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Rationale & Objective: To address the need for an intradialytic exercise program that is easily delivered in clinical setting, engaging and scalable, we developed a novel COMprehensive EXercise (COMEX) program based on input from patients receiving hemodialysis (HD), dialysis staff members and nephrologists. The objective of this study was to determine the feasibility, safety, and acceptance of COMEX during HD. Study Design: Single-arm prospective pilot feasibility study. Setting & Participants: Seventeen patients receiving in-center HD. Intervention: Three-month participation in the COMEX program, which included video-based dialysis chair exercises (aerobic and resistance) integrated with educational and motivational components. Outcomes: Data on recruitment, adherence, safety and acceptability were collected. Additional assessments were performed to evaluate changes in physical functioning, patient-reported symptoms, and objectively measured sleep and physical activity. We also examined the feasibility of obtaining skeletal muscle biopsies and blood samples to explore molecular mechanisms of muscle atrophy and to assess platelet mitochondrial function and adaptation to exercise during HD. Results: Thirteen of the 17 (76%) participants completed the 3-month intervention. The mean participant age was 63.6 ± 15.1 years. In total, 46% of participants were males, and 55% were White. The mean body mass index was 38.7 ± 11.6 kg/m2. There were no reported adverse effects, and the adherence rate to exercise sessions was high with 88% of the sessions completed. Patient satisfaction was high, as 100% of the patients would recommend the program to other dialysis patients. It was feasible to collect data on physical functioning, patient-reported symptoms, and objective sleep and physical activity and to obtain muscle biopsies and blood samples. Limitations: Small sample size, lack of an onsite exercise professional, and technological issues with telemedicine behavioral motivation. Conclusions: The COMEX intradialytic exercise intervention is safe and acceptable to patients, and outcome measures were feasible to obtain. Future studies should consider including exercise professionals to facilitate progression through a personalized exercise protocol. Funding Source: This work is supported by pilot award from P30 DK079307 (PI, Jhamb). Trial Registration: ClinicalTrials.gov, NCT03055299. Plain-Language Summary: We tested a new COMprehensive EXercise (COMEX) program to deliver exercise during dialysis. This 3-month program included video-based dialysis chair exercises (aerobic and resistance) integrated with educational and motivational components. Our study shows COMEX was feasible, had high satisfaction and adherence, and was safe. It was feasible to collect data on physical functioning, patient-reported symptoms, and objective sleep and physical activity and to obtain muscle biopsies and blood samples. Future studies should consider including exercise professionals to facilitate progression through a personalized exercise protocol.

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OBJECTIVES: To identify patient-centered domains with long-term relevance to people with rheumatoid arthritis (RA). METHODS: We conducted semi-structured individual cognitive interviews of patients with RA with at least five years of disease duration, sampled from five different countries (United States, Italy, Spain, Mexico, and Argentina). Participants were encouraged to discuss their long-term concerns regarding RA. Interviews were transcribed and analyzed using qualitative content analysis within a constructivist/interpretivist theoretical framework. RESULTS: Twenty-eight participants were interviewed, 24 were women. Six main themes, representing important aspects of the daily life of people with RA were generated: (i) Living with symptoms and functional limitations, (ii) Lack of participation, (iii) Partner and family issues, (iv) Risk of damage to vital organs, (v) Coping strategies, and (vi) Healthcare concerns, primarily expressed by participants from non-European countries lacking universal healthcare coverage. In addition, participants discussed the importance of contextual factors and how they impact long-term outcomes. These included attitudes towards disease, social support, or financial burdens. CONCLUSIONS: We identified six domains of importance to people with RA that are seldom measured in longitudinal registries and should be considered in patient-centered longitudinal studies.

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OBJECTIVES: The study was aimed at comparing implants installed with guided and conventional surgery. MATERIAL AND METHODS: Twenty-nine total edentulous patients were selected, and maxillary contralateral quadrants were randomly assigned to static computer-aided implant surgery (S-CAIS): flapless computer-guided surgery, and conventional surgery (CS): flap surgery with conventional planning. Tomography scans were performed at baseline and 10 days after the surgery for deviation measurement, and radiography was done at baseline and after 6 and 12 months, for peri-implant bone level (PIBL) analysis. Peri-implant fluid and subgingival biofilm were collected to evaluate bone markers and periodontal pathogens. RESULTS: S-CAIS showed less linear deviation at the apical point and the midpoint and less angular deviation (p < 0.05), with greater depth discrepancy in the positioning of the platform (p < 0.05). Higher values of vertical PIBL were observed for the S-CAIS group at baseline (p < 0.05), while lower values of horizontal PIBL were observed for CS (p < 0.05). Bone markers and Tf presented higher levels in CS (p < 0.05). Flapless S-CAIS allowed smaller linear and angular deviations than the conventional technique. CONCLUSION: However, PIBL was higher in S-CAIS; the conventional technique led to a greater angiogenic and bone remodeling activity by elevating the angiogenic levels and bone markers. CLINICAL RELEVANCE: Evaluating the different implant insertion techniques can guide clinical and surgical regarding the accuracy, the release pattern of bone markers, and the peri-implant bone level. TRIAL REGISTRATION: ReBEC-RBR-8556fzp.

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OBJECTIVE: This factorial randomized clinical trial (RCT) tested the effects of the surgical approach (flapped-FPS vs. flapless-FLS surgery) and loading protocol (delayed-DL vs. immediate-IL) for treatment with a four mini implant mandibular overdenture. MATERIAL AND METHODS: A total of 296 one-piece titanium-zirconium mini-implants were inserted in 74 patients (IL/FLS = 17; IL/FPS = 18; DL/FLS = 20; and DL/FPS = 19). Outcomes included patient's perceived surgical burdens, clinical time, implant survival, and post-surgical symptoms and complications, assessed immediately after surgery, in the 7-day and 6-week follow-ups. RESULTS: Perceived surgical burdens were relatively low, higher for females, and no difference was found between FPS and FLS surgery. Surgical time was lower for FLS surgery. Overall symptoms were mild after 24 h, and higher for females. Less symptoms were recorded for the FLS surgery compared to the FPS for the delayed loading patients, and FLS surgery was associated with a lower risk of bleeding. No early implant failure was observed until the 6-week follow-up. Delayed was associated with discontinuous use of the prosthesis and poor function. Lower complaint rates were observed for immediate loading regardless of the surgery protocol. CONCLUSIONS: Mini implants for mandibular overdenture are a feasible option regardless of surgical access and loading protocol, with high safety and predictable survival rates, and low incidence of post-insertion complications. FLS surgery requires less clinical time and results in easier intraoral prosthetic incorporation of attachments compared to FPS surgeries. Immediate loading did not increase the risk of early implant failure when satisfactory primary stability was achieved.

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Resumen La calidad de vida relacionada con la salud se ha convertido en la actualidad en uno de los desenlaces que se proponen para evaluar la efectividad de intervenciones terapéuticas, sobre todo en condiciones que no tienen cura médica y en las cuales se espera que las intervenciones en salud impacten la forma en la que viven las personas. En el caso de las personas con discapacidad intelectual hay controversia no sólo por la evaluación de la calidad de vida como desenlace, sino también por las consideraciones éticas y metodológicas que implica su uso. Este ensayo aborda los temas éticos y metodológicos de la inclusión de la calidad de vida relacionada con la salud como desenlace clínico en personas con discapacidad intelectual. (Acta Med Colomb 2022; 47. DOI:https://doi.org/10.36104/amc.2022.2019).

Abstract Health-related quality of life is one of the outcomes proposed today for assessing the effectiveness of therapeutic interventions, especially in conditions with no medical cure and in which it is expected that the healthcare interventions will have an impact on the way people live. In the case of people with intellectual disability, there is controversy not only about the assessment of quality of life as an outcome, but also over the ethical and methodological considerations involved in its use. This paper addresses the ethical and methodological issues of including health-related quality of life as a clinical outcome in people with intellectual disability. (Acta Med Colomb 2022; 47. DOI:https://doi.org/10.36104/amc.2022.2019).

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OBJECTIVE: To determine treatment frequency and duration of histamine-2 receptor antagonist (H2RA)/proton pump inhibitor (PPI) use among infants hospitalized within US children's hospital neonatal intensive care units and evaluate diagnoses/demographic factors associated with use. STUDY DESIGN: We retrospectively analyzed a cohort of neonatal intensive care unit infants admitted to 43 US children's hospitals within the Pediatric Health Information System database between January 2006 and March 2013 to determine H2RA/PPI treatment frequency, timing/duration of treatment, factors associated with use, percent of infants remaining on treatment at discharge, and interhospital prescribing variation. We used a modified Poisson regression to calculate the adjusted probability of infants ever receiving H2RAs/PPIs in relation to diagnosis, gestation, and sex. RESULTS: Of the 122 002 infants evaluated, 23.8% (n = 28 989) ever received an H2RA or PPI; 19.0% received H2RAs (n = 23 187), and 10.5% (n = 12 823) received PPIs. Extremely preterm infants and term infants were the most likely to receive H2RA and PPI treatment. Infants with gastroesophageal reflux disease (relative risk [RR] = 3.13) and congenital heart disease (RR = 2.41) had the highest H2RA/PPI treatment probabilities followed by those with an ear, nose, and throat diagnosis (RR = 2.34; P < .05). The majority of treated infants remained treated at discharge. CONCLUSIONS: Despite limited evidence and increasing safety concerns, H2RAs/PPIs are frequently prescribed to extremely preterm neonates and those with congenital anomalies and continued through discharge. Our findings support the need for innovative studies to examine the comparative effectiveness and safety of H2RA/PPIs vs no treatment in these high-risk neonatal populations.

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