Completed Patient-reported Outcome Measures Research Articles

Patients with more complex ankle fractures are associated with poorer patient-reported outcome: an observational study of 11,733 patients from the Swedish Fracture Register.

Patient-reported outcome measures (PROMs) following ankle fractures, including all fracture types, have not been reported. It is therefore unclear whether fracture morphology correlates with outcome. We aimed to analyze PROMs in patients with an ankle fracture in relation to the Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association (AO/OTA) fracture classification using population-based register data from the Swedish Fracture Register (SFR). All patients aged ≥ 18 years with an ankle fracture (AO/OTA 44A1-C3) registered in the SFR between 2012 and 2019 were retrieved from the register. Patients with completed PROM questionnaires (Short Musculoskeletal Function Assessment and EuroQol-Visual Analogue Scale) on both day 0 (pre-trauma) and 1-year post-trauma were included. The difference in PROMs between day 0 and 1 year was calculated for each patient (delta value) and mean delta values were calculated at group level, based on the AO/OTA fracture classification. 11,733 patients with 11,751 fractures with complete PROMs were included. According to the AO/OTA classification, 21% were A fractures, 67% were B fractures and 12% were C fractures. All groups of patients, regardless of fracture class (A1-C3), displayed an impairment in PROMs after 1 year compared with day 0. Type C fractures displayed a larger impairment in PROMs at group level than type B, which in turn had a greater impairment than type A. The same pattern was seen in groups 3, 2, and 1 for A and B fractures. We found that the AO/OTA classification is prognostic, where more complex fractures were associated with poorer PROMs.

Image guided radiotherapy in curative treatment for prostate cancer. 5-year results from a randomized controlled trial (RIC-trial)

BackgroundBetween 2012 and 2015 we conducted a randomized controlled trial in prostate cancer patients comparing weekly 2-D portal imaging versus daily 3-D verification. AimTo evaluate the clinical outcomes of image guided radiotherapy by presenting rectal and urinary side effects, health related quality of life and progression free survival after 5-years follow up of a randomized controlled trial. MethodsWe randomized 260 men with intermediate or high-risk prostate cancer to weekly 2-D portal imaging with 15 mm margin from CTV to PTV (Arm A) or daily 3-D cone-beam computer tomography with 7 mm margins (Arm B). Prescribed doses were 78 Gy/39 fractions. All patients received hormonal therapy. Primary end point was patient reported bowel symptoms and secondary outcomes were patient reported urinary symptoms, health- related quality of life and progression free survival. ResultsOf the 216 patients available for analyses at 5 years more than 90 % completed patient reported outcome measures. There were no significant differences between study arms for any single items nor scales evaluating bowel symptoms. There were also no differences in self-reported urinary symptoms nor in health-related quality of life. Symptom scores were low in both study arms. Progression free survival was similar in Arm B as compared to arm A (Hazard ratio 1.01; 95 % CI 0.57 to 1.97). ConclusionsOur results support that both 2-D weekly and 3-D daily image guided radiotherapy are safe and efficient treatments for PC and emphasize the need to evaluate technological progress in clinical trials with long follow-up.

Patient adherence and response time in electronic patient-reported outcomes: insights from three longitudinal clinical trials.

Patient-reported outcome measures (PROMs) are used to collect data on disease symptoms in support of clinical trial endpoints. Clinical studies can last a year or more, and the patients' adherence and response time to daily at-home questionnaires may vary significantly over time. The aim of this study was to understand patterns and changes in patients' completion of daily PROMs during longitudinal clinical studies. Data were collected from 1342 patients randomized into three respiratory clinical trials (NCT03401229, NCT03347279, and NCT03406078). PROMs were completed by patients using electronic handheld devices that collected the starting and completion times. A Bayesian generalized linear mixed-effects model was used to identify unbiased coefficients associated with PROM adherence and response time using patient, site, and calendar features as covariates. Adherence decreased over time after randomization, and the rate of decrease was higher in younger patients. The 14-day pre-randomization adherence was correlated with adherence throughout the study. Patients were also more adherent during working days compared to non-working days. Oldest patients took twice as long to complete PROMs throughout the study; however, the response time for all patients decreased during the first month of the study regardless of age. Response time increased 7days before and after the date of a scheduled clinic visit and when a patient-reported higher symptom burden. Detailed analyses of adherence and response time for daily PROMs in clinical trials can provide significant insights about trends of patient behavior in longitudinal clinical studies with high baseline adherence.

Is Limited English Proficiency Associated With Differences in Care Processes and Treatment Outcomes in Patients Undergoing Orthopaedic Surgery? A Systematic Review

Background Approximately 25 million people in the United States have limited English proficiency. Current developments in orthopaedic surgery, such as the expansion of preoperative education classes or patient-reported outcome collection in response to bundled payment models, may exacerbate language-related barriers. Currently, there are mixed findings of the associations between limited English proficiency and care processes and outcomes, warranting a cross-study synthesis to identify patterns of associations. Questions/purposes In this systematic review, we asked: Is limited English proficiency associated with (1) differences in clinical care processes, (2) differences in care processes related to patient engagement, and (3) poorer treatment outcomes in patients undergoing orthopaedic surgery in English-speaking countries? Methods On June 9, 2023, a systematic search of four databases from inception through the search date (PubMed, Ovid Embase, Web of Science, and Scopus) was performed by a medical librarian. Potentially eligible articles were observational studies that examined the association between limited English proficiency and the prespecified categories of outcomes among pediatric and adult patients undergoing orthopaedic surgery or receiving care in an orthopaedic surgery setting. We identified 10,563 records, of which we screened 6966 titles and abstracts after removing duplicates. We reviewed 56 full-text articles and included 29 peer-reviewed studies (outcome categories: eight for clinical care processes, 10 for care processes related to patient engagement, and 15 for treatment outcomes), with a total of 362,746 patients or encounters. We extracted data elements including study characteristics, definition of language exposure, specific outcomes, and study results. The quality of each study was evaluated using adapted Newcastle-Ottawa scales for cohort or cross-sectional studies. Most studies had a low (48%) or moderate (45%) risk of bias, but two cross-sectional studies had a high risk of bias. To answer our questions, we synthesized associations and no-difference findings, further stratified by adjusted versus unadjusted estimates, for each category of outcomes. No meta-analysis was performed. Results There were mixed findings regarding whether limited English proficiency is associated with differences in clinical care processes, with the strongest adjusted associations between non-English versus English as the preferred language and delayed ACL reconstruction surgery and receipt of neuraxial versus general anesthesia for other non-Spanish versus English primary language in patients undergoing THA or TKA. Limited English proficiency was also associated with increased hospitalization costs for THA or TKA but not opioid prescribing in pediatric patients undergoing surgery for fractures. For care processes related to patient engagement, limited English proficiency was consistently associated with decreased patient portal use and decreased completion of patient-reported outcome measures per adjusted estimates. The exposure was also associated with decreased virtual visit completion for other non-Spanish versus English language and decreased postoperative opioid refill requests after TKA but not differences in attendance-related outcomes. For treatment outcomes, limited English proficiency was consistently associated with increased hospital length of stay and nonhome discharge per adjusted estimates, but not hospital returns. There were mixed findings regarding associations with increased complications and worse postoperative patient-reported outcome measure scores. Conclusion Findings specifically suggest the need to remove language-based barriers for patients to engage in care, including for patient portal use and patient-reported outcome measure completion, and to identify mechanisms and solutions for increased postoperative healthcare use. However, interpretations are limited by the heterogeneity of study parameters, including the language exposure. Future research should include more-precise and transparent definitions of limited English proficiency and contextual details on available language-based resources to support quantitative syntheses. Level of Evidence Level III, therapeutic study

Socioeconomic Disparities in Online Patient Portal Utilization Among Total Knee Arthroplasty Recipients

BackgroundSince 2021, the Centers for Medicare and Medicaid Services have mandated that patients have open access to their medical records. Many institutions use online portals, which allow patients to access their health information and communicate with care teams. Our research aimed to evaluate demographic patterns for online patient portal utilization in patients undergoing total knee arthroplasty (TKA). Further, we assessed if and how portal engagement contributes to perioperative outcomes. MethodsThis study retrospectively reviewed primary and elective TKA from 2017 to 2022 at a single academic institution. Patients were stratified into two groups based on their online portal status: activated (A) or not-activated (NA). Baseline characteristics and postoperative outcomes were collected from the electronic medical record and compared. ResultsIn total, 10,995 patients were included: 8,330 (75.8%) were A and 2,625 (24.2%) were NA. The NA group was significantly older (P < 0.001); more likely to be Black (P < 0.001), women (P < 0.001), single/divorced/widowed (P < 0.001), non-English speaking (P < 0.001), and Medicare or Medicaid insured (P < 0.001); from zip codes with median incomes below $50,000 (P < 0.001), and more likely to be American Society of Anesthesiologists (ASA) class III or IV (P < 0.001). Patient-reported outcome measure (PROM) completion rates were significantly lower in the NA group (15.3 versus 47.7%, P < 0.001). Lengths of stay (LOS) were significantly higher in the NA group (2.7 versus 2.1 days, P < 0.001). The NA group was significantly more likely to be discharged to skilled nursing facilities (P < 0.001). Comparable rates of 90-day emergency department visits, readmissions, as well as 90-day and two-year revisions, were observed across groups. ConclusionThere are significant disparities in online portal activation status based on patient demographics. Patients who have activated portals had significantly higher PROM completion rates, shorter LOS, and higher rates of home discharge. Further research should determine which other factors may affect patient portal utilization and inform interventions to improve portal utilization among minority populations.

Implementing strategies to improve uptake of patient-reported outcome measures (PROMs) in gender-affirming care: a mixed-methods implementation study.

The Practical Guide to Implementing PROMs in Gender-Affirming Care (PG-PROM-GAC) is an evidence-based resource, which was developed in response to international calls for improved patient-reported outcome measure (PROM) implementation in gender-affirming care. The PG-PROM-GAC has the potential to improve PROM implementation; however, its real-world effectiveness has not yet been investigated. Investigate effectiveness and fidelity of three implementation strategies from the PG-PROM-GAC in a real-world gender clinic setting. Interrupted time series mixed-methods study investigating response rates to a PROM deployed alongside implementation strategies from the PG-PROM-GAC; and open-ended feedback on the fidelity and effectiveness of implementation strategies. Participants were recruited from a National Health Service (NHS) gender clinic. Eligible participants were being seen at an NHS gender clinic for an appointment during the study period, and were invited to participate in this study via email. Three implementation strategies from the PG-PROM-GAC deployed alongside a PROM. Response rates were calculated at 2-week intervals, in line with the deployment of each implementation strategy. Open-ended responses were thematically analysed by two researchers following guidance from implementation science and interpretation from Normalisation Process Theory. A total of 28 participants were included in this study with a mean (SD) age of 39 (17) years. In general, participants rated education material for PROMs as the most important for PROM implementation, and accessibility options for PROMs as the second most important. Response rates to PROM completion dropped as the study progressed, as the burden of reviewing implementation strategies increased. Results were used to construct recommendations for future PROM implementation efforts. The PG-PROM-GAC and implementation strategy materials developed from this study (ie, educational video on PROMs co-developed with key stakeholders) can be used by clinicians, researchers and policymakers to lead PROM implementation efforts in gender-affirming care.

225 SpineTrak: The First Randomized Controlled Trial Using the Apple Watch to Objectively Track Spine Surgical Patients

INTRODUCTION: Early mobilization after surgery is associated with reduced complications, shorter hospitalization, and improved psychological well-being. Current methods for evaluating spine surgery outcomes rely on subjective, patient-reported outcome measures (PROMs). Wearable activity monitors, including the Apple Watch (AW), allow for real-time tracking of objective activity metrics. METHODS: Eligibility: Adult patients undergoing elective spine surgery. Patients are randomized 1:1 to the intervention vs control group. All patients complete PROMs pre-operatively and at 6-weeks, 3-months, 6-months, and 1-year post-operatively. Only intervention patients receive AW and download a study-specific app to collect AW data. AW health measures are visualized in reports provided to patients and surgeons. RESULTS: To date, we have enrolled 200 patients (n=100 intervention; n=100 control). Among patients past 1-year post-operation (n=129), 74% reached the minimal clinically-important difference in improvement for ODI/NDI, SF-36 PCS, and/or EQ-VAS relative to pre-operation. Intervention patients (n=95) have worn AW 81.3%±21.1% of the days for 14.6±4.7 hours/day. At 6-weeks post-operation, 73% of patients responded that they were very satisfied with using the AW in their spine care. 61% found seeing their AW activity data helpful. 96% of neurosurgeons agreed that AW reports help them understand their patients’ recovery. Preliminary analyses of patient recovery profiles have predicted the requirement for revision surgery in some participants. CONCLUSIONS: Preliminary results indicate patients are compliant with wearing the AW, and both patients and surgeons are satisfied with its use in their spine care. Initial analyses show poor correlation between AW measures and PROMs, emphasizing the need for a metric that combines objective and subjective measures to better track spine surgery recovery.

Exploring patient reported quality of life in lung cancer patients: A qualitative study of patient-reported outcome measures.

Lung cancer is the leading cause of cancer-related death globally and provides a major disease burden likely to substantially impact quality of life (QoL). Patient-reported outcome measures (PROMs) have been identified as effective methods of evaluating patient QoL. Existing lung cancer-specific PROMs however have uncertain utility and minimal patient involvement in their design and development. This qualitative study aimed to evaluate the patient perspective of existing PROMs and to explore their appropriateness for population-based descriptions of lung cancer-related QoL. A descriptive qualitative study was conducted consisting of semi-structured interviews with 14 patients recruited from the Victorian Lung Cancer Registry and Alfred Hospital using purposive sampling. Interviews first explored the factors most important to lung cancer patients QoL, and second, patient's perspectives on the appropriateness of existing PROMs. Thematic analysis was used to develop themes, and content analysis was conducted to determine PROM acceptability. Five novel themes were identified by patients as being important impacts on QoL: Personal attitude toward the disease is important for coping; independence is valued; relationships with family and friends are important; relationships with treating team are meaningful; personal and public awareness of lung cancer is limited. These patient-identified impacts are poorly covered in existing lung cancer-specific PROMs. Patients welcomed and appreciated the opportunity to complete PROMs; however, they identified problems with existing PROMs relevance, tone, and formatting. Existing lung cancer PROMs poorly reflect the five themes identified in this study as most important to lung cancer patients QoL. This study reaffirms the need to review existing PROMs to ensure utility and construct validity. Future PROM development must engage key patient-generated themes and evolve to reflect the changing management and therapeutic landscape.

Disparities in Patient Reported Outcome Measure Completion Rates and Baseline Function in Newly Presenting Spine Patients.

Retrospective Review. The purpose of this study was to evaluate disparities in patient reported outcome measures (PROM) completion rates and baseline function scores among newly presenting spine patients. Prior studies have demonstrated that minority patients and those of low socioeconomic status may present with worse physical and mental health on PROMs. As PROMs are increasingly used in clinical care, research, and health policy, accurate assessment of health status among populations relies on the successful completion of PROM instruments. A retrospective review of 10,803 consecutive new patients presenting to a single multidisciplinary spine clinic from June 2020 to September 2022 was performed. Univariate statistics were performed to compare demographics between patients who did and did not complete PROMs. Multivariable analysis was used to compare PROM instrument completion rates by race, ethnicity, and Social Vulnerability Index (SVI) and baseline scores among responders. 68.4% of patients completed PROMs at the first clinic visit. After adjusting for age, sex, body mass index, and diagnosis type, patients of non-white race (OR=0.661, 95%-CI=0.599-0.729, P<0.001), Hispanic ethnicity (OR=0.569, 95%-CI=0.448-0.721, P<0.001), and increased social vulnerability (OR=0.608, 95%-CI=0.511-0.723, P<0.001) were less likely to complete PROMs. In the multivariable models, patients of non-white race reported lower levels of physical function (β=-6.5, 95%-CI=-12.4 to -0.6, P=0.032) and higher levels of pain intensity (β=0.6, 95%-CI=0.2-1.0, P=0.005). Hispanic ethnicity (β=1.5, 95%-CI=0.5-2.5, P=0.004) and increased social vulnerability (β=1.1, 95%-CI=0.4-1.8, P=0.002) were each associated with increased pain intensity. Among newly presenting spine patients, those of non-white race, Hispanic ethnicity, and with increased social vulnerability were less likely to complete PROMs. As these subpopulations also reported worse physical function or pain intensity, additional strategies are needed to better capture patient reported health status in order to avoid bias in clinical care, outcomes research and health policy.

Patient Experiences Completing Patient Reported Outcome Measures in Behavioral Health Within a Health Safety-Net Setting.

Measurement based care (MBC), a practice that uses patient reported outcome measures (PROMs), is not widely used in behavioral health settings and little is known about the patient experience with MBC in safety-net settings. This study aimed to understand patient experiences completing PROMs on paper when presenting to an outpatient, behavioral health setting within a public safety-net hospital. Semi-structured interviews were conducted with 22 participants in English and Spanish. Participants were 42 years old (SD = 12.7), mostly white (36.4%) and Black (31.8%). Thematic analysis was used to analyze findings. Overall, participants were engaged with PROMs and described them as helpful for themselves and their clinicians. Participants also expressed themes focused on PROMs user-friendliness, including formatting, time to complete measures, and participant characteristics such as attention and literacy. These findings are important to consider to ensure equitable access to MBC when implemented in behavioral health in the health safety-net setting.

Predictors of poor and excellent outcomes following reverse shoulder arthroplasty for glenohumeral osteoarthritis with an intact rotator cuff

BackgroundAs the indications for reverse total shoulder arthroplasty (RSA) continue to evolve, it has been more commonly utilized for the treatment of glenohumeral osteoarthritis with an intact rotator cuff (GHOA). Given the increased use of RSA for GHOA, it is important to identify factors influential of clinical outcomes. In this study, we sought to identify variables predictive of clinical outcomes following RSA for GHOA. MethodsPatients undergoing primary RSA for GHOA between 2015-2020 were retrospectively identified through a prospectively maintained, single surgeon registry. Eligible patients had complete patient-reported outcome measures and range of motion measurements with a minimum 2-year follow-up. Univariate analysis was utilized to compare characteristics and outcome measures of patients with poor and excellent outcomes, which was defined as postoperative American Shoulder and Elbow Surgeons (ASES) scores in the bottom and top quartiles, respectively. Multivariate linear regression was performed to determine factors independently predictive of postoperative ASES score. ResultsA total of 230 patients were included with a mean follow-up of 33.4 months (SD 13.2). The mean age of the study population was 71.9 (SD 6.1). Two hundred twenty-four patients (97.4%) surpassed the minimal clinically important difference and 209 patients (90.1%) achieved substantial clinical benefit for ASES score. Preoperative factors differing between the poor and excellent outcome groups were sex (male: poor 37.9%, excellent 58.6%; P = .041), opioid use (poor 24.1%, excellent 5.2%; P = .009), ASES score (poor 32.9, excellent 41.0; P = .011), and forward elevation (poor 92°, excellent 101°; P = .030). Linear regression demonstrated that Walch B3 glenoids (β 7.08; P = .010) and higher preoperative ASES scores (β 0.14; P = .025) were predictors of higher postoperative ASES score, while postoperative complications (β -18.66; P < .001) and preoperative opioid use (β -11.88; P < .001) were predictive of lower postoperative ASES scores. ConclusionOver 90% of patients who underwent RSA for GHOA with an intact rotator cuff experienced substantial clinical benefit. An unsurprising handful of factors were associated with postoperative clinical outcomes; higher preoperative ASES scores were slightly associated with higher postoperative ASES, whereas preoperative opioid use and postoperative complications were associated with lower postoperative ASES. Additionally, Walch glenoid type B3 was associated with higher postoperative ASES, indicating that patients with posterior glenoid defects are not predisposed to poor clinical outcomes following RSA. These results serve as a resource to improve preoperative patient counseling and manage postoperative expectations.

Assessing the impact of atrial fibrillation on symptoms and quality of life in hypertrophic cardiomyopathy.

In hypertrophic cardiomyopathy (HCM), atrial fibrillation (AF) has historically been regarded to have a deleterious impact on clinical course, strongly associated with progressive heart failure (HF) symptoms. However, there is a paucity of information regarding the impact of AF on HCM employing validated quality of life (QoL) surveys. Therefore, we evaluated the impact of AF on QoL utilizing patient reported outcome measures (PROMs). 218 consecutive HCM patients with or without AF at the Lahey HCM center in 2022 completed PROMs at their most recent visit evaluating HF (Kansas City Cardiomyopathy Questionnaire [KCCQ]) and AF symptoms (AF Effect on QoL [AFEQT]). Among the 218 patients, 50 (23%) had a history of AF and comprise the primary study cohort. AF was diagnosed at 55 ± 10 years of age, median of 5.5 years before PROM, with 66% of patients treated with a rhythm control strategy with antiarrhythmic drug and/or AF ablation. AFEQT indicated that 52% of patients experienced no or minimal AF-related disability, mild to moderate in 22%, and severe in 26%. There was no substantial difference in HCM phenotype in patients with no or minimal AF disability compared to those with severe disability. HF symptoms for most HCM patients with prior AF history was consistent with no or minimal (59%) or only mild (27%) disability as measured by KCCQ overall summary scores. In addition, with multivariate analysis, AF history was associated with less HF symptoms and improved QoL (OR 0.4, p = 0.02). In contrast to prior perceptions, HCM patients with prior AF history were less likely to incur HF symptoms impairing QoL compared to HCM patients without AF. After treatment, prior history of AF did not substantially impact current QoL. These data provide a realistic appraisal for the impact that AF has on HCM patients and also offers a measure of reassurance for this patient subgroup.

N29 Patient evaluation of digital IBD care in patient initiated follow up pathway using MyIBD Care app and home calprotectin test

Abstract Background Remote patient monitoring via web applications has been reported to have benefits with improvement in patient-reported quality of life, medication adherence, and decreased heath care costs. Mobile applications can be used for symptom reporting and this along with home biomarker testing can facilitate patient initiated follow up. There remain uncertainties in the acceptance of digital technologies in routine follow up care among IBD patients. We aimed to survey the pilot users of MyIBD care app and CalproSmart home calprotectin monitoring in an IBD cohort Methods Patients participating in the patient initiated follow up (PIFU) cohort in IBD Home digital care pathway at a tertiary IBD referral centre were included in this pilot survey before full roll out of the programme. Patients were given detailed written and electronic information about the pathway before signing up. Predefined survey questions were administered using electronic in app methodology. The survey questions were ranked in Likert scale from strongly agree, agree, neither agree or disagree, disagree and strongly disagree. Data reported as proportion of responses to each category. Results 132 surveys were collected and analysed. Ninety three percent of responses understood the rationale for their inclusion to the digital pathway. Confidence in contacting the IBD team through digital pathway was reported in 89% of responses and 68% felt more in control of own condition. Eight six percent of patients understood the requirements for completing patient reported outcome measures and home calprotectin test while in the pathway and also felt confident in taking home calprotectin test. However only 44% felt closer to the clinical care team with the pathway. Conclusion Digital pathway incorporating a patient initiated follow up and self-monitoring is acceptable to IBD patients in stable remission with high satisfaction scores in all domains

Feasibility of a cannabidiol-dominant cannabis-based medicinal product for the treatment of long COVID symptoms: A single-arm open-label feasibility trial.

To conduct a single-arm open-label feasibility trial of the safety and tolerability of a full-spectrum cannabidiol (CBD)-dominant cannabis-based medicinal product for treating the symptoms of long COVID. The treatment phase ran for a total of 21 weeks, followed by ~3weeks without the study drug. Participants received up to 3mL of MediCabilis 5% CBD Oil (50 mg CBD/mL, <2mg δ-9-tetrahydrocannabinol/mL) per day orally. Monthly patient-reported outcome measures of common symptoms and daily self-report of symptoms were collected via a smartphone app. Key measures of heart rate, activity, sleep and oxygen saturation were assessed using wearable technology. Twelve (1 male, 11 female) individuals diagnosed with long COVID were recruited into the trial. All participants adhered to the treatment protocol for the duration of the study and there were no serious adverse events. Response rates for the research assessments were high with over 90% completion of patient-reported outcome measures and daily self-report. The study drug was safe and well-tolerated, demonstrating feasibility of CBD-dominant cannabis-based medicinal products in individuals diagnosed with long COVID. However, there were limitations in research design related to recruitment strategy demonstrating a lack of feasibility in the approach implemented in this study. Future work with larger samples and incorporating a control group are required to test the efficacy of this treatment.

Completion of Patient-Reported Outcome Measures Improved With Use of a Mobile Application in Arthroplasty Patients: Results From a Randomized Controlled Trial

BackgroundThe collection of patient-reported outcome measures (PROMs) has historically been reported as costly and time-consuming, with low compliance rates that may impact reimbursement. Little research has reported the effects of mobile applications to support PROMs collection following arthroplasty. MethodsSecondary analysis of data from a multicenter randomized controlled trial was performed. Patients undergoing knee and hip arthroplasty were randomized to utilize a smartphone-based care management platform (app) for self-directed rehabilitation and completed joint-specific PROMs (Hip Dysfunction and Osteoarthritis Outcome Score, Joint Replacement or Knee Injury and Osteoarthritis Score, Joint Replacement) via the application at prescribed intervals or on paper during clinic visits. Control patients received practice standard of care, and completed PROMs via emailed hyperlink or during clinic visits following lower limb arthroplasty. Overall, 455 patients underwent knee arthroplasty procedures (245 control, 210 app group) and 380 underwent total hip arthroplasty (206 control, 174 app group). Compliance with expected PROMs completion was calculated through one year postoperatively. ResultsCompliance was higher in the app group preoperatively in both knee (98.1 versus 86.9%, P < .0001) and hip cohorts (96.0 versus 88.4%, P = .008), and postoperatively, including at one year (knees, 72.2 versus 53.7%, P < .0001; hips, 71.1 versus 49.2%, P < .0001). On log-binomial regressions, intervention arm was the strongest predictor of completion of all PROMs, where app users undergoing knee (Relative Risk 2.039, 95% confidence interval (CI) 1.595 to 2.607, P < .000) and hip arthroplasty (2.268 95% CI 1.742 to 2.953, P < .0001) were more likely to be compliant at all timepoints. The majority of patients in the app group, including those over 65 years of age, completed PROMs using the application as opposed to paper methods. ConclusionsA smartphone mobile application that engages patients during recovery after knee and hip joint arthroplasty improved compliance with completion of preoperative and postoperative PROMs compared to other electronic and paper methods.

Validation of Claims Data for Absorbing Pads as a Measure for Urinary Incontinence after Radical Prostatectomy, a National Cross-Sectional Analysis.

The use of healthcare insurance claims data for urinary incontinence (UI) pads has the potential to serve as an objective measure for assessing post-radical prostatectomy UI rates, but its validity for this purpose has not been established. The aim of this study is to correlate claims data with Patient Reported Outcome Measures (PROMs) for UI pad use. Patients who underwent RP in the Netherlands between September 2019 and February 2020 were included. Incontinence was defined as the daily use of ≥1 pad(s). Claims data for UI pads at 12-15 months after RP were extracted from a nationwide healthcare insurance database in the Netherlands. Participating hospitals provided PROMS data. In total, 1624 patients underwent RP. Corresponding data of 845 patients was provided by nine participating hospitals, of which 416 patients were matched with complete PROMs data. Claims data and PROMs showed 31% and 45% post-RP UI (≥1 pads). UI according to claims data compared with PROMs had a sensitivity of 62%, specificity of 96%, PPV of 92%, NPV of 75% and accuracy of 81%. The agreement between both methods was moderate (κ = 0.60). Claims data for pads moderately align with PROMs in assessing post-prostatectomy urinary incontinence and could be considered as a conservative quality indicator.

Optimising HIV care using information obtained from PROMs: protocol for an observational study

IntroductionSuccessful antiviral therapy has transformed HIV infection into a chronic condition, where optimising quality of life (QoL) has become essential for successful lifelong treatment. Patient-reported outcome measures (PROMs) can signal...

Comparative effectiveness of new treatment modalities for localized prostate cancer through patient-reported outcome measures

PurposeThere is scarce comparative effectiveness research on the new treatment modalities for localized prostate cancer. We aim to compare through Patient-Reported Outcome Measures (PROMs) the impact of active surveillance, robot-assisted radical prostatectomy (RARP), intensity-modulated radiotherapy (IMRT), and real-time brachytherapy, considering side effects (incontinence, irritative/obstructive urinary symptoms, sexual dysfunction and bowel symptoms) and physical and mental health. Materials and MethodsProspective cohort of men diagnosed with clinically localized prostate cancer (age 50-75y, T1-T2, and low risk including Gleason 3 + 4 in T1c) from 18 Spanish hospitals, followed up to 24 months. Treatment decisions were jointly made by patients and physicians (n = 572). The Expanded Prostate cancer Index Composite (EPIC-26) and Short-Form 36 (SF-36v2) were administered through telephone interviews before and three, six, 12, and 24 months after treatment. To account for correlation among repeated measures, generalized estimating equation models were constructed. All analyses were performed with propensity score weights to solve treatment selection bias. ResultsThe PROMs completion rate at 24 months was 95.0 %. Active surveillance entails the fewest side effects, but with significant sexual (0.4 standard deviations [SD], p < 0.001) and physical health deterioration (0.5 SD, p < 0.001); and moderate mental health improvement (0.4 SD, p = 0.001) at 24 months. Compared with active surveillance, RARP presented greater urinary incontinence (p = 0.030), and IMRT and real-time brachytherapy worse bowel symptoms (p = 0.027 and p = 0.007) at 24 months. ConclusionsMost side effects of the new treatment modalities seem to be limited to short-term deteriorations, except for moderate-large urinary incontinence in patients who had undergone RARP and moderate bowel deterioration in patients treated with IMRT or with real-time brachytherapy. Furthermore, patients under active surveillance, IMRT, and real-time brachytherapy showed a moderate improvement in mental health.

Safety and upscaling of remote consulting for long-term conditions in primary health care in Nigeria and Tanzania (REaCH trials): stepped-wedge trials of training, mobile data allowance, and implementation

In-person health care poses risks to health workers and patients during pandemics. Remote consultations can mitigate these risks. The REaCH intervention comprised training and mobile data allowance provision for mobile phones to support remotely delivered primary care in Africa compared with no training and mobile data allowance. The aim of this study was to estimate the effects of REaCH among adults with non-communicable diseases on remote and face-to-face consultation rates, patient safety, and trustworthiness of consultations. In these two independent stepped-wedge cluster randomised controlled trials, we enrolled 20 primary care clusters in each of two settings (Oyo State, Nigeria, and Morogoro Region, Tanzania). Eligible clusters had 100 or more patients with diabetes, hypertension, and cardiovascular or pulmonary disease employing five health workers. Clusters were computer-randomised to one of ten (Nigeria) or one of seven (Tanzania) sequences to receive the REaCH intervention. Only outcome assessors were masked. Primary outcomes were consultation, prescription, and investigation rates, and trustworthiness collected monthly for 12 months (Nigeria) and 9 months (Tanzania) from open cohorts. Ten randomly sampled consulting patients per cluster-month completed patient reported outcome measures. This trial was registered with ISRCTN, ISRCTN17941313. Overall, 40 clusters comprising 8776 (Nigeria) and 3246 (Tanzania) patients' open cohort data were analysed (6377 [72·7%] of 8776 females in Nigeria, and 2235 [68·9%] of 3246 females in Tanzania). The mean age of the participants was 55·3 years (SD 13·9) in Nigeria and 59·2 years (14·2) in Tanzania. In Nigeria, no evidence of change in face-to-face consulting rate was observed (rate ratio [RR] 1·06, 95% CI 0·98 to 1·09; p=0·16); however, remote consultations increased four-fold (4·44, 1·34 to >10; p=0·01). In Tanzania, face-to-face (0·94, 0·61 to 1·67; p=0·99) and remote consulting rates (1·17, 0·56 to 5·57; p=0·39) were unchanged. There was no evidence of difference in prescribing rates (Nigeria: 1·05, 0·60 to 1·14; p=0·23; Tanzania: 0·92, 0·60 to 1·67; p=0·97), investigation rates (Nigeria: 1·06, 0·23 to 2·12; p=0·49; Tanzania: 1·15, 0·35 to 1·64; 0·58) or trustworthiness scores (Nigeria: mean difference 0·05, 95% CI -0·45 to 0·42; p=0·89; Tanzania: 0·07, -0·15 to 0·76; p=0·70). REaCH can be implemented and could improve intervention versus control health-care access. Remote consultations appear safe and trustworthy, supporting universal health coverage. The UK Research and Innovation Collective Fund. For the Swahili and Yoruba translations of the abstract see Supplementary Materials section.

Looking Beyond the Chair: Psycho-Perceptual Predictors of Sexual Distress and Sexual Satisfaction in Individuals with Spinal Cord Injury

ABSTRACT Despite a large body of biomedical research, little is known about the psychological and perceptual predictors of sexual satisfaction (SS) and sexual distress (SD) post spinal cord injury (SCI). Guided by a bio-psycho-perceptual framework, this cross-sectional research aimed at assessing SS and SD in a large SCI sample using validated patient-reported outcome measures (PROM). Significant correlates and predictors of SS and SD were also identified. Ninety-one men and women with SCI completed PROMs of SS and SD, as well as psychological (mood, sexual and body esteem) and perceptual (interoceptive awareness, trait mindfulness, sexual mindfulness) factors. Neurological profiles were also assessed, along with experience of orgasm. Correlates of SS and SD were first identified using Pearson’s correlations, then multiple hierarchical regression models were computed to isolate predictors. Orgasm experience and psychological factors emerged as moderate correlates of both SS and SD, while neurological factors did not. Interoceptive awareness and trait mindfulness showed weak associations with SD and none with SS. Among the tested predictors, experience of orgasm emerged as the strongest for SS (β = -.29, p < .01), followed by mood, which predicted SS and SD. Sexual and body esteem was predictive of SD only. In sexually active participants, sexual mindfulness predicted both SS (β = 0.55, p < .001) and SD (β = -0.56, p < .001) above and beyond all other variables. This study reveals unique aspects of SS and SD postinjury and supports further consideration of psychological and perceptual dimensions of SCI sexuality in rehabilitation research.