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1.
J Pain ; : 104556, 2024 May 04.
Artículo en Inglés | MEDLINE | ID: mdl-38710259

RESUMEN

Investigating how individual characteristics modify treatment effects can improve understanding, interpretation, and translation of trial findings. The purpose of this secondary analysis was to identify treatment effect modifiers of the MI-NAV trial, a three arm, parallel randomized controlled trial which compared motivational interviewing and stratified vocational advice intervention in addition to usual case management, to usual case management alone. This study included (n=514) participants with musculoskeletal disorders on sick leave for at least 50% of their contracted work hours for at least 7 consecutive weeks with the Norwegian Labour and Welfare Administration. Sickness absence days was the primary outcome, measured from baseline assessment date until the six-month follow-up. Potential treatment effect modifiers, identified a priori and informed by expert consultation and literature, were evaluated using linear regression models and statistical interaction tests. For motivational interviewing versus usual case management, age (mean difference -0.7, 95% confidence interval -1.5 to 0.2; P=0.13) and self-perceived health status (mean difference -0.3, 95% confidence interval -0.7 to 0.1; P=0.19) were identified as potential effect modifiers (p ≤ 0.2). For stratified vocational advice intervention versus usual case management, analgesic medication use (MD -26.2, 95% CI -45.7 to -6.7; P=0.009) was identified as a treatment effect modifier (p ≤ 0.05). These findings may assist in more targeted treatment adaptation and translation as well as the planning of future clinical trials. PERSPECTIVE: This secondary analysis of the MI-NAV trial found that analgesic medication use, age and self-perceived health may modify the effect of two vocational interventions on reducing sickness absence in people with musculoskeletal disorders.

3.
J Med Internet Res ; 26: e53951, 2024 Mar 19.
Artículo en Inglés | MEDLINE | ID: mdl-38502157

RESUMEN

BACKGROUND: Spinal disorders are highly prevalent worldwide with high socioeconomic costs. This cost is associated with the demand for treatment and productivity loss, prompting the exploration of technologies to improve patient outcomes. Clinical decision support systems (CDSSs) are computerized systems that are increasingly used to facilitate safe and efficient health care. Their applications range in depth and can be found across health care specialties. OBJECTIVE: This scoping review aims to explore the use of CDSSs in patients with spinal disorders. METHODS: We used the Joanna Briggs Institute methodological guidance for this scoping review and reported according to the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) statement. Databases, including PubMed, Embase, Cochrane, CINAHL, Web of Science, Scopus, ProQuest, and PsycINFO, were searched from inception until October 11, 2022. The included studies examined the use of digitalized CDSSs in patients with spinal disorders. RESULTS: A total of 4 major CDSS functions were identified from 31 studies: preventing unnecessary imaging (n=8, 26%), aiding diagnosis (n=6, 19%), aiding prognosis (n=11, 35%), and recommending treatment options (n=6, 20%). Most studies used the knowledge-based system. Logistic regression was the most commonly used method, followed by decision tree algorithms. The use of CDSSs to aid in the management of spinal disorders was generally accepted over the threat to physicians' clinical decision-making autonomy. CONCLUSIONS: Although the effectiveness was frequently evaluated by examining the agreement between the decisions made by the CDSSs and the health care providers, comparing the CDSS recommendations with actual clinical outcomes would be preferable. In addition, future studies on CDSS development should focus on system integration, considering end user's needs and preferences, and external validation and impact studies to assess effectiveness and generalizability. TRIAL REGISTRATION: OSF Registries osf.io/dyz3f; https://osf.io/dyz3f.


Asunto(s)
Sistemas de Apoyo a Decisiones Clínicas , Humanos , Algoritmos , Toma de Decisiones Clínicas , Bases de Datos Factuales
5.
BMJ Open ; 14(3): e080567, 2024 Mar 01.
Artículo en Inglés | MEDLINE | ID: mdl-38431296

RESUMEN

OBJECTIVES: The objective was to identify modifiable prognostic factors of high societal costs among people on sick leave due to musculoskeletal disorders, and to identify modifiable prognostic factors of high costs related to separately healthcare utilisation and productivity loss. DESIGN: A prospective cohort study with a 1-year follow-up. PARTICIPANTS AND SETTING: A total of 549 participants (aged 18-67 years) on sick leave (≥ 4 weeks) due to musculoskeletal disorders in Norway were included. OUTCOME MEASURES AND METHOD: The primary outcome was societal costs aggregated for 1 year of follow-up and dichotomised as high or low, defined by the top 25th percentile. Secondary outcomes were high costs related to separately healthcare utilisation and productivity loss aggregated for 1 year of follow-up. Healthcare utilisation was collected from public records and included primary, secondary and tertiary healthcare use. Productivity loss was collected from public records and included absenteeism, work assessment allowance and disability pension. Nine modifiable prognostic factors were selected based on previous literature. Univariable and multivariable binary logistic regression analyses were performed to identify associations (crude and adjusted for selected covariates) between each modifiable prognostic factor and having high costs. RESULTS: Adjusted for selected covariates, six modifiable prognostic factors associated with high societal costs were identified: pain severity, disability, self-perceived health, sleep quality, return to work expectation and long-lasting disorder expectation. Depressive symptoms, work satisfaction and health literacy showed no prognostic value. More or less similar results were observed when high costs were related to separately healthcare utilisation and productivity loss. CONCLUSION: Factors identified in this study are potential target areas for interventions which could reduce high societal costs among people on sick leave due to musculoskeletal disorders. However, future research aimed at replicating these findings is warranted. TRIAL REGISTRATION NUMBER: NCT04196634, 12 December 2019.


Asunto(s)
Enfermedades Musculoesqueléticas , Ausencia por Enfermedad , Humanos , Estudios de Cohortes , Estudios Prospectivos , Pronóstico
7.
JAMA Netw Open ; 7(2): e2355024, 2024 Feb 05.
Artículo en Inglés | MEDLINE | ID: mdl-38324310

RESUMEN

Importance: Lumber disc herniation surgery can reduce pain and disability. However, a sizable minority of individuals experience minimal benefit, necessitating the development of accurate prediction models. Objective: To develop and validate prediction models for disability and pain 12 months after lumbar disc herniation surgery. Design, Setting, and Participants: A prospective, multicenter, registry-based prognostic study was conducted on a cohort of individuals undergoing lumbar disc herniation surgery from January 1, 2007, to May 31, 2021. Patients in the Norwegian Registry for Spine Surgery from all public and private hospitals in Norway performing spine surgery were included. Data analysis was performed from January to June 2023. Exposures: Microdiscectomy or open discectomy. Main Outcomes and Measures: Treatment success at 12 months, defined as improvement in Oswestry Disability Index (ODI) of 22 points or more; Numeric Rating Scale (NRS) back pain improvement of 2 or more points, and NRS leg pain improvement of 4 or more points. Machine learning models were trained for model development and internal-external cross-validation applied over geographic regions to validate the models. Model performance was assessed through discrimination (C statistic) and calibration (slope and intercept). Results: Analysis included 22 707 surgical cases (21 161 patients) (ODI model) (mean [SD] age, 47.0 [14.0] years; 12 952 [57.0%] males). Treatment nonsuccess was experienced by 33% (ODI), 27% (NRS back pain), and 31% (NRS leg pain) of the patients. In internal-external cross-validation, the selected machine learning models showed consistent discrimination and calibration across all 5 regions. The C statistic ranged from 0.81 to 0.84 (pooled random-effects meta-analysis estimate, 0.82; 95% CI, 0.81-0.84) for the ODI model. Calibration slopes (point estimates, 0.94-1.03; pooled estimate, 0.99; 95% CI, 0.93-1.06) and calibration intercepts (point estimates, -0.05 to 0.11; pooled estimate, 0.01; 95% CI, -0.07 to 0.10) were also consistent across regions. For NRS back pain, the C statistic ranged from 0.75 to 0.80 (pooled estimate, 0.77; 95% CI, 0.75-0.79); for NRS leg pain, the C statistic ranged from 0.74 to 0.77 (pooled estimate, 0.75; 95% CI, 0.74-0.76). Only minor heterogeneity was found in calibration slopes and intercepts. Conclusion: The findings of this study suggest that the models developed can inform patients and clinicians about individual prognosis and aid in surgical decision-making.


Asunto(s)
Dolor de Espalda , Desplazamiento del Disco Intervertebral , Femenino , Humanos , Masculino , Persona de Mediana Edad , Calibración , Desplazamiento del Disco Intervertebral/cirugía , Aprendizaje Automático , Nonoxinol , Estudios Prospectivos , Adulto
8.
BMC Musculoskelet Disord ; 25(1): 60, 2024 Jan 13.
Artículo en Inglés | MEDLINE | ID: mdl-38216905

RESUMEN

BACKGROUND: Back pain is the number one condition contributing to years lived with disability worldwide, and one of the most common reasons for seeking primary care. Research on this condition in the ageing population is sparse. Further, the heterogeneity of patients with back pain complicates the management in clinical care. It is possible that subgrouping people with similar characteristics would improve management. This paper aimed to identify latent classes based on demographics, pain characteristics, psychosocial behavior, and beliefs and attitudes about back pain, among older patients seeking primary care with a new episode of back pain, and to examine if there were differences regarding the classes' first point-of-contact. METHODS: The study was part of the international BACE (Back complaints in elders) consortium and included 435 patients aged ≥ 55 years seeking primary care (general practitioners, physiotherapists, and chiropractors) in Norway from April 2015 to March 2020. A latent class analysis was performed to identify latent classes. The classes were described in terms of baseline characteristics and first point-of-contact in primary care. RESULTS: Four latent classes were identified. The mean age was similar across groups, as were high expectations towards improvement. Class 1 (n = 169, 39%), the "positive" class, had more positive attitudes and beliefs, less pain catastrophizing and shorter duration of current pain episode. Class 2 (n = 31, 7%), the "fearful" class, exhibited the most fear avoidance behavior, and had higher mean pain intensity. Class 3 (n = 33, 8%), the "distressed" class, had the highest scores on depression, disability, and catastrophizing. Finally, class 4 (n = 202, 46%), the "hopeful" class, showed the highest expectations for recovery, although having high pain intensity. The identified four classes showed high internal homogeneity, sufficient between-group heterogeneity and were considered clinically meaningful. The distribution of first point-of-contact was similar across classes, except for the positive class where significantly more patients visited chiropractors compared to general practitioners and physiotherapists. CONCLUSIONS: The identified classes may contribute to targeting clinical management of these patients. Longitudinal research on these latent classes is needed to explore whether the latent classes have prognostic value. Validation studies are needed to evaluate external validity. TRIAL REGISTRATION: Clinicaltrials.gov NCT04261309.


Asunto(s)
Personas con Discapacidad , Dolor de la Región Lumbar , Anciano , Humanos , Miedo , Dolor de la Región Lumbar/epidemiología , Atención Primaria de Salud , Pronóstico , Persona de Mediana Edad
9.
J Occup Med Toxicol ; 18(1): 25, 2023 Nov 14.
Artículo en Inglés | MEDLINE | ID: mdl-37964240

RESUMEN

OBJECTIVES: This study evaluates the six-month cost-effectiveness and cost-benefits of motivational interviewing (MI) or a stratified vocational advice intervention (SVAI) added to usual case management (UC) for workers on sick leave due to musculoskeletal disorders. METHODS: This study was conducted alongside a three-arm RCT including 514 employed workers on sick leave for at least 50% for ≥ 7 weeks. All participants received UC. The UC + MI group received two MI sessions, and the UC + SVAI group received 1-4 SVAI sessions. Sickness absence days, quality-adjusted life-years (QALYs), and societal costs were measured between baseline and six months. RESULTS: Adding MI to UC, resulted in incremental cost-reduction of -2580EUR (95%CI -5687;612), and a reduction in QALYs of -0.001 (95%CI -0.02;0.01). Secondly, adding MI to UC resulted in an incremental cost-reduction of -538EUR (95%CI -1358;352), and reduction of 5.08 (95%CI -3.3;13.5) sickness-absence days. Financial return estimates were positive, but not statistically significant. Adding SVAI to UC, resulted in an incremental cost-reduction of -2899 EUR (95% CI -5840;18), and a reduction in QALYs of 0.002 (95% CI -0.02;0.01). Secondly, adding SVAI to UC resulted in an statistically significant incremental cost-reduction of -695 EUR (95% CI -1459;-3), and a reduction of 7.9 (95% CI -0.04;15.9) sickness absence days. Financial return estimates were positive and statistically significant. The probabilities of cost-effectiveness for QALYs were high for adding MI or SVAI (ceiling ratio 0.90). CONCLUSIONS: In comparison to UC only, adding MI to UC tends to be cost-effective. Adding SVAI to UC is cost-effective for workers on sick leave due to musculoskeletal disorders. TRIAL REGISTRATION: ClinicalTrials.gov (identifier: NCT03871712).

10.
BMC Musculoskelet Disord ; 24(1): 714, 2023 Sep 08.
Artículo en Inglés | MEDLINE | ID: mdl-37684597

RESUMEN

OBJECTIVE: To evaluate the efficacy of strength exercise or aerobic exercise compared to usual care on knee-related quality of life (QoL) and knee function at 4 months and 1 year in individuals with knee osteoarthritis. METHODS: A three-arm randomized controlled trial (RCT) compared 12 weeks of strength exercise or aerobic exercise (stationary cycling) to usual care supervised by physiotherapists in primary care. We recruited 168 participants aged 35-70 years with symptomatic knee osteoarthritis. The primary outcome was The Knee Injury and Osteoarthritis Outcome Score (KOOS) QoL at 1 year. Secondary outcomes were self-reported function, pain, and self-efficacy, muscle strength and maximal oxygen uptake (VO2max) at 4 months and 1 year. RESULTS: There were no differences between strength exercise and usual care on KOOS QoL (6.5, 95% CI -0.9 to 14), or for aerobic exercise and usual care (5.0, 95% CI -2.7 to 12.8), at 1 year. The two exercise groups showed better quadriceps muscle strength, and VO2max at 4 months, compared to usual care. CONCLUSION: This trial found no statistically significant effects of two exercise programs compared to usual care on KOOS QoL at 1 year in individuals with symptomatic and radiographic knee osteoarthritis, but an underpowered sample size may explain lack of efficacy between the intervention groups and the usual care group. GOV IDENTIFIER: NCT01682980.


Asunto(s)
Osteoartritis de la Rodilla , Humanos , Osteoartritis de la Rodilla/terapia , Estudios de Seguimiento , Articulación de la Rodilla , Ejercicio Físico , Calidad de Vida
11.
Spine (Phila Pa 1976) ; 48(24): 1699-1708, 2023 Dec 15.
Artículo en Inglés | MEDLINE | ID: mdl-37759351

RESUMEN

STUDY DESIGN: Secondary analyses of a randomized trial [Antibiotics In Modic changes (MCs) study]. OBJECTIVE: To assess whether or not reduced MC edema over time is related to reduced disability and pain in patients with chronic low back pain (LBP). SUMMARY OF BACKGROUND DATA: It is not clear whether or not reduced MC edema implies improved clinical outcomes. PATIENTS AND METHODS: Linear regression was conducted separately in 2 subgroups with MC edema at baseline on short tau inversion recovery (STIR) or T1/T2-weighted magnetic resonance imaging, respectively. Independent variable: reduced edema (yes/no) at 1 year on STIR or T1/T2-series, respectively. Dependent variable: 1-year score on the Roland-Morris Disability Questionnaire (RMDQ), Oswestry Disability Index (ODI), or 0 to 10 numeric rating scale for LBP intensity, adjusted for the baseline score, age, smoking, body mass index, physical workload, and baseline edema on STIR (STIR analysis only). Post hoc, we, in addition, adjusted all analyses for baseline edema on STIR, treatment group (amoxicillin/placebo), and prior disc surgery-or for disc degeneration. RESULTS: Among patients with MC edema on STIR at baseline (n = 162), reduced edema on STIR was not significantly related to the RMDQ ( B : -1.0, 95% CI: -2.8, 0.8; P = 0.27), ODI ( B :-1.4, 95% CI: -5.4, 2.6; P = 0.50), or LBP intensity scores ( B : -0.05, 95% CI: -0.8, 0.7; P = 0.90) after 1 year. Among patients with MC edema on T1/T2-series at baseline (n = 116), reduced edema on T1/T2 ( i.e ., reduced volume of the type 1 part of MCs) was not significantly related to RMDQ ( B: -1.7, 95% CI: -3.8, 0.3; P = 0.10) or ODI score ( B : -2.3, 95% CI: -7.1, 2.5; P = 0.34) but was significantly related to LBP intensity at 1 year ( B : -0.9, 95% CI: -1.8, -0.04; P = 0.04; correlation coefficient: 0.24). The post hoc analyses supported these results. CONCLUSION: Reduced MC edema over 1 year was not significantly associated with pain-related disability but was (on T1/T2-series) significantly but weakly related to reduced LBP intensity. LEVEL OF EVIDENCE: Level 3.


Asunto(s)
Dolor Crónico , Personas con Discapacidad , Degeneración del Disco Intervertebral , Dolor de la Región Lumbar , Humanos , Amoxicilina/uso terapéutico , Antibacterianos/uso terapéutico , Dolor Crónico/tratamiento farmacológico , Dolor Crónico/complicaciones , Degeneración del Disco Intervertebral/complicaciones , Dolor de la Región Lumbar/complicaciones
12.
Scand J Work Environ Health ; 49(7): 477-486, 2023 Oct 01.
Artículo en Inglés | MEDLINE | ID: mdl-37634251

RESUMEN

OBJECTIVE: This study aimed to evaluate the effectiveness of motivational interviewing (MI) - a counselling approach offered by caseworkers at the Norwegian Labor and Welfare Administration (NAV) - on return to work (RTW) for individuals sick-listed for ≥8 weeks due to any diagnoses. MI was compared to usual case management and an active control during 12 months of follow-up. METHODS: In a randomized clinical trial with three parallel arms, participants were randomized to MI (N=257), usual case management (N=266), or an active control group (N=252). MI consisted of two MI sessions while the active control involved two sessions without MI, both were offered in addition to usual case management. The primary outcome was number of sickness absence days based on registry data. Secondary outcomes included time to sustainable RTW, defined as four consecutive weeks without medical benefits. RESULTS: The median number of sickness absence days for the MI group was 73 days [interquartile range (IQR) 31-147], 76 days (35-134) for usual care, and 75 days (34-155) for active control. In total 89%, 88% and 86% of the participants, respectively, achieved sustainable RTW. The adjusted hazard ratio (HR) for time to sustainable RTW was 1.12 (95% CI 0.90-1.40) for MI compared to usual case management and HR 1.16 (95% CI 0.93-1.44) compared to the active control. CONCLUSIONS: This study did not provide evidence that MI offered by NAV caseworkers to sick-listed individuals was more effective on RTW than usual case management or an active control. Providing MI in this context could be challenging as only half of the MI group received the intervention.


Asunto(s)
Entrevista Motivacional , Humanos , Seguridad Social , Ausencia por Enfermedad , Empleo , Reinserción al Trabajo
13.
Pain ; 164(12): 2759-2768, 2023 Dec 01.
Artículo en Inglés | MEDLINE | ID: mdl-37490100

RESUMEN

ABSTRACT: Prognostic prediction models for 3 different definitions of nonrecovery were developed in the Back Complaints in the Elders study in the Netherlands. The models' performance was good (optimism-adjusted area under receiver operating characteristics [AUC] curve ≥0.77, R2 ≥0.3). This study aimed to assess the external validity of the 3 prognostic prediction models in the Norwegian Back Complaints in the Elders study. We conducted a prospective cohort study, including 452 patients aged ≥55 years, seeking primary care for a new episode of back pain. Nonrecovery was defined for 2 outcomes, combining 6- and 12-month follow-up data: Persistent back pain (≥3/10 on numeric rating scale) and persistent disability (≥4/24 on Roland-Morris Disability Questionnaire). We could not assess the third model (self-reported nonrecovery) because of substantial missing data (>50%). The models consisted of biopsychosocial prognostic factors. First, we assessed Nagelkerke R2 , discrimination (AUC) and calibration (calibration-in-the-large [CITL], slope, and calibration plot). Step 2 was to recalibrate the models based on CITL and slope. Step 3 was to reestimate the model coefficients and assess if this improved performance. The back pain model demonstrated acceptable discrimination (AUC 0.74, 95% confidence interval: 0.69-0.79), and R2 was 0.23. The disability model demonstrated excellent discrimination (AUC 0.81, 95% confidence interval: 0.76-0.85), and R2 was 0.35. Both models had poor calibration (CITL <0, slope <1). Recalibration yielded acceptable calibration for both models, according to the calibration plots. Step 3 did not improve performance substantially. The recalibrated models may need further external validation, and the models' clinical impact should be assessed.


Asunto(s)
Dolor de Espalda , Dolor de la Región Lumbar , Humanos , Anciano , Pronóstico , Estudios Prospectivos , Dolor de Espalda/diagnóstico , Dolor de Espalda/terapia , Atención Primaria de Salud
15.
Occup Environ Med ; 80(5): 246-253, 2023 05.
Artículo en Inglés | MEDLINE | ID: mdl-36863864

RESUMEN

OBJECTIVES: To investigate whether and to what extent, return to work (RTW) expectancy and workability mediate the effect of two vocational interventions on reducing sickness absence in workers on sick leave from a musculoskeletal condition. METHODS: This is a preplanned mediation analysis of a three-arm parallel randomised controlled trial which included 514 employed working adults with musculoskeletal conditions on sick leave for at least 50% of their contracted work hours for ≥7 weeks. Participants were randomly allocated (1:1:1) to one of three treatment arms; usual case management (UC) (n=174), UC plus motivational interviewing (MI) (n=170) and UC plus a stratified vocational advice intervention (SVAI) (n=170). The primary outcome was the number of sickness absence days over 6 months from randomisation. Hypothesised mediators included RTW expectancy and workability assessed 12 weeks after randomisation. RESULTS: The mediated effect of the MI arm compared with UC on sickness absence days through RTW expectancy was -4.98 days (-8.89 to -1.04), and workability was -3.17 days (-8.55 to 2.32). The mediated effect of the SVAI arm compared with UC on sickness absence days through RTW expectancy was -4.39 days (-7.60 to -1.47), and workability was -3.21 days (-7.90 to 1.50). The mediated effects for workability were not statistically significant. CONCLUSIONS: Our study provides new evidence for the mechanisms of vocational interventions to reduce sickness absence related to sick leave due to musculoskeletal conditions. Changing an individual's expectation that RTW is likely may result in meaningful reductions in sickness absence days. TRIAL REGISTRATION NUMBER: NCT03871712.


Asunto(s)
Entrevista Motivacional , Enfermedades Musculoesqueléticas , Adulto , Humanos , Reinserción al Trabajo , Análisis de Mediación , Empleo , Ausencia por Enfermedad
16.
Pilot Feasibility Stud ; 9(1): 44, 2023 Mar 17.
Artículo en Inglés | MEDLINE | ID: mdl-36932432

RESUMEN

BACKGROUND: Patients with chronic low back pain (LBP) and lumbar disc degeneration are recommended to try out nonsurgical treatment options before surgery. There is need for good nonsurgical alternatives that can be adapted to the patient's needs and level of function. The aim of this pilot trial was to test study feasibility of a future full randomized controlled trial (RCT) evaluating the feasibility and benefit of the physiotherapy-based Godelieve Denys-Struyf (GDS) muscle and articulation chain treatment for patients with chronic LBP and lumbar disc degeneration referred to surgical assessment in a hospital outpatient clinic. METHODS: This study is a single-center, two-arm, single-blinded, pilot RCT conducted in a regional hospital in Norway. Patients of age 35-75 years with chronic (> 3 months) LBP and degenerative lumbar disc(s) verified by imaging were included. They filled in a baseline questionnaire prior to randomization, including the Oswestry Disability Index (ODI), numerical rating scale for pain in back and pain in leg, and the EuroQoL 5L. Patients in the control group were free to use treatment as usual. Patients in the intervention group received 8 sessions over a period of 10 to 14 weeks of GDS muscle and articulation chain treatment. RESULTS: The recruitment rate was slow, approximately 3/4th of the referred patients met the inclusion criteria, but majority of eligible participants (94%) were willing to participate. A total of 30 patients were randomized into the two groups. The randomization led to skewed distribution of radiating leg pain in the two groups. All participants except one (97%) completed 4 months follow-up. No serious adverse events attributable to the trial treatments were reported. The Oswestry Disability Index (ODI) and leg pain intensity scale were both suitable as primary outcomes in a full trial. The mean change in the ODI score was 8.7 (SD 16.1) points in the GDS arm, whereas there was a minor deterioration in the ODI scores of -3.7 (7.5) points in the control arm. A sample size calculation based on the ODI scores resulted in a number needed to treat of 3. CONCLUSIONS: A future full RCT is feasible and would provide evidence about the effectiveness of a GDS treatment for patients with chronic LBP and lumbar disc degeneration. TRIAL REGISTRATION: ClinicalTrials.gov ID: 910193.

17.
Trials ; 24(1): 179, 2023 Mar 11.
Artículo en Inglés | MEDLINE | ID: mdl-36906593

RESUMEN

BACKGROUND: Around one-third of workdays lost in Norway are due to musculoskeletal conditions, with persistent (chronic) pain being the most frequent cause of sick leave and work disability. Increasing work participation for people with persistent pain improves their health, quality of life, and well-being and reduces poverty; however, it is not clear how to best help unemployed people who have persistent pain to return to work. The aim of this study is to examine if a matched work placement intervention featuring case manager support and work-focused healthcare improves return to work rates and quality of life for unemployed people in Norway with persistent pain who want to work. METHODS: We will use a cohort randomised controlled approach to test the effectiveness and cost-effectiveness of a matched work placement intervention featuring case manager support and work-focused healthcare compared to those receiving usual care in the cohort alone. We will recruit people aged 18-64, who have been out of work for at least 1 month, had pain for more than 3 months, and want to work. Initially, all (n = 228) will be recruited to an observational cohort study on the impact of being unemployed with persistent pain. We will then randomly select one in three to be offered the intervention. The primary outcome of sustained return to work will be measured using registry and self-reported data, while secondary outcomes include self-reported levels of health-related quality of life and physical and mental health. Outcomes will be measured at baseline and 3, 6, and 12 months post-randomisation. We will run a process evaluation parallel to the intervention exploring implementation, continuity of the intervention, reasons for participating, declining participation, and mechanisms behind cases of sustained return to work. An economic evaluation of the trial process will also be conducted. DISCUSSION: The ReISE intervention is designed to increase work participation for people with persistent pain. The intervention has the potential to improve work ability by collaboratively navigating obstacles to working. If successful, the intervention may be a viable option for helping people in this population. TRIAL REGISTRATION: ISRCTN Registry 85,437,524 Registered on 30 March 2022.


Asunto(s)
Dolor Crónico , Calidad de Vida , Humanos , Reinserción al Trabajo , Rehabilitación Vocacional/métodos , Desempleo , Análisis Costo-Beneficio , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Observacionales como Asunto
18.
Health Qual Life Outcomes ; 21(1): 13, 2023 Jan 31.
Artículo en Inglés | MEDLINE | ID: mdl-36721146

RESUMEN

BACKGROUND: This paper presents a novel methodology for translation and cross-cultural adaptation of health-related quality-of-life patient-reported outcome measures, incorporating the Delphi method. Specifically, we describe the process of translating the Pelvic Floor Distress Inventory-20 and Pelvic Floor Impact Questionnaire-7 from English to Norwegian using this method. METHODS: The multistep translation method combined the European Organization for Research and Treatment of Cancer Quality of Life guidelines, an Expert Panel review, and the Delphi method. It comprised two independent forward- and back-translations. While the bilingual pelvic floor Expert Panel ensured rigorous cross-checking and effective cross-cultural adaptation, the addition of the Delphi method (comprising the attributes of anonymity, controlled feedback, and statistical group response) further established consensus on translated items. OUTCOMES: The application of the Delphi method in the Expert Panel phase proved adequate in producing comprehensible intermediate Norwegian versions ready for pilot testing. The Expert Panel reviewed the comments made by patients completing the instruments and offered advice to allow final translated versions to be produced and tested for measurement properties. This iterative approach, internal logic, and anonymity between rounds improved the evaluations that the panel members provided, which in turn enhanced the final translated Patient Reported Outcome Measures (PROMs). CONCLUSIONS: To our knowledge, this work represents the first demonstration of the application of an Expert Panel review incorporating a Delphi method to assess health-related quality-of-life instruments. The controlled feedback approach, iterative nature, internal logic, and anonymity of the Delphi consensus method appeared to ensure a good cross-cultural adaptation of these PROMs.


Asunto(s)
Comparación Transcultural , Calidad de Vida , Humanos , Traducciones , Consenso , Medición de Resultados Informados por el Paciente
19.
Occup Environ Med ; 80(1): 42-50, 2023 01.
Artículo en Inglés | MEDLINE | ID: mdl-36428098

RESUMEN

OBJECTIVES: To evaluate if adding motivational interviewing (MI) or a stratified vocational advice intervention (SVAI) to usual case management (UC), reduced sickness absence over 6 months for workers on sick leave due to musculoskeletal disorders. METHODS: We conducted a three-arm parallel pragmatic randomised controlled trial including 514 employed workers (57% women, median age 49 (range 24-66)), on sick leave for at least 50% of their contracted work hours for ≥7 weeks. All participants received UC. In addition, those randomised to UC+MI were offered two MI sessions from social insurance caseworkers and those randomised to UC+SVAI were offered vocational advice from physiotherapists (participants with low/medium-risk for long-term sickness absence were offered one to two sessions, and those with high-risk were offered three to four sessions). RESULTS: Median sickness absence was 62 days, (95% CI 52 to 71) in the UC arm (n=171), 56 days (95% CI 43 to 70) in the UC+MI arm (n=169) and 49 days (95% CI 38 to 60) in the UC+SVAI arm (n=169). After adjusting for predefined potential confounding factors, the results showed seven fewer days in the UC+MI arm (95% CI -15 to 2) and the UC+SVAI arm (95% CI -16 to 1), compared with the UC arm. The adjusted differences were not statistically significant. CONCLUSIONS: The MI-NAV trial did not show effect on return to work of adding MI or SVAI to UC. The reduction in sickness absence over 6 months was smaller than anticipated, and uncertain due to wide CIs. TRIAL REGISTRATION NUMBER: NCT03871712.


Asunto(s)
Entrevista Motivacional , Enfermedades Musculoesqueléticas , Humanos , Femenino , Persona de Mediana Edad , Masculino , Manejo de Caso , Reinserción al Trabajo , Enfermedades Musculoesqueléticas/terapia , Ausencia por Enfermedad
20.
Spine (Phila Pa 1976) ; 48(3): 147-154, 2023 Feb 01.
Artículo en Inglés | MEDLINE | ID: mdl-36223435

RESUMEN

STUDY DESIGN: Exploratory subgroup analyses of a randomised trial [Antibiotics in Modic changes (AIM) study]. OBJECTIVE: The aim was to assess the effect of amoxicillin versus placebo in reducing Modic change (MC) edema in patients with chronic low back pain. SUMMARY OF BACKGROUND DATA: The AIM study showed a small, clinically insignificant effect of amoxicillin on pain-related disability in patients with chronic low back pain and MC type 1 (edema type) on magnetic resonance imaging (MRI). MATERIALS AND METHODS: A total of 180 patients were randomised to receive 100 days of amoxicillin or placebo. MC edema was assessed on MRI at baseline and one-year follow-up. Per-protocol analyses were conducted in subgroups with MC edema on short tau inversion recovery (STIR) or T1/T2-weighted MRI at baseline. MC edema reductions (yes/no) in STIR and T1/T2 series were analyzed separately. The effect of amoxicillin in reducing MC edema was analyzed using logistic regression adjusted for prior disk surgery. To assess the effect of amoxicillin versus placebo within the group with the most abundant MC edema on STIR at baseline ("STIR3" group), we added age, STIR3 (yes/no), and STIR3×treatment group (interaction term) as independent variables and compared the marginal means (probabilities of edema reduction). RESULTS: Compared to placebo, amoxicillin did not reduce MC edema on STIR (volume/intensity) in the total sample with edema on STIR at baseline (odds ratio 1.0, 95% CI: 0.5, 2.0; n=141) or within the STIR3 group (probability of edema reduction 0.69, 95% CI: 0.47, 0.92 with amoxicillin and 0.61, 95% CI: 0.43, 0.80 with placebo; n=41). Compared with placebo, amoxicillin did not reduce MC edema in T1/T2 series (volume of the type 1 part of MCs) (odds ratio: 1.0, 95% CI: 0.5, 2.3, n=104). Edema declined in >50% of patients in both treatment groups. CONCLUSIONS: From baseline to one-year follow-up, amoxicillin did not reduce MC edema compared with placebo. LEVEL OF EVIDENCE: 2.


Asunto(s)
Amoxicilina , Dolor de la Región Lumbar , Humanos , Amoxicilina/uso terapéutico , Amoxicilina/farmacología , Antibacterianos/uso terapéutico , Dolor de la Región Lumbar/tratamiento farmacológico , Dolor de la Región Lumbar/patología , Vértebras Lumbares/patología , Imagen por Resonancia Magnética , Edema/tratamiento farmacológico
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