Statistical analysis plan for the 5-year and 10-year follow-up assessments of the FIDELITY trial

Background The research objectives of the 5-year and 10-year assessments in the Finnish degenerative meniscal lesion study (FIDELITY) are twofold: (1) to assess the long-term efficacy of arthroscopic partial meniscectomy (APM) in adults (age 35 to 65 years) with a degenerative meniscus tear and (2) to determine the respective effects of APM and degenerative meniscus tear on the development of radiographic and clinical knee osteoarthritis (OA). Methods and design FIDELITY is an ongoing multi-center, randomized, participant and outcome assessor blinded, placebo-surgery-controlled trial in 146 patients. This statistical analysis plan (SAP) article describes the overall principles for analysis of long-term outcomes (5-year and 10-year follow up), including how participants will be included in each analysis, the primary and secondary outcomes and their respective analyses, adjustments for covariates, and the presentation of the results. In addition, we will present the planned sensitivity and subgroup analyses. Discussion To assess the long-term efficacy of APM on knee symptoms and function we are carrying out a long-term (5-year and 10-year) follow up of our placebo-surgery-controlled FIDELITY trial according to statistical principles outlined in detail in this document. As our second primary objective, whether APM (resection of torn meniscus tear) accelerates or delays the development of knee osteoarthritis in patients with an arthroscopically verified degenerative tear of the medial meniscus, a pre-registered follow-up is also carried out.Peer reviewe

Pohjois-Pohjanmaan maaseudun kehittämissuunnitelma 2023-2027

Pohjois-Pohjanmaan maaseudun kehittämissuunnitelma 2023–2027 on alueellinen, maaseudun kehittämistyötä ohjaava asiakirja, jonka toimeenpano perustuu kansalliseen CAP-suunnitelmaan. Kehittämissuunnitelman päämääränä on, että Pohjois-Pohjanmaan maaseutu menestyy alueidensa vahvuuksiin nojaten, sekä yhteistyössä rohkeasti ja kestävästi uutta kehittäen. Suunnitelman painopisteiksi ovat valikoituneet 1) aktiivinen maatalous ja ruoantuotanto, 2) ympäristö- ja ilmastoviisas maatalous ja maaseutu sekä 3) uudistuva ja monipuolinen maaseutu. Kehittämissuunnitelman toteutuksessa huomioidaan läpileikkaavat teemat ovat ympäristö- ja elinkeinolähtöisyys, osaamisen, innovaatioiden ja digitalisuuden edistäminen sekä vaikuttavuus. Maaseudun toimintaympäristön ja painopisteiden kuvausten lisäksi kehittämissuunnitelmassa esitetään muun muassa rahoitussuunnitelma, yhteensovitus muiden EU-osarahoitteisten ja kansallisten ohjelmien kanssa sekä kuvaus alueellisesta valmistelusta. Maaseudun kehittämissuunnitelman laadinta on ajoittunut usean vuoden ajalle, ja työhön on sisältynyt monia eri sidosryhmiä ja viranomaistahoja suunnitteluprosessiin osallistavia vaiheita. Valmistelua on tehty muun muassa seminaareissa, sähköisillä osallistavilla alustoilla, webinaareissa ja työkokouksissa. Koko suunnitelman toteutusprosessia on ohjannut maakunnan yhteistyöryhmän maaseutujaosto, sekä alueellisen CAP suunnitelman valmistelua varten perustettu fokusryhmä. Kehittämissuunnitelman ensimmäinen versio toimitettiin maa- ja metsätalousministeriöön kesällä 2021 ja suunnitelmaa on täydennetty vuoden 2022 aikana huomioimalla toimintaympäristöön tapahtuneet muutokset ja niiden vaikutukset kehittämissuunnitelmaan

Finnish Trial on Practices of Anterior Cervical Decompression and Fusion (FACADE): a protocol for a prospective randomised non-inferiority trial comparing outpatient versus inpatient care

Peer reviewe

Influence of Respiratory Tract Infections on Vocabulary Growth in Relation to Child's Sex: The STEPS Study

Common health issues have been less examined in studies of early language development, particularly in relation to the child's sex. Respiratory tract infections, often complicated by acute otitis media, are common in children during the first years of life, when early vocabulary development takes place. The present study, conducted in Finland, aimed to investigate whether possible associations between recurrent respiratory tract infections, background factors, and vocabulary growth differ in boys and girls aged 13 to 24 months. The participants (N = 462, 248 boys and 214 girls) were followed for respiratory tract infections and acute otitis media from 0 to 23 months of age. The parents completed daily symptom diaries of respiratory symptoms, physician visits, and diagnoses. The expressive vocabulary was measured with parental reports. We found that recurrent respiratory tract infections were not associated with slower vocabulary development in boys or girls. In fact, boys with recurrent respiratory tract infections had more vocabulary growth during the second year than boys who were less sick. We found that vocabulary growth was associated differently with respiratory tract infections and background factors as a function of the child's sex. The vocabulary growth of boys seems to be more influenced by environmental factors than that of girls.</p

Arthroscopic partial meniscectomy for a degenerative meniscus tear : a 5 year follow-up of the placebo-surgery controlled FIDELITY (Finnish Degenerative Meniscus Lesion Study) trial

Objectives To assess the long-term effects of arthroscopic partial meniscectomy (APM) on the development of radiographic knee osteoarthritis, and on knee symptoms and function, at 5 years follow-up. Design Multicentre, randomised, participant- and outcome assessor-blinded, placebo-surgery controlled trial. Setting Orthopaedic departments in five public hospitals in Finland. Participants 146 adults, mean age 52 years (range 35-65 years), with knee symptoms consistent with degenerative medial meniscus tear verified by MRI scan and arthroscopically, and no clinical signs of knee osteoarthritis were randomised. Interventions APM or placebo surgery (diagnostic knee arthroscopy). Main outcome measures We used two indices of radiographic knee osteoarthritis (increase in Kellgren and Lawrence grade >= 1, and increase in Osteoarthritis Research Society International (OARSI) atlas radiographic joint space narrowing and osteophyte sum score, respectively), and three validated patient-relevant measures of knee symptoms and function ( Western Ontario Meniscal Evaluation Tool (WOMET), Lysholm, and knee pain after exercise using a numerical rating scale). Results There was a consistent, slightly greater risk for progression of radiographic knee osteoarthritis in the APM group as compared with the placebo surgery group (adjusted absolute risk difference in increase in Kellgren-Lawrence grade >= 1 of 13%, 95% CI -2% to 28%; adjusted absolute mean difference in OARSI sum score 0.7, 95% CI 0.1 to 1.3). There were no relevant between-group differences in the three patient-reported outcomes: adjusted absolute mean differences (APM vs placebo surgery), -1.7 (95% CI -7.7 to 4.3) in WOMET, -2.1 (95% CI -6.8 to 2.6) in Lysholm knee score, and -0.04 (95% CI -0.81 to 0.72) in knee pain after exercise, respectively. The corresponding adjusted absolute risk difference in the presence of mechanical symptoms was 18% (95% CI 5% to 31%); there were more symptoms reported in the APM group. All other secondary outcomes comparisons were similar. Conclusions APM was associated with a slightly increased risk of developing radiographic knee osteoarthritis and no concomitant benefit in patient-relevant outcomes, at 5 years after surgery.Peer reviewe

Finnish Trial on Practices of Anterior Cervical Decompression and Fusion (FACADE): A protocol for a prospective randomised non-inferiority trial comparing outpatient versus inpatient care

IntroductionAlthough a great majority of patients with cervical radiculopathy syndrome can successfully be treated non-operatively, a considerable proportion experience persistent symptoms, severe enough to require neurosurgical intervention. During the past decade, cervical spine procedures have increasingly been performed on an outpatient basis and retrospective database analyses have shown this to be feasible and safe. However, there are no randomised controlled studies comparing outpatient care with inpatient care, particularly with emphasis on the patients’ perception of symptom relief and their ability to return to normal daily activities and work.Methods and analysisThis is a prospective, randomised, controlled, parallel group non-inferiority trial comparing the traditional hospital surveillance (inpatient, patients staying in the hospital for 1–3 nights after surgery) with outpatient care (discharge on the day of the surgery, usually within 6–8 hours after procedure) in patients who have undergone anterior cervical decompression and fusion procedure. To determine whether early discharge (outpatient care) is non-inferior to inpatient care, we will randomise 104 patients to these two groups and follow them for 6 months using the Neck Disability Index (NDI) as the primary outcome. We expect that early discharge is not significantly worse than the current care in terms of change in NDI. Non-inferiority will be declared if the mean improvement for outpatient care is no worse than the mean improvement for inpatient care, by a margin of 17.3%. We hypothesise that a shorter hospital stay results in more rapid return to normal daily activities, shorter duration of sick leave and decreased secondary costs to healthcare system. Secondary outcomes in our study are arm pain and neck pain using the Numeric Rating Scale, operative success (Odom’s criteria), patient’s satisfaction to treatment, general quality of life (EQ-5D-5L), Work Ability Score, sickness absence days, return to previous leisure activities and complications.Trial registration number NCT03979443.</p

Kokeilut käytäntöön -työkirja

Palvelutalouden vallankumous – Ihminen digitalisaation keskiössä -projekt

Statistical analysis plan for the 5-year and 10-year follow-up assessments of the FIDELITY trial

Background: The research objectives of the 5-year and 10-year assessments in the Finnish degenerative meniscal lesion study (FIDELITY) are twofold: (1) to assess the long-term efficacy of arthroscopic partial meniscectomy (APM) in adults (age 35 to 65 years) with a degenerative meniscus tear and (2) to determine the respective effects of APM and degenerative meniscus tear on the development of radiographic and clinical knee osteoarthritis (OA). Methods and design: FIDELITY is an ongoing multi-center, randomized, participant and outcome assessor blinded, placebo-surgery-controlled trial in 146 patients. This statistical analysis plan (SAP) article describes the overall principles for analysis of long-term outcomes (5-year and 10-year follow up), including how participants will be included in each analysis, the primary and secondary outcomes and their respective analyses, adjustments for covariates, and the presentation of the results. In addition, we will present the planned sensitivity and subgroup analyses. Discussion: To assess the long-term efficacy of APM on knee symptoms and function we are carrying out a long-term (5-year and 10-year) follow up of our placebo-surgery-controlled FIDELITY trial according to statistical principles outlined in detail in this document. As our second primary objective, whether APM (resection of torn meniscus tear) accelerates or delays the development of knee osteoarthritis in patients with an arthroscopically verified degenerative tear of the medial meniscus, a pre-registered follow-up is also carried out. Trial registration: ClinicalTrials.gov, NCT00549172 (Arthroscopy in the Treatment of Degenerative Medial Meniscus Tear). Registered on 25 October 2007 (NCT00549172). ClinicalTrials.gov, NCT01052233 (Development of Knee Osteoarthritis After Arthroscopic Partial Resection of Degenerative Meniscus Tear). Registered on 20 January 2010.publishedVersionPeer reviewe

Arthroscopic partial meniscectomy versus placebo surgery for a degenerative meniscus tear : a 2-year follow-up of the randomised controlled trial

Objective To assess if arthroscopic partial meniscectomy (APM) is superior to placebo surgery in the treatment of patients with degenerative tear of the medial meniscus. Methods In this multicentre, randomised, participant-blinded and outcome assessor-blinded, placebo-surgery controlled trial, 146 adults, aged 35-65 years, with knee symptoms consistent with degenerative medial meniscus tear and no knee osteoarthritis were randomised to APM or placebo surgery. The primary outcome was the between-group difference in the change from baseline in the Western Ontario Meniscal Evaluation Tool (WOMET) and Lysholm knee scores and knee pain after exercise at 24 months after surgery. Secondary outcomes included the frequency of unblinding of the treatment-group allocation, participants' satisfaction, impression of change, return to normal activities, the incidence of serious adverse events and the presence of meniscal symptoms in clinical examination. Two subgroup analyses, assessing the outcome on those with mechanical symptoms and those with unstable meniscus tears, were also carried out. Results In the intention-to-treat analysis, there were no significant between-group differences in the mean changes from baseline to 24 months in WOMET score: 27.3 in the APM group as compared with 31.6 in the placebo-surgery group (between-group difference, -4.3; 95% CI, -11.3 to 2.6); Lysholm knee score: 23.1 and 26.3, respectively (-3.2; -8.9 to 2.4) or knee pain after exercise, 3.5 and 3.9, respectively (-0.4; -1.3 to 0.5). There were no statistically significant differences between the two groups in any of the secondary outcomes or within the analysed subgroups. Conclusions In this 2-year follow-up of patients without knee osteoarthritis but with symptoms of a degenerative medial meniscus tear, the outcomes after APM were no better than those after placebo surgery. No evidence could be found to support the prevailing ideas that patients with presence of mechanical symptoms or certain meniscus tear characteristics or those who have failed initial conservative treatment are more likely to benefit from APM.Peer reviewe

A multi-centre randomized controlled trial comparing arthroscopic osteochondroplasty and lavage with arthroscopic lavage alone on patient important outcomes and quality of life in the treatment of young adult (18-50) Femoroacetabular impingement

Background: Several cross-sectional studies have estimated that the prevalence of femoroacetabular impingement (FAI) ranges from 14-17% among asymptomatic young adults to almost 95% among competitive athletes. With FAI, there is abnormal contact between the proximal femur and the acetabulum, resulting in abnormal mechanics with terminal motion such as hip flexion and rotation. This condition results from bony anomalies of the acetabular rim (Pincer) and or femoral head/neck junction (CAM) and typically causes hip pain and decreased hip function. The development of hip pain potentially serves as an indicator for early cartilage and labral damage that may result in hip osteoarthritis. Although surgical correction of the misshaped bony anatomy and associated intra-articular soft tissue damage of the hip is thought to improve hip pain and alter the natural history of degenerative disease, the supportive evidence is based upon low quality observational studies. The Femoroacetabular Impingement RandomiSed controlled Trial (FIRST) compares outcomes following surgical correction of the impingement morphology (arthroscopic osteochondroplasty) with/without labral repair versus arthroscopic lavage of the hip joint in adults aged 18 to 50 diagnosed with FAI. Methods and design: FIRST is a multi-centre, randomized controlled trial with a sample size of 220 patients. Exclusion criteria include the presence of hip syndromes, previous surgery or trauma to the affected hip, and significant medical comorbidities. The primary outcome is pain and the secondary outcomes include patient function, quality of life, complications, and cost-effectiveness - all within one year of follow-up. Patients are stratified based on centre and impingement sub-type. Patients, outcome assessors, data analysts, and the Steering Committee are blinded to surgical allocation. Using an intention-to-treat approach, outcome analyses will be performed using an analysis of covariance and descriptive statistics. Discussion: Symptomatic FAI is associated with chronic hip pain, functional limitations, and secondary osteoarthritis. Therefore, optimizing treatment has the potential to improve the lives millions of young, active persons who are diagnosed with this condition. Few orthopaedic surgical trials have similar potential to shift the paradigm of care dramatically towards (or away) from surgical bony and soft tissue interventions.Peer reviewe