Can job insecurity be managed? Evaluating an organizational-level intervention addressing the negative effects of restructuring

Although downsizing and reorganisation are recognised as serious threats to the psychological well-being of employees, intervention strategies for addressing these events are limited. This study evaluated the effects of a participatory organisational-level intervention in which employees and managers chose to address the psychosocial consequences, specifically job insecurity, of restructuring. The intervention was conducted among postal service letter carriers in Denmark and was evaluated based on quantitative and qualitative data. Using interviews (N = 24) and observations, the programme theory of the intervention and to what extent the intervention had been implemented were assessed. Using survey data (N = 238), repeated measures ANOVAs were conducted to test for differences in the development of job insecurity between the intervention group and a comparison group. The results indicate that the intervention group had a significantly smaller increase in one dimension of job insecurity as compared to the comparison group. Therefore, we conclude that employees’ experiencing of job insecurity, which typically follows in the wake of restructuring, can be addressed by planned efforts at the workplace level

Effectiveness of a participatory physical and psychosocial intervention to balance the demands and resources of industrial workers: A cluster-randomized controlled trial

Objectives The aim of this study was to evaluate the effectiveness of a participatory physical and psychosocial workplace intervention (known as PIPPI) on work ability and recovery among industrial workers. Methods Eligible workers were cluster-randomized into intervention (N=193) and control (N=222) groups. Intervention group members participated in three workshops where they mapped positive and negative aspects of their physical and psychosocial work environment and developed action plans addressing the highlighted issues, which were subsequently implemented by the participants. Questionnaire-based data on work ability and recovery were collected at baseline and 8-, 10- and 12-month follow-up. Data on productivity, well-being, mental health, and physical demands and resources were collected at baseline and 12-month follow-up. Results The intervention was delivered and received as planned (100% planned workshops conducted, 69% [standard deviation (SD) 7%] participation in workshops) and with a response rate of 76% (SD 8%) to the questionnaires. No significant between-group improvements for any of the outcomes were found in intention-to-treat multi-level mixed models. On the contrary, tendencies were observed for poorer recovery and reduced work ability in the intervention compared to control group. Conclusion The intervention did not improve the outcomes. This result can have several explanations, such as a regression-toward-the-mean effect or that the intervention might have put an additional burden on the workers already facing high work demands. In addition, there may have been an insufficient match between the intervention components implemented and the predetermined outcomes, and implementation may have been unsuccessful. These potential explanations need to be investigated using process evaluation data

Simple roads to failure, complex paths to success: an evaluation of conditions explaining perceived fit of an organizational occupational health intervention

Organizational occupational health interventions (OOHIs) that are perceived by employees as relevant for their workplace are more likely to be implemented successfully, yet little is known about the conditions that produce such perceptions. This study identifies the conditions that create a perception among employees that an intervention fits their organization as well as the conditions that result in low levels of perceived fit. We used two-wave data from 40 Danish preschools a that underwent a quasi-experimental OOHI. Perceived fit was assessed through employee ratings at follow-up, while survey responses from implementation team members at five time points were used to assess four context and fourteen process factors. The results of a coincidence analysis showed that high levels of perceived fit were achieved through two paths. Each path consisted of a lack of co-occurring changes together with either very high levels of managerial support (path_1) or a combination of implementation team role clarity, staff involvement, and team learning (path_2). In contrast, low levels of perceived fit were brought about by single factors: limited leader support, low degree of role clarity, or concurrent organizational changes. The findings reveal the complexity involved in implementing OOHIs and offer insights into reasons they may fail

International myeloma working group recommendations for the diagnosis and management of myeloma-related renal impairment

Purpose: The aim of the International Myeloma Working Group was to develop practical recommendations for the diagnosis and management of multiple myeloma–related renal impairment (RI). Methods: Recommendations were based on published data through December 2015, and were developed using the system developed by the Grading of Recommendation, Assessment, Development, and Evaluation Working Group. Recommendations: All patients with myeloma at diagnosis and at disease assessment should have serum creatinine, estimated glomerular filtration rate, and electrolytes measurements as well as free light chain, if available, and urine electrophoresis of a sample from a 24-hour urine collection (grade A). The Chronic Kidney Disease Epidemiology Collaboration, preferably, or the Modification of Diet in Renal Disease formula should be used for the evaluation of estimated glomerular filtration rate in patients with stabilized serum creatinine (grade A). International Myeloma Working Group criteria for renal reversibility should be used (grade B). For the management of RI in patients with multiple myeloma, high fluid intake is indicated along with antimyeloma therapy (grade B). The use of high-cutoff hemodialysis membranes in combination with antimyeloma therapy can be considered (grade B). Bortezomib-based regimens remain the cornerstone of the management of myeloma-related RI (grade A). High-dose dexamethasone should be administered at least for the first month of therapy (grade B). Thalidomide is effective in patients with myeloma with RI, and no dose modifications are needed (grade B). Lenalidomide is effective and safe, mainly in patients with mild to moderate RI (grade B); for patients with severe RI or on dialysis, lena-lidomide should be given with close monitoring for hematologic toxicity (grade B) with dose reduction as needed. High-dose therapy with autologous stem cell transplantation (with melphalan 100 mg/m2 to 140 mg/m2) is feasible in patients with RI (grade C). Carfilzomib can be safely administered to patients with creatinine clearance > 15 mL/min, whereas ixazomib in combination with lenalidomide and dex-amethasone can be safely administered to patients with creatinine clearance > 30 mL/min (grade A). © 2016 by American Society of Clinical Oncology

Oral ixazomib maintenance following autologous stem cell transplantation (TOURMALINE-MM3): a double-blind, randomised, placebo-controlled phase 3 trial

Background: Maintenance therapy following autologous stem cell transplantation (ASCT) can delay disease progression and prolong survival in patients with multiple myeloma. Ixazomib is ideally suited for maintenance therapy given its convenient once-weekly oral dosing and low toxicity profile. In this study, we aimed to determine the safety and efficacy of ixazomib as maintenance therapy following ASCT. Methods: The phase 3, double-blind, placebo-controlled TOURMALINE-MM3 study took place in 167 clinical or hospital sites in 30 countries in Europe, the Middle East, Africa, Asia, and North and South America. Eligible participants were adults with a confirmed diagnosis of symptomatic multiple myeloma according to International Myeloma Working Group criteria who had achieved at least a partial response after undergoing standard-of-care induction therapy followed by high-dose melphalan (200 mg/m2) conditioning and single ASCT within 12 months of diagnosis. Patients were randomly assigned in a 3:2 ratio to oral ixazomib or matching placebo on days 1, 8, and 15 in 28-day cycles for 2 years following induction, high-dose therapy, and transplantation. The initial 3 mg dose was increased to 4 mg from cycle 5 if tolerated during cycles 1–4. Randomisation was stratified by induction regimen, pre-induction disease stage, and response post-transplantation. The primary endpoint was progression-free survival (PFS) by intention-to-treat analysis. Safety was assessed in all patients who received at least one dose of ixazomib or placebo, according to treatment actually received. This trial is registered with ClinicalTrials.gov, number NCT02181413, and follow-up is ongoing. Findings: Between July 31, 2014, and March 14, 2016, 656 patients were enrolled and randomly assigned to receive ixazomib maintenance therapy (n=395) or placebo (n=261). With a median follow-up of 31 months (IQR 27·3–35·7), we observed a 28% reduction in the risk of progression or death with ixazomib versus placebo (median PFS 26·5 months [95% CI 23·7–33·8] vs 21·3 months [18·0–24·7]; hazard ratio 0·72, 95% CI 0·58–0·89; p=0·0023). No increase in second malignancies was noted with ixazomib therapy (12 [3%] patients) compared with placebo (eight [3%] patients) at the time of this analysis. 108 (27%) of 394 patients in the ixazomib group and 51 (20%) of 259 patients in the placebo group experienced serious adverse events. During the treatment period, one patient died in the ixazomib group and none died in the placebo group. Interpretation: Ixazomib maintenance prolongs PFS and represents an additional option for post-transplant maintenance therapy in patients with newly diagnosed multiple myeloma. Funding: Millennium Pharmaceuticals, a wholly owned subsidiary of Takeda Pharmaceutical Company. © 2019 Elsevier Lt

Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study.

Promising new drugs are being evaluated for treatment of multiple myeloma (MM), but their impact should be measured against the expected outcome in patients failing current therapies. However, the natural history of relapsed disease in the current era remains unclear. We studied 286 patients with relapsed MM, who were refractory to bortezomib and were relapsed following, refractory to or ineligible to receive, an IMiD (immunomodulatory drug), had measurable disease, and ECOG PS of 0, 1 or 2. The date patients satisfied the entry criteria was defined as time zero (T(0)). The median age at diagnosis was 58 years, and time from diagnosis to T(0) was 3.3 years. Following T(0), 213 (74%) patients had a treatment recorded with one or more regimens (median=1; range 0-8). The first regimen contained bortezomib in 55 (26%) patients and an IMiD in 70 (33%). A minor response or better was seen to at least one therapy after T(0) in 94 patients (44%) including ≥ partial response in 69 (32%). The median overall survival and event-free survival from T(0) were 9 and 5 months, respectively. This study confirms the poor outcome, once patients become refractory to current treatments. The results provide context for interpreting ongoing trials of new drugs