The use of PRO in adverse event identification during cancer therapy - choosing the right questions to ask.

Background: Adequate and timely monitoring of adverse events to cancer treatment is from our view dependent on a suitable Patient Reported Outcome (PRO) tool developed for the specific patient population based on cytostatic drugs included in the treatment. Therefore, a systematic method for construction of PRO questionnaires including selection of the appropriate questions is needed. Purpose: The purpose of the present study was to develop and test a method of item selection for a PRO questionnaire to monitor adverse events in oncologic routine treatment of metastatic prostate cancer patients. Patient and methods: Documentation on common symptomatic adverse events for the three drugs was collected from five different sources: 1) FDA product summary information; 2) EMA product summary information; 3) phase 3 Randomized Controlled Trials (RCT) leading to drug approval; 4) audit of the electronic patient files focusing on the oncologist's documentation of adverse events and 5) individual patient interview (n = 16) focusing on adverse events. The Patient Reported Outcome of Common Terminology Criteria for Adverse Events (PRO-CTCAE) was used as PRO item library. Selected symptoms were transformed into corresponding PRO-CTCAE questions. The questionnaire was tested by patients in a pilot test (n = 12). Patients for interviews and pilot testing were included by purposive sampling. Results: A method for constructing a PRO questionnaire was developed, and a questionnaire of 25 PRO-CTCAE symptoms with 46 questions including an open write-in space for additional adverse events was constructed and tested. Conclusion: This study demonstrates a systematic method to select questions on adverse events for a PRO questionnaire in a specific cancer population receiving oncologic treatment. The present study reveals that audit of patient files and patient interviews in our setting only add little to the information on adverse events obtained from FDA, EMA and RCT. The obtained questionnaire was found useful and acceptable by patients.

Danish translation and pilot testing of the European Organization for Research and Treatment of Cancer QLQ-TC 26 (EORTC QLQ-TC26) questionnaire to assess health-related quality of life in patients with testicular cancer.

BACKGROUND: The European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 is a core questionnaire designed to evaluate health-related quality of life (HRQoL) of cancer patients participating in international clinical trials. It is available in several languages including Danish. The EORTC QLQ-TC26 is a supplemental module developed for patients with testicular cancer, which can be useful in clinical trials. Despite Denmark holding a high prevalence and incidence of testicular cancer, no Danish translation was previously available. This paper describes the translation process and pilot testing of the Danish translation of QLQ-TC26. METHODS: The English language EORTC QLQ-TC26 was translated into Danish using forward and backward procedures with reconciliation. The translated instrument was assessed in semi structured cognitive interviews in a sample of 10 patients ages 20-56 receiving treatment for testicular cancer. RESULTS: In one round of pilot testing, no changes were required for the Danish translation based upon patient comments. The Danish translation was agreed by participants to be both culturally acceptable and semantically comprehensible. CONCLUSIONS: The pilot testing of the Danish translation of the EORTC QLQ-TC26 was performed in one round of patient interviews; these results support the Danish translation as a comparable instrument to the English language version. However, further validation is required to ensure complete equivalency. These results support the use of the EORTC QLQ-TC26 in future clinical trials conducted with Danish-speaking patients.

The patient's experience of temporary paralysis from spinal anaesthesia, a part of total knee replacement.

AIMS AND OBJECTIVES: The aim of this study was to describe the meaning of being temporary paralysed from spinal anaesthesia when undergoing total knee replacement. BACKGROUND: Total knee arthroplasty is a common procedure, and regional anaesthesia is used as a method for anaesthetising the patient. The experience is highly individual in substance and duration, and it can extend far beyond care settings as intraoperative care and the postanaesthesia care unit that have been investigated so far. DESIGN: A qualitative phenomenological hermeneutic design was chosen to gain a deeper understanding of the experience of spinal anaesthesia, as a part of having a total knee replacement. METHODS: Twelve patients were interviewed in March 2014 after undergoing an elective total knee arthroplasty under spinal anaesthesia. The interviews were analysed with a Ricoeur-inspired interpretation method. RESULTS: Three themes were derived from the interviews: 'anaesthesia--an unavoidable necessity', 'an unrecognisable and incomprehensible body' and 'the body returns--joy and agony'. CONCLUSION: The results reveal that trust in the health care personnel and knowledge of the course of events play a key role in the experience. The trust can be breached by unforeseen events, or if the patient's experiences were not taken into account. The ability of the health care personnel to be in contact, share relevant knowledge with- and compensate for the patient is crucial in the prevention of negative experiences. RELEVANCE TO CLINICAL PRACTICE: The results of this study contribute to insights and deeper knowledge that can enhance staff's ability to provide care for patients undergoing total knee arthroplasty in spinal anaesthesia. The results provide perspectives that argue for care in accordance to individual needs.

Constipation--prevalence and incidence among medical patients acutely admitted to hospital with a medical condition.

AIMS AND OBJECTIVES: To examine the prevalence and incidence of patient-reported symptoms of constipation in acutely hospitalised medical patients. BACKGROUND: Constipation is a common medical problem with severe consequences, and most people suffer from constipation at some point in their lives. In the general population, constipation is one of the most common complaints and is a significant personal and public health burden. Alteration in patients' patterns of elimination while in hospital has long been identified as either a potential or an actual problem that requires attention. Knowledge of the prevalence and incidence of constipation during hospitalisation is only sporadic. DESIGN: The study was descriptive and a prospective cohort design was chosen. METHODS: The Constipation Assessment Scale was translated into Danish and was used for the assessment of patient-reported bowel function. Five nurses made the assessments at admission to the acute medical ward and three days after admission. Three hundred and seventy-three patients participated in this study. RESULTS: Thirty-nine percent of the patients showed symptoms of constipation at admission. Of the patients who did not have the symptoms at admission, 43% developed the symptoms during the first three days of their stay in hospital. Significantly more of the older patients developed symptoms of moderate constipation. The incidence rate was 143 new cases per 1000 patient days. CONCLUSIONS: In this study, symptoms of constipation were common among patients acutely admitted to hospital due to different medical conditions. Symptoms of constipation were also developed during the first three days of the stay in hospital. RELEVANCE TO CLINICAL PRACTICE: The study highlights the need to develop both clinical guidelines towards treating constipation, and preventive measures to ensure that patients do not become constipated while staying in hospital.