Detailed statistical analysis plan for the Danish Palliative care trial (DanPaCT)

Acknowledgements We wish to thank the students who sent out the questionnaires, who entered and compared all data, help with data management, made material blind to the investigators, and were/will be outcome assessors of interventions given. They were: Nicla Rohde Christensen, Ellen Lundorff, Marc Klee Olsen, Charlotte Lund Rasmussen, and Nete Skjødt. This work was funded by the Tryg Foundation [journal number 7-10-0838A] and the Danish Cancer Society [journal number R16-A695]. Other than funding the trial, the funding body had no role in the design, conduct, analysis, or reporting of the present trial.Peer reviewedPublisher PD

Symptoms of prolonged grief disorder in bereaved partners: Frequency and risk factors

The loss of a spouse causes a painful, but natural, grieving process. However, a significant minority of bereaved partners develops symptoms of prolonged grief disorder (PGD). This is especially common in people who lose their partner after a long and difficult period of illness, as is often the case with patients in specialized palliative care. This project investigated frequency and risk factors of symptoms of PGD in bereaved partners of patients who prior to their deaths received specialized palliative care from Palliative Team Funen, Odense University Hospital. Participants (N=182) completed questionnaires at respectively three and seven months post-loss. Analyses showed that three months after the loss, 55% of participants showed an increased symptom-level of PGD (score ≥29 on PG-13), while the frequency had decreased to 36% seven months after the loss. In addition, we found that female sex, a low degree of positive affect and a high degree of orientation towards the loss after three months were statistically significant risk factors for symptoms of PGD seven months after the loss. The results confirm that bereaved partners to patients with a complicated course of disease requiring specialized palliative efforts are at high risk of developing symptoms of PGD. Health care services should pay special attention to providing adequate support for this population.Tabet af en ægtefælle medfører ofte en smertelig sorgproces. Et væsentligt mindretal udvikler imidlertid symptomer på vedvarende sorglidelse (VSL). Dette kan være særligt hyppigt hos mennesker, der mister deres partner efter et langt og vanskeligt sygdomsforløb, som det ofte er tilfældet i specialiseret palliativ pleje. Nærværende projekt undersøgte hyppigheden af og risikofaktorer for symptomer på VSL hos efterladte partnere til patienter, der op til deres død modtog specialiseret palliativ indsats fra Palliativt Team Fyn, Odense Universitetshospital.Deltagerne (N = 182) udfyldte spørgeskemaer henholdsvis tre og syv måneder efter deres tab. Analyser viste, at tre måneder efter tabet udviste 55 % af deltagerne et forhøjet symptomniveau af VSL (score ≥29 på PG-13), mens andelen var faldet til 36 % syv måneder efter tabet. Desuden fandt vi, at en lav grad af positiv affekt og en høj grad af orientering mod tabet efter tre måneder samt det at være kvinde var statistisk signifikante risikofaktorer for symptomer på VSL syv måneder efter tabet. Resultaterne bekræfter, at efterladte partnere til patienter med komplicerede sygdomsforløb, som har krævet specialiseret palliativ indsats, er i højrisiko for udvikling af symptomer på VSL. Sundhedsvæsenet bør være særlig opmærksom på at tilbyde tilstrækkelig støtte til personer i denne befolkningsgruppe