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Jenny L Donovan

Publications and source records attributed to Jenny L Donovan.

At least 19 recordsLinked to original sources
PubMed2006

A comparison of socio-demographic and psychological factors between patients consenting to randomisation and those selecting treatment (the ProtecT study).

BACKGROUND: Patient preferences for treatment can pose problems for the conduct of randomised controlled trials: patients with a preference may refuse participation and thereby potentially compromise external validity. Moreover, randomising patients with a preference may affect treatment efficacy and threaten internal validity. AIMS: This study compared baseline characteristics and short-term psychological outcomes of patients who selected their treatment and those who agreed to random allocation. METHODS: Men participating in the prostate testing for cancer and treatment (ProtecT) study and who were randomised to active monitoring (n=138) were compared with those who had refused randomisation and selected this management (n=180). Socio-demographic data were collected at baseline, and anxiety and depression data were collected at baseline and six month follow-up. Socio-demographic characteristics were compared across these two groups in univariable analyses, and then linear regression was used to compare levels of anxiety and depression at follow-up with adjustments for confounders. RESULTS: Participants who selected active monitoring were more affluent (based on occupation details) and had less anxiety at baseline than those who were randomised. There were no differences with respect to age and marital status. Levels of anxiety and depression at six months follow-up were similar across the two groups of men. CONCLUSIONS: This study found some differences at baseline between the socio-demographic and psychological status of those randomised and self-selecting treatment, but no psychological differences at short-term follow-up. Further empirical evidence is required to assess whether preferences impact upon the process and outcome of randomised controlled trials.

Aged↗
PubMed2006

Satisfaction with care: an independent outcome measure in surgical oncology.

BACKGROUND: Outcomes for treatment for upper gastrointestinal cancer traditionally include procedure-related morbidity and mortality and long-term survival. Patient-reported outcomes, such as quality of life (QOL) and satisfaction measures, add to standard end points, but associations between these factors are not fully understood. This study examined how patient satisfaction related to surgical morbidity, treatment type, and QOL outcomes after inpatient treatment for upper gastrointestinal cancer. METHODS: Consecutive patients who had completed treatment in one unit were invited to participate in this study and complete the European Organization for Research and Treatment of Cancer QLQ-PATSAT32 and QLQ-C30 questionnaires within 2 months of discharge. Regression analyses examined relationships between satisfaction and surgical morbidity (major complications and type of treatment) and between satisfaction and QOL variables, adjusting for age and sex. RESULTS: During the study, 181 patients were treated, 162 were eligible, and 139 returned both questionnaires (response rate, 86%). Of the study sample, the treatment outcome was potential cure in 105 (67 esophagectomy and 38 D2 gastrectomy), and 34 received palliative treatment. Thirty-seven patients (27%) had major complications. Patients who received palliative treatment reported satisfaction and QOL scores similar to those of patients who received curative treatment. However, patients who experienced major morbidity reported significantly worse QOL than those without morbidity (P<.01). Satisfaction scores were the same in patients with or without complications. There were no associations between satisfaction and QOL scores (r<.34). CONCLUSIONS: Patient satisfaction with hospital care is independent of morbidity, treatment type, and QOL outcomes. It may be used to feed back information to providers of health care to improve patients' experiences of treatment.

Adult↗
PubMed2006

Impact of Helicobacter pylori eradication on dyspepsia, health resource use, and quality of life in the Bristol helicobacter project: randomised controlled trial.

OBJECTIVE: To determine the impact of a community based Helicobacter pylori screening and eradication programme on the incidence of dyspepsia, resource use, and quality of life, including a cost consequences analysis. DESIGN: H pylori screening programme followed by randomised placebo controlled trial of eradication. SETTING: Seven general practices in southwest England. PARTICIPANTS: 10,537 unselected people aged 20-59 years were screened for H pylori infection (13C urea breath test); 1558 of the 1636 participants who tested positive were randomised to H pylori eradication treatment or placebo, and 1539 (99%) were followed up for two years. INTERVENTION: Ranitidine bismuth citrate 400 mg and clarithromycin 500 mg twice daily for two weeks or placebo. MAIN OUTCOME MEASURES: Primary care consultation rates for dyspepsia (defined as epigastric pain) two years after randomisation, with secondary outcomes of dyspepsia symptoms, resource use, NHS costs, and quality of life. RESULTS: In the eradication group, 35% fewer participants consulted for dyspepsia over two years compared with the placebo group (55/787 v 78/771; odds ratio 0.65, 95% confidence interval 0.46 to 0.94; P = 0.021; number needed to treat 30) and 29% fewer participants had regular symptoms (odds ratio 0.71, 0.56 to 0.90; P = 0.05). NHS costs were 84.70 pounds sterling (74.90 pounds sterling to 93.91 pounds sterling) greater per participant in the eradication group over two years, of which 83.40 pounds sterling (146 dollars; 121 euro) was the cost of eradication treatment. No difference in quality of life existed between the two groups. CONCLUSIONS: Community screening and eradication of H pylori is feasible in the general population and led to significant reductions in the number of people who consulted for dyspepsia and had symptoms two years after treatment. These benefits have to be balanced against the costs of eradication treatment, so a targeted eradication strategy in dyspeptic patients may be preferable.

Adult↗
PubMed2006

Measuring the psychosocial impact of population-based prostate-specific antigen testing for prostate cancer in the UK.

OBJECTIVE: To evaluate the psychosocial impact of participation in a population-based prostate-specific antigen (PSA) testing programme, akin to screening, and to explore the relationship between urinary symptoms reported before PSA testing and the response to the subsequent PSA result. PATIENTS AND METHODS: This prospective questionnaire study was nested within the case-finding component of the ProtecT (prostate testing for cancer and treatment) feasibility study (ISRCTN20141297). Men aged 50-69 years from 18 general practices in three cities in the UK completed the Hospital Anxiety and Depression Scale (HADS), the Short Form-12 (SF-12) Health Survey, and the International Continence Society 'male' (ICSmale) questionnaires before giving consent for a PSA test in a community clinic (baseline). Men with an 'abnormal' PSA result returned for further investigation (including biopsy) and repeated these questionnaires before biopsy. RESULTS: At baseline, study participants had similar levels of anxiety and depression to the general male population. There was no increase in the HADS scores, or reduction in the SF-12 mental health component summary score, on attendance at the biopsy clinic after receiving an 'abnormal' PSA result. Urinary symptoms were associated with levels of anxiety and depression before receiving a PSA result (baseline), but were not associated with anxiety and depression at biopsy independently of baseline scores. Therefore changes in anxiety or depression at biopsy did not appear to differ between those with and without urinary symptoms. CONCLUSIONS: This study confirms the findings of other studies that the deleterious effects of receiving an abnormal PSA result during population screening are not identified by generic health-status questionnaires. Comparisons with outcomes of studies measuring cancer-specific distress and using qualitative research methods raise the question of whether a prostate cancer screening-specific instrument is required. However, a standardized measure of anxiety identified differences at baseline between those who did and did not report urinary symptoms. These findings suggest that it might be advisable to better inform men undergoing PSA testing about the uncertain relationship between urinary symptoms and prostate cancer, to minimize baseline levels of psychological distress.

Aged↗
PubMed2006

Young adults' perceptions of GPs as a help source for mental distress: a qualitative study.

BACKGROUND: Few young adults with mental disorder seek help from a GP. AIM: To explore young adults' perceptions of GPs as a source of help for mental distress. DESIGN OF STUDY: Qualitative interviews. SETTING: Bristol and surrounding areas, UK. METHOD: Males and females aged 16-24 years screened as 'cases' with probable mental disorder (GHQ [General Health Questionnaire]-12 score> or =4) or describing past episodes of mental disorder (n = 23) were sampled purposively according to help-seeking behaviour. Semi-structured interviews explored help-seeking choices. Transcripts were analysed using thematic, constant comparison and case study analysis. RESULTS: Most young adults did not value or recognise GPs as a source of help for mental disorder or distress. They thought that GPs deal exclusively with physical illness, lack training in mental health, are unable to provide 'talking' therapy, and may be dismissive of those consulting with mental distress. A prescription for antidepressants was seen as the most likely outcome of a consultation, but young adults wished to avoid this and so rarely consulted. Encounters with GPs could challenge or reinforce these perceptions. CONCLUSION: Negative perceptions about the value of consulting a GP for mental distress may explain low rates of help-seeking among young adults, including those with severe distress. Young people require a better understanding of GPs' role. It is also necessary to address evidence reported elsewhere that some GPs also experience uncertainties about what they can offer within the constraints of primary care.

Adolescent↗
PubMed2005

Health-related quality of life during neoadjuvant treatment and surgery for localized esophageal carcinoma.

BACKGROUND: Esophagectomy has a negative influence on health-related quality of life (HRQL) during the first postoperative year, but it is not known how chemotherapy or chemoradiotherapy treatment before surgery affects HRQL. The current study examined HRQL during preoperative chemotherapy/chemoradiotherapy treatment and compared postoperative recovery of HRQL in patients undergoing combined treatment with patients undergoing surgery alone. METHODS: One hundred three patients completed standardized HRQL measures before and during neoadjuvant treatment and before and after surgery. Mean HRQL scores were calculated and preoperative scores were used to model postoperative ratings using linear regression. RESULTS: Deterioration in most aspects of HRQL occurred during preoperative chemotherapy. Patients proceeding to concomitant radiotherapy further deteriorated with specific problems with reflux symptoms and role function (difference between means >15, P < 0.01). After neoadjuvant treatment, but before surgery, HRQL returned to baseline levels. Six weeks after surgery, patients reported marked reductions in physical, role, and social function (difference between means > 30, P < 0.01) and increase in fatigue, nausea and emesis, pain, dyspnea, appetite loss, and coughing (difference between means > 15, P < 0.01). Recovery of HRQL was not hampered by preoperative treatment, and fewer problems with postoperative nausea, emesis, and dysphagia were reported by patients who had undergone neoadjuvant treatment compared with patients who had undergone surgery alone. CONCLUSIONS: Preoperative chemotherapy or chemoradiotherapy had a negative impact on HRQL that was restored in patients proceeding to surgery. Recovery of HRQL after esophagectomy was not impaired by neoadjuvant treatment. These results supported the use of neoadjuvant treatment before surgery.

Adenocarcinoma↗
PubMed2004

Randomised controlled trial of effects of Helicobacter pylori infection and its eradication on heartburn and gastro-oesophageal reflux: Bristol helicobacter project.

OBJECTIVES: To investigate the effects of Helicobacter pylori infection and its eradication on heartburn and gastro-oesophageal reflux. DESIGN: Cross sectional study, followed by a randomised placebo controlled trial. SETTING: Seven general practices in Bristol, England. PARTICIPANTS: 10,537 people, aged 20-59 years, with and without H pylori infection (determined by the (13)C-urea breath test). MAIN OUTCOME MEASURES: Prevalence of heartburn and gastro-oesophageal acid reflux at baseline and two years after treatment to eradicate H pylori infection. RESULTS: At baseline, H pylori infection was associated with increased prevalence of heartburn (odds ratio 1.14, 95% confidence interval 1.05 to 1.23) but not reflux (1.05, 0.97 to 1.14). In participants with H pylori infection, active treatment had no effect on the overall prevalence of heartburn (0.99, 0.88 to 1.12) or reflux (1.04, 0.91 to 1.19) and did not improve pre-existing symptoms of heartburn or reflux. CONCLUSIONS: H pylori infection is associated with a slightly increased prevalence of heartburn but not reflux. Treatment to eradicate H pylori has no net benefit in patients with heartburn or gastro-oesophageal reflux.

Adult↗
PubMed2004

A scored form of the Bristol Female Lower Urinary Tract Symptoms questionnaire: data from a randomized controlled trial of surgery for women with stress incontinence.

OBJECTIVE: Lower urinary tract symptoms are common among older women. The Bristol Female Lower Urinary Tract Symptoms (BFLUTS) questionnaire was designed to assess a wide range of symptoms, including incontinence, and impact on sexual function and quality of life. This paper describes development and validation of a scored form BFLUTS questionnaire. STUDY DESIGN: Baseline and 6-month follow-up data from a randomized trial compared tension-free vaginal tape with colposuspension for 344 women with urodynamically proven stress incontinence. Problematic and responsive items were identified and subjected to factor analysis to develop a scoring system. RESULTS: Three domains were identified to assess symptoms: incontinence (5 items); voiding (3 items); and filling (4 items); with additional subscales for sexual function (2 items) and quality of life (5 items). All scales have simple additive scores. CONCLUSION: A scored form of the BFLUTS questionnaire is now available and should be useful in research and clinical practice in urology and gynecology.

Factor Analysis, Statistical↗
PubMed2004

Serum insulin-like growth factor-I is positively associated with serum prostate-specific antigen in middle-aged men without evidence of prostate cancer.

We have examined the relationship between serum insulin-like growth factor-I (IGF-I) and prostate-specific antigen in 367 healthy men without evidence of prostate cancer and found a positive association (P = 0.05). In men without prostate cancer, serum prostate-specific antigen is closely related to prostate size, and our findings, therefore, suggest that IGF-I may induce prostatic epithelial proliferation. Higher circulating levels of IGF-I have been associated with increased risk of both prostate cancer and possibly benign prostatic hyperplasia. Greater rates of cell proliferation induced by IGF-I may be a key biological pathway underlying these disorders.

Age Distribution↗
PubMed2004

Factors influencing help seeking in mentally distressed young adults: a cross-sectional survey.

BACKGROUND: Young adults, especially men, are among those least likely to consult healthcare professionals when mentally distressed or suicidal. AIMS: To investigate the help-seeking behaviours of mentally distressed young adults. DESIGN OF STUDY: Cross-sectional survey. SETTING: Bristol and surrounding areas, including inner-city, suburban and urban locations. METHOD: A questionnaire was sent to a sample of 3004 young adults aged 16-24 years. This assessed probable mental disorder (using the 12-item general health questionnaire [GHQ-12]), suicidal thoughts (GHQ-28 suicide subscale), and help-seeking behaviours. RESULTS: Most responders who were assessed as having probable mental disorders (GHQ "cases") had not sought help. Help seeking was more common in female GHQ cases than male cases (34.8% and 21.8%,respectively; P = 0.003) and women with suicidal thoughts more commonly sought help than men with suicidal thoughts (41.6% and 30.9%, respectively; P = 0.15). Small proportions of male and female GHQ cases (7.5% and 8.9%, respectively; P = 0.6), and less than one in five responders with suicidal thoughts, had consulted a general practitioner. In more female than male cases, help was sought from family and friends (30.7% and 18.4%, respectively; P = 0.004). GHQ score was the strongest predictor of help seeking. Men had a higher threshold of severity at which they would seek help than women. Recent experience of suicidal thoughts appeared to be a stronger predictor of formal help seeking in mentally distressed women than mentally distressed men. CONCLUSION: Distressed young adults are reluctant to seek help. Men are particularly unlikely to do so unless severely distressed and tend not to seek lay support. Sex differences in help seeking may be important in understanding the high suicide rate for men.

Adolescent↗
PubMed2003

Perceptions of equipoise are crucial to trial participation: a qualitative study of men in the ProtecT study.

Recruitment to trials is known to be difficult. Previous research suggests that a crucial factor may be participants' difficulty with the concept of randomization. This study explored patients' perceptions of randomization and reasons for consent or refusal to participate in the ProtecT study (a randomized trial of surgery, radiotherapy, and monitoring for localized prostate cancer). In-depth interviews were conducted with 21 men diagnosed with localized prostate cancer who were invited to participate in the ProtecT treatment trial. Interviewees were selected purposefully from three U.K. clinical centers to ensure the inclusion of similar proportions of those agreeing or refusing random treatment allocation in each of the treatment groups. Interviews explored men's recall and understanding of chance, comparison, and equipoise, and reasons for consent/refusal of randomization and acceptance/rejection of treatment allocation. Data were analyzed methodically using the techniques of constant comparison. Checking of coding and interpretation was assured by four experienced qualitative researchers. Recall and understanding of the major principles of the randomized design were good and were similar for "chance" and "comparison" between those who consented to and refused randomization. Clinical equipoise, however, caused difficulty. Almost all recalled and understood it, but those who found it acceptable tended to consent to randomization and those who could not accept it tended to refuse to participate. Belief in clinical equipoise was key to participants' consent to randomization. Ensuring patients understand and accept equipoise may thus increase their readiness to consent to participate in trials. A priority for future research is to focus on the provision and presentation of suitable and effective trial information, concentrating in particular on the neglected concept of clinical equipoise.

Aged↗
PubMed2003

Who can best recruit to randomized trials? Randomized trial comparing surgeons and nurses recruiting patients to a trial of treatments for localized prostate cancer (the ProtecT study).

BACKGROUND AND OBJECTIVE: Recruitment to randomized trials is often difficult, but few studies have investigated interventions to improve recruitment. In a randomized trial nested within a trial of treatments for localized prostate cancer, we investigated the comparative effectiveness and cost-effectiveness of nurses and surgeons in recruiting patients. METHODS: Men with localized prostate cancer were randomized to see a nurse or urologic surgeon for an "information appointment" in which they were asked to consent to the ProtecT treatment trial comparing surgery, radiotherapy, and active monitoring. Analysis was conducted by intention to treat using chi-square with 95% confidence intervals for proportions and differences between groups. An economic evaluation was performed using the duration of appointments and grade of recruitment staff. RESULTS: Case-finding identified 167 men with localized prostate cancer. One hundred fifty (90%) took part in the recruitment trial. There was a 4.0% difference between nurses and surgeons in recruitment rates (67% nurses, 71% urologists, 95% CI -10.8% to +18.8%, P=.60). Cost-minimization analysis showed that nurses spent longer times with patients but surgeon costs were higher and nurses often supported surgeon-led clinics. CONCLUSION: Nurses were as effective and more cost-effective recruiters than urologic surgeons. This suggests an increased role for nurses in recruiting patients to randomized trials.

Aged↗
PubMed2002

Sexual dysfunction in men after treatment for lower urinary tract symptoms: evidence from randomised controlled trial.

OBJECTIVE: To examine the impact on sexual function of treatments for lower urinary tract symptoms in men. DESIGN: Multicentre pragmatic randomised controlled trial of standard surgery (transurethral resection of the prostate), non-contact laser therapy, and conservative management (no active intervention). SETTING: Three clinical centres in the United Kingdom. PARTICIPANTS: 340 men aged between 48 and 90 years with lower urinary tract symptoms related to benign prostatic enlargement. MAIN OUTCOME MEASURES: ICSsex questionnaire items concerned with erectile stiffness, ejaculatory volume, pain or discomfort on ejaculation, whether sex life was spoilt by urinary symptoms. RESULTS: Erectile and ejaculatory dysfunction were common (70%) and problematic at baseline and showed the expected trends with ageing. After treatment, reduced ejaculation was reported in all groups but was not significantly worse after standard surgery than after laser therapy. Erectile function was significantly improved after standard surgery; no significant difference was found between standard surgery and laser therapy (odds ratio 0.70, 95% confidence interval 0.36 to 1.38). Standard surgery was significantly better at relieving pain or discomfort on ejaculation than either conservative management (0.06, 0.007 to 0.49) or laser therapy (0.09, 0.01 to 0.73). CONCLUSIONS: Compared with laser therapy standard surgery for lower urinary tract symptoms has a beneficial effect on aspects of sexual function-particularly in improving erectile function and reducing reported pain or discomfort on ejaculation. Older men who need treatment and want to retain or improve sexual function may thus want to consider standard surgery rather than non-contact laser therapy.

Aged↗
PubMed2002

Transurethral prostate resection, noncontact laser therapy or conservative management in men with symptoms of benign prostatic enlargement? An economic evaluation.

PURPOSE: We evaluated the cost-effectiveness of noncontact laser therapy compared with transurethral prostate resection and conservative treatment in men with symptoms associated with benign prostatic enlargement. MATERIALS AND METHODS: A total of 340 men with uncomplicated lower urinary tract symptoms participated in a large multicenter pragmatic randomized trial called the CLasP (Conservative management, Laser therapy, transurethral resection of the Prostate) study. Costs to the United Kingdom National Health Service and patients were determined from the time of randomization to the 7.5-month followup. Incremental cost-effectiveness ratios using conservative management as the base case were calculated for certain trial outcomes, including International Prostate Symptom Score (I-PSS), I-PSS quality of life score, maximum urinary flow, post-void residual urine volume, quality adjusted life-years and a composite measure of success based on I-PSS and maximum urinary flow. One-way sensitivity analysis of the basic costs and incremental cost-effectiveness ratios were done from the NHS viewpoint. RESULTS: Mean costs per patient were greatest for noncontact laser therapy and least for conservative management. The incremental cost-effectiveness ratios showed that transurethral prostate resection was more cost-effective than noncontact laser treatment for all primary trial outcomes. The incremental cost-effectiveness ratios of transurethral prostate resection compared with conservative management were pound 81 per unit decrease in the I-PSS score and pound 1,338 per additional successful case per 100 patients. Sensitivity analysis showed that the initial results were robust. CONCLUSIONS: Noncontact laser was the mostly costly treatment option. Transurethral prostate resection was more cost-effective than noncontact laser therapy in terms of symptomatic improvement. In men wishing to delay treatment conservative treatment appears to provide a cost-effective alternative in the short term.

Adult↗
PubMed2002

A placebo-controlled randomized trial of eradication of Helicobacter pylori in the general population: study design and response rates of the Bristol Helicobacter Project.

The Bristol Helicobacter Project is an ongoing, pragmatic, double-blind placebo-controlled trial of the effect of Helicobacter pylori eradication on symptoms of dyspepsia, health utilization and costs, and quality of life in the adult population. Commencing in 1996, 27,536 individuals ages 20-59 years who were registered with seven primary care centers in Bristol and the surrounding areas in southwest England were invited to undergo a 13C urea breath test. There was no selection on the basis of symptoms and 23.5% had dyspepsia on entry to the study. A total of 10,537 people were tested (38.3% of those invited), 1636 tested positive (15.5% of those tested), and 1558 (95.2% of those who tested positive) were randomized to H. pylori eradication therapy or placebo. The rate of participation in the screening phase increased with age (odds ratio [OR]: 1.42 per decade, 95% CI: 1.31 to 1.54) and female gender (OR: 1.35, 95% CI: 1.27 to 1.43) but decreased with lower socioeconomic status (OR: 0.70, 95% CI: 0.56 to 0.86 comparing lowest with highest category). H. pylori prevalence increased with age (OR: 1.69 per decade, 95% CI: 1.51 to 1.89) and lower socioeconomic status (OR: 1.33, 95% CI: 1.05 to 1.69) but was lower in women (OR: 0.87, 95% CI: 0.76 to 1.00). Population-based trials of H. pylori eradication are feasible but necessitate screening large numbers of people to identify those who are infected and who may benefit from eradication. In the Bristol Helicobacter Project the rate of participation varied inversely with both social deprivation and the prevalence of the infection.

Adult↗