Patients case records

Each of the safety performance measurement methods can be characterised as a combination of the following three facets (a) data source (b) identification procedrrre and (c) data category. Typical data sources for safety performance in healthcare are patient case records, incident reports, field data (for example, obtained by observation), and self-reported data (typically elicited by the use of a questiormaire or interview). 

The case records used in this chapter are from the Records of the Philadelphia Committee for Clinical Study of Opium Addiction, housed at the College of Physicians of Philadelphia. Patient names have been changed. The stenographer s words are recorded here with misspellings corrected. 

In some cases, it may be prudent to obtain a certified copy for the subject s clinical trial file. For example, if the records are not owned by the investigator or under his or her control, such as patient medical records held by the hospital, depending on the hospital s archiving procedures it would be advisable to obtain certified copies for the clinical trial file in case the hospital loses, misplaces, or intentionally destroys the documents under an established record retention schedule. This is all part of CQA s oversight role regarding the appropriate transfer and authentication of raw data and source documents. 

Complete Patient Records (case forms) should be included, with any gaps clearly indicated and discussed. The natural FDA assumption is that any missing case record form represents either (a) an adverse reaction, (b) sloppy procedures, or (c) an attempt at fraud. Clearly document the reason for any missing case form, including the results of a Quality Assurance follow-up investigation. 

The protocol should include an adverse experience statement, such as All adverse experiences occurring during the study must be reported on the drug reaction record provided in the patient case report forms. The drug reaction record is a complete questionnaire that covers all pertinent items concerning adverse experiences. (See Chapter 9.)... 

Interactions There is only one item on the prescription form. However, it would also be advisable for the pharmacist or pharmacy technician to check the patient medication record (PMR) for any concurrent medication that could cause an interaction. In this case, the patient s PMR indicated that she also used E45 cream (an emollient). 

Fabricated data Data that have been deliberately invented without performing the work, for example making entries in case record forms when no data were obtained or patients not seen. 

All fraud is also misconduct by definition, but misconduct per se is not so clear-cut. It could be accidental, for example missing the due date for patient assessments, or carelessly completing case record forms, but the point where carelessness becomes misconduct and misconduct becomes fraud is indistinct. A safety assessment might be omitted because the research team forgot... 

Institutional gateway systems safeguard personal health records in accord with patients informed consents. In cases where patients deny consent for their health records to be shared with other institutions or other healthcare professionals, the institutional gateway system has to refuse the access request from the PHR system to those patients health records. Again, the institutional gateway systems are also responsible for transforming the health records into the standard ontology and formats for the PHR system. 

CRF. Case record (or report) form. The form or recording schedule on which the trial data are recorded. These are nearly always maintained on a patient-by-patient basis. 

The control group was obtained by a random search of the case record index of similar patients treated by the same clinicians in Vale of Leven Hospital over the last 10 years. For each treated patient, 10 controls were found of the same sex, within 5 years of the same age, and who had suffered from cancer of the same primary organ and histological tumor type. These 1000 cancer patients comprise the control group. 

The detailed case records of these 1000 were then analyzed quite independently by Dr. Frances Meuli, M.B., Ch.B. (Otago, New Zealand), who established their presentation date of untreatability by such conventional standards as the establishment of inoperability at laparotomy, the abandonment of any definitive form of anti-cancer treatment, or the final date of admission for terminal care. This presentation date of untreatability corresponds to the date when ascorbate supplementation was initiated in the treated group. Comparable survival times of the 10 matched controls could then be calculated. We accept that the presentation date of untreatability can be influenced by many factors in individual patients, but we contend that the use of 1(K)0 controls managed by the same clinicians in the same hospital over the last 10 years provides a sound basis for this comparative study. We record our thanks to Dr. Meuli for her unbiased and valuable contribution to this investigation. 

Self-reported staff reactions that would potentially be taken after the event may be stated as follows (1) keep the event to oneself, (2) report the event to one s leader or the doctor in charge, (3) report the event to the local reporting system, (4) write in the patient s case-record about the event, (5) inform the patient about the event and future risk, (6) ejq)lain to the patient that the event was eaused by one s mistake and (7) apologise about the event to the patient. 

To examine the occurrence of secondary rhegmatogenous retinal detachment after intravitreal bevacizumab injection in patients with Bales disease, clinical records of 14 eyes from 14 patients with Bales disease were reviewed in a retrospective, comparative case series [103 ]. Four patients were recorded as developing secondary rhegmatogenous retinal detachment with retinal breaks localised to the base of fractional retinal bands within 1 week of bevacizumab injection. 

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