What are the potential ethical issues to be considered for the research participants and

Transcription

1 What are the potential ethical issues to be considered for the research participants and researchers in the following types of studies? 1. Postal questionnaires 2. Focus groups 3. One to one qualitative interviews 4. Non-participant observation 5. Extraction of data from written documentation 6. Controlled study of new health care service

2 1. Postal questionnaires The aim of this study is to assess the prevalence of adherence to antiretroviral treatment in HIV-infected patients and to evaluate factors associated with adherence. All HIV-treated patients, who attend the participating outpatient clinics during the study period, will be sent a questionnaire, to be completed and returned by post. The questionnaire consists of three parts: A demographic questionnaire, collecting data on gender, age, origin, homelessness, method of HIV transmission, viral load, drug or alcohol problems, and contacts with psychiatric health care. Medication Adherence Scale (9 item questionnaire) Motivation index (2 item scale)

3 2. Focus groups The aim of this study is to develop an understanding of the medicines information needs of women who have had a diagnosis of breast cancer. Six focus groups, each containing 7-12 participants, will be held with purposively selected women from a defined geographical area. Posters will be displayed in the outpatient clinic areas of the local hospital and hospice, and the researcher will personally invite women who attend her Medication Management Clinic. Women will be selected for inclusion because they are likely to have an opinion, and based on their age, their current medication (including complementary therapies), whether they are pre- or post-menopausal, whether they are/ever have been involved in a clinical trial, and whether they are or are not IT literate. The focus groups will be tape recorded, and an assistant will also take notes, to provide context for the tape and non-verbal communication within the group.

4 3. One to one qualitative interviews The aims of this study are to describe some of the types of prescribing decisions that cause a feeling of discomfort in secondary care prescribers and to explore why particular decisions are perceived to be uncomfortable by these prescribers. Potential participants will be sent a short questionnaire, which requests general information about the participant, relating to their grade, position, time employed in that position, department and their contact details. Participants for the interviews will be purposively selected from those who return the questionnaire, based on their grade and department. Prior to the interview, the participants will be asked to remember any instances where they have felt uncomfortable when making a prescribing decision, regardless of whether a prescription was actually issued or not. An interview will follow within two weeks, where the incident(s) will be discussed in-depth, followed by a less structured set of questions about their general perceptions about uncomfortable prescribing decisions.

5 4. Non-participant observation The aim of this study is to assess the aseptic technique, and consequent patient risk, of trained nurses who are preparing injections immediately prior to administration to patients in an intensive care unit and a special care baby unit. An observation form will be prepared, based on the standard operating procedures for the preparation of injections in Near Patient Areas. A non-participant observer will assess the nursing staff when they are preparing injections as part of their normal daily routine. Data to be collected will include the number of manipulations and calculations performed, a description of the immediate ward environment, the number of checks performed by other staff, whether the patient is immunocompromised, any potential contamination risk and any other potential for medication errors.

6 5. Extraction of data from written documentation The aim of this study is to assess the proportion of adverse drug reactions that could be attributed to inappropriate prescriptions in a sample of hospitalised elderly patients. All patients aged 65 years or over admitted to the acute geriatric and medical wards will be recruited. Patients who are admitted from their own homes, elderly person's homes, or nursing homes, and including both emergency and booked admissions, will be eligible. The following data will be collected for each patient: basic demographic information, drugs on admission, presenting complaint, previous medical history and known diagnoses, the results of biochemical tests or blood counts and other relevant tests carried out, on or shortly after, admission; and alterations to drug therapy whilst in hospital. All patients entering the study will be reviewed daily. Using the above data, inappropriate prescriptions (unnecessary drugs and those with absolute contra-indications), interacting drugs, adverse drug reactions and drug-related admissions will be identified.

7 6. Controlled study of new health care service The aim of this study is to assess the benefits of a new structured clinical pharmacy wardbased team to the patient, pharmacy department and ward staff. The new service involves a junior pharmacist and a pharmacy technician, with the support of a senior pharmacist, being based on the wards and providing a clinical pharmacy service during the normal working day (9am to 5pm). The current service involves a single pharmacist visiting the ward daily for 1-2 hours. The new service will be provided to two medical wards in the hospital and two other medical wards will continue to receive the current service, and act as controls. Data that will be collected will include the number, nature and outcome of recommendations made regarding prescriptions, the number of patients counselled, the time delay between prescription and supply of medication, the patients length of hospital admission and the satisfaction of doctors and nurses with the pharmacy services.