RESUMO
OBJECTIVES: Women living with HIV are underrepresented in clinical trials assessing outcomes of antiretroviral treatment (ART), justifying the need for observational studies. We investigated differences in viral non-suppression between women and men in the Swedish InfCareHIV cohort and analysed results in relation to biological and socio-demographic variables and patient-reported outcome measures (PROMs). METHODS: The study included people living with HIV (PLWH) aged ≥18 years, who initiated ART at least 6 months prior to inclusion. Data from the InfCareHIV registry 2011-2018 were collected. Associations between variables and HIV RNA ≥50 copies/mL were investigated in uni- and multivariable analyses using generalized estimating equations, providing relative risks (RRs) as effect size. RESULTS: The study included 38% (n = 2981) women. Women were more likely to have HIV RNA ≥50 copies/mL than were men [RR = 1.20, 95% confidence interval (CI): 1.10-1.31]. After adjusting for origin and route of transmission, sex at birth was no longer associated with viral non-suppression. PROMs were available in 52.4% of PLWH, and items associated with viral non-suppression were impaired adherence in women (RR = 2.38, 95% CI: 1.79-3.17) and men (RR 1.84, 95% CI: 1.40-2.42), and experience of side effects in women (RR = 1.49, 95% CI: 1.10-2.02). CONCLUSIONS: This observational study found a 20% higher relative risk of viral non-suppression in women than in men and the difference was associated with socio-demographic factors. The associations between PROMs and viral non-suppression varied between women and men. PROMs are important health outcomes that may identify PLWH in need of support to achieve viral non-suppression.
Assuntos
Infecções por HIV , Carga Viral , Humanos , Masculino , Feminino , Infecções por HIV/tratamento farmacológico , Infecções por HIV/epidemiologia , Suécia/epidemiologia , Adulto , Pessoa de Meia-Idade , Fatores Sexuais , Estudos de Coortes , Medidas de Resultados Relatados pelo Paciente , Fármacos Anti-HIV/uso terapêutico , RNA Viral , Adulto Jovem , AdolescenteRESUMO
OBJECTIVE: To assess whether patient reported outcome measures (PROMs) improve after autologous conditioned serum (ACS) administration in patients with osteoarthritis. METHODS: Databases and clinical trial registers were searched to March 2024 for randomised controlled trial (RCTs) comparing ACS vs comparators/controls. Primary outcomes were pain, function and stiffness measured with Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and visual analogue scale (VAS). Secondary outcome was complications. Risk of bias (RoB) and certainty of evidence were assessed using RoB 2 and the Grades of Recommendation, Assessment, Development and Evaluation Working Group (GRADE) respectively. Meta-analysis was undertaken using RevMan v5.4. Results are presented as standardised mean differences (SMD) or mean differences (MD) with 95% confidence intervals (CI). Sensitivity analysis compared all comparators and saline control. RESULTS: Five RCTs were identified (n = 741 participants); two (n = 529 participants) compared ACS against saline (placebo). Three studies were "some concern" and two studies "high risk" for bias. Analysis comparing ACS with all comparators significantly favoured ACS at 6 months for WOMAC: SMD -0.61 (95% CI -1.01 to -0.21; p = 0.003); and VAS: SMD -1.24 (95% CI -2.11 to -0.38; p = 0.005); with high heterogeneity. Comparing ACS with saline, there was no significant difference in WOMAC or VAS at 6 months: SMD -0.40 (95% CI -0.93 to 0.12; p = 0.13) and MD -9.87 (95% CI -27.73 to 7.98, p = 0.28). Complications were similar: ACS (24.8%) vs saline (24.4%), with serious complications rare. CONCLUSION: There is currently insufficient data to support the use of ACS in osteoarthritis with conflicting results when compared to alternative therapies and saline control, with high heterogeneity. Before consideration as a potential treatment, a high-quality multicentre RCT is required to assess the efficacy of ACS.
RESUMO
In patients with cerebellar ataxia (CA), symptoms related to oculomotor dysfunction significantly affect quality of life (QoL). This study aimed to analyze the literature on patient-related outcome measures (PROMs) assessing QoL impacts of vestibular and cerebellar oculomotor abnormalities in patients with CA to identify the strengths and limitations of existing scales and highlight any areas of unmet need. A systematic review was conducted (Medline, Embase) of English-language original articles reporting on QoL measures in patients with vertigo, dizziness or CA. Pre-specified parameters were retrieved, including diseases studied, scales applied and conclusions drawn. Our search yielded 3671 articles of which 467 studies (n = 111,606 participants) were deemed relevant. The most frequently studied disease entities were (a) non-specific dizziness/gait imbalance (114 studies; 54,581 participants), (b) vestibular schwannomas (66; 15,360), and (c) vestibular disorders not further specified (66; 10,259). The Dizziness Handicap Inventory (DHI) was the most frequently used PROM to assess QoL (n = 91,851), followed by the Penn Acoustic Neuroma Quality-of-Life Scale (n = 12,027) and the Activities-Specific Balance Confidence Scale (n = 2'471). QoL-scores capturing symptoms related to oculomotor abnormalities in CA were rare, focused on visual impairments (e.g., National-Eye-Institute Visual Function Questionnaire, Oscillopsia Functional Impact, oscillopsia severity score) and were unvalidated. The DHI remains the most widely used and versatile scale for evaluating dizziness. A lack of well-established PROMs for assessing the impact of oculomotor-related symptoms on QoL in CA was noted, emphasizing the need for developing and validating a new QoL-score dedicated to the oculomotor domain for individuals with CA.
Assuntos
Ataxia Cerebelar , Qualidade de Vida , Humanos , Ataxia Cerebelar/fisiopatologia , Tontura/fisiopatologia , Tontura/diagnóstico , Medidas de Resultados Relatados pelo Paciente , Transtornos da Motilidade Ocular/fisiopatologia , Transtornos da Motilidade Ocular/etiologia , Transtornos da Motilidade Ocular/diagnósticoRESUMO
BACKGROUND: The minimal important difference is a valuable metric in ascertaining the clinical relevance of a treatment, offering valuable guidance in patient management. There is a lack of available evidence concerning this metric in the context of outcomes related to female urinary incontinence, which might negatively impact clinical decision-making. OBJECTIVES: To summarize the minimal important difference of patient-reported outcome measures associated with urinary incontinence, calculated according to both distribution- and anchor-based methods. METHODS: This is a systematic review conducted according to the PRISMA guidelines. The search strategy including the main terms for urinary incontinence and minimal important difference were used in five different databases (Medline, Embase, CINAHL, Web of Science, and Scopus) in 09 June 2021 and were updated in January 09, 2024 with no limits for date, language or publication status. Studies that provided minimal important difference (distribution- or anchor-based methods) for patient-reported outcome measures related to female urinary incontinence outcomes were included. The study selection and data extraction were performed independently by two different researchers. Only studies that reported the minimal important difference according to anchor-based methods were assessed by credibility and certainty of the evidence. When possible, absolute minimal important differences were calculated for each study separately according to the mean change of the group of participants that slightly improved. RESULTS: Twelve studies were included. Thirteen questionnaires with their respective minimal important differences reported according to distribution (effect size, standard error of measurement, standardized response mean) and anchor-based methods were found. Most of the measures for anchor methods did not consider the smallest difference identified by the participants to calculate the minimal important difference. All reports related to anchor-based methods presented low credibility and very low certainty of the evidence. We pooled 20 different estimates of minimal important differences using data from primary studies, considering different anchors and questionnaires. CONCLUSIONS: There is a high variability around the minimal important difference related to patient-reported outcome measures for urinary incontinence outcomes according to the method of analysis, questionnaires, and anchors used, however, the credibility and certainty of the evidence to support these is still limited.
Assuntos
Incontinência Urinária , Humanos , Feminino , Incontinência Urinária/diagnóstico , Incontinência Urinária/terapia , Inquéritos e Questionários , Medidas de Resultados Relatados pelo PacienteRESUMO
PURPOSE: The purpose of this study was to explore ovarian cancer patients' preferences regarding follow-up care and, in particular, the use of patient-reported outcome measures (PROMs) as an approach to personalise follow-up care. METHODS: Between May and June 2021, semi-structured interviews were conducted with ovarian cancer patients, who had finished their primary treatment at least 6 months prior and were receiving follow-up care at our centre. Interviews were transcribed verbatim and analysed using an inductive thematic approach. A thematic flow chart was created describing interacting themes. RESULTS: Seventeen patients were interviewed, of which 11 were familiar with PROMs. Two key themes emerged from the data: the need for reassurance and the wish for personalised care. A follow-up scheme using PROMs was identified as a separate theme with the potential to personalise care. Several barriers and facilitators of PROMs were mentioned. CONCLUSIONS: Ovarian cancer patients have a desire for personalised follow-up care and seek reassurance. PROMs may be able to support both of these needs. Future research is needed to determine the most effective, patient-centred way to implement them. IMPLICATIONS FOR CANCER SURVIVORS: By understanding what patients' preferences are regarding follow-up care, more initiatives can be set up to personalise follow-up care, through which patient anxiety and dissatisfaction can be reduced.
Assuntos
Assistência ao Convalescente , Neoplasias Ovarianas , Humanos , Feminino , Pesquisa Qualitativa , Neoplasias Ovarianas/terapia , Preferência do Paciente , Medidas de Resultados Relatados pelo PacienteRESUMO
PURPOSE: This study examines providers' and clinic staff's perspectives on patient-reported outcomes (PROs) implementation at an academic medical center. METHODS: An anonymous and voluntary survey was administered to Henry Ford Cancer providers and clinic staff 18 months after PROs program implementation in September 2020, to obtain their feedback on perceived barriers, impact on workflows, and PROs administration frequency in routine cancer care. RESULTS: A total of 180 providers and 40 clinic staff were invited to complete the survey; 31% and 63% completed the survey, respectively. Approximately 68% of providers reported that electronically integrated PROs scores were either beneficial or somewhat beneficial to their patients, while only 28% of the clinic staff reported that PROs were beneficial or somewhat beneficial to patients. According to the clinic staff, the most common barriers to PROs completion included lack of patients' awareness of the utility of the program with respect to their care, patients' health status at check-in, and PROs being offered too frequently. CONCLUSION: There is favorable acceptance of the PROs program by providers, but clinic staff found it less favorable. Interventions to address barriers and improve program engagement are needed to ensure broad adoption of PROs in oncology practice.
Assuntos
Neoplasias , Humanos , Neoplasias/terapia , Oncologia , Medidas de Resultados Relatados pelo Paciente , Inquéritos e QuestionáriosRESUMO
PURPOSE: In this study, we evaluated readability and understandability of nine French-language Patient-Reported Outcome Measures (PROMs) that are currently used in a contemporary longitudinal cohort of breast cancer survivors as part of an effort to improve equity in cancer care and research. METHODS: Readability of PROMs was assessed using the Flesh Reading Ease Score (FRES), the Gunning's Fog Index (FOG), and the FRY graphics. Readability was considered ideal if mean score ≤ 6th-grade level and acceptable if between 6th and 8th grade. Understandability was evaluated using the Patient Education Materials Assessment Tool and defined as ideal if PEMAT ≥ 80%. The Evaluative Linguistic Framework for Questionnaires (ELF-Q) provided additional qualitative elements to assess understandability. Plain-language best practice was met if both readability and understandability were ideal. RESULTS: None of the 9 PROMs evaluated had ideal readability scores and only 1 had an acceptable score. Understandability ranged from 55% to 91%, and only 3 PROMs had ideal scores. ELF-Q identified points for improvement in several understandability dimensions of the PROMs. None of the instruments met the definition of plain-language best practice. CONCLUSION: None of the studied PROMs met the standards of readability and understandability. Future development and translation of PROMs should follow comprehensive linguistic and cultural frameworks to ensure plain-language standards and enhance equitable patient-centered care and research.
Assuntos
Compreensão , Medidas de Resultados Relatados pelo Paciente , Humanos , Feminino , Inquéritos e Questionários , Neoplasias da Mama/psicologia , Estudos de Coortes , Sobreviventes de Câncer/psicologia , Pessoa de Meia-Idade , Estudos Longitudinais , Letramento em Saúde , Sobrevivência , Qualidade de VidaRESUMO
BACKGROUND: Patient-reported outcome measures (PROMs) are increasingly being used as an assessment and monitoring tool in clinical practice. However, patient adherence to PROMs completions are typically not well documented or explained in published studies and reports. Through a collaboration between the International Society for Quality-of-Life Research (ISOQOL) Patient Engagement and QOL in Clinical Practice Special Interest Groups (SIGs) case studies were collated as a platform to explore how adherence can be evaluated and understood. Case studies were drawn from across a range of clinically and methodologically diverse PROMs activities. RESULTS: The case studies identified that the influences on PROMs adherence vary. Key drivers include PROMs administeration methods within a service and wider system, patient capacity to engage and clinician engagement with PROMs information. It was identified that it is important to evaluate PROMs integration and adherence from multiple perspectives. CONCLUSION: PROM completion rates are an important indicator of patient adherence. Future research prioritizing an understanding of PROMs completion rates by patients is needed.
Assuntos
Medidas de Resultados Relatados pelo Paciente , Qualidade de Vida , Humanos , Qualidade de Vida/psicologia , Participação do Paciente , Cooperação do PacienteRESUMO
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.
RESUMO
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.
RESUMO
OBJECTIVE: To compare problems reported on EQ-5D-5L dimensions, index, and EQ visual analog scale (VAS) scores in patients receiving specialized rehabilitation in Norway with general population norms. DESIGN: Multicenter observational study. SETTING: Five specialist rehabilitation facilities participating in a national rehabilitation register between March 11, 2020, and April 20, 2022. PARTICIPANTS: 1167 inpatients admitted (N=1167), with a mean age of 56.1 (range, 18-91) years; 43% were female. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: EQ-5D-5L dimension, index, and EQ VAS scores. RESULTS: At admission, mean±SD EQ-5D-5L index scores were 0.48 (0.31) compared to 0.82 (0.19) for general population norms. EQ VAS scores were 51.29 (20.74) compared to 79.46 (17.53) for population norms. Together with those for the 5 dimensions, these differences were all statistically significant (P<.01). Compared to population norms, patients undergoing rehabilitation had more health states as assessed by the 5 dimensions (550 vs 156) and EQ VAS (98 vs 49). As hypothesized, EQ-5D-5L scores were associated with number of diagnoses, admission to/from secondary care, and help with completion. At discharge there were statistically significant improvements in all EQ-5D-5L scores that compare favorably with available estimates for minimal important differences. CONCLUSIONS: The large deviations in scores at admission and score changes at discharge lend support to EQ-5D-5L application in national quality measurement. Evidence for construct validity was found through associations with number of secondary diagnoses and help with completion.
Assuntos
Medidas de Resultados Relatados pelo Paciente , Qualidade de Vida , Humanos , Feminino , Pessoa de Meia-Idade , Masculino , Centros de Reabilitação , Hospitalização , Alta do Paciente , Inquéritos e Questionários , Nível de Saúde , Psicometria/métodosRESUMO
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.
Assuntos
Hérnia Inguinal , Herniorrafia , Qualidade de Vida , Humanos , Hérnia Inguinal/cirurgia , Masculino , Feminino , Pessoa de Meia-Idade , Estudos Transversais , Brasil , Adulto , Idoso , Traduções , Comparação Transcultural , Inquéritos e Questionários , Telas Cirúrgicas , Reprodutibilidade dos Testes , Medidas de Resultados Relatados pelo PacienteRESUMO
STUDY OBJECTIVE: To examine pain improvement after endometriosis surgery and whether it can be predicted by the observed surgical phenotype. DESIGN: Prospective longitudinal survey study. SETTING: A University hospital. PATIENTS: A total of 125 patients completed a preoperative questionnaire (response rate: n = 227 of 277, 81.9%), had surgically confirmed endometriosis (n = 202 of 227), and returned a second postoperative questionnaire (response rate: n = 125 of 202, 61.9%). INTERVENTIONS: All patients underwent complete laparoscopic removal of the endometriotic lesions. Surgical phenotype was classified according to the rASRM and #Enzian classification. MEASUREMENTS AND MAIN RESULTS: The intensity of 5 specific pain symptoms was questioned by postal paper-pencil questionnaires with a numerical rating scale (0-10) both preoperatively (3.01 ± 2.72 months before surgery) and one year after surgery (12.62 ± 1.59 months). A postoperative pain improvement score was computed (postoperative pain-preoperative pain) for each specific pain symptom (0-10) and for the overall/global pain sum score (0-50). The mean intensity of all pain scores was lower postoperatively as compared with preoperatively (p <.0001). A statistically significant weak correlation was observed between the surgical phenotype "rectovaginal endometriosis" and postoperative improvement of dyspareunia (r = .265; p = .003). The other 11 hypothesized correlations between surgical phenotype and postoperative improvement of pain intensity failed to reach statistical significance. CONCLUSION: Clinicians can inform patients that surgery is effective in reducing endometriosis-related pain symptoms and the overall/global pain scores at 12 months postoperatively. From our data, we can conclude that patients with rectovaginal endometriosis might benefit the most from the reduction of their sexual pain. On the basis of these results, we could suggest that deep dyspareunia (even if present as an isolated symptom) might be a valid indication for surgery. Further research could explore the association between a certain surgical phenotype and more detailed assessments of sexual functioning, as well as explore whether feedback from the surgeon on expected pain improvement affects patient-reported outcomes.
Assuntos
Dispareunia , Endometriose , Laparoscopia , Dor Pós-Operatória , Humanos , Endometriose/cirurgia , Endometriose/complicações , Feminino , Adulto , Estudos Prospectivos , Laparoscopia/métodos , Dor Pós-Operatória/etiologia , Estudos Longitudinais , Dispareunia/etiologia , Medição da Dor , Inquéritos e Questionários , Fenótipo , Resultado do Tratamento , Dor Pélvica/cirurgia , Dor Pélvica/etiologia , Pessoa de Meia-Idade , Procedimentos Cirúrgicos em Ginecologia/métodosRESUMO
BACKGROUND: Unhelpful illness perceptions can be changed by means of interventions and can lead to improved outcomes. However, little is known about illness perceptions in patients with chronic kidney disease (CKD) prior to kidney failure, and no tools exist in nephrology care to identify and support patients with unhelpful illness perceptions. Therefore, this study aims to: (1) identify meaningful and modifiable illness perceptions in patients with CKD prior to kidney failure; and (2) explore needs and requirements for identifying and supporting patients with unhelpful illness perceptions in nephrology care from patients' and healthcare professionals' perspectives. METHODS: Individual semi-structured interviews were conducted with purposive heterogeneous samples of Dutch patients with CKD (n = 17) and professionals (n = 10). Transcripts were analysed using a hybrid inductive and deductive approach: identified themes from the thematic analysis were hereafter organized according to Common-Sense Model of Self-Regulation principles. RESULTS: Illness perceptions considered most meaningful are related to the seriousness (illness identity, consequences, emotional response and illness concern) and manageability (illness coherence, personal control and treatment control) of CKD. Over time, patients developed more unhelpful seriousness-related illness perceptions and more helpful manageability-related illness perceptions, caused by: CKD diagnosis, disease progression, healthcare support and approaching kidney replacement therapy. Implementing tools to identify and discuss patients' illness perceptions was considered important, after which support for patients with unhelpful illness perceptions should be offered. Special attention should be paid towards structurally embedding psychosocial educational support for patients and caregivers to deal with CKD-related symptoms, consequences, emotions and concerns about the future. CONCLUSIONS: Several meaningful and modifiable illness perceptions do not change for the better by means of nephrology care. This underlines the need to identify and openly discuss illness perceptions and to support patients with unhelpful illness perceptions. Future studies should investigate whether implementing illness perception-based tools will indeed improve outcomes in CKD.
Assuntos
Insuficiência Renal Crônica , Humanos , Insuficiência Renal Crônica/terapia , Insuficiência Renal Crônica/psicologia , Pesquisa Qualitativa , EmoçõesRESUMO
PURPOSE: The core outcome measures index (COMI) for the back is a questionnaire that evaluates five domains and has been translated into several languages and validated for different populations. We aimed to translate, cross-culturally adapt and validate it in European Portuguese for use in patients with degenerative lumbar disease. Additionally, we aimed to establish the minimal clinically important change score (MCIC). METHODS: The translation and cultural adaptation were done according to published guidelines. Patients awaiting surgery at a neurosurgical center completed the COMI, Oswestry Disability Index (ODI), EQ-5D questionnaires and a pain visual analog scale (VAS). To evaluate COMI's reproducibility, patients completed the questionnaire twice within two weeks, preoperatively, in addition to answering a transition question. The MCIC was determined by analysis of postoperative changes in total COMI score, using the anchor method, with a question ascertaining surgical outcome as perceived by the patient. RESULTS: The first set of questionnaires was answered by 108 patients and the second, by 98 patients. COMI's construct validity was confirmed by demonstrating the hypothesized correlation between each domain's score (Spearman Rho > 0.4) and the corresponding questionnaire score (ODI, EQ-5D and VAS) and through adequate correlation (Spearman > 0.6) between COMI's total score and ODI and EQ-5D total scores. Intraclass correlation coefficients between each domain and COMI's total score were > 0.8. The MCIC was calculated as 2.1. CONCLUSION: The cross-culturally adapted COMI questionnaire is a valid clinical assessment tool for European Portuguese-speaking patients with degenerative lumbar disease, with an MCIC of 2.1 points.
Assuntos
Comparação Transcultural , Idioma , Humanos , Portugal , Reprodutibilidade dos Testes , Região LombossacralRESUMO
PURPOSE: This study aimed to investigate the impact of sarcopenia and lumbar paraspinal muscle composition (PMC) on patient-reported outcomes (PROs) after lumbar fusion surgery with 12-month follow-up (12 M-FU). METHODS: A prospective investigation of patients undergoing elective lumbar fusion was conducted. Preoperative MRI-based evaluation of the cross-sectional area (CSA), the functional CSA (fCSA), and the fat infiltration(FI) of the posterior paraspinal muscles (PPM) and the psoas muscle at level L3 was performed. Sarcopenia was defined by the psoas muscle index (PMI) at L3 (CSAPsoas [cm2]/(patients' height [m])2). PROs included Oswestry Disability Index (ODI), 12-item Short Form Healthy Survey with Physical (PCS-12) and Mental Component Scores (MCS-12) and Numerical Rating Scale back and leg (NRS-L) pain before surgery and 12 months postoperatively. Univariate and multivariable regression determined associations among sarcopenia, PMC and PROs. RESULTS: 135 patients (52.6% female, 62.1 years, BMI 29.1 kg/m2) were analyzed. The univariate analysis demonstrated that a higher FI (PPM) was associated with worse ODI outcomes at 12 M-FU in males. Sarcopenia (PMI) and higher FI (PPM) were associated with worse ODI and MCS-12 at 12 M-FU in females. Sarcopenia and higher FI of the PPM are associated with worse PCS-12 and more leg pain in females. In the multivariable analysis, a higher preoperative FI of the PPM (ß = 0.442; p = 0.012) and lower FI of the psoas (ß = -0.439; p = 0.029) were associated with a worse ODI at 12 M-FU after adjusting for covariates. CONCLUSIONS: Preoperative FI of the psoas and the PPM are associated with worse ODI outcomes one year after lumbar fusion. Sarcopenia is associated with worse ODI, PCS-12 and NRS-L in females, but not males. Considering sex differences, PMI and FI of the PPM might be used to counsel patients on their expectations for health-related quality of life after lumbar fusion.
Assuntos
Vértebras Lombares , Músculos Paraespinais , Medidas de Resultados Relatados pelo Paciente , Sarcopenia , Fusão Vertebral , Humanos , Masculino , Feminino , Sarcopenia/diagnóstico por imagem , Pessoa de Meia-Idade , Vértebras Lombares/cirurgia , Vértebras Lombares/diagnóstico por imagem , Estudos Prospectivos , Idoso , Músculos Paraespinais/diagnóstico por imagem , Seguimentos , Distinções e PrêmiosRESUMO
BACKGROUND: Decision aids can help patients set realistic expectations. In this study, we explored alternative presentations to visualise patient-reported outcomes (EQ-5D-5L) data within an online, individualized patient decision aid for total knee arthroplasty (TKA) that, in part, generates individualized comparisons based on age, sex and body mass index, to enhance usability prior to implementation into routine clinical practice. METHODS: We used data visualization techniques to modify the presentation of EQ-5D-5L outcomes data within the decision aid. The EQ-5D-5L data was divided into two parts allowing patients to compare themselves to similar individuals (1) pre-surgery and (2) 1-year post-surgery. We created 2 versions for each part and sought patient feedback on comprehension, usefulness, and visual appeal. Patients from an urban orthopedic clinic were recruited and their ratings and comments were recorded using a researcher-administered checklist. Data were managed using Microsoft Excel, R version 3.6.1 and ATLAS.ti V8 and analyzed using descriptive statistics and directed content analysis. RESULTS: A total of 24 and 25 patients participated in Parts 1 and 2, respectively. Overall, there was a slight preference for Version 1 in Part 1 (58.3%) and Version 2 in Part 2 (64%). Most participants demonstrated adequate comprehension for all versions (range 50-72%) and commented that the instructions were clear. While 50-60% of participants rated the content as useful, including knowing the possible outcomes of surgery, some participants found the information interesting only, were unsure how to use the information, or did not find it useful because they had already decided on a treatment. Participants rated visual appeal for all versions favorably but suggested improvements for readability, mainly larger font and image sizes and enhanced contrast between elements. CONCLUSIONS: Based on the results, we will produce an enhanced presentation of EQ-5D-5L data within the decision aid. These improvements, along with further usability testing of the entire decision aid, will be made before implementation of the decision aid in routine clinical practice. Our results on patients' perspectives on the presentation of EQ-5D-5L data to support decision making for TKA treatments contributes to the knowledge on EQ-5D-5L applications within healthcare systems for clinical care.
Assuntos
Artroplastia do Joelho , Qualidade de Vida , Humanos , Alberta , Artroplastia do Joelho/métodos , Visualização de Dados , Reprodutibilidade dos Testes , Inquéritos e Questionários , Técnicas de Apoio para a Decisão , Psicometria/métodos , Nível de SaúdeRESUMO
BACKGROUND: There has long been discussion regarding the impact of medial malleolar osteotomies (MMO) as an adjunctive treatment for osteochondral lesions of the talus (OCLT). MMO may improve the visibility and accessibility of the talus, but they also pose a risk of periprocedural morbidity. There is a lack of research about the prevalence and consequences of MMO in the surgical treatment of OCLT. METHODS: This study retrospectively evaluated data from the German Cartilage Register (KnorpelRegister DGOU) from its implementation in 2015 to December 2020. The impact of MMO on patient-reported outcome measures (PROMs) was investigated. Wherever possible, subgroups were built and matched using a propensity score which matched a group undergoing OCLT without MMO. Matching included age, sex, weight, localization of the OCLT, the international cartilage repair society (ICRS) grading, surgical procedure and preoperative symptoms using the Foot and Ankle Ability Measure (FAAM) and the Activities of Daily Living Subscale (ADL). RESULTS: The prevalence of MMO in the operative treatment of OCLT was 15.9%. Most of the osteotomies were performed in OCL of the medial talar dome (76.8%) and in more serious lesions with an ICRS grade of III (29.1%) and IV (61.4%). More than half of the osteotomies (55.6%) were performed during revision surgery. A matched pair analysis of n = 44 patients who underwent AMIC® via arthrotomy and MMO vs. arthrotomy alone showed no significant differences in patient-reported outcome measures (PROMs, i.e. FAAM-ADL, and FAOS) at 6,12 and 24 months. CONCLUSIONS: MMO are mostly used in the treatment of severe (≥ ICRS grade 3) OCL of the medial talar dome and in revision surgery. Functional and patient-reported outcome measures are not significantly affected by MMO compared to arthrotomy alone. TRIAL REGISTRATION: The German Cartilage Register (KnorpelRegister DGOU) was initially registered at the German Clinical Trials Register ( https://www.drks.de , register number DRKS00005617, Date of registration 03.01.2014) and was later expanded by the ankle module.
Assuntos
Osteotomia , Medidas de Resultados Relatados pelo Paciente , Sistema de Registros , Tálus , Humanos , Feminino , Masculino , Osteotomia/métodos , Osteotomia/efeitos adversos , Tálus/cirurgia , Estudos Retrospectivos , Adulto , Alemanha/epidemiologia , Pessoa de Meia-Idade , Resultado do Tratamento , Cartilagem Articular/cirurgia , Adulto Jovem , Incidência , Articulação do Tornozelo/cirurgia , Atividades Cotidianas , Adolescente , Recuperação de Função FisiológicaRESUMO
BACKGROUND: Several systematic reviews (SRs) assessing the use of telemedicine for musculoskeletal conditions have been published in recent years. However, the landscape of evidence on multiple clinical outcomes remains unclear. OBJECTIVE: We aimed to summarize the available evidence from SRs on telemedicine for musculoskeletal disorders. METHODS: We conducted an umbrella review of SRs with and without meta-analysis by searching PubMed and EMBASE up to July 25, 2022, for SRs of randomized controlled trials assessing telemedicine. We collected any kind of patient-reported outcome measures (PROMs), patient-reported experience measures (PREMs), and objective measures, including direct and indirect costs. We assessed the methodological quality with the AMSTAR 2 tool (A Measurement Tool to Assess systematic Reviews 2). Findings were reported qualitatively. RESULTS: Overall, 35 SRs published between 2015 and 2022 were included. Most reviews (n=24, 69%) were rated as critically low quality by AMSTAR 2. The majority of reviews assessed "telerehabilitation" (n=29) in patients with osteoarthritis (n=13) using PROMs (n=142 outcomes mapped with n=60 meta-analyses). A substantive body of evidence from meta-analyses found telemedicine to be beneficial or equal in terms of PROMs compared to conventional care (n=57 meta-analyses). Meta-analyses showed no differences between groups in PREMs (n=4), while objectives measures (ie, "physical function") were mainly in favor of telemedicine or showed no difference (9/13). All SRs showed notably lower costs for telemedicine compared to in-person visits. CONCLUSIONS: Telemedicine can provide more accessible health care with noninferior results for various clinical outcomes in comparison with conventional care. The assessment of telemedicine is largely represented by PROMs, with some gaps for PREMs, objective measures, and costs. TRIAL REGISTRATION: PROSPERO CRD42022347366; https://osf.io/pxedm/.
Assuntos
Doenças Musculoesqueléticas , Osteoartrite , Telemedicina , Telerreabilitação , Humanos , Atenção à Saúde , Doenças Musculoesqueléticas/terapia , Revisões Sistemáticas como Assunto , Metanálise como AssuntoRESUMO
PURPOSE: Osteochondritis dissecans (OCD) is a common cause of knee pain. Management for adult-onset OCD (AOCD) usually involves surgery. Surgical treatments include palliative, reparative and reconstructive techniques. The aim of this systematic review and meta-analysis is to evaluate the efficacy of reconstructive techniques for the treatment of OCD in skeletally mature knees. METHODS: A systematic search was carried out on four databases up to November 2023 (Medline, Embase, Cochrane Library, Web of Science). The study was registered on international prospective register of systematic reviews and performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. Clinical studies on skeletally mature patients were included, which utilised reconstructive techniques such as autologous chondrocyte implantation (ACI), matrix-induced autologous chondrocyte implantation, osteochondral allograft transplantation surgery or bone marrow-derived cellular transplantation. Demographical data, patient-reported outcome measures and postoperative complications were recorded. Quantitative outcome measures that were comparable across studies were pooled for meta-analysis. A random effects model was used. Heterogeneity was assessed using the I2 statistic and Cochran's Q test. Statistical significance was set at p < 0.05. Risk of bias was assessed using the risk of bias in non-randomised studies - of interventions tool for nonrandomised studies. RESULTS: Sixteen studies were included with 458 OCD lesions in 432 patients. The average age was 24.9, and 62.6% were male. The mean follow-up time was 61.5 months. At 36 months follow-up, International Knee Documentation Committee (IKDC) subjective, Tegner and EuroQol-visual analogue scale (EQ-VAS) scores improved from 42.4 to 78.6 (standard mean difference [SMD]: 2.47; p < 0.001), 2.27-4.99 (SMD: 2.363; p = 0.002) and 30.4-57.5 (SMD: 2.390; p < 0.001), respectively. Overall complication rate was 8.9%. Smaller OCD lesion sizes resulted in a greater improvement in IKDC subjective (SMD: 2.64 vs. 2.01; p = 0.038), EQ-VAS (SMD: 3.16 vs. 0.95; p = 0.046) and Tegner scores (SMD: 3.13 vs. 1.05; p = 0.007) and had a lower complication rate (p = 0.008). Males showed a larger improvement in IKDC subjective scores than females (SMD: 2.56 vs. 1.56; p = 0.029), while younger patients had a larger improvement in IKDC subjective scores (SMD: 2.71 vs. 2.12; p = 0.045) and fewer complications than older patients (p = 0.003). There were no significant differences between cohorts treated with ACI and those treated with non-ACI reconstructive techniques. Publication bias was not detected (n.s.). CONCLUSION: Reconstructive techniques used to treat OCD in the skeletally mature knee resulted in significant improvements in clinical and functional outcomes, with a low overall complication rate. Since a younger age leads to a greater improvement in IKDC subjective score and a lower complication rate, surgical intervention should not be delayed, especially in AOCD lesions which are more likely to follow a progressive and unremitting clinical course. LEVEL OF EVIDENCE: Level III.