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Background: Many studies have shown that injury to the popliteus tendon has little consequence for the static stability of the knee following total knee arthroplasty (TKA). However, very few studies have evaluated the effect of intraoperative iatrogenic popliteus tendon injury on the patient-reported outcome measures (PROMs) following TKA. This study aimed to determine the incidence of iatrogenic popliteus tendon injury in our subset of the population and to find out its effect on PROMs. Methods: 100 consecutive osteoarthritic varus knees with flexion deformities less than 20° were operated upon by a single senior experienced arthroplasty surgeon. Patients were assessed intraoperatively for any iatrogenic popliteus tendon injury, the injury site, and the amount of injury which was quantified and graded. PROMs applied for assessment at 1-year follow-up were Knee Society Score (KSS 1), Knee Function Score (KSS 2), and Western Ontario and McMaster University Osteoarthritis Index (WOMAC). Results: 17% of cases had an iatrogenic popliteus tendon injury. Thirteen had grade II injuries, whereas four had grade III injuries. There was no statistical significance in post-operative knee mobility and PROMs among those with popliteus tendon injury versus non-injured patients. Conclusion: The incidence of iatrogenic popliteus tendon injury is higher than what we expected. The tendon injury remains a risk, but it is unclear how the popliteus tendon injury will affect patients after the TKA. In our series, such an injury during knee replacement does not affect the functioning of the knee in the short term; however, a long-term follow-up is warranted.
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CONTEXT: To assess the effect of a surgical procedure on a patient, it is conventional to use clinical scores before and after the procedure, but it is increasingly common and recommended to weight the results of these scores with the notion of minimal clinically important difference ("MCID"). This MCID should be determined using either the data distribution method based on score variation, or the anchor method, which uses an external question to categorize the results. MCIDs vary from one population to another, and to our knowledge there has been no investigation in France for total knee arthroplasties (TKAs). We therefore conducted a prospective study on a population of TKAs in order to: 1) Define MCID in France on a population of TKAs for the Oxford score, KOOS (Knee injury and Osteoarthritis Outcome Score) and its derivatives, 2) Determine whether MCID for these scores in France is comparable to results in the literature. HYPOTHESIS: Is the MCID for total knee arthroplasty in France comparable to other results in the literature? MATERIAL AND METHOD: This was a prospective observational study in which 218 patients (85 men, 133 women) with a mean age of 72 years [27-90] who had undergone a primary TKA out of 300 initially included responded, before and after surgery, to the Oxford-12, KOOS and Forgotten Joint Score (FJS) questions (mean follow-up 24 months). MCID was calculated using the distribution method as well as the anchor method ("improvement 1 to 5" and "improvement yes or no"). RESULTS: At a mean follow-up of 24 months [18-36], the Oxford-12 score increased from 16 ± 8 [0-41] to 34 ± 11 [6-48] (p < 0.001), all components of the KOOS score were improved and the FJS at follow-up was 47 ± 32 [0-100]. For the anchor "improvement 1 to 5", there were 14 unimproved patients, 23 patients in identical condition and 179 patients improved by surgery. For the anchor "are you improved yes/no", there were 8 unimproved patients, 22 in identical condition and 187 surgically-improved patients. The mean MCID for all methods (anchor method and distribution) was 10 [7-13] for Oxford-12, 12 [12-12] for KOOS Symptom, 14 [12-17] for KOOS Pain, 12 [11-14] for KOOS Function, 14 [12-16] for KOOS Sport, 15 [15-16] for KOOS Quality of Life (QOL), 11 [10-12] for KOOS 12, 15 [12-18] for KOOS 12 Pa in. 12 [12-13] for KOOS 12 Function, 15 [15-15] for KOOS 12 QOL, 14 [13-14] for KOOS Physical Function Short-form (PS) and 14 [13-16] for KOOS Joint Replacement (JR). DISCUSSION: The MCID for the Oxford-12, KOOS and its derivatives scores in a French population is comparable to that observed in other populations in the literature. LEVEL OF EVIDENCE: IV; prospective study without control group.
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OBJECTIVE: Orthopaedic surgery is an effective intervention for treating the symptoms of degenerative joint disease or osteoarthritis (OA). Frequent wound dressing changes, unless clinically indicated, can disrupt the healing process and increase the occurrence of incision site contamination. Protection from contamination is critical for surgical incisions and, therefore, undisturbed wound healing (UWH) in surgical wound management is vital. This article describes a retrospective study reporting the clinical performance of a self-adherent, absorbent postoperative dressing, with a focus on dressing wear time. METHOD: A single-centre, retrospective electronic medical record review of a convenience sample of adult patients treated with a dressing (Mepilex Border Post Op; Mölnlycke, Sweden) following elective hip or knee replacement was undertaken. Data relating to dressing wear time, rationale for dressing changes and patient-reported outcomes were extracted from a mobile health application moveUP Therapy (moveUP NV, Belgium). Health-related quality of life assessment was conducted using the EQ-5D-5L questionnaire and orthopaedic-specific quality of life (QoL) indicator tools. RESULTS: Of the 558 records reviewed, 151 respondents (27.1%) reported outcomes relating to dressing wear time and frequency of dressing change. The average wear time of the first dressing was 13.6 days (second dressing: 5.3 days). The proportion of patients who wore the first dressing for 1-7 days, 8-13 days and for ≥14 days was 17.2%, 13.2% and 69.5%, respectively. Data from the completed questionnaires revealed improvement in QoL over time. CONCLUSION: The results of this study are a good indicator of the suitability of the postoperative dressing for a 14-day wear time, in line with the principles of UWH.
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Vendajes , Medición de Resultados Informados por el Paciente , Cicatrización de Heridas , Humanos , Estudios Retrospectivos , Masculino , Femenino , Anciano , Persona de Mediana Edad , Anciano de 80 o más Años , Factores de Tiempo , Calidad de Vida , Artroplastia de Reemplazo de Cadera , Adulto , Infección de la Herida Quirúrgica/prevención & control , Artroplastia de Reemplazo de Rodilla , Encuestas y CuestionariosRESUMEN
PURPOSE: Inguinal hernias are highly prevalent worldwide and its surgical repair is one of the most common procedures in general surgery. The broad use of mesh has decreased the recurrence rates of inguinal hernia to acceptable levels, thus centering the attention on Quality of Life as a pivotal postoperative outcome. Carolinas Comfort Scale is a well-studied questionnaire designed to identify Quality of Life changes following hernia repair with mesh techniques. The aim of this study is to validate the CCS in Brazilian Portuguese for inguinal hernias. METHODS: The original CCS was translated into Brazilian Portuguese according to cross-cultural adaptation guidelines. We conducted a cross-sectional study in individuals aged 18 and above who had undergone inguinal laparo-endoscopic hernia repair for at least 6 months prior, between January 2019 and August 2022, at a Brazilian tertiary hospital. Participants answered an online survey containing the Brazilian CCS and the generic Patient-Reported Outcome Measure (PROM) Short-Form Health 36 (SF-36). Participants answered the same questionnaires in the follow-up after at least three weeks, with an additional question about satisfaction with surgery results. RESULTS: The survey was completed by 115 patients, of whom 78 (67%) responded to the follow-up questionnaire after 3 to 10 weeks. CCS showed excellent internal consistency, with Cronbach's α of 0.94. Intraclass correlation coefficient ranged from 0.60 to 0.82 in the test-retest analysis. Compared to SF-36, a strong correlation was observed in the physical functioning dimension, and a moderate correlation was found in role-physical and bodily pain (Pearson's Coefficient Correlation = 0.502, 0.338 and 0.332 respectively), for construct analysis. The mean CCS score was significantly lower (p < 0.001) among satisfied patients compared to the unsatisfied ones. CONCLUSION: The Brazilian version of CCS is a valid and reliable method to assess long-term quality of life after inguinal laparo-endoscopic hernia repair.
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Hernia Inguinal , Herniorrafia , Calidad de Vida , Humanos , Hernia Inguinal/cirugía , Masculino , Femenino , Persona de Mediana Edad , Estudios Transversales , Brasil , Adulto , Anciano , Traducciones , Comparación Transcultural , Encuestas y Cuestionarios , Mallas Quirúrgicas , Reproducibilidad de los Resultados , Medición de Resultados Informados por el PacienteRESUMEN
BACKGROUND: Penile cancer (PeCa) is a rare cancer with surgical options that affect patients' quality-of-life. Patient-reported outcome measures (PROMs) are uncommonly utilized in this cohort despite their several patient-centered benefits and there are recommendations to further digitalize PROMs. This prospective, population-based study aimed to report the development and feasibility of a novel electronic patient-reported outcome measures (ePROMs) questionnaire for patients with PeCa. MATERIALS AND METHODS: A novel ePROMs questionnaire was developed and sent to patients 3 days before outpatient clinic appointments. The questionnaire included up to 30 items on patient symptomology and quality-of-life, including a self-reported quality-of-life score (rated 0 being worst and 100 being best). Data were collected for patients followed up between August 2021 and May 2022. The primary feasibility outcomes, adherence and engagement, were measured by response and drop-out rates. Differences in responders and nonresponders were also ascertained. Secondary outcomes explored the clinical utility of the questionnaire. Responders were subcategorized into 3 groups: circumcision (Ci), partial penectomy (PP) or total penectomy (TP) and differences were analyzed. This study was approved by the local Trust Governance Panel, including for ethical considerations. RESULTS: 220 adult males were sent ePROMs questionnaires, and 141 (64%) responded initially. The mean dropout rate of subsequent questionnaires was 56%. The maximum number of questionnaires sent to and completed by a patient was 8 (n = 1). Nonresponders were older (P < .0001), with poorer performance status (P < .0001) and lower body mass index (P = .0288). TP patients reported the lowest median quality-of-life score 68.50 (8-99), followed by the Ci group (72.0, 37-94) and the PP group (76.0, 10-99). CONCLUSIONS: Patients initially engaged and adhered to the ePROMs questionnaire but struggled to maintain this over time. Clinical data gathered by the questionnaire may be utilized to inform patient care. The questionnaire requires additional validation, research, and education.
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OBJECTIVE: Patient-Reported Outcome Measures (PROMs) are now an integral part of clinical and academic practice in ENT, and it is essential to have tools with a validated French version. However, there are no guidelines on ENT questionnaires available in French or those that could have transcultural adaptation. METHODS: The present study, under the auspices of the ENT National Professional Council and the French Society of ENT, inventoried PROMs, for each super-specialty and pathology, meeting one of the following inclusion criteria: validated French version, not translated but used internationally (i.e., translated into other languages and widely cited since 2017), or subjectively deemed useful by experts in the super-specialty in question. RESULTS: In total, 103 questionnaires were identified. To encourage and accompany their intercultural adaptation and statistical validation, this article presents the rationale and methodology of such an undertaking. CONCLUSION: PROMs either already validated in French or which it would be useful to translate were inventoried. The methodology of translation and validation to guarantee reliability and relevance is presented.
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Evaluating the effectiveness of orthognathic treatment can be difficult. To address this issue, patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) have been proposed as valuable instruments for understanding the quality of healthcare from the patients' standpoint. Therefore, the aim of this project was to employ PROMs and PREMs questionnaires to capture the patients' perspectives regarding their experience during the orthognathic treatment process, as well as their perception of their postoperative state. Preoperative and postoperative questionnaires were offered to patients at consenting appointment and at various timepoints after the surgery. The assessment of statistical relationships was carried out by means of Fisher's exact test. A total of 64 preoperative and 126 postoperative responses were received. The primary motivators for pursuing the surgery were the improvement of facial and dental aesthetics, as well as increased satisfaction with photographic and video appearances. These three factors were also cited as the most important postoperative benefits. Of the respondents, 58% reported experiencing altered sensation to the lower lip at the 24-month follow up (p = 0.02); however, the affected patients reported that this did not have an impact on their daily activities. The use of PROMs and PREMs to appraise the quality of life constitutes a valuable method for surgeons to gauge their treatment efficacy. Above all, such tools are particularly useful for evaluating patient satisfaction, which is the ultimate objective of any treatment.
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Patient-reported knee-related rating scores and scales are widely used in reporting the clinical outcomes of anterior cruciate ligament (ACL) surgery. Understanding the psychometric properties of such measures is vital to recognizing the limitations that such measures may confer. The aim of this study was to review the available evidence as to the psychometric properties of patient-reported outcome measures (PROMs) used in ACL surgery. Eleven studies were identified, the majority being prospective cohort studies. Eight English, ACL-specific patient-reported outcome measures were identified and evaluated: Lysholm score, Tegner Activity Scale (TAS), Cincinnati score, ACL-Quality of Life (QOL) score, International Knee Documentation Committee (IKDC) Subjective Knee Form (SKF), Knee Injury and Osteoarthritis Outcome Score (KOOS)-ACL score, and ACL-Return to Sport Injury (RSI) scale. Only the Lysholm score, ACL-QOL, IKDC SKF, and ACL-RSI were evaluated for internal consistency, having an acceptable Cronbach's α (α>0.70). Most of the scoring systems were assessed for test-retest reliability, with four of them (Lysholm score, TAS, Cincinnati score, and IKDC SKF) having acceptable intraclass correlation coefficient (ICC) values (ICC > 0.70). Criterion validity was assessed for most measures with a good correlation with the IKDC. Effect sizes and standardized response means were large for three instruments that measured responsiveness (Lysholm score, TAS, and Cincinnati score) and moderate for one (ACL-QOL). Evidence is stronger and more robust for the Lysholm score, TAS, ACL-QOL, and IKDC SKF. However, there is variation in their psychometric properties as well as the aspect of knee-related health they are assessing. Hence, none can be universally applicable to all patients with ACL injuries. Recognizing these parameters is vital when choosing which instrument to use in reporting the outcomes of ACL injury or ACL surgery studies.
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Introduction: The knee is the most commonly affected joint in osteoarthritis (OA), affecting millions of people worldwide. Knee OA significantly impacts the activities of daily living (ADL) along with affecting overall quality of life of patients (QoL), thereby leading to substantial socio-economic burden. Conservative therapies are prioritized, resorting to surgery only when needed. However, these traditional approaches have limitations. Regenerative medicine, involving the use of orthobiologics, including autologous peripheral blood-derived orthobiologics such as growth factor concentrate (GFC), has evolved and shown potential for managing knee OA. The primary goal of this review is to summarize the results of in vitro, preclinical and clinical studies involving GFC for the management of knee OA. Methods: Multiple databases (PubMed, Scopus, Google Scholar, Web of Science and Embase) were searched applying terms for the intervention 'GFC' and treatment 'knee OA' for the studies published in the English language to March 10, 2024. Results: Only three clinical studies met our pre-defined criteria and were included in this review. Conclusion: Intra-articular administration of GFC is safe and potentially efficacious to manage OA of the knee. More, adequately powered, multi-center, prospective, RCTs are warranted to demonstrate the long-term effectiveness of GFC in patients suffering from mild-to-moderate knee OA and to justify its routine clinical use. Further studies evaluating the efficacy of GFC compared to other orthobiologics are also required to allow physicians/surgeons to choose the optimal orthobiologic for the treatment of OA of the knee.
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Patient-Reported Outcome Measures (PROMs) are valuable in the assessment and management of rhinitis and chronic rhinosinusitis [CRS]. They measure outcomes which may include symptoms, disease control, well-being, and health-related quality of life (QOL). PROMS for rhinitis and rhinosinusitis are often used before and after an intervention, e.g., medication, therapeutic procedure or, in allergic rhinitis (AR), allergen immunotherapy. Although widely used in clinical trials for AR and conjunctivitis, symptom score PROMs are less validated than disease control or QOL measures. The best validated PROM for AR is the RQLQ (Rhinitis Quality of Life Questionnaire), but there is no universally accepted criterion standard for symptom and disease control PROMs. For CRS, at least 15 different criteria have been used to assess disease control in clinical studies, but what CRS disease control means and how it should be measured are concepts in evolution. The most used QOL measure for CRS is the SNOT-22 Sinonasal Outcome Test (SNOT-22). The use of PROMs to support clinical decisions and for shared decision making for rhinitis and rhinosinusitis still has many challenges, including selection of the preferred instrument, when and how to administer, the impact of co-morbidities, and questionnaire fatigue for both patient and provider.
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OBJECTIVES: To compare early implant placement (EP) to alveolar ridge preservation and delayed implant placement (ARP/DP) in terms of contour changes, along with clinician- and patient-reported outcome measures (PROMs) until the delivery of the implant-supported restoration. MATERIALS AND METHODS: Patients with a failing single tooth in the maxilla or mandible were recruited in two centres. After tooth extraction, patients were randomly assigned (1:1) to either EP or ARP/DP. At abutment connection and crown delivery, the buccal contour changes at 3 mm below the mucosal margin (primary outcome) along with clinician- (ease of treatment) and patient-reported outcomes were assessed using numeric rating scales and OHIP-14. RESULTS: A total of 46 patients were analysed. The mean buccal contour at abutment connection decreased by -1.2 ± 0.6 mm in group EP and -1.6 ± 0.8 mm in group ARP/DP (estimated mean difference; 0.45 [95%CI, -0.02; 0.94]; p = .061) with no significant differences between the groups. ARP/DP was consistently easier than EP across all stages of the surgery (estimated mean difference; 2.0 [95%CI, 1.3; 2.7] p < .001): during flap elevation (EP: 4.8 vs. ARP/DP: 1.6), implant placement (EP: 5.7 vs. ARP/DP: 2.2) and wound closure (EP: 3.4 vs. ARP/DP: 1.6). Both interventions improved quality of life but patients who underwent ARP/DP were significantly more satisfied at the time of crown delivery (ARP/DP: 9.6 vs. EP: 9.1, p = .02). CONCLUSIONS: EP and ARP/DP show no significant differences in buccal contour changes, aesthetics and patient-reported outcomes. However, ARP/DP is an easier procedure at all stages of the surgery compared to EP and could therefore be the preferred therapy for less experienced clinicians.
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BACKGROUND: Lysosomal storage diseases (LSDs) are a group of rare inherited metabolic disorders, consisting of over 70 diseases that are characterised by lysosomal dysfunction. Due to their varied and progressive symptoms, LSDs have a continual impact on patients' health-related quality of life (HRQoL). Several recently published studies have provided insight into the HRQoL of individuals with LSDs. However, it is challenging to meaningfully synthesise this evidence, since studies often focus upon a particular type of LSD and / or utilise different self-report questionnaires or patient-reported outcome measures (PROMs) to assess HRQoL. AIMS: The aim of this study was to review the published literature in LSDs, to identify the PROMs which have been used to assess HRQoL and generate a conceptual map of HRQoL domains measured in individuals diagnosed with LSDs. METHODS: Three electronic databases were searched in March 2022. Primary studies of any design which utilised multi-item PROMs to assess at least one aspect of HRQoL in individuals with LSDs since 2017 were identified. Data were extracted to assess both the characteristics of each study and of the PROMs utilised within each study. The extraction of HRQoL domains and synthesis were informed by an a priori framework, inductively modified to reflect data emerging from the identified literature. Selection and extraction was undertaken independently by two reviewers; discrepancies were ratified by a third reviewer. RESULTS: Sixty nine studies were identified which were published 2017-2022, with a combined total of 52 PROMs (71 variants) used to assess HRQoL in individuals with LSDs. The final extracted HRQoL framework included 7 domains (Activities; Physical sensations; Autonomy; Cognition; Feelings and emotions; Self-identity; Relationships), characterised by 37 sub-domains. CONCLUSIONS: This review highlights the breadth and variety of HRQoL domains assessed in individuals with LSDs, across three broad domains of physical, psychological and social functioning. The resultant framework and mapped PROMs will aid researchers and clinicians in the selection of PROMs to assess aspects of HRQoL in people living with LSDs, based on their conceptual coverage.
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Enfermedades por Almacenamiento Lisosomal , Calidad de Vida , Humanos , Enfermedades por Almacenamiento Lisosomal/psicología , Medición de Resultados Informados por el Paciente , Encuestas y CuestionariosRESUMEN
PURPOSE: Patient-report outcome measures (PROMs) have gained widespread support as a mechanism to improve healthcare quality. We aimed to map out key enablers and barriers influencing PROMs implementation strategies in routine clinical practice. METHODS: An umbrella review was conducted to identify reviews exploring enablers and barriers related to the integration of PROMs in routine clinical practice from January 2000 to June 2023. Information on key enablers and barriers was extracted and summarised thematically according to the Theoretical Domains Framework. RESULTS: 34 reviews met our criteria for inclusion. Identified reviews highlighted barriers such as limited PROMs awareness among clinicians and patients, perceived low value by clinicians and patients, PROMs that were too complex or difficult for patients to complete, poor usability of PROMs systems, delayed feedback of PROMs data, clinician concerns related to use of PROMs as a performance management tool, patient concerns regarding privacy and security, and resource constraints. Enablers encompassed phased implementation, professional training, stakeholder engagement prior to implementation, clear strategies and goals, 'change champions' to support PROMs implementation, systems to respond to issues raised by PROMs, and integration into patient pathways. No consensus favoured paper or electronic PROMs, yet offering both options to mitigate digital literacy bias and integrating PROMs into electronic health records emerged as important facilitators. CONCLUSIONS: The sustainable implementation of PROMs is a complex process that requires multicomponent organisational strategies covering training and guidance, necessary time and resources, roles and responsibilities, and consultation with patients and clinicians.
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PURPOSE: To evaluate which factors exert a predictive value for not reaching the minimal clinically important difference (MCID) in patients who underwent a tailored operative treatment for recurrent lateral patellar dislocation (RLPD). METHODS: A total of 237 patients (male/female 71/166; 22.4 ± 6.8 years) were included. The Banff Patellofemoral Instability Instrument 2.0 (BPII 2.0) and subjective rating of knee function and pain (numeric analogue scale [NAS]; 0-10) were used to evaluate patients' outcomes from pre- to postoperatively. Gender, age at the time of surgery, body mass index (BMI), nicotine abuse, psychiatric diseases, cartilage status and pathoanatomic risk factors were evaluated as potential predictors for achieving the MCID using univariate logistic regression analysis. RESULTS: The MCID for the BPII 2.0 was calculated at 9.5 points. Although the BPII 2.0 and NAS for knee function and pain improved significantly in the total cohort from pre- to postoperatively (all p < 0.001), 29 patients did not reach the MCID at the final follow-up. The analysis yielded that only the preoperative NAS for function and BPII 2.0 score values were significant predictors for reaching the MCID postoperatively. The optimal threshold was calculated at 7 (NAS function) and 65.2 points (BPII 2.0). Age at the time of surgery should be considered for patients with a preoperative BPII 2.0 score >62.5. CONCLUSION: The probability of reaching BPII 2.0 MCID postoperatively depends only on the preoperative BPII 2.0 value and subjective rating of knee function, as well as age at the time of surgery for patients undergoing surgical treatment of RLPD. Here, presented results can assist clinicians in advising and presenting patients with potential outcomes following treatment for this often complex and multifactorial pathology. LEVEL OF EVIDENCE: Level III.
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The International Patient Organisation for Primary Immunodeficiencies (IPOPI) held its second Global Multi-Stakeholders' Summit, an annual stimulating and forward-thinking meeting uniting experts to anticipate pivotal upcoming challenges and opportunities in the field of primary immunodeficiency (PID). The 2023 summit focused on three key identified discussion points: (i) How can immunoglobulin (Ig) therapy meet future personalized patient needs? (ii) Pandemic preparedness: what's next for public health and potential challenges for the PID community? (iii) Diagnosing PIDs in 2030: what needs to happen to diagnose better and to diagnose more? Clinician-Scientists, patient representatives and other stakeholders explored avenues to improve Ig therapy through mechanistic insights and tailored Ig preparations/products according to patient-specific needs and local exposure to infectious agents, amongst others. Urgency for pandemic preparedness was discussed, as was the threat of shortage of antibiotics and increasing antimicrobial resistance, emphasizing the need for representation of PID patients and other vulnerable populations throughout crisis and care management. Discussion also covered the complexities of PID diagnosis, addressing issues such as global diagnostic disparities, the integration of patient-reported outcome measures, and the potential of artificial intelligence to increase PID diagnosis rates and to enhance diagnostic precision. These proceedings outline the outcomes and recommendations arising from the 2023 IPOPI Global Multi-Stakeholders' Summit, offering valuable insights to inform future strategies in PID management and care. Integral to this initiative is its role in fostering collaborative efforts among stakeholders to prepare for the multiple challenges facing the global PID community.
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Salud Global , Humanos , Participación de los InteresadosRESUMEN
Patients' self-reporting is increasingly considered essential to measure quality-of-life and treatment-related side-effects. However, if multiple patient-reported instruments are used, redundancy may represent an overload for patients. Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) are a tool allowing direct patients' reporting of side-effects. We tested psychometric properties of a selected list of PRO-CTCAE items, in a cohort of 303 breast cancer patients, using validated instruments for quality of life assessment as anchors. The analysis of convergent validity with HADS (Hospital Anxiety and Depression Scale) and EORTC BR-23 sub-scales, and the analysis of responsiveness with the PGIC (Patients Global Impression of Change) score supported that a selected list of PRO-CTCAE symptoms might represent a standardized, agile tool for both research and practice settings to reduce patient burden without missing relevant information on patient perceptions. Among patients using digital devices, those with a higher education levels required shorter time to fulfil questionnaires. In conclusion, a selected list of PRO-CTCAE items can be considered as a standardized, agile tool for capturing crucial domains of side-effects and quality of life in patients with breast cancer. The study is registered on clinicaltrials.gov (NCT04416672).
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BACKGROUND: Obesity rates have been increasing globally, leading to a higher incidence of knee osteoarthritis and a surge in primary and revision total knee arthroplasty (TKA). The debate continues on the impact of obesity on TKA success, particularly regarding the use of stemmed tibial components in obese patients. This systematic review aimed to compare the effectiveness of stemmed tibial components versus standard keeled tibial components in obese patients undergoing TKA, hypothesizing that stemmed components would yield better clinical and radiological outcomes. METHODS: A systematic review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement guidelines. Databases including PubMed, Embase, Scopus, and Web of Science were searched from inception to December 2023. The eligibility criteria were based on the PICO framework; Participants: Patients who have obesity undergoing TKA, Intervention: stemmed TKA, Comparator: standard keeled tibial TKA, Outcome: aseptic loosening, Patient-Reported Outcome Measures (PROMs), and overall revision. Data extraction and quality assessment were performed using the Newcastle-Ottawa Scale for cohort studies and the Cochrane risk-of-bias tool for randomized trials. RESULTS: The search yielded 470 studies, with 10 studies (42,533 knees) meeting the inclusion criteria. These studies included three randomized clinical trials and seven retrospective cohorts. The primary outcomes measured were aseptic loosening and overall revision rates, while secondary outcomes included PROMs. Results indicated mixed findings, with some studies suggesting improved outcomes with stemmed components in cases of aseptic loosening and mechanical failure, while others showed no significant difference. The PROMs did not show a significant difference between groups post-TKA. The certainty of the evidence was graded as "very low" using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) framework. CONCLUSION: Current literature does not provide conclusive evidence to support the routine use of stemmed tibial components in TKA for obese patients. The decision to use stem extensions should not solely rely on the patient's obesity status. Further high-quality studies are needed to clarify the role of stemmed components in TKA for this patient population.
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This systematic review investigates Patient-reported Outcome Measures (PROMs) and Observed Reported Outcome Measures (ObsROMs) pertinent to assessing Health-Related Quality of Life (HRQoL) in short-stature paediatric patients, focusing on Achondroplasia (ACH), Growth Hormone Deficiency (GHD), Isolated Growth Hormone Deficiency (IGHD), and Small-for-Gestational-Age (SGA) diagnoses. Utilising rigorous selection criteria, 53 studies published from 1998 to 2023 were analysed, revealing a predominance of European-based research. Notably, the review elucidated the utilisation of disease-specific and generic HRQoL measures, showcasing the multifaceted nature of short-stature conditions and their impact across physical, emotional, and social domains. The Quality of Life in Short Stature Youth (QoLISSY), Paediatric Quality of Life Inventory (PedsQL), and KIDSCREEN emerged as frequently employed instruments, offering nuanced insights into HRQoL perceptions across diverse age demographics. Additionally, the review highlighted the adaptation of adult HRQoL measures for adolescent populations, signalling a need for age-appropriate assessment tools. Furthermore, integrating PROMs and ObsROMs in HRQoL assessment underscored a comprehensive approach, considering both subjective patient perspectives and observed outcomes. Future research directions encompass comprehensive search strategies, longitudinal studies with diverse populations, and the development of age-appropriate HRQoL assessment tools. In conclusion, this review emphasises the importance of comprehensive HRQoL assessment to address the diverse needs of short-stature paediatric patients effectively.
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BACKGROUND: There is no established consensus on the postoperative follow-up from which the aesthetic and functional outcomes of rhinoseptoplasty are considered as stable. OBJECTIVES: To contribute to defining the postoperative follow-up from which rhinoseptoplasty outcomes cease to evolve. METHODS: Postoperative assessments of Nasal Obstruction Symptom Evaluation (NOSE) and Rhinoplasty Outcome Evaluation (ROE) scores from 357 closed structural rhinoseptoplasty procedures were prospectively gathered from January 2019 to December 2023. These measurements encompassed the postoperative period from 1 to 12 months. All procedures were performed utilizing closed technique. RESULTS: No statistically significant difference was detected between the scores at 1, 2, and 6 months versus 12 months postoperatively (ROE: p = 0.388; 0.268; 0.162; NOSE: p = 0.265; 0.192; 0.975, Mann-Whitney test). Similarly, no follow-up impact was revealed between the scores at 1, 2, 6, and 12 months postoperatively (ROE: p = 0.548; NOSE: p = 0.280, Kruskal-Wallis test). No significant correlation was established between follow-up (in months) and ROE and NOSE scores (ROE: p = 0.397; NOSE: p = 0.632, Spearman). CONCLUSION: Follow-up duration does not influence NOSE and ROE scores over the 1- to 12-month timeframe. The 1-month postoperative outcome can be regarded as a reliable indicator of the 12-month outcome. These conclusions apply to NOSE and ROE scores of rhinoseptoplasty conducted using closed technique for the 1- to 12-month period. Further research is needed for open techniques, preservation rhinoplasty, other patient-reported outcomes measures (PROMs) as well as for the follow-up beyond 12 months postoperatively.