| 1. |
- Ahlin, Sofie, 1985, et al.
(författare)
-
Fracture risk after three bariatric surgery procedures in Swedish obese subjects : up to 26 years follow-up of a controlled intervention study
- 2020
-
Ingår i: Journal of Internal Medicine. - : Wiley. - 0954-6820 .- 1365-2796. ; 287:5, s. 546-557
-
Tidskriftsartikel (refereegranskat)abstract
- Background: Previous studies have reported an increased fracture risk after bariatric surgery. Objective: To investigate the association between different bariatric surgery procedures and fracture risk. Methods: Incidence rates and hazard ratios for fracture events were analysed in the Swedish Obese Subjects study; an ongoing, nonrandomized, prospective, controlled intervention study. Hazard ratios were adjusted for risk factors for osteoporosis and year of inclusion. Information on fracture events were captured from the Swedish National Patient Register. The current analysis includes 2007 patients treated with bariatric surgery (13.3% gastric bypass, 18.7% gastric banding, and 68.0% vertical banded gastroplasty) and 2040 control patients with obesity matched on group level based on 18 variables. Median follow-up was between 15.1 and 17.9 years for the different treatment groups. Results: During follow-up, the highest incidence rate for first-time fracture was observed in the gastric bypass group (22.9 per 1000 person-years). The corresponding incidence rates were 10.4, 10.7 and 9.3 per 1000 person-years for the vertical banded gastroplasty, gastric banding and control groups, respectively. The risk of fracture was increased in the gastric bypass group compared with the control group (adjusted hazard ratio [adjHR] 2.58; 95% confidence interval [CI] 2.02–3.31; P < 0.001), the gastric banding group (adjHR 1.99; 95%CI 1.41–2.82; P < 0.001), and the vertical banded gastroplasty group (adjHR 2.15; 95% CI 1.66–2.79; P < 0.001). Conclusions: The risk of fracture is increased after gastric bypass surgery. Our findings highlight the need for long-term follow-up of bone health for patients undergoing this treatment.
|
|
| 2. |
- Struglics, A., et al.
(författare)
-
Molecular and imaging biomarkers of local inflammation at 2 years after anterior cruciate ligament injury do not associate with patient reported outcomes at 5 years
- 2020
-
Ingår i: Osteoarthritis and Cartilage. - : Elsevier BV. - 1063-4584. ; 28:3, s. 356-362
-
Tidskriftsartikel (refereegranskat)abstract
- Objective: To estimate the association between molecular or imaging inflammatory biomarkers at 2 years after anterior cruciate ligament (ACL) injury and patient-reported outcomes at 5 years. Methods: For 116 ACL-injured patients, molecular biomarkers of inflammation (synovial fluid and serum cytokines) and Hoffa- and effusion-synovitis as visualized on magnetic resonance imaging (MRI) were assessed 2 years post-injury. Knee injury and Osteoarthritis Outcome Score (KOOS) and SF-36 were assessed at 2 and 5 years. We used multiple imputation to handle biomarker values that were below the level of detection or missing, and linear regression for statistical analyses. Results: None of the synovial fluid cytokines or imaging biomarkers of inflammation at 2 years were associated with any of the patient-reported outcomes at 5 years. With each log10 unit higher of serum tumor necrosis factor concentration the knee-related quality of life of KOOS was increased (i.e., better outcome) by 35 (95% confidence interval 7 to 63) points. No other serum biomarker measured at 2 years was associated with patient-reported outcome at 5 years. Conclusion: Local joint inflammation assessed by biomarkers in synovial fluid and Hoffa- and effusion-synovitis on MRI at 2 years after an ACL injury did not associate with patient-reported outcomes at 5 years. Thus, chronic inflammation in the ACL-injured knee, as reflected by the biomarkers studied here, seems not to be a key determinant for the long-term patient-reported outcomes.
|
|
| 3. |
- Beard, David J., et al.
(författare)
-
Placebo comparator group selection and use in surgical trials : The aspire project including expert workshop
- 2021
-
Ingår i: Health Technology Assessment. - 1366-5278. ; 25:53
-
Tidskriftsartikel (refereegranskat)abstract
- Background: The use of placebo comparisons for randomised trials assessing the efficacy of surgical interventions is increasingly being considered. However, a placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges. Objectives: To provide a summary of knowledge on placebo controls in surgical trials and to summarise any recommendations for designers, evaluators and funders of placebo-controlled surgical trials. Design: To carry out a state-of-the-art workshop and produce a corresponding report involving key stakeholders throughout. Setting: A workshop to discuss and summarise the existing knowledge and to develop the new guidelines. Results: To assess what a placebo control entails and to assess the understanding of this tool in the context of surgery is considered, along with when placebo controls in surgery are acceptable (and when they are desirable). We have considered ethics arguments and regulatory requirements, how a placebo control should be designed, how to identify and mitigate risk for participants in these trials, and how such trials should be carried out and interpreted. The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics rationale. Surgical placebos might be most appropriate when there is poor evidence for the efficacy of the procedure and a justified concern that results of a trial would be associated with a high risk of bias, particularly because of the placebo effect. Conclusions: The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics rationale. Feasibility work is recommended to optimise the design and implementation of randomised controlled trials. An outline for best practice was produced in the form of the Applying Surgical Placebo in Randomised Evaluations (ASPIRE) guidelines for those considering the use of a placebo control in a surgical randomised controlled trial. Limitations: Although the workshop participants involved international members, the majority of participants were from the UK. Therefore, although every attempt was made to make the recommendations applicable to all health systems, the guidelines may, unconsciously, be particularly applicable to clinical practice in the UK NHS. Future work: Future work should evaluate the use of the ASPIRE guidelines in making decisions about the use of a placebo-controlled surgical trial. In addition, further work is required on the appropriate nomenclature to adopt in this space.
|
|
| 4. |
- Cronström, Anna, et al.
(författare)
-
On the waiting list for joint replacement for knee osteoarthritis : are first-line treatment recommendations implemented?
- 2020
-
Ingår i: Osteoarthritis and Cartilage Open. - : Elsevier. - 2665-9131. ; 2:2
-
Tidskriftsartikel (refereegranskat)abstract
- Objective: To investigate to what extent individuals participated in guideline-based first-line treatments before being assigned to a wait list for knee replacement for osteoarthritis (OA), and to what extent they were recommended such treatments once on the list. Factors associated with participation in first-line management were also investigated.Design: All patients on the waiting list ≥ three months for knee replacement due to knee OA (n = 229) at a public hospital in Sweden were invited to participate in this cross-sectional survey study. 136 individuals (mean age 70 ± 9 years, 59% women) answered self-reported questionnaires including demographics, physical activity level, knee function and treatments before and during their time on the waiting list.Results: Before being referred to the waiting list, 40% had participated in guideline-based OA management (Better management of patients with OsteoArthritis (BOA)), 53% in physiotherapy, 67% in either BOA or physiotherapy whilst 23% of those overweight (BMI≥25) had received weight-management advice. Women had participated in BOA and physiotherapy twice as often as men (51% vs. 25%, p = 0.002 and 66% vs. 34%, p < 0.001) prior to waiting list referral. During their time on the waiting list, only 10% were recommended BOA, 30% physiotherapy and 15% weight-management. 38% of the patients that had never participated in BOA indicated that they were interested in participating while waiting for their knee replacement.Conclusion: Our results suggest that recommended treatment guidelines for OA may not be adequately implemented in Swedish health-care. Further exploration of implementation barriers and lack of equality of care appears warranted.
|
|
| 5. |
- Ekman, B, et al.
(författare)
-
Costing analysis of a digital first-line treatment platform for patients with knee and hip osteoarthritis in Sweden
- 2020
-
Ingår i: PLoS ONE. - : Public Library of Science (PLoS). - 1932-6203. ; 15:8, s. 0236342-0236342
-
Tidskriftsartikel (refereegranskat)abstract
- Osteoarthritis (OA) constitutes a major and increasing burden on patients, health care systems and the broader society. It is estimated that around a quarter of the adult population is affected by OA in the knee and hip and that the prevalence of OA will increase over the coming decades largely due to aging and adverse life-style factors. Prevention and effective care are critical to manage the challenges posed by OA. Digital technologies offer opportunities to deliver cost-effective care for chronic diseases, including for OA. We report the results of a costing analysis of a new digital platform for delivering first-line care including disease information and physiotherapy to patients with OA and compare this with an existing face-to-face model of treatment. Both models are in accordance with National Treatment Guidelines in Sweden. The results show that overall the digital model costs around 25% of the existing face-to-face model of care. Based on existing evidence on the effects of these models, our findings also suggest that the digital platform offers a cost-effective alternative to the existing model of OA care. Depending on the extent to which the digital model substitutes for the existing model of care, significant resources can be saved.
|
|
| 6. |
|
|
| 7. |
|
|
| 8. |
- Lohmander, A, et al.
(författare)
-
Canonical Babbling and Early Consonant Development Related to Hearing in Children With Otitis Media With Effusion With or Without Cleft Palate
- 2021
-
Ingår i: The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association. - : SAGE Publications. - 1545-1569. ; 58:7, s. 894-905
-
Tidskriftsartikel (refereegranskat)abstract
- To investigate and compare babbling, early consonant production and proficiency from 10 to 36 months of age and its relationship with hearing in children with otitis media with effusion (OME) with or without cleft palate. Design: Prospective, longitudinal group comparison study. Setting: University hospital. Participants: Fifteen children born with nonsyndromic cleft palate with or without cleft lip (CP±L) and 15 age-matched children with hearing loss (HL) associated with OME but without cleft palate (noncleft group). Main Outcome Measures: Canonical babbling (CB) and early consonant variables (presence of oral stops, anterior stops, dental/alveolar stops, number of different true consonants) at 10 and 18 months, and percentage of consonants correct proficiency (PCC) at 36 months. Results: A total of 54% of the CP±L group and 77% of the noncleft group had CB. The noncleft group had a significantly higher prevalence of all consonant variables. Percentage of consonants correct was 61.9% in the CP±L group and 81.6% in the noncleft group. All early consonant variables except CB were significantly related to PCC. Hearing sensitivity at 18 and 30 months correlated with PCC and explained 40% of the variation. Conclusions: Mild HL impacted presence of CB at 10 months and was related to consonant proficiency at 36 months in children with HL associated with OME and children with cleft palate. The noncleft group showed results at 36 months similar to children with normal hearing; however, the CP±L group did not. Although the cleft palate may have a bigger impact on the speech development, management of hearing sensitivity would also be beneficial.
|
|
| 9. |
- Lundeborg Hammarström, Inger, 1956-, et al.
(författare)
-
Scandcleft Project Trial 2—Comparison of Speech Outcome in 1- and 2-Stage Palatal Closure in 5-Year-Olds With UCLP
- 2020
-
Ingår i: Cleft Palate-Craniofacial Journal. - : SAGE Publications. - 1055-6656 .- 1545-1569. ; 57:4, s. 458-469
-
Tidskriftsartikel (refereegranskat)abstract
- Objective: To investigate in-depth speech results in the Scandcleft Trial 2 with comparisons between surgical protocols and centers and with benchmarks from peers without cleft palate. Design: A prospective randomized clinical trial. Setting: Two Swedish and one Finnish Cleft Palate center. Participants: One hundred twelve participants were 5-years-old born with unilateral cleft lip and palate randomized to either lip repair and soft palate closure at 4 months and hard palate closure at 12 months or lip repair at 3 to 4 months (Arm A), or a closure of both the soft and hard palate at 12 months (Arm C). Main Outcome Measures: A composite measure dichotomized into velopharyngeal competency (VPC) or velopharyngeal incompetency (VPI), overall assessment of velopharyngeal function (VPC-Rate), percentage of consonants correct (PCC score), and consonant errors. In addition, number of speech therapy visits, average hearing thresholds, and secondary surgeries were documented to assess burden of treatment. Results: Across the trial, 53.5% demonstrated VPC and 46.5% VPI with no significant differences between arms or centers. In total, 27% reached age-appropriate PCC scores with no statistically significant difference between the arms. The Finnish center had significantly higher PCC scores, the Swedish centers had higher percentages of oral consonant errors. Number of speech therapy visits was significantly higher in the Finnish center. Conclusion: At age 5, poor speech outcomes with some differences between participating centers were seen but could not be attributed to surgical protocol. As one center had very few participants, the results from that center should be interpreted with caution. © 2019, American Cleft Palate-Craniofacial Association.
|
|
| 10. |
- Macri, E. M., et al.
(författare)
-
Importance of patellofemoral and tibiofemoral cartilage lesions on trajectory of self-reported outcomes in patients at high risk of knee OA : 4–6 years follow-up of patients undergoing meniscal surgery
- 2021
-
Ingår i: Osteoarthritis and Cartilage. - : Elsevier BV. - 1063-4584. ; 29:9, s. 1291-1295
-
Tidskriftsartikel (refereegranskat)abstract
- Objective: We evaluated whether patient-reported outcome trajectories (i.e., changes over time) differed by intraoperative compartmental cartilage lesion pattern over 4–6 years following arthroscopic meniscal surgery. Methods: In this ancillary study of the Knee Arthroscopy Cohort Southern Denmark cohort, we intraoperatively categorized cartilage lesions as isolated patellofemoral, isolated tibiofemoral, or combined patellofemoral/tibiofemoral. Participants completed the Knee injury and Osteoarthritis Outcome Score (KOOS) pre-operatively, at 3 and 12 months, and at 4–6 years post-operatively and reported overall satisfaction at final follow-up. Our main outcome was KOOS4 (grand mean of four subscale means). We evaluated whether KOOS4 scores changed over time according to cartilage lesion patterns using adjusted mixed linear regression. We also estimated probability of treatment satisfaction using logistic regression. Results: Of 630 participants with complete cartilage scores, 280 (44%) were women, mean (standard deviation) age was 49 (13) years, and BMI was 27.3 (4.4) kg/m2. KOOS4 scores at baseline were slightly lower in all lesion groups compared to the no lesion group, yet only the combined group was statistically significantly lower. KOOS4 trajectories were similar across cartilage lesion patterns, but by final follow-up, adjusted mean KOOS4 scores were 6.8 (95% CI 2.2, 11.4) to 9.8 (1.1, 18.5) points lower in groups with cartilage lesions compared to the no lesion group. Probability of patient-reported satisfaction did not differ statistically by group. Conclusions: Though KOOS4 scores were slightly lower in groups with arthroscopically assessed cartilage lesions compared to the no lesion group, trajectories were similar across all groups.
|
|
