Biomedical Scientists' Perceptions of Ethical and Social Implications: Is There a Role for Research Ethics Consultation?

Background

Research ethics consultation programs are being established with a goal of addressing the ethical, societal, and policy considerations associated with biomedical research. A number of these programs are modelled after clinical ethics consultation services that began to be institutionalized in the 1980s. Our objective was to determine biomedical science researchers'' perceived need for and utility of research ethics consultation, through examination of their perceptions of whether they and their institutions faced ethical, social or policy issues (outside those mandated by regulation) and examination of willingness to seek advice in addressing these issues. We conducted telephone interviews and focus groups in 2006 with researchers from Stanford University and a mailed survey in December 2006 to 7 research universities in the U.S.

Findings

A total of 16 researchers were interviewed (75% response rate), 29 participated in focus groups, and 856 responded to the survey (50% response rate). Approximately half of researchers surveyed (51%) reported that they would find a research ethics consultation service at their institution moderately, very or extremely useful, while over a third (36%) reported that such a service would be useful to them personally. Respondents conducting human subjects research were more likely to find such a service very to extremely useful to them personally than respondents not conducting human subjects research (20% vs 10%; chi² p<0.001).

Conclusion

Our findings indicate that biomedical researchers do encounter and anticipate encountering ethical and societal questions and concerns and a substantial proportion, especially clinical researchers, would likely use a consultation service if they were aware of it. These findings provide data to inform the development of such consultation programs in general.     

Cervical spine arthrodesis in rheumatoid arthritis: a long-term follow-up.

Forty-one patients with rheumatoid arthritis involving the cervical spine had a posterior cervical arthrodesis. They were followed for a minimum period of seven years. The diagnoses prior to surgery included cranial settling, atlantoaxial subluxation, subaxial subluxation, and any combination of these three. All patients had posterior arthrodesis, with or without methylmethacrylate, and iliac crest autogenous bone graft. In addition, one patient had an anterior vertebrectomy, and two had transoral resection of the odontoid. Follow-up consisted of a subjective questionnaire, standard radiographs, and physical examination, including a neurologic exam. This information was compared to preoperative data available in the patient''s medical record, postoperative data, and the information obtained in a similar study undertaken in 1987. At the time of follow-up, thirteen patients were known to be dead. One patient could not be located. Of the remaining twenty-six patients, eighteen underwent the full examination, including physical exam and radiographs. The remaining nine patients were contacted and interviewed, but were unavailable for exam and radiographs. All patients considered the operation a success. Only one patient at follow-up had a non-union. This was stable over time. No patient had a deterioration in neurologic function. There was no significant degeneration or instability seen at levels adjacent to the fused segments as compared to the rest of the cervical spine. Posterior cervical spine arthrodesis for rheumatoid involvement of the neck is a safe, efficacious procedure with no significant deterioration of effects over time.     

What do patients with medically unexplained physical symptoms (MUPS) think? A qualitative study

Context Medically unexplained physical symptoms (MUPS) are frequently encountered in family medicine, and lead to disability, discomfort, medicalisation, iatrogenesis and economic costs. They cause professionals to feel insecure and frustrated and patients to feel dissatisfied and misunderstood. Doctors seek answers for rather than with the patient.Objectives This study aimed to explore patients'' explanations of the medically unexplained physical symptoms that they were experiencing by eliciting their own explanations for their complaints, their associated fears, their expectations of the consultation, changes in their ideas of causality, and the therapeutic approach that they considered would be useful.Methodology A qualitative analysis was under-taken of interviews with 15 patients with MUPS in a family medicine unit, 6 months after diagnosis.Results Experience is crucial in construction of the meaning of symptoms and illness behaviour. Many patients identify psychosocial causes under-lying their suffering. These patients received more medication and fewer requests for diagnostic examinations than they had expected. Normalisation is a common behaviour in the clinical approach. Normalisation without explanation can be effective if an effective therapeutic relationship exists that may dispense with the need for words. Listening is the procedure most valued by patients. Diagnostic tests may denote interest in patients'' problems. The clinician''s flexibility should allow adaptation to the patient''s phases of acceptance of the significance of their physical, emotional and social problems.Conclusion Patients with MUPS have explanations and fears associated with their complaints. The patient comes to the consultation not because of the symptom, but because of what he or she thinks about the symptom. The therapeutic relationship, therapeutic listening, and flexibility should be the basis for approaching patients with MUPS. Patients do not always expect medication, although it is what they most often receive. Diagnostic tests, although used sparingly, can be a way to maintain and build a relationship. Drugs and tests can be a ritual statement of clinical interest in the patient and their symptoms.     

Attitudes to the psychiatric outpatient clinic.

Fifty patients were interviewed before their first ever appointment at a psychiatric outpatient clinic about their attitude to the forthcoming visit. Many did not know that it was a psychiatrist they were to see at the hospital. Widespread misconceptions about the nature of a psychiatric consultation were uncovered. Many felt the referral carried an implicit threat of social stigma. Patient''s misconceptions were relieved, and only 13% subsequently failed to attend the clinic compared with 30% of a control group.     

Assessment of clinical competence using objective structured examination.

To avoid many of the disadvantages of the traditional clinical examination we have introduced the structured clinical examination. In this students rotate round a series of stations in the hospital ward. At one station they are asked to carry out a procedure, such as take a history, undertake one aspect of physical examination, or interpret laboratory investigations in the light of a patient''s problem, and at the next station they have to answer questions on the findings at the previous station and their interpretation. As they cannot go back to check on omissions multiple-choice questions have a minimal cueing effect. The students may be observed and scored at some stations by examiners using a check list. In the structured clinical examination the variables and complexity of the examination are more easily controlled, its aims can be more clearly defined, and more of the student''s knowledge can be tested. The examination is more objective and a marking strategy can be decided in advance. The examination results in improved feed-back to students and staff.     

Self referral to accident and emergency department: patients' perceptions.

A study was conducted (a) to assess the number of patients registered with a south London general practice who over 11 weeks referred themselves to an accident and emergency department, (b) to identify the characteristics of those patients, and (c) to determine their perceptions of the services and resources available within their general practices and of the role of accident and emergency departments. Two hundred and thirty four patients referred themselves to a casualty department during the study period, of whom 217 (93%) were interviewed by means of a semistructured questionnaire. Of the 217 patients interviewed, only 15 had tried to contact their general practitioner before attending the casualty department. Eighty nine patients considered that their problem was urgent and required immediate attention and many that they would need an x ray examination. A substantial minority of patients thought that their doctor would not be available. It is concluded that patients'' perceptions of their problems and of access to their doctors are the main determinants of self referral to a casualty department. These findings have important implications for patient education.     

Diagnostic and therapeutic efficacy of barium meal examination: a prospective evaluation in general practice.

OBJECTIVE--To assess the efficacy of barium meal examinations in managing patients with dyspepsia in general practice. DESIGN--Prospective study by questionnaires completed by general practitioners before and within three to six months after the barium meal examination. Information was requested about the patients'' symptoms, current treatment, reason for requesting the examination, and the working diagnosis, including degree of certainty and, after the examination, about any change in diagnosis, diagnostic confidence, or management and to determine whether the examination was judged to be helpful or not. SETTING--Inner city health district. PATIENTS--133 Patients with dyspepsia referred by general practitioners for outpatient barium meal examination, 31 of whom failed to attend for the examination, or refused it on arrival, or did not have fully completed questionnaires. Two patients were not available for follow up. MAIN OUTCOME MEASURES--Prevalence of radiological abnormalities and the influence of the examination result on management, particularly changes in drug treatment. RESULTS--Fully completed pairs of questionnaires were available for 100 patients, 58 of whom were aged below 50. Most of the barium meal reports (64) were to confirm the clinical diagnosis; only 22 were to exclude serious disease. Ninety nine patients were already receiving treatment, with 39 taking an H2 receptor antagonist. Fifty eight barium meal examinations showed abnormalities (31 major abnormalities); there were no cancers and in only 18 patients was the working diagnosis changed as a result of the findings. Although the barium meal result increased management confidence (63 patients) and allayed patients'' anxiety (46), changes in management attributed directly to the examination occurred in only 22 patients. Management changes were minor, usually comprising interchange of antacids and H2 receptor antagonists. CONCLUSIONS--Young patients (aged below 50) with dyspepsia are still being overinvestigated. Although barium meal examination improves diagnostic confidence and allays patients'' anxiety, fully utilising communication skills at the initial consultation might allay anxiety more economically.     

Do patients wish to be involved in decision making in the consultation? A cross sectional survey with video vignettes

ObjectiveTo determine patients'' preferences for a shared or directed style of consultation in the decision making part of the general practice consultation.DesignStructured interview, with video vignettes of acted consultations.Setting5 practices in Lothian, Scotland.Participants410 patients (adults and adults accompanying children) attending surgery appointments.ResultsPatients varied in their preference for involvement in decision making in the consultation. Under multiple regression analysis, patients'' preference was found to be independently predicted by the problem viewed (patients presented with physical problems preferred a directed approach), patients'' age (patients aged 61 or older were more likely to prefer the directed approach), social class (social classes I and II were more likely to prefer the shared approach), and smoking status (smokers more likely to prefer the shared approach). Those patients who were able to answer (or who thought their doctor''s style similar to those in the vignettes) were more likely to describe their own doctor''s style as similar to their preferred style. No major association in preference was found with sex, frequency of attendance, or perceived chronic ill health.ConclusionPatients may vary in their desire for involvement in decision making in consultations. Although this variation seems to depend on the presenting problem, age, social class, and smoking status, these associations are not absolute, with large minorities in each group. Doctors need the skills, knowledge of their patients, and the time to determine on which occasions, with which illnesses, and at which level their patients wish to be involved in decision making.     

Assessing the consultation: methods of observing trainees in general practice.

We compared two different methods of observing trainees at work in general practice: the traditional one of a senior or training general practitioner sitting in during selected surgeries and the more modern video recording, with the patients'' written consent. Patients who had experienced the presence of a second doctor during the consultation were less likely to show an increase in arousal after their consultations than those who had been recorded on video. Patients who refused consent to be recorded were more highly stressed than those who agreed and showed smaller decreases in stress after consultations. The presence of two doctors generated fewer reductions in stress after the consultation than video recording did, but this was a non-significant trend. The group that was recorded on video did not differ appreciably from a control group in changes in stress or arousal.     

The unmet need for interpreting provision in UK primary care

Background

With increasing globalisation, the challenges of providing accessible and safe healthcare to all are great. Studies show that there are substantial numbers of people who are not fluent in English to a level where they can make best use of health services. We examined how health professionals manage language barriers in a consultation.

Methods and Findings

This was a cross-sectional study in 41 UK general practices . Health professionals completed a proforma for a randomly allocated consultation session.Seventy-seven (63%) practitioners responded, from 41(59%) practices. From 1008 consultations, 555 involved patients who did not have English as a first language; 710 took place in English; 222 were in other languages, the practitioner either communicating with the patient in their own language/using an alternative language. Seven consultations were in a mixture of English/patient''s own language. Patients'' first languages numbered 37 (apart from English), in contrast to health practitioners, who declared at least a basic level of proficiency in 22 languages other than English. The practitioner''s reported proficiency in the language used was at a basic level in 24 consultations, whereas in 21, they reported having no proficiency at all. In 57 consultations, a relative/friend interpreted and in 6, a bilingual member of staff/community worker was used. Only in 6 cases was a professional interpreter booked. The main limitation was that only one random session was selected and assessment of patient/professional fluency in English was subjective.

Conclusions

It would appear that professional interpreters are under-used in relation to the need for them, with bilingual staff/family and friends being used commonly. In many cases where the patient spoke little/no English, the practitioner consulted in the patient''s language but this approach was also used where reported practitioner proficiency was low. Further research in different setting is needed to substantiate these findings.     

Needs for care from a demand led community psychiatric service: a study of patients with major mental illness.

OBJECTIVE--To measure needs for care of patients aged 18-65 years with major mental illness. DESIGN. Identification of everyone in one area seen by a health professional within the previous five years because of a psychotic disorder. Interview of a one in three sample of patients and their main carers with the cardinal needs schedule. SETTING--Hamilton, a socially deprived district of Scotland. SUBJECTS--71 subjects were interviewed from the original sample of 263 patients. MAIN OUTCOME MEASURES--"Cardinal problems" in seven clinical and eight social areas of functioning; these are defined as problems requiring action. "Needs"-cardinal problems for which suitable interventions exist but have not been tried recently. RESULTS--High levels of morbidity were found. 30 interviewed patients (42%; 95% confidence interval 31% to 54%) had one or more clinical needs. 35 (49%; 38% to 61%) had one or more social needs. Skills to deal with all but seven needs in the sample were available at the time of investigation. Patients not being seen by the community mental health team were similar in severity and levels of need to those who were on the community team''s caseload. Care was unequivocally and severely inadequate for four patients. Shortcomings in service delivery usually arose from failure to monitor some patients at home. Problems were not due to shortage of acute psychiatric beds nor the absence of an elaborate assertive community care team. CONCLUSIONS--Systematic assessment of needs with research instruments can give valuable insights into the successes and failures of community care of people with major mental illness. Most needs could be dealt with in these patients but in our area (and probably most other parts of the United Kingdom) this would entail diversion of resources from people with less severe disorders.     

Assessment of psychological care in general practice.

OBJECTIVE--To pilot a method of assessing psychological care by general practitioners. DESIGN--Prospective examination of psychological care given in general practice by using general health questionnaire with predetermined quantifiable and case specific indices of outcome established at the original consultation. SETTING--Rural general practice in Clwyd, North Wales. SUBJECTS--447 consecutive adult general practice attenders. MAIN OUTCOME MEASURES--Three month follow up consultation rates, one year retrospective consultation rates, continuity of care, changes in general health questionnaire scores at follow up, general satisfaction, and acceptability of outcome measures. RESULTS--The principal and trainee identified 72 patients with psychological problems, 46 of whom had new conditions. 133 patients scored over 6 on the 28 item general health questionnaire, 33 of whom were identified as new cases by the general practitioners. 62 patients were seen at follow up, including 23 patients identified by the questionnaire but not by the doctor. The doctors used diagnostic terms to describe the presenting condition in 38 cases. At three month follow up the general health questionnaire scores had fallen by more than 5 points in 22/39 patients identified and managed by doctors and 11/23 identified by the questionnaire. The agreed index of good outcome was almost or completely achieved by 20 of the 39 patients managed by doctors. CONCLUSION--Quantifiable methods of evaluating the quality of the structure, process, and outcome of psychological care can be achieved in general practice.     

Evaluation of Early Diagnostic Services for the Elderly

Medical examination was offered to a group of “high risk” old people who were not necessarily patients or known to their family doctors, but with the agreement of these family doctors. Two clinics set up for this purpose have been running for several years, and the results of examination and follow-up of 300 consecutive patients are reported.Major conditions were found in two-thirds of patients producing functional impairment in most of these.Recommendations as to therapy and management were carried out in 161 of 194 patients but not in the remainder.Clear evidence of improvement was found in half of the patients who carried out recommendations, and this improvement was attributable to earlier diagnosis than would have been achieved without these clinics in 42% of cases.Including all patients examined, the proportion helped by early diagnosis at 18 to 30 months'' follow-up was 23%.It is concluded that the offer of a routine examination to high risk groups is of benefit to old people and a form of medical practice which should be widely adopted.     

Patients' assessment of out of hours care in general practice

A sample of 177 patients drawn from 13 north London practices were interviewed shortly after they had sought help from their practice outside normal surgery hours. Patients were asked to describe the process and outcome of their out of hours call, to comment on specific aspects of the consultation, and to access their overall satisfaction with the encounter.Parents seeking consultations for children were least satisfied with the consultation; those aged over 60 responded most positively. Visits from general practitioners were more acceptable than visits from deputising doctors for patients aged under 60, but for patients aged over 60 visits from general practitioners and deputising doctors were equally acceptable.Monitoring of patients'' views of out of hours consultations is feasible, and the findings of this study suggest that practices should regularly review the organisation of their out of hours care and discuss strategies for minimising conflict in out of hours calls—particularly those concerning children.     

Terminal cancer care and patients' preference for place of death: a prospective study.

OBJECTIVE--To assess the preference of terminally ill patients with cancer for their place of final care. DESIGN--Prospective study of randomly selected patients with cancer from hospital and the community who were expected to die within a year. Patients expected to live less than two months were interviewed at two week intervals; otherwise patients were interviewed monthly. Their main carer was interviewed three months after the patient''s death. SETTING--District general hospital, hospices, and patients'' homes. MAIN OUTCOME MEASURE--Stated preferred place of final care; actual place of death; reason for final hospital admission for those in hospital; community care provision required for home care. RESULTS--Of 98 patients approached, 84 (86%) agreed to be interviewed, of whom 70 (83%) died during the study and 59 (84%) stated a preferred place of final care: 34 (58%) wished to die at home given existing circumstances, 12 (20%) in hospital, 12 (20%) in a hospice, and one (2%) elsewhere. Their own home was the preferred place of care for 17 (94%) of the patients who died there, whereas of the 32 patients who died in hospital 22 (69%) had stated a preference to die elsewhere. Had circumstances been more favourable 67% (41) of patients would have preferred to die at home, 16% (10) in hospital, and 15% (9) in hospice. CONCLUSION--With a limited increase in community care 50% more patients with cancer could be supported to die at home, as they and their carers would prefer.     

Decision making by general practitioners in diagnosis and management of lower urinary tract symptoms in women.

OBJECTIVE--To identify factors influencing decision making by general practitioners in the diagnosis and treatment of lower urinary tract symptoms in women. SETTING--Two suburban London general practices. SUBJECTS--Women presenting to their family doctor with lower urinary tract symptoms. DESIGN--After each consultation the doctor completed a questionnaire on presenting symptoms; clinical examination; investigations undertaken; presence of psychological, social, and menstrual problems; patients'' requests for antibiotics; antibiotic prescribing; knowledge of the patient; attitude towards the consultation; and any other factors assisting in diagnosis and management. Finally, doctors predicted the presence or absence of clinically important bacteriuria. Each woman completed a demographic questionnaire, the 12 item general health questionnaire, and the modified menstrual distress questionnaire, after which each provided a clean catch midstream urine sample. Case notes were examined for information on previous reports of results of urine analysis. RESULTS--When the general practitioners did not know the patients well they were 4.5 times more likely to assume that there was a clinically important infection. When they knew the patient well, they were four times more likely to make a correct prediction of the test result and 12 times less likely to prescribe antibiotics. Doctors were five times more likely to predict the test result correctly in patients from social classes 1 and 2 and were six times more likely to prescribe antibiotics for the older women in the sample. CONCLUSIONS--In women presenting with urinary tract symptoms, these family practitioners seemed to take no particular regard of physical, psychological, or menstrual factors in making their assessments. They were most accurate in their prediction of the result of urine analysis and least likely to prescribe antibiotics when they had a good general knowledge of the patient. Which came first, the diagnosis or prescribing, is difficult to say and probably differed in individual cases. Doctors tended to be more conservative in their management of older women and those whom they knew less well.     

Effect of Supervised Students' Involvement on Diagnostic Accuracy in Hospitalized Medical Patients �� A Prospective Controlled Study

Background

During internships most medical students engage in history taking and physical examination during evaluation of hospitalized patients. However, the students'' ability for pattern recognition is not as developed as in medical experts and complete history taking is often not repeated by an expert, so important clues may be missed. On the other hand, students'' history taking is usually more extensive than experts'' history taking and medical students discuss their findings with a Supervisor. Thus the effect of student involvement on diagnostic accuracy is unclear. We therefore compared the diagnostic accuracy for patients in the medical emergency department with and without student involvement in the evaluation process.

Methodology/Principal Findings

Patients in the medical emergency department were assigned to evaluation by either a supervised medical student or an emergency department physician. We only included patients who were admitted to our hospital and subsequently cared for by another medical team on the ward. We compared the working diagnosis from the emergency department with the discharge diagnosis. A total of 310 patients included in the study were cared for by 41 medical students and 21 emergency department physicians. The working diagnosis was changed in 22% of the patients evaluated by physicians evaluation and in 10% of the patients evaluated by supervised medical students (p = .006). There was no difference in the expenditures for diagnostic procedures, length of stay in the emergency department or patient comorbidity complexity level.

Conclusion/Significance

Involvement of closely supervised medical students in the evaluation process of hospitalized medical patients leads to an improved diagnostic accuracy compared to evaluation by an emergency department physician alone.     

Traumatic vasospastic disease in chain-saw operators.

Raynaud''s phenomenon is commonly induced in chain-saw operators by vibration; the hand guiding the tool is the more severely affected. The condition tends to persist after use of the chain-saw is stopped but compensation is rarely sought. Among 17 cases of Raynaud''s phenomenon in lumberjacks the condition was found to be related to use of the chain-saw in 14, 10 of whom had to give up their work in colder weather because the disease was so disabling. Two criteria essential to establish the condition as vibration-induced Raynaud''s phenomenon are the presence of symptoms for at least 2 years and a history of at least 1 year''s constant use of the chain-saw. Careful physical examination and simple tests of vascular function will provide objective evidence of permanent damage by which the patients may be classified and compensated.     

General practice consultations: is there any point in being positive?

A group of 200 patients who presented in general practice with symptoms but no abnormal physical signs and in whom no definite diagnosis was made were randomly selected for one of four consultations: a consultation conducted in a "positive manner," with and without treatment, and a consultation conducted in a "non-positive manner," called a negative consultation, with and without treatment. Two weeks after consultation there was a significant difference in patient satisfaction between the positive and negative groups but not between the treated and untreated groups. Similarly, 64% of those receiving a positive consultation got better, compared with 39% of those who received a negative consultation (p = 0.001) and 53% of those treated got better compared with 50% of those not treated (p = 0.5).