Halo and spillover effect illustrations for selected beneficial medical devices and drugs.

BACKGROUND: Negative news media reports regarding potential health hazards of implanted medical devices and pharmaceuticals can lead to a 'negative halo effect,' a phenomenon whereby judgments about a product or product type can be unconsciously altered even though the scientific support is tenuous. To determine how a 'negative halo effect' may impact the rates of use and/or explantation of medical products, we analyzed the occurrence of such an effect on three implanted medical devices and one drug: 1) intrauterine contraceptive devices (IUDs); 2) silicone gel-filled breast implants (SGBI); 3) metal-on-metal hip implants (MoM); and 4) the drug Tysabri. METHODS: Data on IUD use from 1965 to 2008 were gathered from the Department of Health and Human Services Vital and Health Statistics and peer-reviewed publications. Data regarding SGBI implant and explantation rates from 1989 to 2012 were obtained from the Institute of Medicine and the American Society of Plastic Surgeons. MoM implant and explantation data were extracted from the England and Wales National Joint Registry and peer-reviewed publications. Tysabri patient data were reported by Elan Corporation or Biogen Idec Inc. Data trends for all products were compared with historical recall or withdrawal events and discussed in the context of public perceptions following such events. RESULTS: We found that common factors altered public risk perceptions and patterns of continued use. First, a negative halo effect may be driven by continuing patient anxiety despite positive clinical outcomes. Second, negative reports about one product can spill over to affect the use of dissimilar products in the same category. Third, a negative halo effect on an entire category of medical devices can be sustained regardless of the scientific findings pertaining to safety. Fourth, recovery of a product's safety reputation and prevalent use may take decades in the U.S., even while these products may exhibit widespread use and good safety records in other countries. CONCLUSIONS: We conclude that the 'negative halo effect' associated with a stigma, rather than an objective risk-benefit assessment of medical products can increase negative health outcomes for patients due to reduced or inappropriate product usage.

Validation study of the Forgotten Joint Score-12 as a universal patient-reported outcome measure.

PURPOSE: The Forgotten Joint Score-12 (FJS-12) is for patients to forget their artificial joint and is reportedly a useful patient-reported outcome tool for artificial joints. The purpose of this study was to determine whether the FJS-12 is as useful as the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) or the Japanese Orthopaedic Association Hip Disease Evaluation Questionnaire (JHEQ) in Japan. METHODS: All patients who visited our hospital's hip joint specialists following unilateral THA from August 2013 to July 2014 were evaluated. Medical staff members other than physicians administered three questionnaires. Items evaluated were (1) the reliability of the FJS-12 and (2) correlations between the FJS-12 and the total and subscale scores of the WOMAC or JHEQ. RESULTS: Of 130 patients, 22 were excluded. Cronbach's α coefficient was 0.97 for the FJS-12. The FJS-12 showed a significantly lower score than the WOMAC or JHEQ (p < 0.01). The FJS-12 was moderately correlated with the total WOMAC score (r = 0.522) and its subscale scores for "stiffness" (r = 0.401) and "function" (r = 0.539) and was weakly correlated with the score for "pain" (r = 0.289). The FJS-12 was favorably correlated with the total JHEQ score (r = 0.686) and its subscale scores (r = 0.530-0.643). CONCLUSION: The FJS-12 was correlated with and showed reliability similar to that of the JHEQ and WOMAC. The FJS-12, which is not affected by culture or lifestyle, may be useful in Japan.

[Influence on the results of surgical treatment of osteoarthritis of the hip using anatomical stem ABG]. / Wplyw dostepu operacyjnego na wyniki leczenia choroby zwyrodnieniowej stawu biodrowego z zastosowaniem trzpienia anatomicznego ABG.

The aim of this study was to evaluate the clinical and radiological results of treatment and quality of life, and impact of surgical approach in patients after arthroplasty using anatomical stem ABG II in the Department of Orthopaedics and Trauma Regional Hospital. St. Luke in Tarnów of years 2008-2011. The material consisted of 68 patients operated using a Proxima stem (surgical approaches; anterolateral--34 cases, posterior lateral---34 cases similarly). The average age was 62.2 years. Patients stayed in the hospital an average of 8 days. Term follow-up was determined after 6 weeks, 3 months and then once a year. Postoperative results were evaluated using the scale: Harris and WOMAC NRS. X-rays were evaluated for setting and migration of the prosthesis components. In assessing patients with HHS to scale achieved 73.5% of very good and good. Compared to the pre-operative assessment resulted in a significant improvement in mobility of the hip after arthroplasty. According to the standardized WOMAC extended the average score of treatment was 77.0 points. During the study showed significant reduction in pain intensity after surgery. Average NRS score before surgery was 6.4 points and 1.4 points after surgery. In the material appropriate settings were 51 and 17 axial axis of the prosthesis. No effect on clinical outcomes set in the HHS and WOMAC scales. There was no effect on the results of surgical treatment.

Translation, cross-cultural adaption and validation of the French version of the Forgotten Joint Score in total hip arthroplasty.

INTRODUCTION: The ability to "forget" a joint implant in everyday life is considered to be the ultimate objective in arthroplasty. Recently, a scoring system, the Forgotten Joint Score (FJS-12), was published based on a self-administered questionnaire comprising 12 questions assessing how far patients had been able to forget their hip or knee prosthesis. The main objective of the present study was to translate, adapt and assess a French-language version of the FJS-12 in total hip arthroplasty (THA) patients. PATIENTS AND METHODS: The questionnaire was translated by 2 orthopedic surgeons and a medical physician, all bilingual, then back-translated into English by two native English-speaking translators unacquainted with the original. A concertation meeting adopted a beta-version of this Score de Hanche Oubliée (SHO-12), which was then tested on 15 randomly selected THA patients and adapted according to their comments. The final version was validated following the international COSMIN methodology. Data collection was prospective, included all patients operated on by a single surgeon using a single technique. Reference questionnaires comprised Oxford Hip Score (OHS-12) and modified Harris Hip Score (HHS). The 3 assessments were conducted with a minimum 1 year's follow-up. The SHO-12 was administered twice, with a 1-week interval. Statistical tests assessed construct validity (Pearson correlation test), internal coherence (Cronbach alpha), reliability (intraclass correlation coefficient) and feasibility (percentage missing values, administration time and ceiling and floor effects). RESULTS: Translation/back-translation encountered no particular linguistic problems. Fifty-eight patients (63 THAs) responded to all questionnaires: 22 female, 36 male; mean age, 62.7±15.2 years. Mean follow-up was 1.6±0.4 years. SHO-12 correlated strongly with OHS-12 and HHS. Internal coherence was good (alpha=0.96) and reproducibility excellent. No floor or ceiling effects were found. CONCLUSION: SHO-12, the French-language version of the FJS-12 in THA, is a valid, reproducible self-administered questionnaire, comparable to the English-language version. LEVEL OF EVIDENCE: I, Testing of previously developed diagnostic criteria on consecutive patients - Diagnostic study.

Comparison of Quality of Life of Patients after Hip Disarticulation and Those after Stump Lengthening with Modular Prosthesis.

BACKGROUND: Disarticulation has been used less and less often in the treatment of musculoskeletal neoplasms; however, in some cases it allows the patient to achieve good oncological and functional outcomes. The aim of this paper is to present the possibilities, surgical technique and treatment outcomes of patients after hip disarticulation and stump lengthening with a modular prosthesis. MATERIAL AND METHODS: Three classic hip disarticulation surgeries and 2 hip disarticulation procedures with stump lengthening with a modular prosthesis were performed at the Department of Oncological Orthopaedics in Brzozów in 2013 and 2014. The present paper discusses the indications, surgical technique and outcomes. Pain intensity was assessed in a VAS scale and physical function was measured with the Karnofsky scale. The mental status of the patients was analysed in the Beck Depression Inventory and the ability to perform daily living activities was evaluated according to Katz. The ability to walk after surgery was assessed. RESULTS: Patients after hip disarticulation showed considerably worse functional outcomes. The mean physical function score was 53 points in the Karnofsky scale and 3.33 points in the Katz scale. The patients had difficulty walking and did not ambulate with their prostheses. They reported problems with sitting and using the toilet. Patients with lengthened stumps showed visibly better physical function scores, achieving, on average, 65 points in the Karnofsky scale and 5.5 points in the Katz scale. These patients used their prostheses, ambulated efficiently and were independent. CONCLUSIONS: Stump lengthening with a modular prosthesis in patients after hip disarticulation results in significantly better outcomes than the classic procedure.

[Fear of falling in a fall clinic for geriatric patients: a pilot study]. / Angst voor vallen op een valpolikliniek geriatrie: een pilotstudy.

OBJECTIVE: In this pilot study we want to determine how often fear of falling occurs in geriatric patients visiting a fall clinic and to study the characteristics of fear of falling and its consequences. DESIGN: Retrospective study of patient's records. METHOD: A random sample of 100 medical records of geriatric patients of the fall clinic of the Jeroen Bosch Ziekenhuis in Den Bosch was systematical examined. RESULTS: The mean age of the patients was 79.8 +/- 6 years. Before visiting the fall clinic, the patients had a history of falling during 34.6 months, and 62% of them visited a hospital due to the consequences of falling. In the fall clinic a mean number of 2.5 probable causes per fall was diagnosed. In this study 31% of the patients had fear of falling. The demographic characteristics and the causes of falling of the patients with or without fear of falling, were almost the same. Patients with fear of falling had a hip prothesis in 26%, whereas patients without fear of falling only in 7% had a hip prothesis (P < 0.05). In patients with fear of falling, in 90% extra diagnostic investigation was needed, whereas in patients without fear of falling extra diagnostic investigation only occurred in 53% (P < 0.01). Finally, patients with fear of falling needed 1.8 more times physical therapy compared to patients without fear of falling (P < 0.01). CONCLUSION: After a fall, fear of falling occurs often in geriatric patients. In this study, no causes for fear of falling could be determinated, although hip prothesis are associated with fear of falling. In patients with fear of falling more medical consumption occurs. In medical practice as in science fear of falling needs more attention.

Influence of personality psychology on outcome of total hip arthroplasty: a cross-sectional study on 69 patients.

AIM: Patient's satisfaction after total hip arthroplasty is influenced by many surgical and rehabilitation aspects, but is not available in the literature, a study that analyses the correlation between patient's psychology and clinical results of this procedure. The aim of this study was to investigate the relationship between memory of pain, clinical outcome and subjective satisfaction with the Multidimensional Health Locus of Control. METHODS: We conducted a cross-sectional study on a cohort of 69 patients operated of total hip arthroplasty in our department from November 2008 to August 2011. Pre- and post-operative hip function was assessed by the Harris Hip Score. At the follow-up visit, patient satisfaction was assessed by means of the Patient Satisfaction Questionnaire. The memory of pain was evaluated by a modified questionnaire of pain experience. Multidimensional Health Locus of Control was evaluated in all patients, and results were connected with patient's subjective satisfaction and pain indexes. RESULTS: Patients were divided into two groups about patient satisfaction, those with GPS > 15 and those with GPS ≤ 15. Patients very satisfied showed a significantly higher mean value of IHLC. Regarding pain experience, patients were divided into two categories: those recalling less pain with OvP score ≤11 (Q1 < 3, avg. score Q2-Q4 ≤ 3) and those recalling more pain with OvP score >11. IHLC score resulted significantly higher in patients recalling less pain. DISCUSSION: Multidimensional Health Locus of Control can be considered a predictor of patient's satisfaction after an invasive surgical procedure as total hip arthroplasty.

The validity and reliability of a Total Hip Arthroplasty Outcome Evaluation Questionnaire.

The Société Internationale de Chirurgie Orthopédique et de Traumatologie (SICOT), the Task Force on Outcome Studies of The American Academy of Orthopaedic Surgeons, and The Hip Society reached a consensus on the nomenclature to be used for the evaluation of the results of total hip arthroplasty. The Task Force of The American Academy of Orthopaedic Surgeons, to assess the results of total hip arthroplasty from the perspective of the patient, subsequently developed a questionnaire that incorporated this nomenclature. The validity and reliability data regarding this questionnaire are reported in this study. Twenty-five patients participated in the reliability test. The non-response rate was five (0.5 per cent) of 941 possible responses. Test-retest reliability was determined by calculating the Spearman correlation coefficients for each question. The coefficients ranged from 0.41 to 1.0 over a mean test-retest interval of sixteen days. Most items had Spearman coefficients that were greater than 0.50, indicating good or excellent reliability. Validity was assessed, for the fifty-four patients who participated, by calculating the Spearman correlation coefficients for the items regarding pain in the affected hip, limitation of usual activities, capacity for walking without support, and the Sickness Impact Profile. The coefficients ranged from 0.11 (pain and limitation of activity) to 0.56 (Sickness Impact Profile and limitation of activity). These coefficients reflected modest associations, as anticipated, indicating that pain, function, and health status are related yet distinct concepts.(ABSTRACT TRUNCATED AT 250 WORDS)

Physiological and subjective stress responses in surgical patients.

Autonomic responses, mood and psychological coping were assessed in two groups of orthopaedic patients during hospitalisation for major or minor surgery. Eight patients admitted for total hip replacement and seven patients undergoing knee arthroscopy were seen daily for two days before surgery until discharged from hospital. Mood and coping questionnaires were administered on each session, while pain, heart rate, blood pressure, skin conductance level, palmar sweat prints and forearm EMG were also recorded. Heart rate increased from pre- to post-operative assessments, while skin conductance and palmar sweating fell to low levels on the days immediately following surgery, returning to basal values only after several days. Self ratings of anxiety, fatigue, depression and pain were highest on the immediate post-operative days. Patients utilised the coping factors Rational Cognition and Behavioural Action to the greatest extent, but ratings on coping factors fluctuated little over the study period. The interrelations between these measures and possible explanations of the results are discussed.

Prehospital education: effectiveness with total hip replacement surgery patients.

In-hospital education can reduce anxiety, improve coping and shorten hospital stays of surgical patients. However, hospitals are containing costs by shortening pre- and postoperative stays and reducing the time available for in-hospital teaching. This study evaluated prehospital education for total hip replacement (THR) surgery. Half of the patients waiting for admission for THR surgery were randomly selected to receive a THR education booklet in the mail 4-6 weeks before their scheduled THR surgery. Compared to the No-Booklet patients, patients who had received the booklet were less anxious at the time of hospital admission and at discharge, were more likely to have practised physiotherapy exercises prior to hospitalization, and required significantly less occupational therapy and physiotherapy while in hospital. There were no group differences for length of hospital stay.

Patient-perceived functional outcomes associated with elective hip and knee arthroplasties.

The purpose of this study was to determine the effect elective hip and knee arthroplasties had on functional activities of daily living and if the background variables of age, gender, and surgery location can be used to predict functional outcome after these types of surgeries. Data were collected from 43 subjects, 6 to 35 months after they had elective hip or knee arthroplasties. The subjects responded to a mail survey that defined before surgery and after recovery functioning in relation to 22 activities of daily living representing personal care, housework-yard work, and recreation-social activities. Approximately 65% of the subjects reported no change in their ability to perform the 22 surveyed activities. Psychosocial variables appeared to be significant determinants of function. When the selected background data were compared with surgery results, women performed significantly better than men (p less than .05), but age and surgery location were not significant variables affecting outcome.

Short-term recovery from hip and knee arthroplasty.

There are many studies of long-term recovery from major point arthroplasty, but little is known about the first days and weeks after operation. We measured function, emotional state and life evaluation before arthroplasty and at seven and 50 days after in a consecutive series of 40 hip and 23 knee replacements. Pain was relieved significantly at seven days after hip arthroplasty and even more at 50 days. In knee patients, pain relief was modest and was not apparent until 50 days. Functional ability was much improved by 50 days in hip patients, but hardly changed in knee patients. Positive mood and life satisfaction did not improve in either group. Our findings will help with more accurate information for patients before operation and also in judging the rate of recovery.

Total hip replacement in children with juvenile chronic arthritis.

The results of 75 total hip replacements in 42 children with juvenile chronic arthritis are reported after a mean follow-up of 5.4 years. Their ages ranged from 11 to nearly 17 years at operation and many had active disease. Severe pain and marked stiffness of the hips were limiting their independence. At least half of the children were still growing and continued to grow after operation. The patients were carefully selected and gratifying results were obtained, but pre-operative assessment and overall supervision by a rheumatologist are important. Technical difficulties related to the size and maldevelopment of the hip are discussed. There was no infection and the single case of loosening of a femoral component after nine years has been successfully revised.

Comparison of measures to assess outcomes in total hip replacement surgery.

OBJECTIVES: To compare the performance of a disease specific and a general health questionnaire in assessing changes resulting from total hip replacement. DESIGN: Two stage prospective study of patients undergoing total hip replacement surgery involving an assessment at a clinic before and six months after surgery. 60(32%) patients were followed up by post. SETTING: Outpatient departments at a specialist orthopaedic hospital and peripheral clinics within Oxfordshire. PATIENTS: 188 patients admitted for unilateral total hip replacement between February and mid-August 1994. MAIN MEASURES: Patients' self assessed scores with the 12 item Oxford hip score and SF-36 general health questionnaire together with surgeons' assessment with Charnley hip score obtained before and again at six months after surgery. RESULTS: 186 patients were followed up six months after total hip replacement; a subsample (n=60) by post. Of the 60 postal patients, 59(98.3%) fully completed the Oxford hip score compared with 44(73.3%) who fully completed the SF-36. For the followup sample as a whole, post operative changes in scores produced a large effect size of 2.75 on the Oxford hip score, compared with -1.89 physical function (SF-36), -2.13 pain (SF-36). With the exception of physical function and role (physical), postoperative SF-36 scores were shown to be similar to or better than those found by two population surveys on patients of comparable age. The responsiveness of a disease specific questionnaire, the Oxford hip score, and relevant sections of a general questionnaire, SF-36, were found to be similar as assessed by three different criteria. CONCLUSIONS: A disease specific questionnaire, the Oxford hip score, and a general state of health questionnaire, SF-36, performed similarly in assessing outcomes of total hip replacement except that the disease specific questionnaire resulted in a higher completion rate and greater responsiveness in some sections. On the other hand the general health questionnaire drew attention to broader problems of physical function not considered by the Oxford hip score. The health questionnaires examined here offer a valid and practical means of monitoring outcomes of hip replacement surgery.

The burden of waiting for hip and knee replacements in Ontario. Ontario Hip and Knee Replacement Project Team.

The objectives of this study were to assess the impact of major joint replacements in reducing pain and disability and to describe the burden of pain and disability that could be avoided by ordering the queues with respect to severity of disease. A secondary goal was to compare the uses of a general health status measure, the Short Form Health Survey (SF-36), and a disease-specific measure, the Western Ontario McMaster Osteoarthritis Index (WOMAC), for accomplishing the objectives. The results are based on interviews with 209 patients before and after they had surgery. Only 15.9% of the patients had surgery within 3 months' waiting time, 19.2% waited 4-6 months, 30.7% waited 7-9 months, and the remaining 34.1% waited a year or more. The waiting times were unrelated to the severity of pain or disability reported in the initial interview. Following surgery, there were large reductions in the WOMAC scores for pain, stiffness and difficulty in functioning. The SF-36 showed substantial improvements in relief from pain and in physical functioning, and reductions in role limitation due to physical problems, but not for scores related to mental health. The WOMAC scores were more responsive to the benefits of surgery than the SF-36 scores. Queuing systems keyed on burden of symptoms could reduce the burden of pain and disability suffered by patients awaiting surgery. The improvements from hip and knee replacements suggest that equitable access for these procedures should be a priority in Ontario.

Effect of preparatory information prior to elective total hip replacement on post-operative physical coping outcomes.

The aim of the study was to evaluate the effect of preparatory information on a patient's post-operative physical coping outcomes following a Total Hip Replacement (THR). The research design was quasi-experimental. Eighty-two healthy individuals, scheduled for an elective THR were used and selected using non-random techniques, and placed into one of two groups on an alternating basis. The subjects in the experimental group were given procedural, sensory and coping information relating to the whole surgical procedure of a THR. In addition, written information was provided for each experimental subject to support the verbal information. Subjects in the control group only received the advice and support that would routinely be given to THR patients by ward, medical and nursing staff. The study measured a number of physical outcomes using a "Physical Indicators of Coping Questionnaire" developed to measure physiological and physical outcomes post-operatively. In addition, a Linear Analogue Coping Scale was developed to assess a patient's personal perception of their overall coping ability with the THR. The study demonstrated that preparatory information, given pre-operatively, post-operatively and pre-discharge had positive effects on the physical recovery and coping outcomes measured. Subjects in the experimental group had significantly less post-operative intramuscular analgesia, mobilized sooner with a Zimmer frame and walking sticks and lastly, their length of stay was on average, 2 days less than the control group. The Linear Analogue Coping Scale demonstrated that patients in the experimental group did perceive they were coping more effectively post-operatively. Preparatory information of various types and in different forms appear to have positive effects on the ability of patients to cope with and recover physically from a THR in the immediate post-operative period.

Effects of an experimental program on post-hospital adjustment of early discharged patients.

This paper reports the results of a study evaluating the effects of an experimental program on post-hospital adjustment of early discharged patients after total hip arthroplasties. This experimental program consisted of patient teaching by means of a pamphlet and videotape, and regular home visits by a community health nurse. A significant difference was found between the experimental and control patients in perceived preparedness for discharge and post-hospital exercise compliance. The early discharged experimental patients demonstrated post-hospital objective and subjective functional capabilities equal to those of the control patients. This study is seen to have implications for nursing service and nursing education.

[Clinical results and perceived health among patients with hip prosthesis]. / Resultados clínicos y salud percibida de los pacientes intervenidos de prótesis total de cadera.

BACKGROUND: Assessment of total hip replacement has been performed without careful attention to the patients' perceived health. The objective of this study is to assess, in a standardized way, the benefit of hip replacement in terms of hip pain, mobility, and function and as an increase in general perceived health. And to quantify clinical complications of the procedure. PATIENTS AND METHODS: Observational study of a series of 131 consecutive patients of a tertiary hospital to whom two health questionnaires (one specific and the other generic) were administered before and one year after total hip replacement. The specific instrument, the Hip Pain and Function (HPF) scale, measures the functional capacity of the hip gathering information on pain, function and mobility. Scores for the HPF range from 0 (maximal limitation of functional capacity) to 85 (no limitation). The generic instrument used, the Nottingham Health Profile (NHP) measures perceived health and scores range from 0 (best health status) to 100 (worse). RESULTS: Mean age of patients was 63 years; ostheo-arthritis was the most frequent diagnosis (78%), with 42% of the patients with associated pathology. An improvement in both hip functional capacity and perceived general health was observed after one year. HPF scores increased from 26.6 at baseline to 69.9 (p < 0.001). Improvements was important and statistically significant in each of the three dimensions of the specific instrument: Pain, Function and Mobility. Overall score for the NHP changed from 50.9 (at baseline) to 18.1 (p < 0.001). Regression analysis showed only two variables associated with improvement: a higher improvement hip function for patients with no other joints affected; and a higher improvement of perceived health in patients over 70 years with cemented prosthesis, that had a worse initial perceived health status. CONCLUSION: Total hip replacement decreases pain and significantly improves hip mobility and function, as well as the general perceived health. The improvement of perceived health was higher in patients over 70 years.

The "total solution" for total hip replacement surgery.

Despite the great alleviation in suffering produced by total hip replacement surgery, some caution is indicated. Many of the patients who undergo surgery still present problems some time after the operation and for which there is no obvious or adequate medical or engineering explanation. It is therefore suggested that no report on such surgery is complete without regard for patients' expectations, patients' satisfaction and without common agreement by surgeons on what can be expected from the operation. This paper highlights the importance of patients' and surgeons' expectations and the need for all to be aware of the influence of such expectations. If also suggests that surgeons rely heavily on their own judgements as to what state patients should be in prior to surgery. If the solution for such a radical measure is to be total for the patient, then patients' feelings and judgements should also be considered.

Impact of total hip replacement on quality of life.

This retrospective, descriptive study was designed to investigate the impact of total hip replacement (THR) on the quality of life for those persons who have suffered from osteoarthritis of the hip. Forty six subjects from a population of clients of eight orthopaedic surgeons in a southeastern state agreed to participate in the study. Subjects were predominantly white, married females with varied age. The impact of having a THR was measured by the participant's perception of change in four areas: physiologic function, self-concept, role function, and interdependence. A modified version of the Arthritis Impact Measurement Scales (AIMS) was used to measure change. The results showed positive change in all four variables and in overall satisfaction with having a THR.