Category: Statistics

Acta Orthop Belg. 2024 Mar;90(1):35-40. doi: 10.52628/90.1.11314.

ABSTRACT

There are many different types of cementless anatomically adapted Total Hip Arthroplasties (THAs) on the market, the Anatomic Benoist Gerard (ABG) I and II are such types of cementless THAs. In this retrospective single-centre study we evaluated the overall survival with revision for any reason and aseptic loosening as endpoint at more than 11 years follow-up. Between 2000 and 2004, 244 cementless THAs were performed in 230 patients in a primary care hospital. At a mean of 11.3 years follow-up (range 9.8 – 12.8 years) clinical examination, plain radiography and Patient Reported Outcome Measures (PROMs) were obtained and analysed. The PROMs consisted of the Oxford Hip Score (OHS) and the Western Ontario and McMaster University Index (WOMAC). At a mean of 11.3 years follow-up 32 patients (13.1%) had died of unrelated causes. Of the remaining cohort all 198 patients (212 THAs) have been reached for evaluation. There were no patients considered as lost to follow-up. At a mean of 11.3 years 11 patients (11 THAs) have had a revision of either the femoral implant or acetabular component resulting in an overall survival of 95.5%. There was no statistically significant difference (p=0.564) in survival between the ABG I and II THAs. Radiographic there were no changes between the ABG I and II last follow up. The ABG II performed statistically significant better in PROMs. We concluded that both anatomically adapted hydroxyapatite coated cementless THAs show excellent survival at more than 11 years follow-up.

PMID:38669646 | DOI:10.52628/90.1.11314

Acta Orthop Belg. 2024 Mar;90(1):27-34. doi: 10.52628/90.1.12054.

ABSTRACT

The number of hospital admissions for a hip prosthesis increased by more than 91% between 2002 and 2019 in Belgium (1), making it one of the most common interventions in hospitals. The objective of this study is to evaluate patient-report- ed outcomes and hospital costs of hip replacement six months after surgery. Both generic (EQ-5D) and specific (HOOS) PROMs of general hospital patients undergoing hip replacement surgery in 2021 were conducted. The results of these PROMs were then combined with financial and health management data. The mean difference (SD) in QALYs between the preoperative and postoperative phases is 0.20 QALYs (0.32 QALYs). The average cost (SD) of all stays is €4,792 (€1,640). Amongst the five dimensions evaluated in the EQ-5D health questionnaire, the ‘pain’ dimension seems to be associated with the greatest improvement in quality of life. As regards Belgium, the 26,066 arthroplasties performed in 2020 might constitute a gain of 123,000 years of life in good health. The relationship between QALYs and costs described in this study posits a ratio of €23,960 per year of life gained in good health. Given that in Belgium more than 3% of the hospital healthcare budget is devoted to hip prostheses, it would seem relevant to us to apply PROM tools to the entire patient population to assess treatment effectiveness more broadly, identify patient needs and, also, monitor the quality of care provided.

PMID:38669645 | DOI:10.52628/90.1.12054

Acta Orthop Belg. 2024 Mar;90(1):11-15. doi: 10.52628/90.1.12345.

ABSTRACT

The utilization of local infiltration analgesia (LIA) is a common practice in total hip arthroplasty (THA) procedures to mitigate postoperative pain and diminish the necessity for opioids. However, contemporary literature reports conflicting results. Our working hypothesis was that LIA renders better postoperative VAS-scores and reduces the need for oral analgetics. We performed a randomized, double-blind, placebo-controlled trial aimed at examining the effectiveness of LIA in THA. A total of 90 patients were included for statistical analysis. Our primary endpoint was the Visual Analogue Scale, VAS, (0: no pain, 10: unbearable pain) preoperatively, at the 1st, 2nd, 3rd, 4th and 12th hour postoperative intervals and at discharge. Our secondary endpoints included the postoperative opioid consumption, as well as patient satisfaction at 2 and 6 weeks postoperatively, measured using the Numeric Rating Scale, NRS. LIA has a tendency for superior results regarding VAS- Scores at 3 and 4 hours postoperatively. There were no notable statistical distinctions observed in terms of patients necessitating rescue opioid consumption. Patient satisfaction using the NRS at both the 2-week and 6-week postoperatively did not differ significantly between both groups. The administration of LIA could offer advantages during the initial stages of postoperative recovery, which could be particularly valuable in rapid recovery programs.

PMID:38669643 | DOI:10.52628/90.1.12345

Acta Orthop Belg. 2024 Mar;90(1):5-10. doi: 10.52628/90.1.11289.

ABSTRACT

The aim of the study is to determine the revision ratio after implantation of the femoral neck system (FNS) for the treatment of femoral neck fractures. A retrospective single center cohort analysis with a total of 71 patients who underwent the implantation of the FNS between December 2019 and December 2021, was performed. 31 males and 40 females were included. There was no exclusion based on BMI, ASA score, Garden classification or Pauwels classification. Primary outcome was the revision rate after FNS implantation. Secondary outcomes comprise the reason for revision surgery as well as the time toward revision surgery and the 30-day mortality. The revision ratio was 11 out of 71 patients (15.5%) with an average time to revision surgery of 10 months. Most common reason for revision was avascular necrosis (AVN) in 45.5%. Other reasons for revision surgery were implant failure due to a secondary fall on to the hip with the FNS implant in place, cut-out, cut-through and malunion in respectively 27.3%, 9%, 9% and 9% of the revision patients. The one- hole plate was used in 72% of the patients. Mean follow-up was 18.07 months (range 6-30 months). Full weight bearing instruction was given to 85.9% of the patients. Partial weight bearing in 14.1% of the patients. In conclusion, the FNS has similar revision ratio when used for femoral neck fractures compared to cannulated screw fixation in literature. The predominant reason for revision is AVN and implant failure with no difference between the use of the one- or-two-hole plate in this study.

PMID:38669642 | DOI:10.52628/90.1.11289

Blood. 2024 Apr 26:blood.2024023944. doi: 10.1182/blood.2024023944. Online ahead of print.

ABSTRACT

Obinutuzumab (O) and Rituximab (R) are two CD antibodies that have never been compared in a prospective randomised trial in mantle cell lymphoma (MCL). Herein, we report the long-term outcome of the LYMA-101 (NCT02896582) trial, in which newly diagnosed MCL patients were treated with chemotherapy plus O before transplantation followed by O maintenance (O group). We then compared these patients to those treated with the same treatment design with Rituximab instead of O (R group) (NCT00921414). A propensity score matching (PSM) was used to compare the two populations (O vs R groups) in terms of MRD at the end of induction (EOI), PFS and OS. In LYMA-101, the estimated five-year PFS and OS since inclusion (n=85) were 83.4% (95%CI: 73.5-89.8%) and 86.9% (95%CI: 77.6-92.5%), respectively. At EOI, patients treated in the O group had more frequent bone marrow MRD negativity than those treated in the R group (83.1% vs 63.4% Chi2 p=0.007). The PSM resulted in 2 sets of 82 patients with comparable characteristics at inclusion. From treatment initiation, the O group had a longer estimated five-year PFS (p=0.029; 82.8% versus 66.6%, HR 1.99, IC95 1.05-3.76) and OS (p=0.039; 86.4% versus 71.4% (HR 2.08, IC95 1.01-4.16) compared to the R group. Causes of death were comparable in the 2 groups, the most common cause being lymphoma. Obinutuzumab prior to transplantation and in maintenance provides better disease control and enhances PFS and OS, as compared to Rituximab in transplant-eligible MCL patients.

PMID:38669626 | DOI:10.1182/blood.2024023944

J Osteopath Med. 2024 Apr 29. doi: 10.1515/jom-2024-0013. Online ahead of print.

ABSTRACT

CONTEXT: Children and adolescents young adults (AYAs) undergoing treatment for oncologic diagnoses are frequently hospitalized and experience unwanted therapy-induced side effects that diminish quality of life. Osteopathic manipulative treatment (OMT) is a medical intervention that utilizes manual techniques to diagnose and treat body structures. Few studies have investigated the implementation of OMT in the pediatric oncology outpatient setting. To date, no studies have investigated the safety and feasibility of OMT in the pediatric oncology inpatient setting.

OBJECTIVES: The objective of this study is to investigate the safety and feasibility of OMT in the pediatric oncology inpatient setting.

METHODS: This is a prospective, single-institution pilot study evaluating children and AYAs aged ≥2 years to ≤30 years with a diagnosis of cancer hospitalized at Riley Hospital for Children (RH) from September 2022 to July 2023. Approval was obtained from the Indiana University Institutional Review Board (IRB). Patients were evaluated daily with a history and physical examination as part of routine inpatient management. Patients who reported chemotherapy side effects commonly encountered and managed in the inpatient setting, such as pain, headache, neuropathy, constipation, or nausea, were offered OMT. Patients provided written informed consent/assent prior to receiving OMT. OMT was provided by trained osteopathic medical students under the supervision of a board-certified osteopathic physician and included techniques commonly taught in first- and second-year osteopathic medical school curricula. Safety was assessed by a validated pain (FACES) scale immediately pre/post-OMT and by adverse event grading per Common Terminology Criteria for Adverse Events (CTCAE) 24 h post-OMT. All data were summarized utilizing descriptive statistics.

RESULTS: A total of 11 patients were screened for eligibility. All patients met the eligibility criteria and were enrolled in the study. The majority of patients were male (n=7, 63.6 %) with a median age of 18.2 years at time of enrollment (range, 10.2-29.8 years). Patients had a variety of hematologic malignancies including B-cell acute lymphoblastic leukemia (ALL) (n=5, 45.5 %), T-cell ALL (n=1, 9.1 %), acute myeloid leukemia (AML) (n=2, 18.2 %), non-Hodgkin’s lymphoma (n=2, 18.2 %), and Hodgkin’s lymphoma (n=1, 9.1 %). All patients were actively undergoing cancer-directed therapy at the time of enrollment. There were 40 unique reasons for OMT reported and treated across 37 encounters, including musculoskeletal pain (n=23, 57.5 %), edema (n=7, 17.5 %), headache (n=5, 12.5 %), peripheral neuropathy (n=2, 5.0 %), constipation (n=2, 5.0 %), and epigastric pain not otherwise specified (n=1, 2.5 %). Validated FACES pain scores were reported in 27 encounters. Of the 10 encounters for which FACES pain scores were not reported, 8 encounters addressed lower extremity edema, 1 encounter addressed peripheral neuropathy, and 1 encounter addressed constipation. The total time of OMT was documented for 33 of the 37 encounters and averaged 9.8 min (range, 3-20 min).

CONCLUSIONS: Hospitalized children and AYAs with cancer received OMT safely with decreased pain in their reported somatic dysfunction(s). These findings support further investigation into the safety, feasibility, and efficacy of implementing OMT in the pediatric oncology inpatient setting and to a broader inpatient pediatric oncology population.

PMID:38669608 | DOI:10.1515/jom-2024-0013

Biostatistics. 2024 Apr 26:kxae009. doi: 10.1093/biostatistics/kxae009. Online ahead of print.

ABSTRACT

There is an increasing interest in the use of joint models for the analysis of longitudinal and survival data. While random effects models have been extensively studied, these models can be hard to implement and the fixed effect regression parameters must be interpreted conditional on the random effects. Copulas provide a useful alternative framework for joint modeling. One advantage of using copulas is that practitioners can directly specify marginal models for the outcomes of interest. We develop a joint model using a Gaussian copula to characterize the association between multivariate longitudinal and survival outcomes. Rather than using an unstructured correlation matrix in the copula model to characterize dependence structure as is common, we propose a novel decomposition that allows practitioners to impose structure (e.g., auto-regressive) which provides efficiency gains in small to moderate sample sizes and reduces computational complexity. We develop a Markov chain Monte Carlo model fitting procedure for estimation. We illustrate the method’s value using a simulation study and present a real data analysis of longitudinal quality of life and disease-free survival data from an International Breast Cancer Study Group trial.

PMID:38669589 | DOI:10.1093/biostatistics/kxae009

J Parkinsons Dis. 2024;14(3):545-556. doi: 10.3233/JPD-230285.

ABSTRACT

BACKGROUND: REM-sleep behavior disorder (RBD) and other non-motor symptoms such as hyposmia were proposed by the Movement Disorder Society as research criteria for prodromal Parkinson’s disease (P-PD). Global cognitive deficit was later added.

OBJECTIVE: To compare non-motor symptoms, focusing on cognition, between a P-PD group and a matched control group.

METHODS: In this cross-sectional, case-control study, in a first set of analyses, we performed extensive cognitive testing on people with (n = 76) and a control group without (n = 195) probable RBD and hyposmia. Furthermore, we assessed motor and non-motor symptoms related to Parkinson’s Disease (PD). After propensity score matching, we compared 62 P-PD with 62 age- and sex-matched controls. In addition, we performed regression analyses on the total sample (n = 271). In a second set of analyses, we used, a.o., the CUPRO to evaluate retrograde procedural memory and visuo-constructive functions.

RESULTS: People with P-PD showed significantly poorer performances in global cognition, visuo-constructive and executive functions, mainly in mental flexibility (p < 0.001; p = 0.004; p = 0.003), despite similar educational levels (p = 0.415). We observed significantly more motor and non-motor symptoms (p < 0.001; p = 0.004), higher scores for depression (p = 0.004) and apathy (p < 0.001) as well as lower quality of life (p < 0.001) in P-PD.

CONCLUSIONS: Our findings confirm that global cognitive, executive, and visuo-constructive deficits define the P-PD group. In addition, depression, apathy, and lower quality of life were more prevalent in P-PD. If replicated in other samples, executive and visuo-constructive deficits should be considered in non-motor P-PD. Determining specific patterns will support early recognition of PD, secondary prevention of complications and the development of neuroprotective treatments.

PMID:38669560 | DOI:10.3233/JPD-230285

JMIR Mhealth Uhealth. 2024 Apr 26;12:e51201. doi: 10.2196/51201.

ABSTRACT

BACKGROUND: Numerous smartphone apps are targeting physical activity (PA) and healthy eating (HE), but empirical evidence on their effectiveness for the initialization and maintenance of behavior change, especially in children and adolescents, is still limited. Social settings influence individual behavior; therefore, core settings such as the family need to be considered when designing mobile health (mHealth) apps.

OBJECTIVE: The purpose of this study was to evaluate the effectiveness of a theory- and evidence-based mHealth intervention (called SMARTFAMILY [SF]) targeting PA and HE in a collective family-based setting.

METHODS: A smartphone app based on behavior change theories and techniques was developed, implemented, and evaluated with a cluster randomized controlled trial in a collective family setting. Baseline (t₀) and postintervention (t₁) measurements included PA (self-reported and accelerometry) and HE measurements (self-reported fruit and vegetable intake) as primary outcomes. Secondary outcomes (self-reported) were intrinsic motivation, behavior-specific self-efficacy, and the family health climate. Between t₀ and t₁, families of the intervention group (IG) used the SF app individually and collaboratively for 3 consecutive weeks, whereas families in the control group (CG) received no treatment. Four weeks following t₁, a follow-up assessment (t₂) was completed by participants, consisting of all questionnaire items to assess the stability of the intervention effects. Multilevel analyses were implemented in R (R Foundation for Statistical Computing) to acknowledge the hierarchical structure of persons (level 1) clustered in families (level 2).

RESULTS: Overall, 48 families (CG: n=22, 46%, with 68 participants and IG: n=26, 54%, with 88 participants) were recruited for the study. Two families (CG: n=1, 2%, with 4 participants and IG: n=1, 2%, with 4 participants) chose to drop out of the study owing to personal reasons before t₀. Overall, no evidence for meaningful and statistically significant increases in PA and HE levels of the intervention were observed in our physically active study participants (all P>.30).

CONCLUSIONS: Despite incorporating behavior change techniques rooted in family life and psychological theories, the SF intervention did not yield significant increases in PA and HE levels among the participants. The results of the study were mainly limited by the physically active participants and the large age range of children and adolescents. Enhancing intervention effectiveness may involve incorporating health literacy, just-in-time adaptive interventions, and more advanced features in future app development. Further research is needed to better understand intervention engagement and tailor mHealth interventions to individuals for enhanced effectiveness in primary prevention efforts.

TRIAL REGISTRATION: German Clinical Trials Register DRKS00010415; https://drks.de/search/en/trial/DRKS00010415.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/20534.

PMID:38669071 | DOI:10.2196/51201

J Child Health Care. 2024 Apr 26:13674935241249770. doi: 10.1177/13674935241249770. Online ahead of print.

ABSTRACT

This pilot and acceptability study sought to report provider acceptability and developmental concerns expressed by caregivers of children with prenatal opioid exposure using the Shared Decision-Making Tool (SDMT), an instrument created by study authors. Data were collected from five health care and early intervention providers and 83 caregivers from a medical clinic and early intervention service center. Descriptive statistics were used to identify frequency, mean level, and prioritization of developmental concerns using the SDMT, and to summarize provider acceptability about integrating the SDMT into their workflow. Communication was the most frequently cited concern in four consecutive age categories, followed by Inattention/impulsivity and Problem behavior. All providers “strongly agreed” or “agreed” with all statements on the provider feedback survey, except two instances. Results of this study support the SDMT as a potential tool to help engage caregivers and providers of children with prenatal opioid exposure in the shared decision-making process by standardizing communication related to areas of developmental concern and caregivers’ priority needs. Findings from this pilot study will inform modifications to the SDMT and administration instructions before our next study, which will examine psychometric properties and caregiver acceptability of the scale.

PMID:38669063 | DOI:10.1177/13674935241249770