depression, stress, fatigue, sleep issues, and reduced positive affect (p < 0.05); caregivers' sleep disturbances were significantly associated with lower mobility in survivors (p < 0.05). Family conflicts were associated with survivors' sleep problems (p < 0.05). Residing in socioeconomically deprived areas was significantly associated with survivors' poorer sleep quality (p < 0.05), while higher physical environment deprivation was associated with survivors' higher psychological stress and fatigue and lower positive affect and mobility (p < 0.05). Parental, family, and neighborhood factors are critical influences on young survivors' quality of life and well-being and represent new intervention targets.

Survivorship and Patient Outcomes of Conforming Bearings in Modern Primary Total Knee Arthroplasty: Mean 3.5 Year Follow-Up.

BACKGROUND: Conforming and congruent bearings in total knee arthroplasty (TKA) have rapidly increased due to the benefits of increased stability and the potential for replicating normal knee kinematics. However, limited data exist for these newly available bearings. This study evaluated revision-free survivorship and patient-reported outcome measures (PROMs) of a large granular database of primary TKAs using a single conforming bearing design. METHODS: A total of 1,306 consecutive primary TKAs performed using a single conforming bearing design (85% cemented and 15% cementless) were retrospectively reviewed. Kaplan-Meier (KM) survivorship estimates were calculated based on the latest clinical follow-up. The PROMs and minimal clinically important differences (MCIDs) were evaluated. A total of 93% of cases achieved minimum 1-year clinical follow-up (mean 3.5 years; range, 1 to 7), with a subset of 261 cases that achieved minimum 5-year follow-up (mean 5.8 years; range, 5 to 7). RESULTS: All-cause and aseptic KM survivorship estimates were 97.6 (95% CI [confidence interval], 97 to 99) and 98.1% (95% CI, 97 to 99) at 7.0 years. Revision-free survivorship did not differ by cemented or cementless fixation (98 versus 97%, P = 0.163). All PROM scores significantly improved from preoperative baseline (P < 0.001), and ≥ 86% of patients achieved MCIDs for Knee Society pain and Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) total scores. A total of 89% of cases reported their knees to 'sometimes or always' feel normal. For cases with minimum 5-year PROMs, 93% were 'very satisfied' or 'satisfied.' CONCLUSION: Conforming-bearing TKA demonstrated excellent survivorship up to 7.0 years. In addition, PROMs were comparable to other designs reported in the literature. While mid-term (mean 3.5-year) results are promising, long-term data are warranted on survivorship due to potential polyethylene wear in conforming bearings with more surface area in contact with articulating surfaces.

Determining minimal clinically important difference and patient-acceptable symptom state after arthroscopic isolated subscapularis repair.

Background: Minimal Clinically Important Difference (MCID) and Patient-Acceptable Symptomatic State (PASS) have emerged as patient-based treatment assessments. However, these have not been investigated in patients undergoing arthroscopic isolated subscapularis repair (AISR). The primary purpose of this study was to determine the MCID and PASS for commonly used patient-reported outcomes in individuals who underwent AISR. The secondary purpose was to assess potential associations between preoperative and intraoperative patient characteristics and the MCID and PASS. Methods: A retrospective analysis was conducted on prospectively collected data for patients who underwent primary AISR between 2011 and 2021 at a single institution, with minimum 2-year postoperative follow-up. Functional outcomes were assessed using the American Shoulder and Elbow Surgeons (ASES) score, Subjective Shoulder Value (SSV), and Visual Analog Scale (VAS) pain scale. The MCID was determined using the distribution-based method, while PASS was evaluated using area under the curve analysis. To investigate the relationship between preoperative variables and the achievement of MCID and PASS thresholds, Pearson and Spearman coefficient analyses were employed for continuous and noncontinuous variables, respectively. Results: A total of 77 patients with a mean follow-up of 58.1 months were included in the study. The calculated MCID values for VAS pain, ASES, and SSV were 1.2, 10.2, and 13.2, respectively. The PASS values for VAS pain, ASES, and SSV were 2.1, 68.8, and 68, respectively. There was no significant correlation between tear characteristics and the likelihood of achieving a MCID or PASS. Female sex, worker's compensation status, baseline VAS pain score, and baseline ASES score, exhibited weak negative correlations for achieving PASS for VAS pain and ASES. Conclusion: This study defined the MCID and PASS values for commonly used outcome measures at short-term follow-up in patients undergoing AISR. Tear characteristics do not appear to impact the ability to achieve a MCID or PASS after AISR. Female sex, worker's compensation claim, and low baseline functional scores have weak negative correlations with the achievement of PASS for VAS pain and ASES scores.

Assessment of a novel Ehlers-Danlos syndromes disability index.

Background: The Ehlers-Danlos syndromes (EDS) are a group of inherited connective tissue disorders characterized by disruptions in collagen synthesis and processing. These disorders lead to various symptoms, including hypermobility, musculoskeletal conditions, and chronic pain that can significantly limit patients' daily living. In the absence of a curative treatment, an EDS specific disability index that tracks changes in patient-reported outcomes can facilitate the investigation of new treatment options and enhance the quality of life for EDS patients. Methods: An EDS-specific disability index was created using survey data and input from clinicians. A total of 222 EDS patients in a multidisciplinary clinical program completed the index during their initial visit. Exploratory and confirmatory factor analyses were conducted to determine the index's factor solution and assess its goodness-of-fit. Paired t-tests were performed with follow-up visit data collected over the course of one year. Results: The exploratory and confirmatory factor analyses indicated a two-factor solution, accounting for 42.40% of the variance. The index demonstrated adequate fit to the data, supported by Tucker and Lewis's index (0.85) and root mean square error of approximation (0.1). Data from follow-up visits showed significant improvement in three symptom related variables and one function related variable in addition to the total score and the symptom subscale score when compared to the initial visit. Conclusion: The development of an EDS-specific disability index is a crucial step in creating a clinical tool that enables healthcare professionals to gain a deeper understanding of the impact EDS has on patients' lives and potentially identify new therapeutic interventions.

Comparative Analysis of Clinical and Patient-Reported Outcomes of a New Enhanced Monofocal IOL and a Conventional Monofocal IOL.

Purpose: To compare the outcomes of the Tecnis Eyhance ICB00 IOL, designed to enhance intermediate vision, to a conventional Tecnis Monofocal ZCB00 IOL. Methods: This retrospective analysis compared two cohorts of patients undergoing lens replacement surgery with bilateral implantation of the Tecnis ICB00 or the Tecnis ZCB00 IOL (383 patients in each group). Monocular and binocular uncorrected distance (UDVA), intermediate (UIVA; 66cm), and near (UNVA; 40cm) visual acuities, refractive predictability, and patient-reported outcomes were compared. A sub-analysis of patients with the Eyhance IOL was performed to compare patients who achieved bilateral emmetropia to those with mini-monovision. One-month postoperative outcomes were analyzed. Results: Both groups had comparable UDVA outcomes. On average, both monocular and binocular UIVAs were approximately one Snellen line better in patients implanted with Eyhance IOL (monocular UIVA: ICB00 0.23 ± 0.18 logMAR, ZCB00 0.33 ± 0.19 logMAR; binocular UIVA: ICB00 0.18 ± 0.18 logMAR, ZCB00 0.26 ± 0.20 logMAR, p < 0.01). Likewise, the mean UNVA was also one Snellen line better with the ICB00 model (monocular UNVA: ICB00 0.51 ± 0.20 logMAR, ZCB00 0.61 ± 0.18 logMAR; binocular UNVA: ICB00 0.42 ± 0.19 logMAR, ZCB00 0.51 ± 0.22 logMAR, p < 0.01). There was no difference between the two groups in overall satisfaction or visual phenomena. A subgroup of patients who achieved mini-monovision with Eyhance IOL had, on average, one Snellen line better UIVA and UNVA compared to patients with bilateral emmetropia. Conclusion: Patients receiving the enhanced monofocal IOL had better intermediate and near vision compared to those receiving the conventional monofocal IOL, with similar levels of patient-reported photic phenomena in both groups.

Patient experiences and needs in cancer care- results from a nationwide cross-sectional study in Germany.

BACKGROUND: Patient-centredness has become a central quality indicator for oncology care. Elements include shared decision-making, patient navigation and integration of psychosocial care, which impact patient-reported and clinical outcomes. Despite efforts to promote patient-centred care in Germany in recent decades, implementation remains fragmented. Further, research on patient experiences with cancer care and its determinants is limited. Therefore, this study examines which patient- and facility-specific factors are associated with patient-centred quality care delivery. METHODS: A cross-sectional study was conducted among 1,121 cancer patients in acute treatment, rehabilitation, and aftercare for different cancer entities across Germany. A participatory developed questionnaire was used. Outcome measures were the quality of physician-patient interaction and provision of psychosocial care during acute care. Predictors comprised patient-specific characteristics and treatment facility-specific factors. Multiple linear regression and multivariate binary logistic regression analyses were performed. In addition, a content analysis of open-ended comments on the patients' overall cancer care needs was applied. RESULTS: Multiple linear regression analysis showed recent diagnosis (ß=-0.12, p = < 0.001), being male (ß=-0.11, p = 0.003), and having a preference for passive decision-making (ß=-0.10, p = 0.001) to be significantly associated with higher interaction quality, but not age, education and health insurance type. An overall low impact of patient characteristics on interaction quality was revealed (adj. R2 = 0.03). Binary logistic regression analysis demonstrated the availability of central contact persons (OR = 3.10, p < 0.001) followed by recent diagnosis (p < 0.001), having breast cancer (p < 0.001) and being female (OR = 1.68, p < 0.05) to significantly predict offering psycho-oncological counselling to patients in acute care facilities. The availability of peer support visiting services (OR = 7.17, p < 0.001) and central contact persons (OR = 1.87, p < 0.001) in the care facility, breast cancer diagnosis (p < 0.001) and a higher level of education (p < 0.05) significantly increased the odds of patients receiving information about peer support in the treatment facility. Despite relatively satisfactory quality of physician-patient interactions in cancer care (M = 3.5 (± 1.1)), many patients expressed that better patient-centred communication and coordinated, comprehensive cancer care are needed. CONCLUSION: The findings reflect effective developments and improvements in cancer care and suggest that patients' social characteristics are less decisive for delivering patient-centred quality care than systemic factors surrounding the care facilities. They can serve to inform oncology care in Germany.

Australian Headache Epidemiology Data (AHEAD): a pilot study to assess sampling and engagement methodology for a nationwide population-based survey.

BACKGROUND: There are no robust population-based Australian data on prevalence and attributed burden of migraine and medication-overuse headache (MOH) data. In this pilot cross-sectional study, we aimed to capture the participation rate, preferred response method, and acceptability of self-report questionnaires to inform the conduct of a future nationwide migraine/MOH epidemiological study. METHODS: We developed a self-report questionnaire, available in hard-copy and online, including modules from the Headache-Attributed Restriction, Disability, Social Handicap and Impaired Participation (HARDSHIP) questionnaire, the Eq. 5D (quality of life), and enquiry into treatment gaps. Study invitations were mailed to 20,000 randomly selected households across Australia's two most populous states. The household member who most recently had a birthday and was aged ≥ 18 years was invited to participate, and could do so by returning a hard-copy questionnaire via reply-paid mail, or by entering responses directly into an online platform. RESULTS: The participation rate was 5.0% (N = 1,000). Participants' median age was 60 years (IQR 44-71 years), and 64.7% (n = 647) were female. Significantly more responses were received from areas with relatively older populations and middle-level socioeconomic status. Hard copy was the more commonly chosen response method (n = 736). Females and younger respondents were significantly more likely to respond online than via hard-copy. CONCLUSIONS: This pilot study indicates that alternative methodology is needed to achieve satisfactory engagement in a future nationwide migraine/MOH epidemiological study, for example through inclusion of migraine screening questions in well-resourced, interview-based national health surveys that are conducted regularly by government agencies. Meanwhile, additional future research directions include defining and addressing treatment gaps to improve migraine awareness, and minimise under-diagnosis and under-treatment.

Development and validation of clinical implementation methods for patient-reported outcomes in Japanese multi-center palliative care units.

BACKGROUND: Patient-Reported Outcomes (PROs) are recommended for use in clinical oncology. However, they are not routinely used in professional palliative care practices in Japan. The reasons include both patient and healthcare provider factors and the implementation of PROs. This study aimed to develop and validate clinical implementation methods for PROs in Japanese palliative care units. METHODS: The Consolidated Framework for Implementation Research (CFIR) was conducted with four palliative care units in Japan. The study was conducted in six steps: unit assessment, development and implementation of a PRO implementation plan, PRO post-implementation survey and analysis of its utilization, a review of the PRO implementation process, creation of a PRO implementation method in a palliative care unit, and use and verification of the implementation method. Steps 1-5 were the development phase, and step 6 was the verification phase. RESULTS: Interviews were conducted with healthcare providers prior to PRO implementation. Intervention characteristics, patient needs in the palliative care unit, and factors related to the organization were identified as barriers. The implementation plan was developed, and the core members were selected. The implementation procedures were created in the above mentioned steps. PROs were used in the palliative care units. The same was true in the validation phase. CONCLUSIONS: This study guided PROs in specialized palliative care unit in a clinical setting. The method was developed and validated for the implementation of PROs in the palliative care unit. In the PRO implementation process, it was important to assess the unit, address the barriers to implementation, and reduce the burden on healthcare providers. Furthermore, healthcare providers had to be supported by the champion, a person responsible for the implementation of PROs in the palliative care unit.

Patient-reported outcomes in epilepsy: a case study exploring their usage and impact.

Background: This study aimed to obtain insights from epilepsy specialists on the use of Patient-Reported Outcome (PRO) measures and how they can affect the management of people with epilepsy and healthcare resource utilization. Methods: The heads of two referral units for people with epilepsy at one tertiary care hospital were invited to respond to a structured survey. Results: Paper-based questionnaires and face-to-face interviews were the main modalities used to measure the quality of life of people with epilepsy. The Quality of Life in Epilepsy Inventory-31 (QOLIE-31), the Adverse Event Profile (adult centre), the Generalized Anxiety Disorder-7, Short-Form Health Survey 36, PSY-Flex, SAFA and Child Behavior Checklist (paediatric centre) were the most used scales. There was consensus about the favourable impact of PRO upon patient management, disease management and measurement of the success of a treatment. Both respondents considered the PRO as important as other main indicators like efficacy and tolerability of the treatment. Lack of time, personnel and economic resources was identified as a barrier on the use of PRO. The PRO could reduce the number of visits, exams and treatments, and increase the time spent on each patient and the number of neuropsychological, psychological and rehabilitation services. The standardized use of PRO was considered useful and the increase in human resources was considered a priority to achieve this goal. Conclusions: Despite the heterogeneity in the actual collection of PRO, there was a uniform perception about their role to optimize the care of people with epilepsy.

The use of actigraphy to objectively define motion and function before and after shoulder arthroplasty.

Introduction: Actigraphy is a quantitative means of measuring activity data that has proven viable in post-surgery recovery analysis for arthroplasties in lower extremities, but scant literature has been published on the utilization actigraphy to evaluate shoulder motion and function before and after shoulder arthroplasty. The purpose of this prospective cohort study is to identify if actigraphy can serve as a valid means for objective evaluation of shoulder function and motion before and after shoulder arthroplasty. Secondarily, the data collected by the actigraphy can be analyzed with standard patient-reported outcomes to report correlations between the subjective and objective methods used in this study. Materials and methods: Sixty-four subjects wore an actigraphy device for one day at pre-op, six, twelve and twenty-four weeks. In addition, subjects completed three patient-reported outcome surveys at each time-point. Student t-tests were used to compare percent activity preoperatively with 24-weeks and to compare PROs preoperatively with 24-week results; categorical variables were compared with one-way ANOVAs. Results: All Patient reported outcome scores significantly improved following arthroplasty (p-value<0.001). The percent of physical activity was highly correlated with vector magnitude (p-value<0.001), but neither percent activity or the vector magnitude were correlated with any of the PROs: UCLA Pain p-value = 0.656, SANE p-value = 0.328, UCLA Function p-value = 0.532. Conclusions: Actigraphy results from this study mirror findings in previous literature utilizing the technology in similar manners and demonstrate its potential for motion and function analysis before and after total shoulder arthroplasties. Despite both being suitable methods independently for the evaluation of shoulder function, there was no significant correlation between standard actigraphy measurements and PROs at 24-weeks. Future research to determine clinical utility and an overall broader scope for actigraphy monitoring could benefit from improved technology, such as increased battery life for prolonged durations of data collection during observation periods.

Effects of Asthma on the Performance of Activities of Daily Living: A Retrospective Study.

The study aim was to identify the most problematic self--reported activities of daily living (ADLs). In a retrospective study, 1935 problematic ADLs were reported by 538 clients with 95% experiencing two or more problematic ADLs. Problematic ADLs were assessed by occupational therapists using the Canadian Occupational Performance Measure with walking (67%), household activities (41%), and climbing the stairs (41%) identified as the most prevalent problematic ADLs. Significant but weak associations were found between clinical determinants (e.g. physical, psychosocial) and problematic ADLs. The wide variety of problematic ADLs and the absence of a strong association with clinical determinants emphasizes the need for using individualized interview-based performance measures in clients with asthma.

Patient perspectives in adverse event reporting after vaginal apical prolapse surgery.

BACKGROUND: Many clinical trials use systematic methodology to monitor adverse events (AE) and determine grade (severity), expectedness, and relatedness to treatments as determined by clinicians. However, patient perspective in the process remains lacking. OBJECTIVES: To compare clinician versus patient grading of AE severity in a urogynecologic surgical trial. Secondary objectives were to estimate the association between patient grading of AEs with decision-making and quality of life outcomes and to determine if patient perspective changes over time. STUDY DESIGN: This was a planned supplementary study, "Patient-Perspectives in Adverse Event Reporting" (PPAR), to a randomized trial comparing 3 surgical approaches to vaginal apical prolapse. In the parent trial, AEs experienced by patients were collected per a standardized protocol every 6 months where clinicians graded AE severity (mild, moderate, severe/life threatening). In this sub-study, we obtained additional longitudinal patient perspectives for 19 predetermined "PPAR AEs". Patients provided their own severity grading (mild, moderate, severe/very severe/ life threatening) at initial assessment and at 12 and 36 months postoperatively. Clinicians and patients were masked to each other's reporting. The primary outcome was the interrater agreement (kappa statistic, κ) for AE severity between the initial clinician and patient assessment, combining patient grades of mild and moderate. Association between AE severity and the Decision-Regret Scale (DRS), Satisfaction with Decision Scale (SDS), the Short-Form Health Survey-12 (SF-12), and Patient-Global Impression of Improvement (PGI-I) scores were assessed utilizing Spearman's correlation coefficient (ρ) for continuous scales, Mantel-Haenszel chi-squared test for PGI-I, and T-tests or chi-squared tests comparing assessments of severe vs other grades. To describe patient perspective changes over time, the intra-observer agreement was estimated for AE severity grade over time using weighted kappa-coefficients. RESULTS: Of 360 patients randomized, 219 (61%) experienced a total of 527 PPAR AEs (91% moderate and 9% severe/life threatening by clinician grading). Mean patient age was 67 years, 87% were White, and 12% Hispanic. Of patients reporting any PPAR event, the most common were urinary tract infection (61%), de novo urgency urinary incontinence (35%), stress urinary incontinence (22%), and fecal incontinence (13%). Overall agreement between clinician and participant grading of severity was poor (κ=0.24 (95%CI 0.14, 0.34). Of 414 AEs clinicians graded as moderate, patients graded 120 (29%) mild, and 80 (19%) severe. Of 39 AEs graded severe by clinicians, patients graded 15 (38%) mild or moderate. Initial patient grading of the most severe reported AE was mildly correlated with worse DRS (ρ=0.2, p=0.01), SF-12 (ρ=-0.24, p<0.01) and PGI-I (p<0.01). There was no association between AE severity and SDS. Patients with an initial grading of "severe" had more regret, lower quality of life, and poorer global impressions of health than those whose worst severity grade was mild (p<0.05). Agreement between the patients' initial severity and later timepoints was fair at 12 months (κ=0.48 (95% CI 0.39, 0.58)) and 36 months (κ=0.45 (95% CI 0.37, 0.53)). CONCLUSIONS: Clinician and patient perceptions of AE severity are discordant. Worse severity from the patient perspective was associated with patient-centered outcomes. Including the patient perspective provides additional information for evaluating surgical procedures.

A clinical audit of patient outcomes in real-world acupuncture practice.

INTRODUCTION: Clinical auditing represents a valuable and cost-effective method for the collection of patient outcomes and is increasingly being used to inform clinical guidelines. The aim of this clinical audit was to assess patient outcomes across a small subset of acupuncture practitioners and private practices in the United Kingdom. METHODS: The Measure Yourself Medical Outcomes Profile (MYMOP) questionnaire and the Patient Global Impression of Change (PGIC) scale were used as outcome measures. Additional questions assessed adverse events and patient experience with care. Clinical data were collected utilising an electronic patient-reported outcome measures (ePROMs) system. RESULTS: Baseline data were collected for a total of 233 health complaints (from 232 patients), of which 45.9% were musculoskeletal and 26.2% were psychological. Follow-up outcomes data were available for 144 health complaints (61.8% completion rate). For PGIC responses, >90% of health complaints were reported as at least 'minimally improved'. This was reduced to >51% when controlling for missing data. There was a gradual improvement in both mean MYMOP scores (24.5%-43.0%) and PGIC responses of 'very much improved' (12.3%-56.3%) over a 6-month period. A clinically significant improvement (>1 point change, p ⩽ 0.001) was seen in mean MYMOP scores compared to baseline from 4 to 8 weeks and symptom 1 MYMOP scores from 1 to 4 weeks. A moderately strong, negative correlation was seen between outcome measures (r = -0.507, p < 0.001). CONCLUSIONS: The majority of patients reported clinically meaningful improvements for their main health complaints/symptoms, which appeared to be sustained in the medium to long-term.

Implementation of the International Consortium of Health Outcomes Measurement CHD standard set in patients undergoing pulmonary valve replacement.

BACKGROUND: Despite the burden of CHD, a high cost and utilization condition, an implementation of long-term outcome measures is lacking. The objective of this study is to pilot the implementation of the International Consortium of Health Outcomes Measurement CHD standard set in patients undergoing pulmonary valve replacement, a procedure performed in mostly well patients with diverse CHD. METHODS: Patients ≥ 8 years old undergoing catheterization-based pulmonary valve replacement were approached via various approaches for patient-reported outcomes, with a follow-up assessment at 3 months post-procedure. Implementation strategy analysis was performed via a hybrid type 2 design. RESULTS: Of the 74 patients undergoing pulmonary valve replacement, 32 completed initial patient-reported outcomes with variable response rates by strategy (email and in-person explanation 100%, email only 54%, and email followed by text/call 64%). Ages ranged 8-67 years (mean 30). Pre-procedurally, 34% had symptomatic arrhythmias, which improved post-procedure. For those in school, 43% missed ≥ 6 days per year, and over half had work absenteeism. Financial concerns were reported in 34%. Patients reported high satisfaction with life (50% [n = 16]) and health-related quality of life (90% [n = 26]). Depression symptoms were reported in 84% (n = 27) and anxiety in 62.5% (n = 18), with tendency towards improvement post-procedurally. CONCLUSION: Pilot implementation of the International Consortium of Health Outcomes Measurement CHD standard set in pulmonary valve replacement patients reveals a significant burden of disease not previously reported. Barriers to the implementation include a sustainable, automated system for patient-reported outcome collection and infrastructure to assess in real time. This provides an example of implementing cardiac outcomes set in clinical practice.

Total knee arthroplasty following lateral closing-wedge high tibial osteotomy versus primary total knee arthroplasty: a propensity score matching study.

BACKGROUND: The disparity in patient-reported outcomes between total knee arthroplasty (TKA) following high tibial osteotomy (HTO) and primary TKA has yet to be fully comprehended. This study aims to compare the patient-reported outcomes, radiological parameters and complication rates between TKA following HTO and primary TKA. METHODS: Sixty-five patients who underwent TKA following lateral closing-wedge HTO were compared to a matched group of primary TKA at postoperative 6-months and 1-year. Between-group confounders of age, gender, smoking status, Body Mass index, preoperative Numeric Rating Scale (NRS) pain in rest, Knee injury and Osteoarthritis Outcome Score-Physical function Shortform (KOOS-PS), EuroQol five-dimensional (EQ-5D) overall health score, and Oxford Knee Score (OKS) were balanced by propensity score matching. Patient-reported outcome measures were NRS pain in rest, KOOS-PS, EQ-5D overall health score, and OKS. Radiological parameters were femorotibial angle, medial proximal tibial angle, anatomical lateral distal femoral angle, posterior tibial slope, and patellar height assessed by Insall-Salvati ratio. The complication rates of TKA were compared between the two groups. The HTO survival time, the choice of staple removal before or during TKA in patients who underwent TKA following HTO patients, and the rate of patellar resurfacing were assessed. The p value < 0.0125 indicates statistical significance after Bonferroni correction. RESULTS: After propensity score matching, no significant between-group differences in the patient-reported outcome measures, radiographical parameters and complication rates were found (p > 0.0125). In the TKA following HTO group, with an average HTO survival time of 8.7 years, staples were removed before TKA in 46 patients (71%) and during TKA in 19 patients, and 11 cases (17%) had patella resurfacing. In the primary TKA group, 15 cases (23%) had patella resurfacing. CONCLUSION: The short-term assessment of TKA following HTO indicates outcomes similar to primary TKA. A previous HTO does not impact the early results of subsequent TKA, suggesting that the previous HTO has minimal influence on TKA outcomes. LEVEL OF EVIDENCE: III, cohort study.

Measuring Pelvic Organ Prolapse: An Evolution.

INTRODUCTION AND HYPOTHESIS: Advances in our understanding of pelvic organ prolapse (POP) have been made with the introduction of valid, reliable measures of anatomy and patient-reported outcome measures. METHODS: This review provides an overview of the evolution of POP measurement and its implications for clinical practice and research. RESULTS: Since the introduction of the Pelvic Organ Prolapse Quantification (POPQ), studies have demonstrated that some degree of loss of anatomic support is normal, with as many as 40% of normal women having stage 2 prolapse. Vaginal support is dynamic and can wax and wane but is largely stable over time. Vaginal bulge symptoms are the most reliable and specific symptom for POP and the hymen is an important threshold for symptom development. Most pelvic floor symptoms have only weak to moderate correlation with the anatomic severity of POP. Treatment success rates are highly variable depending upon criteria used and definitions of anatomic success commonly used are too strict and often not clinically relevant. There is substantial discordance between subjective and anatomic measures of success, and both are dynamic, fluctuating between success and failure for many patients without intervening treatment. CONCLUSIONS: Pelvic organ prolapse is multidimensional, dynamic, and has a complex impact on patients. Patients' symptoms are more clinically relevant than anatomic support. Symptomatic cure, particularly the absence of vaginal bulge symptoms, is more clinically relevant than anatomic cure and composite outcomes can be misleading and overestimate failure rates. Future studies should compare treatments using continuous variables along multiple dimensions rather than using composite outcomes or dichotomizing patients into success or failure.