DESFECHOS
Glossário
- Standardization of concepts ICF 2001: Disability = incapacidade; Functioning = funcionalidade; Body functions = funções do corpo; Impairments = deficiências; Activity limitations = limitações de atividade; Environmental factors = fatores ambientais.
- Assessment of Physical Function: clinical testing is at the level of impairment (range of motion, muscular strength, flexibility, proprioception, balance, speed, endurance, …), not the assessment of overall functional ability (Reiman MP, Manske RC, 2011).
- Functional Performance Testing (FPT): are physical and evaluative tests that assess a patient’s ability to perform activities in various settings (Reiman MP, Manske RC, 2011).
- Patient-Reported Outcome Measures (PROMs): used to quantify the benefits of care by assessing patients’ perceived changes in health status in response to a treatment. (Kyte et al., 2015).
- Patient-Reported Experience Measures (PREMs): measure patients’ perception of their personal experience of receiving healthcare (What they experienced; How they felt; Quality of care) (Casaca et al., 2023; Kingsley et al., 2017).
- When selecting the appropriate outcome measures for clinical or research purposes, consider domains that best measure what are most important to patients. Measures that are valid, reliable, and responsive to change should be considered first. PMID: 21952190.
- Minimal Clinically Important Difference (MCID): the smallest difference in score in the domain of interest which patients perceive as beneficial and which would mandate (…) a change in the patient’s management (Jaeschke et al., 1989). MCIDs by contrast, are defined by patients’ perceptions, which led to “anchoring” of effects by the “transition” item, where patients rate their change of health between baseline and follow-up in an evaluation study. (Angst et al., 2017). MCID is the minimum score changes that patients perceive as beneficial, reflecting meaningful changes after a clinical intervention. An MCID should be different depending on disorders as pathology differs. (Ogura et al., 2020).
- Minimal Clinically Important Improvement (MCII): defined as the smallest change in measurement that signifies an important improvement in a patient’s symptom, seems more appropriate and, in clinical trials, provides readers with additional information on the effect size by expressing the results more meaningfully (that is, as a percentage of improved patients). (Tubach F et al., 2005).
- Treatment effects are considered specific if they are attributable solely, according to the theory of the mechanism of action, to the characteristic component of an intervention. Effects which are associated with the incidental elements of an intervention are considered nonspecific effects (synonymous with placebo effects). Nonspecific effects are mostly thought to be due to psychobiologic processes triggered by the overall therapeutic context. They have to be distinguished from the natural course of disease, regression to the mean, effects of being in a study, cointerventions and, as far as possible, from reporting and other biases. The total effect of an intervention consists of both specific and nonspecific effects. (PMID: 21092261).
- Effective Rate (ER) = (“total number of patients” – “number of patients without response”) /total number of patients; “no response” is defined as no significant change in VAS score after treatment. (PMID: 37143907).
| INTRUMENTO | O QUE AVALIA | APLICAÇÃO EM ESTUDOS | PONTO DE CORTE | MCID |
| Standardized Nordic Questionnaire | Standardised questionnaires for the analysis of musculoskeletal symptoms / complaints in an ergonomic or occupational health context. This instrument may be applied through an interview or answered by the person being evaluated. (Kuorinka I et al., 1987. PMID: 15676628); (de Barros EN, Alexandre NM, 2003. PMID: 12752909) | |||
| Body chart / Pain drawing | To assess the number of painful sites and the pain area, used in clinical practice to obtain a graphic representation of where the patient feels pain. (Margolis et al., 1986). Has been used to differentiate between local and widespread pain by analyzing the number of painful sites. (Mansfield et al., 2017). |
A test-retest reliability coefficient of r = 0.85 (Margolis et al., 1988). The intraexaminer and interexaminer reliability for measuring pain distribution were ICC of 0.99 and 0.99, respectively. (Southerest et al., 2013). |
Multisite pain = pain in two or more sites (≥ 2 contralateral quadrants of the body above and below the waist and in the axial skeleton). (Vitta et al. 2022) Local pain ≤ 2 painful sites; Widespread pain ≥ 3 painful sites (Mundal et al., 2014) |
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| Numerical Pain Rating Scale (NPRS) (0-10 points; > pior) | Unidimensional pain measurement (pain intensity)(Joos et al., 1991). In clinical trials the NRS have been demonstrated to be more reliable than the VAS (Ferraz MB et al., 1990). |
≤3 leve, 4-6 moderada, ≥7 severa (Treede et al. 2019); (Boonstra et al., 2016) |
-2 points (FARRAR et al., 2001; SALAFFI et al., 2004); (Tubach et al., 2005); ↓ 30% (FARRAR et al., 2001; FARRAR et al., 2000);
↓ 15% (Salaffi et al., 2004); (French et al., 2022); |
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| Visual analog scale (VAS) (1-10 cm; > pior) | Unidimensional pain measurement (pain intensity) | -1.4 cm (Tashjian et al., 2009) | ||
| Manual muscle testing (MMT) (1-5 grade; > melhor) | (CIESLA et al., 2011) | |||
| Modified sphygmomanometer test (MST) (> melhor) | (SOUZA et al., 2014) | |||
| Barthel Index (BI) (0-100; > melhor) | Activities of daily living in patients with various impairments. | 1.85 points (post-stroke) | ||
| Range of motion (ROM) (graus; > melhor) | (GAJDOSIK e BOHANNON, 1987) | (HUI et al., 2022) | +8.48° (knee, chronic stroke) (GUZIK et al., 2020) | |
| Finger-to-floor distance (FFD) (cm; > pior) |
Trunk range of motion. (PERRET et al., 2001) Closer to the groundind icates greater posterior chain flexibility. |
(VALENZA et al., 2017) | -4.5 cm improvement in finger-to-floor distance (EKEDAHL et al., 2012) | |
| One-legged stance test (OLST) (30 seconds) |
Measures the time, in seconds, that a person can stand on one leg, and is also a good predictor of falls (VILLAR et al., 2011) |
A maximum balance time was 30 seconds (BRIGGS et al. 1989) | +24.1 s (GOLDBERG et al., 2011) | |
| The five Times Sit to Stand Test (5xSST) (< melhor) |
Functional lower-extremity strength and power (Jones et al., 2013) Subjects sat in an armless chair with arms crossed across the trunk and on verbal command stood up and sat down. (Csuka M, McCarty DJ,1985) |
Degenerative pathologies of the lumbar spine = 10.35 seconds (Staartjes et al., 2018) | ||
| Four-Meter gait speed test (4mGS) (segundos; > pior) | ||||
| Short Physical Performance Battery (SPPB) (0-12 points; > melhor) | Measures lower extremity function (GURALNIK et al, 1994); (Nakano, 2007). | |||
| Timed Up and Go Test (TUG) (segundos; > pior) |
Lower-Body Functional Performance / Functional mobility and dynamic balance. (Podsiadlo, Richardson, 1991) Subjects sat with their spine against the back of an armless chair and on verbal command, stood up, walked 3 m around a cone, and returned to the chair. A familiarization attempt was provided, and the best of 2 test trials was analyzed. Subjects were given 1-minute rest periods between trials. |
(GAUTSCHI et al., 2017) |
Healthy people = 10 seconds or less (Shumway-Cook et al., 2000). ≥13.5 seconds = higher risk of falling. (Barry et al., 2014 PMID: 24484314); (PMID: 30768195); ≥13.5 seconds = classified as fallers; sensitivity=87%; specificity=87% (Shumway-Cook A et al. Phys Ther. 2000. PMID: 10960937). |
-1.4 seconds in total time to complete the test (Dobson, 2015) |
| Falls Efficacy Scale-International (FES-I) (16-64 points; > pior) |
Yardley L et al. Age Ageing. 2005. PMID: 16267188. FES-I-Brazil (Camargos FF et al., 2010. PMID: 20730369); |
FES-I-Brazil scores ≥23 suggested an association with a previous history of sporadic falls, whereas scores ≥31 suggested an association with recurrent falls.(Camargos FF et al., 2010. PMID: 20730369); To discriminate falls were >25 pointsfor women, and > 19 points for men (Canever JB et al., 2022. PMID: 35050494); |
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| Oswestry Disability Index (ODI) (0-100 points; > pior) | The impact of LBP on various functional activities. | -10 to -17 points. | ||
| Roland-Morris Disability Questionnaire (RMDQ) (0-24 points; > pior) | Functional disability due to back pain. (Roland, Morris, 1983) | Pregnancy: (13.1 – 3.8) (Vas et al. 2014) | ≥ 14 points (Roland, Morris. Spine. 1983); (Fhuro et al. J Chiropr Med. 2021) |
-2 to -3 points (or 8% to 12%) decrease. (Roland, Faibank, 2020. PMID: 11124727); (PMID: 17572614). -5 points (Wieland LS et al., 2022) ↓ 30% (7,2 points) (Jordan et al. J Clin Epidemiol. 2006); (PMID: 26133923); (Stratford, Riddle, 2016. PMID: 27504045) |
| Western Ontario and Mcmaster Universities Index (WOMAC) (0–96 scores; > pior) |
WOMAC pain (0-20), WOMAC stiffness (0-8), WOMAC function (0-68), WOMAC total score (0-96), (Bellamy et al., 1988). |
39.0 points (Hawker et al., 2000. PMID: 10749964) |
↓16.0% (Hmamouchi et al., 2012. PMID: 22269793); WOMAC total score = -6.432; WOMAC pain = -1.5; WOMAC stiffness = -0.576; WOMAC function = -4.556 (Angst et al., 2001. PMID: 11501727) (Luo et al., 2023. PMID: 36999342); -3 points on the pain subscale, -6 points o the physical function subscale (Bellamy et al., 1997); (French et al., 2022);
MCII p/ WOMAC total score = -9.1 points. (Tubach F et al., 2005. PMID: 15208174) |
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| Disabilities of the Arm, Shoulder and Hand (DASH) (0-100 points; > pior) | Functionality of the arm (Hudak et al., 1996) | -10.83 points for the DASH (sensitivity, 82%; specificity, 74%) (Franchignoni et al., 2014) | ||
| QuickDASH (0-100 points; > pior) |
Functionality of the arm (Hudak et al., 1996) Brazil (Silva et al., 2020. PMID: 32560867) |
30 pontos (Pinho et al., 2023); |
-15.91 points (sensitivity, 79%; specificity, 75%) (Franchignoni et al., 2014) -08.00 points (Mintken et al., 2009. PMID: 19297202) |
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| The Seated Medicine Ball Throw (SMBT) (0-10m; > melhor) |
The upper-extremity functional performance. Subjects sat in an armless chair and were asked to throw a 3-kg medicine ball as far forward as possible while keeping their spines against the back of the chair. The horizontal distance thrown was recorded in centimeters. Before administration of the test, arm length was accounted for by moving the zero mark of the measuring tape to the subject’s extended arms and fingertips. Subjects were allowed 2 familiarization attempts, followed by 2 test trials, with 1-minute recoveries between trials. The best effort was used for analysis. (Harris et al. 2011); Older adults: 3Kg = test-retest reliability ICC of 0.96 (Harris et al. 2011); Older women: (Strand KL et al. 2022) |
Parkinson: (pre 243.0 to 274.0 cm post) (Strand et al. 2021); Spinal cord injury: (Amorim S et al. 2018) Adolescent basketball players (pre 3.42 to 3.68m post) (Santos EJA, Janeira MAAS. 2012) Idosos comunitários: 2.33 m (3Kg) (Martins et al., 2023. PMID: 37539181). |
Brazil: 2Kg = 214 (26.65) cm (Ferreira et al. 2021); 3Kg = 3.8 (1.1) m (Leite et al., 2016) | |
| Closed Kinetic Chain Upper Extremity Stability Test (CKCUEST) (s) | ||||
| Short-Form 36 (0-100; > melhor) | Functional capacity, physical aspects, pain, general health, vitality, social aspects, emotional aspects and mental health (Ciconelli et al., 1999) | +3.6 to 4.6 points. | ||
| The 12-item Short Form Survey (SF-12) (0-100 points; > melhor) |
General health self-report questionnaire reflecting how respondents are able to function, how they feel, and what they think their health status is (Ware et al., 1996). The SF-12 is very sensitive to changes in health status and disease severity. Physical (PCS) and mental (MCS) health summary scores are determined using scoring algorithms. |
Chronic non-specific spinal pain: PCS (35.5 to 42.6), MCS (43.3 to 49.6) (Vas et al. 2014); PCS (34.3 to 46.9), MCS (49.6 to 55.8) (Vas J et al., 2019); (19.7 to 68.7) (Hu et al., 2021); (MANINCOR et al., 2016); (DESCHAMPS et al., 2009);
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A score of 50 or less on the PCS-12 has been recommended as a cut-off to determine the affected physical health, while a score of 42 or less on the MCS-12 has been recommended as a cut-off to determine the affected mental health. (Ware Jr et al., 1995). | In patients with subacute and chronic LBP, improvements >3.77 in MCS and >3.29 in PCS, can be considered clinically relevant. (Díaz-Arribas MJ et al., 2017) |
| Berg balance scale (BBS) (0-56; > melhor) |
High risk for a fall: score of ≤49/56 points and at least one accidental fall in the previous 6 months; High balance disabilities: score < 36 points; Low balance disabilities: score between 36 and 49 points; (PMID: 21958377) |
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| Falls Efficacy Scale-International (FES-I) (10-100 points; > pior) |
Evaluates the confidence one has to complete 10 basic activities of daily living without fear of falling (TINETTI et al., 1990). |
(DESCHAMPS et al., 2009); | ||
| Tampa Scale of Kinesiophobia (TSK) (17-68 points; > pior) | Kinesiophobia (Siqueira et al. 2007) | |||
| Global Perceived Effect Scale (GPE) (-5 to +5 points; > melhor) | Compared to when this episode first started, how would you describe your back these days? (1. Completely recovered; 2. Much improved; 3. Slightly improved; 4. Not changed; 5. Slightly worsened; 6. Much worsened; 7. Worse than ever) (Kamper et al., 2010) | (FREITAS et al., 2019) | +2.5 points (Bobos P et al., 2020. PMID: 32082038). | |
| Pittsburgh Sleep Quality Index (PSQI) (0 to 21 points; > pior) | Evaluate sleep quality. Generate a total score and 7 components or domains: sleep quality; sleep latency; sleep duration; sleep efficiency; sleep disturbances; use of sleeping medication; daytime dysfunction. (BUYSSE et a., 1989); (BERTOLAZI et al., 2011). | Breast cancer: (12.2 – 7.8) (Höxtermann et al., 2021); (12.5 – 8,6) (Zhang et al., 2021); (CARCELÉN-FRAILE et al., 2022) | > 5 points = poor sleep quality. (Veronica et al., 2015) | -4.4 points (Longo et al., 2021). |
| Depression Anxiety Stress Scale (DASS-21) (0 to 42 points; > pior) |
Psychological distress (LOVIBOND; LOVIBOND, 1995). |
Chronic non-specific low back pain (Glazov G et al., 2009); (MANINCOR et al., 2016); | ||
| Biomarkers of Inflammation: pro-inflammatory cytokines (Serum concentrations of inflammatory factors. ELISA kits) |
Acute Lumbar Sprain: TNF-α (27.91 – 10.22 pg/mL), IL-6 (22.39 – 9.71 pg/mL) (Li et al., 2022). Knee Osteoarthritis: TNF-α (29.64 – 16.26 pg/mL), IL-1β (0.93 – 0.59 pg/mL) (Shi et al., 2020). Anterior Cervical Discectomy and Fusion: IL-1β (16.5 – 8.7 ng/L), IL-6 (19.2 – 10.0 ng/L), TNF-α (52.0 – 31.2 ng/L) (Xia et al., 2018). Rheumatoid arthritis: IL-6 (95.4 – 67.45) (Adly et al., 2021). Allergic asthma: IL-6 (2 pg/mL), IL-10 (7 pg/mL) (Joos et al., 2000). Chronic obstructive pulmonary disease: IL-6 (90.2 – 49.4 pg/mL) (Mehani et al., 2017). Breast cancer: IL-6 (2.5) (Höxtermann et al., 2021); IL-1 (0.82 – 0.82 pg/mL), IL-6 (1.26 – 1.62 pg/mL), IL-12 (2.55 – 2.64 pg/mL), IL-17 (8.03 – 7.74 pg/mL), IFN-γ (2.92 – 3.00 pg/mL), TNF-α (4.77 – 4.19 pg/mL) (Bao et al., 2013). Diabetes: IL-6 (1.39 – 1.32 pg/ml), TNF-α (0.66 – 0.60 pg/ml) (Qi et al., 2018). |
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| Biomarkers of Inflammation: anti-inflammatory cytokine (Serum concentrations of inflammatory factors. ELISA kits) |
Knee Osteoarthritis: IL-13 (2.07 – 2.81 pg/mL)(Shi et al., 2020). Allergic asthma: IL-8 (65 pg/mL) (Joos et al., 2000). Breast cancer: IL-8 (8.64 – 7.57 pg/mL), IL-10 (0.96 – 0.95 pg/mL) (Joos et al., 2000). |
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| Blood sugar levels | Diabetes: Fasting glucose (176.5 – 170.1 mg/dl), HbA1C (6.8 – 6.9) (Qi et al., 2018). | |||
| Recording of analgesic medication intake | The score for intake of analgesic medication did not differ significantly between the 2 groups either at the end of treatment (P = 0.75) or throughout the total study period (P = 0.57). (Dufour et al., 2010). | |||
| Adverse Events and Dropouts |
delayed onset. dropped out. lost to follow-up. |
“IL-6 atua como uma citocina pró-inflamatória e uma miocina anti-inflamatória.. Esta citocina está implicada numa grande variedade de estados de doença associadas a inflamação (incluindo diabetes mellitus, artrite reumatóide …). A Interleucina-6 (Interleukin – IL-6) é um fator crítico no controle dos sistemas imune e hematopoiético. IL-6 faz com que as células B iniciem a proliferação e diferenciação nas células formadoras de anticorpos. A IL-6 também atua em conjunto com o IL-3 para induzir a proliferação de progenitores hematopoiéticos. Adicionalmente, esta citoquina induz a produção de proteínas de fase aguda. IL-6 é secretada pelas células T, B, macrófagos, monócitos, linfócitos, fibroblastos, células endoteliais, queratinócitos e muitas linhagens de células tumorais.” <Disponível em LEAC >.
“O TNF-alfa é uma citocina pró-inflamatória que regula múltiplos processos biológicos (incluindo proliferação celular, diferenciação, apoptose, metabolismo lipídico e coagulação).” <Disponível em LEAC >.
“A IL1-BETA é um mediador importante da resposta inflamatória e está envolvida numa variedade de atividades celulares (incluindo proliferação celular, diferenciação e apoptose). A indução da ciclooxigenase-2 (PTGS2 / COX2) por esta citocina no SNC contribui para a hipersensibilidade inflamatória da dor. Esta citocina também foi descrita como sendo ativa no câncer.” <Disponível em LEAC >.
“A interleucina-4 (Interleukin-4) é uma glicoproteína anti-inflamatória de 129 aminoácidos de massa molecular de 15-19 kDa. Ela tem sido referida como fator de crescimento-1 de células B (BCGF)-1, fator estimulante das células B (BSF), fator de crescimento de linfócitos e fator de crescimento-II das células T (TCGF)-II. IL-4 controla a produção de citocinas. Seu efeito inibidor na produção de citocinas faz do IL-4 um candidato potencial para ser utilizado em doenças inflamatórias crônicas. Existem também trabalhos de investigações dizendo que o IL-4 pode ter influencia na atividade anti-tumoral.”<Disponível em LEAC >.
“A IL-10 é uma potente citocina anti-inflamatória com um papel importante na limitação da resposta imunitária do hospedeiro a agentes patogênicos e para evitar danos ao hospedeiro enquanto mantém a homeostase normal dos tecidos. IL-10 também regula o crescimento e/ou diferenciação das células B, granulócitos, neutrófilos, células dendriticas, queratinócitos e células endoteliais. Vários parasitas, bactérias, fungos e vírus deprimem a resposta imune do hospedeiro tanto induzindo a produção de IL-10 ou codificando seu próprio IL-10 homólogo. Apesar de ser um potente imunossupressor, IL-10 é também um antipirético. Níveis circulantes de IL-10 estão aumentados em asma alérgica, esclerose sistêmica, vários tipos de câncer, pacientes pós-transplantados e na sepse. O potencial terapêutico da IL-10 inclui a artrite reumatóide, lupus eritematoso sistêmico, esclerose múltipla e infecções por HIV.” <Disponível em LEAC >.
Valores de referência para os mediadores pró-inflamatórios
