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D J Torgerson

Publications and source records attributed to D J Torgerson.

At least 19 recordsLinked to original sources

Randomized trial of two physiotherapy interventions for primary care neck and back pain patients: 'McKenzie' vs brief physiotherapy pain management.

OBJECTIVES: Interventions that take psychosocial factors into account are recommended for patients with persistent back or neck pain. We compared the effectiveness of a brief physiotherapy pain management approach using cognitive-behavioural principles (Solution-Finding Approach-SFA) with a commonly used method of physical therapy (McKenzie Approach-McK). METHODS: Eligible patients referred by GPs to physiotherapy departments with neck or back pain lasting at least 2 weeks were randomized to McK (n= 161) or to SFA (n= 154). They were further randomized to receive an educational booklet or not. The primary outcome was the Tampa Scale of Kinesiophobia (TSK) (Activity-Avoidance scale used as a proxy for coping) at 6 weeks, and 6 and 12 months. RESULTS: Of 649 patients assessed for eligibility, 315 were recruited (219 with back pain, 96 with neck pain). There were no statistically significant differences in outcomes between the groups, except that at any time point SFA patients supported by a booklet reported less reliance on health professionals (Multidimensional Health Locus of Control Powerful Others Scale), while at 6 months McK patients showed slightly more improvement on activity-avoidance (TSK). At 6 weeks, patient satisfaction was greater for McK (median 90% compared with 70% for SFA). Both interventions resulted in modest but clinically important improvements over time on the Roland Disability Questionnaire Scores and Northwick Park Neck Pain Scores. CONCLUSIONS: The McK approach resulted in higher patient satisfaction overall but the SFA could be more cost-effective, as fewer (three vs four) sessions were needed.

Adaptation, Psychological↗

Patient acceptability of larval therapy for leg ulcer treatment: a randomised survey to inform the sample size calculation of a randomised trial.

BACKGROUND: A trial was commissioned to evaluate the effectiveness of larval therapy to debride and heal sloughy and necrotic venous leg ulcers. Larval therapy in the trial was to be delivered in either loose or bagged form. Researchers were concerned that resistance to larval therapy may threaten the feasibility of the trial. Additionally there was concern that the use of larval therapy may require a larger effect size in time to healing than originally proposed by the investigators. METHODS: To formally evaluate patient preferences a survey using two randomly allocated, nurse administered questionnaires was undertaken. Patients were randomised to receive one of the two following questionnaires (i) preferences between loose larvae and standard treatment (hydrogel) or (ii) patient preferences between bagged larvae and standard therapy (hydrogel). The study was undertaken in a Vascular Clinic, in an Outpatients Department of a large teaching hospital in the North of England. The sample consisted of 35 people aged 18 years and above with at least one leg ulcer of venous or mixed (venous and arterial) aetiology. RESULTS: Approximately 25% of participants would not consider the use of larval therapy as an acceptable treatment option for leg ulcers, regardless of the method of containment. For the patients that would consider the use of larval therapy, different preferences in healing times required to use the therapy were observed depending upon the method of containment. The median response of those participants questioned about bagged larvae found that they would be willing to use this therapy even if they were equally able to achieve healing with the use of hydrogel by 20 weeks. For those participants questioned about the use of loose larvae complete healing would have to have taken place over 17 weeks for them to choose larvae as their preferred option rather than hydrogel. This difference was not significant (p = 0.075). CONCLUSION: We found no evidence of widespread resistance to the utilisation of larval therapy from patients regardless of the method of larval therapy containment. These methods have the potential to inform sample size calculations where there are concerns of patient acceptability.

Aged↗

Cost-effectiveness analysis of open colposuspension versus laparoscopic colposuspension in the treatment of urodynamic stress incontinence.

OBJECTIVES: To compare the cost effectiveness of laparoscopic versus open colposuspension for the treatment of female urinary stress incontinence. DESIGN: Cost utility analysis alongside a randomised controlled trial. SETTING: Six gynaecological surgical centres within the UK. POPULATION/SAMPLE: Women with proven stress urinary incontinence requiring surgery. METHODS: Open abdominal retropubic colposuspension or laparoscopic colposuspension carried out by experienced surgeons. MAIN OUTCOME MEASURES: Cost, measured in pounds sterling and generic health-related quality of life, measured using the EQ-5D. The latter was used to estimate patient-specific quality-adjusted life years (QALYs). RESULTS: Healthcare resource use over 6-month follow up translated into costs of pound 1805 for the laparoscopic arm and pound 1433 for the open arm (differential mean cost pound 372; 95% credibility interval [CrI]: 274-471). At 6 months, QALYs were slightly higher in the laparoscopic arm relative to the open arm (0.005; 95% CrI: -0.012 to 0.023). Therefore, the cost of each extra QALY in the laparoscopic group (the incremental cost-effectiveness ratio [ICER]) was pound 74,400 at 6 months. At 24 months, the laparoscopic arm again had a higher mean QALY score compared to the open surgery group. Thus, assuming that beyond 6 months the laparoscopic colposuspension would not lead to any significant additional costs compared with open colposuspension, the ICER was reduced to pound 9300 at 24 months. Extensive sensitivity analyses were carried out to test assumptions made in the base case scenario. CONCLUSIONS: Laparoscopic colposuspension is not cost effective when compared with open colposuspension during the first 6 months following surgery, but it may be cost effective over 24 months.

Cost-Benefit Analysis↗

Pressure relieving support surfaces: a randomised evaluation.

OBJECTIVES: To determine differences between alternating pressure overlays and alternating pressure replacement mattresses with respect to the development of new pressure ulcers, healing of existing pressure ulcers, patient acceptability and cost-effectiveness of the different pressure-relieving surfaces. Also to investigate the specific additional impact of pressure ulcers on patients' well-being. DESIGN: A multicentre, randomised, controlled, open, fixed sample, parallel-group trial with equal randomisation was undertaken. The trial used remote, concealed allocation and intention-to-treat (ITT) analysis. The main trial design was supplemented with a qualitative study involving a purposive sample of 20-30 patients who developed pressure ulcers, to assess the impact of the pressure ulcers on their well-being. In addition, a focus group interview was carried out with clinical research nurses, who participated in the PRESSURE (Pressure RElieving Support SUrfaces: a Randomised Evaluation) Trial, to explore the experiences of their role and observations of pressure area care. SETTING: The study took place in 11 hospital-based research centres within six NHS trusts in England. PARTICIPANTS: Acute and elective patients aged 55 years or older and admitted to vascular, orthopaedic, medical or care of the elderly wards in the previous 24 hours were investigated. INTERVENTIONS: Patients were randomised to either an alternating pressure overlay or an alternating pressure mattress replacement, with mattress specifications clearly defined to enable the inclusion of centres using products from different manufacturers, and to exclude hybrid mattress systems (which either combine foam or constant low pressure with alternating pressure in one mattress, or can be used as either an overlay or a replacement mattress). MAIN OUTCOME MEASURES: Development of a new pressure ulcer (grade < or =2, i.e. partial-thickness wound involving epidermis/dermis only) on any skin site. Also healing of existing pressures ulcers, patient acceptability and cost-effectiveness. RESULTS: In total, 6155 patients were assessed for eligibility to the trial and 1972 were randomised: 990 to the alternating pressure overlay (989 after one postrandomisation exclusion) and 982 to the alternating pressure mattress replacement. ITT analysis found no statistically significant difference in the proportions of patients developing a new pressure ulcer of grade 2 or above [10.7% overlay patients, 10.3% mattress replacement patients, a difference of 0.4%, 95% confidence interval (CI) -2.3 to 3.1%, p = 0.75]. When logistic regression analysis was used to adjust for minimisation factors and prespecified baseline covariates, there was no difference between the mattresses with respect to the odds of ulceration (odds ratio 0.94, 95% CI 0.68 to 1.29). There was no evidence of a difference between the mattress groups with respect to time to healing (p = 0.86). The Kaplan-Meier estimate of the median time to healing was 20 days for each intervention. More patients allocated overlays requested mattress changes due to dissatisfaction (23.3%) than mattress replacement patients (18.9%, p = 0.02) and more than one-third of patients reporting difficulties associated with movement in bed and getting into or out of bed. There is a higher probability (64%) that alternating mattress replacements are cost-saving; they were associated with lower overall costs (74.50 pounds sterling per patient on average, mainly due to reduced length of stay) and greater benefits (a delay in time to ulceration of 10.64 days on average). Patients' accounts highlighted that the development of a pressure ulcer could be pivotal in the trajectory from illness to recovery, by preventing full recovery or causing varied impacts on their quality of life. CONCLUSIONS: There is no difference between alternating pressure mattress replacements and overlays in terms of the proportion of patients developing new pressure ulcers; however, alternating pressure mattress replacements are more likely to be cost-saving. The results suggest that when renewing alternating pressure surfaces or ordering equipment within a rental contract, mattress replacements should be specified; however, overlays are acceptable if no replacement mattress is available. Similarly, patient preferences can be supported, without any great increase in risk, if individual patients request an overlay rather than a replacement mattress. Further research could include a randomised controlled trial comparing alternating pressure mattress replacements and high-specification foam mattresses in patients at moderate to high risk; an accurate costing study to understand better how much pressure ulcers cost health and social services in the UK; and trials in higher risk groups of patients. Also future trials should measure time to ulceration as the primary end-point, since this is more informative economically and possibly also from a patient and clinical perspective.

Bedding and Linens↗

The use of unequal randomisation ratios in clinical trials: a review.

OBJECTIVE: To examine reasons given for the use of unequal randomisation in randomised controlled trials (RCTs). MAIN MEASURES: Setting of the trial; intervention being tested; randomisation ratio; sample size calculation; reason given for randomisation. METHODS: Review of trials using unequal randomisation. DATABASES AND SOURCES: Cochrane library, Medline, Pub Med and Science Citation Index. RESULTS: A total of 65 trials were identified; 56 were two-armed trials and nine trials had more than two arms. Of the two-arm trials, 50 trials recruited patients in favour of the experimental group. Various reasons for the use of unequal randomisation were given. Six studies stated that they used unequal randomisation to reduce the cost of the trial, with one screening trial limited by the availability of the intervention. Other reasons for using unequal allocation were: avoiding loss of power from drop-out or cross-over, ethics and the gaining of additional information on the treatment. Thirty seven trials papers (57%) did not state why they had used unequal randomisation and only 14 trials (22%) appeared to have taken the unequal randomisation into account in their sample size calculation. CONCLUSION: Although unequal randomisation offers a number of advantages to trials the method is rarely used and is especially under-utilised to reduce trial costs. Unequal randomisation should be considered more in trial design especially where there are large differences between treatment costs.

Humans↗

Screening elderly women for risk of future fractures--participation rates and impact on incidence of falls and fractures.

We have assessed the acceptability of a method for screening for risk of future hip fracture in elderly women. After receipt of an initial response to a mailed risk-factor questionnaire sent out to 5,306 women, women were randomly assigned to active or control groups. The active group was invited to participate in a screening visit that comprised a life-style questionnaire and a quantitative ultrasound heel scan. General practitioners (GPs) of women who were found to be in the lowest quartile of broadband ultrasound attenuation and/or who had two or more risk factors for hip fracture were advised to prescribe a calcium and vitamin D supplement. A second mailed questionnaire was sent to both groups 1 to 3 years later. Compared with the control group, the active group had a 56% lower risk of fracture (odds ratio [OR], 0.44; 95% confidence interval [CI], 0.24-0.81 adjusted age, weight, and treatment status). At follow-up, the proportion of fallers in the active group (25.3%) was lower than that in the control group (29.6%) (P = 0.064). The control group was found to have a higher rate of falls at follow-up than the active group (95% CI, 0.02-0.22); no difference was found at baseline (95% CI, -0.08 to +0.14). The screening method used was found to be acceptable to the majority of elderly women in this study. Screening the elderly in this way together with simple advice on treatment appears to reduce the age-associated increase in fall rates and the number of subsequent fractures. This form of screening may provide a cost-effective method to reduce falls and fractures in free-living elderly women. However, no such cost-effectiveness analysis has been performed to date.

Accidental Falls↗

Axial BMD, change in BMD and bone turnover do not predict breast cancer incidence in early postmenopausal women.

Previous studies have indicated a relationship between bone mineral density and the incidence of breast cancer in middle-aged and elderly women, with women with higher BMD being at significant increased risk. We investigated whether there was such a relationship in younger women who were perimenopausal or in their early postmenopausal years. As part of a population-screening program for osteoporosis, 5,119 women aged between 45 and 54 years were scanned between 1990-1994 at the Osteoporosis Research Unit. In 1997-2001, 3,884 returned for follow-up scans and questionnaires, and 3,144 returned a postal questionnaire in 2002. All cases of incident breast cancer were noted. One hundred sixty-six women indicated that they had suffered from breast cancer, of which 87 were incident cases (59 had prevalent breast cancer at baseline and 20 had benign or unconfirmed diagnosis and were excluded because of the use of agents that may interfere with BMD, e.g., tamoxifen). We compared therefore the incident breast cancer group (BC group; n=87) with a control group (C group; n=3,013). There were no significant differences using a t-test between the BC group and C group for baseline DXA of the spine or femoral neck. Further changes in BMD over a mean period of 6.9 years demonstrated no significant hazard ratio for the lumbar spine or femoral neck. No relationship was seen between the bone turnover markers pyridinoline/creatinine or deoxypyridinoline/creatinine assessed at their second study visit and incidence of breast cancer. In conclusion, in perimenopausal or early postmenopausal women there is no relationship between the incidence of breast cancer and BMD, change in BMD or bone turnover.

Biomarkers↗

Randomized clinical trial of four-layer and short-stretch compression bandages for venous leg ulcers (VenUS I).

BACKGROUND: A randomized clinical trial was undertaken to determine the relative effectiveness of four-layer and short-stretch bandaging for venous ulceration. METHODS: A total of 387 adults with a venous ulcer, who were receiving leg ulcer treatment either in primary care or as a hospital outpatient, were recruited to this parallel-group open study and randomized to either four-layer or short-stretch bandages. Follow-up continued until the patient's reference leg was ulcer free or for a minimum of 12 months. The primary endpoint was time to complete healing of all ulcers on the reference leg. Secondary outcomes included proportion of ulcers healed, health-related quality of life, withdrawals and adverse events. Analysis was by intention to treat. RESULTS: Unadjusted analysis identified no statistically significant difference in median time to healing: 92 days for four-layer and 126 days for short-stretch bandages. However, when prognostic factors were included in a Cox proportional hazards regression model, ulcers treated with the short-stretch bandage had a lower probability of healing than those treated with the four-layer bandage: hazard ratio 0.72 (95 per cent confidence interval 0.57 to 0.91). More adverse events and withdrawals were reported with the short-stretch bandage. CONCLUSION: Venous leg ulcers treated using a four-layer bandage healed more quickly than those treated with a short-stretch bandage.

Adult↗

Economic analysis of VenUS I, a randomized trial of two bandages for treating venous leg ulcers.

BACKGROUND: The study investigated the cost-effectiveness of four-layer and short-stretch compression bandages for treating venous leg ulcers. METHODS: Cost-effectiveness and cost-utility analyses were performed using patient-level data collected alongside the VenUS I leg ulcer study. The perspective for the economic analysis was that of the UK National Health Service (NHS) and Personal Social Service. The time horizon for the analysis was 1 year after recruitment. Health benefit was measured as differences in ulcer-free days and quality-adjusted life years (QALYs). RESULTS: The mean healing time for ulcers treated with four-layer bandages was 10.9 (95 per cent confidence interval (c.i.) -6.8 to 29.1) days less than that for ulcers treated with short-stretch bandages. Mean average difference in QALYs between compression systems was -0.02 (95 per cent c.i. -0.08 to 0.04). The four-layer bandage cost a mean of pound 227.32 (95 per cent c.i. pound 16.53 to pound 448 .30) less per patient per year than the short-stretch bandage. CONCLUSION: On average, four-layer bandaging was associated with greater health benefits and lower costs than short-stretch bandaging.

Adult↗

Risk factors for fracture in a UK population: a prospective cohort study.

BACKGROUND: Common clinical risk factors for fracture in older women have been identified. To date, most of these risk factors have not been confirmed in a UK population. AIM: To confirm the important risk factors for fracture in older women. DESIGN: Comprehensive cohort study (CCS) with a nested randomized controlled trial. METHODS: The CCS included 4292 women aged >70 years. We assessed potential risk factors for fracture, and followed-up participants for 24 months for incidence of non-vertebral fractures. RESULTS: Odds ratios (ORs) for predicting any non-vertebral fracture were: previous fracture, 2.67 (95%CI 2.10-3.40); a fall in the last 12 months, 2.06 (95%CI 1.63-2.59); and age (per year increase), 1.03 (95%CI 1.01-1.05). ORs for predicting hip fracture were: previous fracture, 2.31 (95%CI 1.31-4.08); low body weight (<58 kg), 2.20 (95%CI 1.28-3.77); maternal history of hip fracture, 1.68 (95%CI 0.85-3.31); a fall in the last 12 months, 2.92 (95%CI 1.70-5.01); and age (per year increase), 1.09 (95%CI 1.04-1.13). ORs for predicting wrist fracture were: previous fracture, 2.29 (95%CI 1.56-3.34); and a fall in the last 12 months, 1.60 (95%CI 1.10-2.31). Being a current smoker was not associated with an increase in risk, and was consistent across all fracture types. DISCUSSION: Older women with the clinical risk factors identified in this study should be investigated for osteoporosis or offered preventive treatment.

Accidental Falls↗

Pharmaceutical treatment of symptomatic vertebral fractures in primary care.

BACKGROUND: Vertebral fractures are associated with a reduction in quality of life and are an important predictor of other non-spine fractures. Previous work has shown that up to 60% of patients with a vertebral fracture identified in primary care remain untreated. OBJECTIVE: To examine the prevalence of pharmaceutical treatment and predictors of treatment in a primary care setting. METHODS: Case-control study using the general practice research database (GPRD). All women aged 50 years and over with a first diagnosis of a vertebral fracture since 1990 were identified and matched with a control by age and practice. Appropriate use of a pharmaceutical agent was defined as a prescription occurring within 30 days of the diagnosis being recorded. RESULTS: We identified 2719 women with the same number of controls. Within 30 days of diagnosis 61% of women were prescribed treatment, compared with only 3% of the controls. Bisphosphonate was the single most important treatment prescribed. Predictors of any drug treatment included: year of fracture (most recent year increased the likelihood of treatment); age (younger patients were more likely to receive treatment); history of back pain; low body weight; history of steroid use. CONCLUSIONS: Treatment of diagnosed vertebral fractures is becoming more common. Treated patients tend to be younger but to have a higher prevalence of clinical risk factors than untreated patients. There remain significant numbers of patients who are not offered treatment.

Age Factors↗

VenUS I: a randomised controlled trial of two types of bandage for treating venous leg ulcers.

OBJECTIVES: To compare the clinical and cost-effectiveness of two different compression bandages for the healing of venous leg ulcers. DESIGN: A pragmatic, randomised controlled trial with an economic evaluation. SETTING: Community, district nurse-led services; community leg ulcer clinics; hospital leg ulcer clinics with community outreach. A range of urban and rural settings in England and Scotland. PARTICIPANTS: Patients with a venous leg ulcer of at least 1-week's duration, at least 1 cm in length or width and an ankle:brachial pressure index of at least 0.8. INTERVENTIONS: The four-layer bandage (4LB) (which is multilayer elastic compression) compared with the short-stretch bandage (SSB) (multilayer, inelastic compression). MAIN OUTCOME MEASURES: The primary end-point was complete healing of all the ulcers on the trial leg. Secondary outcomes were the proportion of patients healed at 12 and 24 weeks, rate of recurrence, costs of leg ulcer treatment and quality of life. RESULTS: Between April 1999 and December 2000 the trial recruited 387 people aged from 23 to 97 years at trial entry. The majority of patients in this trial (82%; 316/387) had a reference ulcer of area </=10 cm(2). To test the difference over time of Kaplan--Meier curves for the two bandage groups, the distribution of the cumulative times to healing of individuals in the two trial groups was compared using the log-rank test. The difference in the distribution of cumulative healing times between the individuals in the two groups was not statistically significant at the 5% level. Adjusting for the effects of variables which may influence healing (centre, baseline ulcer area, duration, episodes, ankle mobility, weight) in a Cox proportional hazards model, a statistically significant treatment effect in favour of the 4LB was identified. At any point in time, the probability of healing for individuals in the SSB treatment arm is significantly lower than that for people treated with the 4LB. Our base case economic analysis showed that the 4LB is the dominant strategy, that is, it is associated with a greater health benefit and lower costs than the SSB, although the differences are not statistically significant. This result is explained largely by the greater number of community nurse visits required by participants in the short-stretch arm. CONCLUSIONS: The 4LB, which is currently the UK standard compression bandage for people with venous leg ulcers, was more clinically and cost-effective than the SSB. The bandage costs were less important than the costs of treatment visits, and patients in SSBs required more treatment overall. Generally, this trial supports the use of the 4LB in preference to the SSB. Recommendations for future research include: exploration of the relationship between bandager skill, application technique and ulcer healing; the relative cost-effectiveness of community leg ulcer clinics; and the study of nurse decision-making in venous ulcer management.

Adult↗

Oral treatments for fungal infections of the skin of the foot.

BACKGROUND: About 15% of the population have fungal infections of the feet (tinea pedis or athlete's foot). Whilst there are many clinical presentations of tinea pedis the most common are between the toes (interdigital) and on the soles, heels and sides of the foot (plantar) which is known as moccasin foot. Once acquired the infection can spread to other sites including the nails, which can be a source of reinfection. Oral therapy is usually used for chronic conditions or when topical treatment has failed. OBJECTIVES: To assess the effects and costs of oral treatments for fungal infections of the skin of the foot (tinea pedis). SEARCH STRATEGY: Randomised controlled trials were identified from MEDLINE, EMBASE and CINAHL from the beginning of these databases to January 2000. We also searched the Cochrane Controlled trials Register (Cochrane Library issue 1, 2000) the Science Citation Index, BIOSIS, CAB-Health, Health star and Economic databases. Bibliographies were searched, podiatry journals hand searched and the pharmaceutical industry and schools of podiatry contacted. SELECTION CRITERIA: Randomised controlled trials including participants who have a clinically diagnosed tinea pedis, confirmed by microscopy and growth of dermatophytes in culture. DATA COLLECTION AND ANALYSIS: Study selection was done by two independent reviewers. Methodological quality assessment and data collection was also assessed by two independent reviewers. MAIN RESULTS: Twelve trials, involving 700 participants, were included. The two trials comparing terbinafine and griseofulvin produced a pooled risk difference of 52% (95% confidence intervals 33% to 71%) in favour of terbinafine's ability to cure infection. No significant difference was detected between terbinafine and itraconazole; fluconazole and either itraconazole and ketoconazole; or between griseofulvin and ketoconazole, although the trials were generally small. Two trials showed that terbinafine and itraconazole were effective compared with placebo. Adverse effects were reported for all drugs, with gastrointestinal effects most commonly reported. REVIEWER'S CONCLUSIONS: The evidence suggests that terbinafine is more effective than griseofulvin and that terbinafine and itraconazole are more effective than no treatment.

Administration, Oral↗

Cost-effectiveness of hormone replacement therapy for fracture prevention in young postmenopausal women: an economic analysis based on a prospective cohort study.

A recent systematic review of randomized controlled trials has shown that hormone replacement therapy (HRT) prevents fractures when taken soon after the menopause. HRT for treatment of menopausal symptoms is relatively cost-effective, but whether its use for prevention of perimenopausal fractures is economically efficient is unknown. We undertook a 6-year follow-up of 3645 perimenopausal women who had a bone mineral density (BMD) measurement with recommendation to use HRT if low BMD was present. Data were collected on incident fractures and costs. After an average of 6.2 years of follow-up HRT use significantly reduced incident fractures by 52% (95% CI: 67% to 18%). However, costs were increased by an average of pounds sterling 275 (95% CI: pounds sterling 228 to pounds sterling 330) for the group as a whole; for hysterectomized women costs were increased less (pounds sterling 138), but this was still significantly greater than for non-HRT users (95% CI: pounds sterling 6 to pounds sterling 275). The cost per averted fracture was about pounds sterling 11 000 (95% CI: pounds sterling 8625 to pounds sterling 13 872) for the whole group and for hysterectomized women the corresponding figure was substantially less (pounds sterling 1784; 95% CI: pounds sterling 59 to pounds sterling 3532). HRT given to women at or shortly after the menopause is therefore associated with a halving of fracture incidence. Such a policy for hysterectomized women without menopausal symptoms may be cost-effective as such women are at elevated risk of fracture and need cheaper, unopposed, estrogens.

Bone Density↗

The cost utility of bisphosphonate treatment in established osteoporosis.

BACKGROUND: Hip fracture is an important and costly problem. Bisphosphonate therapy prevents hip and other fractures among women with established osteoporosis, but there are few published economic evaluations of this treatment. AIM: To assess the cost-effectiveness of risedronate, a recently launched bisphosphonate for the prevention of fractures among women with established osteoporosis. METHODS: A state transition Markov model of established post-menopausal osteoporosis based upon randomized clinical trial data was developed. Uncertainty underlying model parameters and outcomes was dealt with using traditional sensitivity analysis and stochastic sensitivity analysis to produce quasi-95%CIs. We focussed on patients aged approximately 75 years, since this population most closely matches the randomized controlled trial, and is typical of osteoporosis patients in the UK. RESULTS: The baseline model of treating a cohort of 1000 75-year-old women for 3 years with risedronate and then modelling the costs and benefits over their expected lifetimes, produced net savings of pound sterling 786 000 for the treatment group per 1000 treated women, (95%CI pound sterling 1.55m savings to pound sterling 47000 extra costs). Restricting the horizon of the analysis to only three years led to a small net cost of pound sterling 138 000 per 1000 treated women (95%CI pound sterling 196 000 savings to pound sterling 477 000 extra costs) with a net increment in Quality Adjusted Life years (QALYs) of 16 per 1000 treated women. This resulted in a cost per QALY of pound sterling 8625 per treated woman. CONCLUSIONS: In this example, the use of risedronate therapy in 75-year-old women at high risk of hip fracture leads to an improvement in quality of life with possible cost savings. Restricting the analysis to a time horizon of only three years leads to a QALY gain at a modest net cost.

Aged↗

Hormone replacement therapy and prevention of vertebral fractures: a meta-analysis of randomised trials.

BACKGROUND: Hormone replacement therapy (HRT) is often seen as the treatment of choice for preventing fractures in women. We undertook a recent meta-analysis of randomised trials which suggested that HRT reduced non-vertebral fractures by 30%. In this analysis we extend that analysis to vertebral fractures. METHODS: We searched the main electronic databases until the end of August 2001. We sought all randomised controlled trials (RCTs) of HRT where women had been randomised to at least 12 months of HRT or to no HRT. RESULTS: We found 13 RCTs. Overall there was a 33% reduction in vertebral fractures (95% confidence interval (CI) 45% to 98%). CONCLUSIONS: This review and meta-analysis showed a significant reduction in vertebral fractures associated with HRT use.

Journal Article↗