Nevin Manimala

JMIR Hum Factors. 2025 Aug 15;12:e65569. doi: 10.2196/65569.

ABSTRACT

BACKGROUND: Informed consent (IC) is a cornerstone of ethical clinical research, yet comprehension gaps persist. The i-CONSENT guidelines aim to improve IC materials by enhancing clarity, accessibility, and tailoring them to the needs of diverse populations. This study evaluates the effectiveness of electronic IC (eIC) materials developed under these guidelines for 3 target populations-minors, pregnant women, and adults-across Spain, the United Kingdom, and Romania.

OBJECTIVE: The primary aim of this study is to assess participants’ comprehension of and satisfaction with eIC materials tailored to their specific needs. The secondary objectives are to identify demographic predictors of comprehension, evaluate the cross-cultural applicability of materials, and explore format preferences.

METHODS: A cross-sectional study was conducted with 1757 participants (620 minors, 312 pregnant women, and 825 adults), who reviewed eIC materials through a digital platform offering layered web content, narrative videos, printable documents, and infographics. Materials were co-designed using participatory methods, including design thinking sessions with minors and pregnant women, and online surveys with adults. Comprehension was assessed using an adapted version of the Quality of the Informed Consent questionnaire. Objective comprehension (part A) was categorized as low (<70%), moderate (70%-80%), adequate (80%-90%), or high (≥90%). Subjective comprehension (part B) was measured using a 5-point Likert scale. Satisfaction was evaluated through Likert scales and usability questions, with scores ≥80% considered acceptable. Multivariable regression models were applied to identify predictors of comprehension.

RESULTS: Objective comprehension exceeded 80% across all groups: minors (mean 83.3, SD 13.5), pregnant women (mean 82.2, SD 11.0), and adults (mean 84.8, SD 10.8). Women/girls outperformed men/boys (β=+.16 to +.36). Generation X adults scored higher than millennials (β=+.26, P<.001), while prior trial participation was associated with lower comprehension scores (β=-.47 to -1.77). Among minors, compared with participants from Spain with no previous clinical trial experience, comprehension was significantly lower in Spain (P=.03), Romania (P<.001), and the United Kingdom (P<.001). Format preferences varied: 382 out of 620 (61.6%) minors and 152 out of 312 (48.7%) pregnant women preferred videos, whereas 452 out of 825 (54.8%) adults favored text (P<.001). Satisfaction rates surpassed 90% in all groups (minors, 604/620, 97.4%; pregnant women, 303/312, 97.1%; and adults, 804/825, 97.5%), with 777 out of 825 (94.2%) adults also indicating that the materials facilitated understanding. While translated materials maintained high efficacy across countries, comprehension scores in Romania were lower among participants with lower educational levels (β=-1.05, P=.001). Materials cocreated in Spain were effective across countries but yielded higher comprehension within the original target population.

CONCLUSIONS: eIC materials developed following the i-CONSENT guidelines achieved high levels of comprehension and satisfaction across diverse populations, demonstrating scalability for multinational trials. Cocreation and multimodal design effectively addressed participant preferences; however, cultural adaptation remained crucial for optimizing outcomes. The negative impact of prior trial participation highlights the need for tailored engagement strategies for returning participants. Future research should explore regional disparities, evaluate interventions for overconfident returning participants, and validate these tools across broader cultural contexts.

PMID:40815855 | DOI:10.2196/65569

Am J Sports Med. 2025 Aug 15:3635465251360794. doi: 10.1177/03635465251360794. Online ahead of print.

ABSTRACT

BACKGROUND: Posttraumatic osteoarthritis (PTOA) often follows anterior cruciate ligament reconstruction (ACLR), especially when combined with meniscal surgery (ACLR+M). The mechanisms underlying development of PTOA remain unclear, including the early mechanical and compositional changes after surgery that potentially lead to irreversible cartilage degeneration.

PURPOSE: To investigate the early effects of ACLR+M on joint arthrokinematics using dual-fluoroscopy with model-based tracking and cartilage composition using quantitative magnetic resonance imaging (qMRI).

STUDY DESIGN: Controlled laboratory study.

METHODS: Twelve participants who underwent ACLR+M were assessed 1 to 2 years after surgery. Dual-fluoroscopy with model-based tracking was used to quantify 6 degrees of freedom joint movements during walking and jogging. Arthrokinematics were assessed at 6% and 3% of the gait cycle for walk and jog, respectively, using magnetic resonance-based cartilage models. qMRI measured T1ρ relaxation times in the weightbearing tibial and femoral cartilage of both medial and lateral compartments.

RESULTS: Reconstructed knees showed increased anterior and lateral tibial translation during walking and jogging, larger abduction rotation during jogging, and a posterior shift of the tibiofemoral contact points on the tibia during walking relative to contralateral knees. The cartilage contact overlap area was increased in the medial compartment during walking in the reconstructed knee compared with the contralateral knee. Higher T1ρ relaxation times were observed in both medial and lateral femoral cartilages of the reconstructed knee compared with the contralateral knee. No correlation was found between reconstructed side-to-normal side differences in arthrokinematics and T1ρ relaxation times.

CONCLUSION: These findings indicate early side-to-side differences in arthrokinematics and cartilage composition 1 to 2 years after ACLR with meniscal surgery, but patients with bigger side-to-side differences in arthrokinematics did not demonstrate bigger side-to-side differences in cartilage composition.

CLINICAL RELEVANCE: Understanding mechanical and compositional differences after surgery, as well as the relationship between mechanics and composition, provides insight into their roles in PTOA initiation. This study underscores how ACLR with meniscal surgery affects tibiofemoral joint arthrokinematics and cartilage composition via qMRI. Results may provide insights into the early stages of PTOA and could inform postoperative strategies and/or targets for rehabilitation.

PMID:40815853 | DOI:10.1177/03635465251360794

Am J Sports Med. 2025 Aug 15:3635465251358487. doi: 10.1177/03635465251358487. Online ahead of print.

ABSTRACT

BACKGROUND: Despite advancements in surgical techniques, the recurrence rate of anterior cruciate ligament (ACL) rupture after reconstruction remains between 2% and 20%. An increased posterior tibial slope (PTS) is associated with higher ACL rupture and reconstruction failure rates.

HYPOTHESIS: Anterior closing wedge high tibial osteotomy (ACW-HTO) combined with ACL reconstruction will result in a lower rate of failure and better functional outcomes for patients with excessive PTS.

STUDY DESIGN: Case series; Level of evidence, 4.

METHODS: The study was conducted on patients who underwent ACW-HTO combined with ACL reconstruction between 2000 and 2020. Inclusion criteria included knee anterior and lateral rotatory instability, ACL rupture, and PTS (≥12°). Exclusion criteria included follow-up <2 years, normal tibial slope, multiligament knee injuries, significant valgus/varus deformity, and Kellgren-Lawrence stage >2 symptomatic osteoarthritis. Primary outcome measures included the International Knee Documentation Committee (IKDC) score, Tegner activity scale score, Self Knee Value, patient satisfaction, and laxity measurements. Radiographic assessments measured PTS on true lateral views of the entire tibia. The surgical goal was to achieve a PTS between 4° and 10°. A subgroup analysis was performed according to the time from surgery (±10 years) and the postoperative correction of the PTS (4°-10°).

RESULTS: The study included 27 patients (23 men, 4 women), with a mean age of 33.4 ± 8.5 years and a mean follow-up of 7.7 ± 5.2 years. No graft failures were reported. Significant improvement was observed in side-to-side anterior laxity (9.9 ± 3.1 mm preoperatively to 1.4 ± 1.2 mm postoperatively; P < .001). The mean IKDC score improved from 59.3 ± 23.0 to 75.8 ± 24.4 (P = .037), and the Tegner activity scale score improved from 3.6 ± 2.6 to 5.9 ± 2.9 (P = .037). The mean PTS decreased from 15.9° ± 2.8° to 5.5° ± 3.7° postoperatively (P < .0001). Overall, 25.9% of patients required reoperation, mainly for hardware removal. There were no statistical differences in both subgroup analysis concerning patient-reported outcome measures and satisfaction.

CONCLUSION: ACW-HTO combined with ACL reconstruction shows promising long-term outcomes, significantly reducing PTS and improving knee stability and function with an acceptable complication rate.

PMID:40815851 | DOI:10.1177/03635465251358487

Am J Sports Med. 2025 Aug 15:3635465251362504. doi: 10.1177/03635465251362504. Online ahead of print.

ABSTRACT

BACKGROUND: Treating lateral meniscal injuries in elite athletes is challenging because of the high demands on knee function and the need for rapid return to play (RTP). Although meniscal repair is often recommended, data are lacking that compare outcomes of partial meniscectomy and repair in elite athletes with isolated lateral meniscal tears.

PURPOSE: To evaluate subsequent surgery after the treatment of isolated lateral meniscal tears and to compare RTP, career longevity, and performance level between meniscal repair and partial meniscectomy in professional soccer players.

STUDY DESIGN: Retrospective case comparative study; Level of evidence, 3.

METHODS: A retrospective review was conducted on a consecutive series of professional soccer players who underwent partial meniscectomy or meniscal repair for isolated lateral meniscal tears between January 2011 and September 2022 with a minimum follow-up of 2 years. The groups were compared for age, tear configuration, tear location, subsequent surgery, RTP rates, career longevity, and performance level. Repair failure was defined as the need for additional surgery to address a recurrent or persistent meniscal tear after the initial repair or not returning to play. Cox proportional hazards models were used to evaluate career longevity based on treatment modality, adjusting for age.

RESULTS: This study included 89 professional soccer players (mean ± SD age, 23.2 ± 5.2 years) who underwent primary isolated lateral meniscal surgery: 49 (55.1%) had partial meniscectomy and 40 (44.9%) underwent repair. Subsequent surgery was required in 15 players (16.9%), with no significant difference between groups (12.2% for meniscectomy vs 22.5% for repair; P = .258). Meniscal repair failure occurred in 6 players (15%), with a mean time to failure of 8.6 ± 8.2 months. RTP was achieved by 98.9% of the total cohort, but meniscectomy led to faster RTP (median, 4 months; range, 0.5-20) than repair (median, 6 months; range, 3-22; P < .001). No significant difference was found in early retirement risk (hazard ratio, 0.65; 95% CI, 0.31-1.3; P = .237) when adjusted for age. At 5 years, retirement rates were 28% (repair) and 32.6% (meniscectomy; P = .789), rising to 45.5% and 58.3% at 10 years (P = .716). Most players (70% for repair and 89% for meniscectomy) returned to the same or higher league, declining to 48.6% and 51.1% at 2 years and 36% and 20.9% at 5 years (P > .05).

CONCLUSION: Partial meniscectomy and repair achieve high RTP rates, with meniscectomy allowing a faster RTP. While 15% of meniscal repairs failed, rates of subsequent surgery and 5- and 10-year professional sport participation did not differ significantly from those after partial meniscectomy, although the lack of statistical significance may be due to the limited sample size. Hence, partial meniscectomy for isolated lateral meniscal tears may be acceptable in carefully selected patients with proper management and recovery.

PMID:40815849 | DOI:10.1177/03635465251362504

Am J Sports Med. 2025 Aug 15:3635465251362501. doi: 10.1177/03635465251362501. Online ahead of print.

ABSTRACT

BACKGROUND: The revision rate due to postoperative instability after anterior cruciate ligament reconstruction (ACLR) remains at 4% to 25%. The physiological mechanisms of tendon-bone healing involve intricate processes, particularly neovascularization and osseointegration at the bone tunnel interface. Currently, no standardized noninvasive method exists to comprehensively evaluate tendon-bone healing progression.

PURPOSE: To investigate longitudinal changes in bone mineral density (BMD) at tendon-bone interface (TBI) sites after ACLR and evaluate their associations with graft maturation and clinical outcomes.

STUDY DESIGN: Cohort study; Level of evidence, 2.

METHODS: This prospective study enrolled 36 consecutive patients undergoing arthroscopic all-inside single-bundle ACLR using a hamstring autograft between October 2020 and October 2021. Quantitative CT assessments using phantom-less software measured BMD at femoral (anterior, posterior, proximal, and distal) and tibial (anterior, posterior, medial, and lateral) tunnel regions (entry/mid/exit segments) at postoperative day 1 (baseline), 6 months, 1 year, and 2 years. Graft maturity was evaluated via the signal-to-noise quotient (SNQ) on magnetic resonance imaging at 1- and 2-year follow-ups.

RESULTS: Significant increases in volumetric BMD (vBMD) were observed at different segments and orientations in the femoral and tibial tunnel regions. From baseline to 6 months, femoral tunnel segments showed increases ranging from +36.1% to +52.7%, and tibial segments from +44.9% to +57.5% (P < .05). From 6 months to 1 year, additional gains were observed in most regions (femoral: +22.4% to +26.1%; tibial: +15.8% to +19.2%; P < .05). However, changes between 1 and 2 years were generally smaller (femoral: +8.6% to +12.5%; tibial: +6.9% to +19.2%) and not statistically significant in all segments and orientations (P > .05). Graft SNQ values demonstrated regional variations, with femoral tunnel areas showing higher values than tibial regions at both the 1-year and 2-year assessments. No significant changes occurred between 1- and 2-year. Negative correlations emerged between BMD changes and SNQ values in corresponding regions (femoral: r = -0.477 to -0.542; tibial: r = -0.427 to -0.493; P < .05).

CONCLUSION: Within 2 years after ACLR, the BMD at the TBI of both femoral and tibial bone tunnels demonstrates a progressive increase. The BMD at these TBIs shows positive correlations with graft maturity at corresponding anatomic locations, providing a valuable reference for clinical assessment of tendon-bone healing.

PMID:40815846 | DOI:10.1177/03635465251362501

J Am Acad Orthop Surg. 2025 Aug 14. doi: 10.5435/JAAOS-D-25-00597. Online ahead of print.

ABSTRACT

BACKGROUND: Total ankle arthroplasty (TAA) has been increasingly used to treat end-stage of ankle arthritis, leading to a corresponding rise in revision TAA (rTAA). Given the greater complexity of rTAA procedures, assessing whether early postoperative complications differ from primary TAA and whether current reimbursement models appropriately account for this complexity remains essential.

METHODS: Using the National Surgical Quality Improvement Program database from 2013 to 2022 and current procedural terminology codes, patients undergoing TAA or rTAA were identified. Demographics, comorbidities, and 30-day early postoperative complications were compared. Compensation metrics included surgical time, work relative value units (wRVU) per hour (wRVU/hr), and reimbursement rate ($/hr). Statistical analyses included chi square tests, unpaired t-tests, and analysis of covariance adjusting for age and postoperative complication rates.

RESULTS: A total of 2,418 TAA and 276 rTAA cases were identified. No statistically notable differences were noted in 30-day mortality, readmission, or revision surgery rates. Secondary complications were similar between groups, except for cardiac arrest, which was higher in the rTAA cohort (0.36% vs. 0%, P = 0.003), although the absolute incidence was low. rTAA was associated with more concomitant procedures (1.10 vs. 0.79, P = 0.001), longer surgical time (166.78 vs. 151.45 minutes, P = 0.003), and higher mean wRVU (20.98 vs. 17.04, P < 0.001), wRVU/hr (9.63 vs. 7.57, P < 0.001), and reimbursement rate/hr ($311.65/hr vs. $244.78/hr, P < 0.001).

CONCLUSION: No notable differences were found in early postoperative outcomes between TAA and rTAA, indicating comparable early postoperative safety. rTAA procedures received appropriately higher compensation metrics, aligning with their greater surgical demands. These findings support the adequacy of current reimbursement models for rTAA in accounting for the increased complexity and surgical time associated with rTAA compared with primary TAA.

LEVEL OF EVIDENCE: Level III.

PMID:40815842 | DOI:10.5435/JAAOS-D-25-00597

JMIR Cancer. 2025 Aug 15;11:e68572. doi: 10.2196/68572.

ABSTRACT

BACKGROUND: Cervical cancer is a common cause of death among women globally, particularly in Africa. Each year, an average of 7093 women in Nigeria die from cervical cancer. Clinical practice guidelines developed by the Society of Obstetrics and Gynecology of Nigeria (SOGON) aim to prevent cervical cancer. However, the extent of their adoption among gynecologists remains unclear.

OBJECTIVE: This study aimed to assess Nigerian gynecologists’ awareness, understanding, and incorporation of the SOGON clinical practice guidelines for cervical cancer prevention in their clinical practices.

METHODS: A convergent parallel mixed methods design was used. Quantitative data were collected via a web-based and in-person survey distributed to gynecologists attending the 57th SOGON Annual General Meeting in Kano, Nigeria (November 2023). A total of 105 gynecologists completed the survey (response rate: 80%). Key informant interviews (n=12) were conducted to provide qualitative insights. Quantitative data were analyzed using descriptive and inferential statistics, including logistic regression (P<.05). Thematic analysis was applied to qualitative data.

RESULTS: Among the 105 respondents (mean age 50, SD 8.3 y and mean postresidency practice 12, SD 9.4 y), 98 (93.3%) reported awareness of the SOGON guidelines, and 74 (70.5%) endorsed their importance for cervical cancer prevention. However, only 58.1% (61/105) of the respondents reported integrating the guidelines into routine clinical practice. Barriers to implementation included limited training (71/105, 67.6%), resource constraints (64/105, 60.9%), and lack of institutional support (57/105, 54.3%). Qualitative data reinforced the need for more tailored guidelines for high-risk populations and rural settings. In addition, 70.5% (74/105) of the respondents advocated for a participatory guideline review process to ensure relevance and feasibility.

CONCLUSIONS: While awareness of the SOGON guidelines is high, their integration into clinical practice remains suboptimal due to systemic barriers. Strengthening training programs, improving access to resources, and enhancing institutional support are critical to increasing guideline adoption and advancing cervical cancer prevention efforts in Nigeria.

PMID:40815838 | DOI:10.2196/68572

JMIR Public Health Surveill. 2025 Aug 15;11:e70182. doi: 10.2196/70182.

ABSTRACT

BACKGROUND: Financial barriers to accessing obstetric care persist in many low-resource settings. With increasing use of mobile phones, mobile money services appear as a promising tool to address this concern. Maternal health care is particularly suitable for a savings program using mobile money due to the predictable timing and costs of delivery. The mobile money-based Mobile Maternal Health Wallet (MMHW) intervention aimed to ease the burden of out-of-pocket expenses related to maternal health care by providing an accessible savings tool.

OBJECTIVE: This study aimed to assess the impact of the MMHW on maternal and neonatal health outcomes.

METHODS: We used a stratified cluster-randomized trial to assess the impact of the MMHW on maternal and neonatal health outcomes in the Analamanga region of Madagascar. All 63 eligible public sector primary care health facilities (Centres de Santé de Base [CSBs]) within 6 strata were randomized to either receive the intervention or not. We estimated intention-to-treat effects and contamination-adjusted effects following an instrumental variable approach. The primary outcomes included (1) delivery at a health facility, (2) antenatal care visits, and (3) total health care expenditure. Between March 2022 and December 2022, a total of 6483 women who had been pregnant between July 2020 and December 2021 were surveyed.

RESULTS: Among women in catchment areas of treated CSBs, 38.79% (1297/3344) had heard of the MMHW, and 37.42% (485/1296) of them registered for the tool. There was considerable variation in uptake across treated CSBs. Descriptively, women in the catchment areas of treated CSBs were more likely to deliver in a facility and had more antenatal care visits and higher total health expenditures compared to women in control CSB catchment areas in the intention-to-treat and contamination-adjusted analyses. However, none of the effects were statistically significant.

CONCLUSIONS: While this study did not identify a statistically significant impact, the estimated contamination-adjusted effects suggest that the MMHW has potential to improve access to maternal care for women who are receptive to such a mobile money-based savings tool. Estimated population-level effects were much smaller, and this study was underpowered to detect such effects due to lower-than-anticipated uptake of the intervention.

TRIAL REGISTRATION: German Clinical Trials Register DRKS00014928; https://www.drks.de/search/de/trial/DRKS00014928.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-021-05694-8.

PMID:40815834 | DOI:10.2196/70182

J Clin Rheumatol. 2025 Aug 15. doi: 10.1097/RHU.0000000000002275. Online ahead of print.

ABSTRACT

BACKGROUND/OBJECTIVE: The DANGER (Death in ANCA Glomerulonephritis-Estimating the Risk) score was developed to assess mortality risk in patients with antineutrophil cytoplasmic antibody-associated vasculitis (AAV). This study aimed to validate score in a cohort of Latin American patients.

METHODS: This cohort study included patients with AAV evaluated between 2000 and 2022. The DANGER score was calculated, and its performance evaluated using the c-statistic and time-dependent area under the receiver operating characteristic curve. Multivariable Cox regression analysis was performed to identify variables that could enhance the score’s predictive accuracy.

RESULTS: We included 154 patients, 104 (68%) female, with a median age of 52 years (interquartile range [IQR], 38-61 years) and creatinine of 2.5 mg/dL (IQR, 1.7-2.5 mg/dL). Over a median follow-up of 74 months (IQR, 32-126 months), 24 patients died, with mortality rates of 6.5%, 8.6%, and 11.9% at 1, 2, and 5 years, respectively. The leading cause of death was infection. Mortality rates at 1 and 3 years in the low-, intermediate-, and high-risk categories were 1.0% and 3.1%, 14.0% and 16.8%, and 40.0% and 70.0%, respectively. The overall c-statistic for the DANGER model was 0.81 (95% confidence interval [CI], 0.73-0.90), with areas under the receiver operating characteristic curve of 0.81 (95% CI, 0.70-0.91), 0.78 (95% CI, 0.67-0.89), and 0.80 (95% CI, 0.70-0.90) at 1, 3, and 5 years, respectively. A revised model incorporating age, creatinine, C-reactive protein, and pulmonary involvement had a c-statistic of 0.86 (95% CI, 0.79-0.94).

CONCLUSIONS: The DANGER score has good predictive accuracy for mortality in AAV patients with kidney involvement. In younger patients, the score may be modified to include variables such as C-reactive protein and severe pulmonary involvement to enhance its performance.

PMID:40815813 | DOI:10.1097/RHU.0000000000002275

Blood Adv. 2025 Aug 15:bloodadvances.2025016670. doi: 10.1182/bloodadvances.2025016670. Online ahead of print.

ABSTRACT

Pediatric Hispanic and Black patients with newly diagnosed B-acute lymphoblastic leukemia (B-ALL) experience worse overall survival (OS). We hypothesized that differential outcomes by race and ethnicity following relapse may contribute to disparities. We examined 2,053 patients with ALL enrolled on frontline Children’s Oncology Group trials from 1996-2014 who relapsed. We assessed association of race and ethnicity, disease characteristics, and socioeconomic status with relapse survival predictors and post-relapse OS. For non-infant B-ALL, post-relapse OS (p=0.002) and disease-related prognosticators such as time-to-relapse (p=0.0002) differed by race and ethnicity. After adjusting for disease and patient characteristics, the OS association with overall race and ethnicity was attenuated, and lost statistical significance; Hispanic ethnicity specifically remained associated with worse OS (hazard ratio, HR=1.19, 95% confidence interval, CI 1.01-1.41). Patients from highest annual median household income ZIP codes (>$85,000, ~highest quartile of patients) had better 5-year OS compared to those from the lowest (<$50,000, HR=0.79, 95%CI 0.63-0.99). Non-Hispanic Black and Hispanic patients more commonly lived in lower income ZIP codes. For T-ALL, race, ethnicity and socioeconomic status were not associated with OS. Worse post-relapse outcomes among racial and ethnic minority patients are largely driven by prevalence of adverse disease-related factors at time of relapse, with a persistent disparity observed in Hispanic patients. The greatest impact in decreasing racial and ethnic B-ALL outcome disparities may come through targeting frontline treatment interventions to address increased relapse among Black and Hispanic patients, as well as developing and enabling equitable access to effective relapse treatments such as novel immunotherapies. (CCG 1991, POG 9404, POG 9407, POG 9904, POG 9905, POG 9906, COG AALL0232, COG AALL0331, COG AALL0434, COG AALL0631, COG AALL07P4, COG AALL08P1).

PMID:40815811 | DOI:10.1182/bloodadvances.2025016670