Relationship between reasons for intermittent missing patient-reported outcomes data and missing data mechanisms.

PURPOSE: Non-response (NR) to patient-reported outcome (PRO) questionnaires may cause bias if not handled appropriately. Collecting reasons for NR is recommended, but how reasons for NR are related to missing data mechanisms remains unexplored. We aimed to explore this relationship for intermittent NRs. METHODS: Patients with multiple myeloma completed validated PRO questionnaires at enrolment and 12 follow-up time-points. NR was defined as non-completion of a follow-up assessment within seven days, which triggered contact with the patient, recording the reason for missingness and an invitation to complete the questionnaire (denoted "salvage response"). Mean differences between salvage and previous on-time scores were estimated for groups defined by reasons for NR using linear regression with clustered standard errors. Statistically significant mean differences larger than minimal important difference thresholds were interpreted as "missing not at random" (MNAR) mechanism (i.e. assumed to be related to declining health), and the remainder interpreted as aligned with "missing completely at random" (MCAR) mechanism (i.e. assumed unrelated to changes in health). RESULTS: Most (7228/7534 (96%)) follow-up questionnaires were completed; 11% (802/7534) were salvage responses. Mean salvage scores were compared to previous on-time scores by reason: those due to hospital admission, mental or physical reasons were worse in 10/22 PRO domains; those due to technical difficulties/procedural errors were no different in 21/22 PRO domains; and those due to overlooked/forgotten or other/unspecified reasons were no different in any domains. CONCLUSION: Intermittent NRs due to hospital admission, mental or physical reasons were aligned with MNAR mechanism for nearly half of PRO domains, while intermittent NRs due to technical difficulties/procedural errors or other/unspecified reasons generally were aligned with MCAR mechanism.

Strategies to improve patient-reported outcome completion rates in longitudinal studies.

PURPOSE: The quality of patient-reported outcome (PRO) data can be compromised by non-response (NR) to scheduled questionnaires, particularly if reasons for NR are related to health problems, which may lead to unintended bias. The aim was to investigate whether electronic reminders and real-time monitoring improve PRO completion rate. METHODS: The population-based study "Quality of life in Danish multiple myeloma patients" is a longitudinal, multicentre study with consecutive inclusion of treatment-demanding newly diagnosed or relapsed patients with multiple myeloma. Education of study nurses in the avoidance of NR, electronic reminders, 7-day response windows and real-time monitoring of NR were integrated in the study. Patients complete PRO assessments at study entry and at 12 follow-up time points using electronic or paper questionnaires. The effect of the electronic reminders and real-time monitoring were investigated by comparison of proportions of completed questionnaires before and after each intervention. RESULTS: The first 271 included patients were analysed; of those, 249 (85%) chose electronic questionnaires. Eighty-four percent of the 1441 scheduled PRO assessments were completed within the 7-day response window and 11% after real-time monitoring, achieving a final PRO completion rate of 95%. A significant higher proportion of uncompleted questionnaires were completed after the patients had received the electronic reminder and after real-time monitoring. CONCLUSIONS: Electronic reminders and real-time monitoring contributed to a very high completion rate in the study. To increase the quality of PRO data, we propose integrating these strategies in PRO studies, however highlighting that an increase in staff resources is required for implementation.

Evaluation of clinical trial eligibility and prognostic indices in a population-based cohort of systemic peripheral T-cell lymphomas from the Danish Lymphoma Registry.

Clinical trials (CTs) are needed to improve the outcome for peripheral T-cell lymphomas (PTCL), and accrual into CTs is one of the main recommendations in international treatment guidelines. The use of risk-adapted strategies has been suggested as a way to optimize treatment outcome in PTCL. The aim of the present study was to evaluate CT eligibility and selected prognostic indices in a population-based PTCL cohort of 481 PTCL patients identified from the Danish Lymphoma Registry in the period 2000-2010. According to five predefined parameters (age, performance status, P-creatinine, P-ALAT and measurable tumour lesion), patients were subdivided into four groups: 'younger fit', 'elderly fit', 'frail' and 'not CT eligible'. International prognostic index (IPI), prognostic index for T-cell lymphoma (PIT) and anaplastic lymphoma kinase (ALK) protein expression were tested at subtype-specific level. Overall, 41% of the patients were considered eligible for interventional CTs implicating curatively intended multiagent chemotherapy, including, if considered appropriate, consolidating stem cell transplantation (SCT), as part of the upfront management strategy. Moreover, 28% was elderly fit and eligible for interventional CT, including those with SCT as part of the trial design. Approximately 7% were defined as 'too frail' for aggressive treatment schedules, whereas 24% were deemed not to be eligible for any CT. Both overall and progression-free survivals were effectively predicted by IPI and PIT (p < 0.001). ALK-positive anaplastic large cell lymphoma patients were significantly younger (median age 40 vs. 62, p < 0.001) and had a better outcome than their ALK-negative counterparts (p < 0.001). However, ALK expression lost its prognostic significance when adjusting for age. In a population-based cohort of adult Caucasian PTCL patients, approximately half were eligible for multiagent chemotherapy with or without consolidating SCT. Both IPI and PIT are useful prognostic indices in all 'primary nodal' PTCL entities. The prognostic value of ALK protein expression in anaplastic large cell lymphoma is significantly downsized when adjusting for age.

Role of routine imaging in detecting recurrent lymphoma: A review of 258 patients with relapsed aggressive non-Hodgkin and Hodgkin lymphoma.

After first-line therapy, patients with Hodgkin lymphoma (HL) and aggressive non-HL are followed up closely for early signs of relapse. The current follow-up practice with frequent use of surveillance imaging is highly controversial and warrants a critical evaluation. Therefore, a retrospective multicenter study of relapsed HL and aggressive non-HL (nodal T-cell and diffuse large B-cell lymphomas) was conducted. All included patients had been diagnosed during the period 2002-2011 and relapsed after achieving complete remission on first-line therapy. Characteristics and outcome of imaging-detected relapses were compared with other relapses. A total of 258 patients with recurrent lymphoma were included in the study. Relapse investigations were initiated outside preplanned visits in 52% of the patients. Relapse detection could be attributed to patient-reported symptoms alone or in combination with abnormal blood tests or physical examination in 64% of the patients. Routine imaging prompted relapse investigations in 27% of the patients. The estimated number of routine scans per relapse was 91-255 depending on the lymphoma subtype. Patients with imaging-detected relapse had lower disease burden (P = 0.045) and reduced risk of death following relapse (hazard ratio = 0.62, P = 0.02 in multivariate analysis). Patient-reported symptoms are still the most common factor for detecting lymphoma relapse and the high number of scans per relapse calls for improved criteria for use of surveillance imaging. However, imaging-detected relapse was associated with lower disease burden and a possible survival advantage. The future role of routine surveillance imaging should be defined in a randomized trial.

[Structured documentation of patients' medical records. A new record structure for emergency admissions is coming]. / Synlig struktureret planlaegning i patientjournalen. En ny journalstruktur for akutte indlaeggelsesforlob pa vej.

INTRODUCTION: In recent years a range of efforts to shorten the length of stay (LOS) for patients admitted to hospitals has been tested. Some studies indicate that this might be accomplished by rigorous planning of patient pathways and structured documentation of medical records. In this study the effect of a structured case record model was tested. METHODS: The new record structure was developed using predefined requirements for content, placement and presentation of documentation. Instruction of staff was followed by a switch to the new model from one day to the next. Collection of data was carried out three months before and five to eight months after implementation of the model. RESULTS: The department succeeded in including well over 50% of all includable patients. However, the analysis encompassed all includable patients (''intention to treat'' principle). The number of cases analysed was 340 before and 353 after implementation of the model. Average LOS was reduced by 1.1 day from before implementation to after implementation. This was not statistically significant. However, the model was subsequently kept in use by the department. DISCUSSION: This pilot study shows a non-significant tendency to shotening of LOS by using a structured case record model. It is important to pay attention to the practical difficulties of implementing new documentation tools.

[The Good Medical Department. Results from a national survey of quality in 1998]. / Den gode medicinske afdeling. Resultater fra en national undersøgelse af kvalitet i 1998.

INTRODUCTION: This cross-sectional study describes quality related data from 39 medical wards in Denmark. MATERIAL AND METHODS: The study is based on a review of 1517 medical records and a short patient interview. The medical departments took part voluntarily in the study, which was initiated by the Danish Society for Internal Medicine. RESULTS: A total of 23 quality-related indicators related to the planning of the treatment, documentation in patient records, and care were registered. The day before the data collection was an inactive inpatient day for 22.8 +/- 1.1% of patients. Allergy was insufficiently documented in the medical record for 18.8 +/- 1.0% of patients. Weight was not documented in 48.8 +/- 1.3% of patients. Considerations about anticoagulation treatment of atrial fibrillation were not documented in 50.1 +/- 3.6% of patients with atrial fibrillation. DISCUSSION: This study indicates that it is possible on a voluntary basis to collect and distribute quality-related data. The survey has recently been repeated with a modified data registration sheet.

[Prescribing and dispensing drugs in Denmark. Frequency of and intervention against errors in documentation and dispensing of drugs]. / Medicinordinationssystemer og medicindispensering i Danmark. Hyppighed af og intervention mod medicindokumentationsfejl og medicindispenseringsfejl.

Foreign studies mainly describe errors in medicine prescriptions in context with adverse drug events unlike most Danish studies and projects, which focus on documentation. Current methods of prescribing medicines in Denmark only partially follow the guidelines given by the National Board of Health. About two thirds of the prescriptions are unambiguous. Errors of potential clinical significance are estimated to occur in 4.5% of prescriptions. Transcription errors occur mainly from patients' records to the medication forms and are found in 23% to 83% of transcribed prescriptions. Several departments have intervened by using only one prescription form, a paper or electronic version, which reduced the number of ambiguous prescriptions and eliminated transcription errors. Dispensing errors are common and demonstrate the importance of further quality improvement.