Symptoms and signs of urogenital cancer in primary care.

BACKGROUND: Urogenital cancers are common, accounting for approximately 20% of cancer incidence globally. Cancers belonging to the same organ system often present with similar symptoms, making initial management challenging. In this study, 511 cases of cancer were recorded after the date of consultation among 61,802 randomly selected patients presenting in primary care in six European countries: a subgroup analysis of urogenital cancers was carried out in order to study variation in symptom presentation. METHODS: Initial data capture was by completion of standardised forms containing closed questions about symptoms recorded during the consultation. The general practitioner (GP) provided follow-up data after diagnosis, based on medical record data made after the consultation. GPs also provided free text comments about the diagnostic procedure for individual patients. RESULTS: The most common symptoms were mainly associated with one or two specific types of cancer: 'Macroscopic haematuria' with bladder or renal cancer (combined sensitivity 28.3%), 'Increased urinary frequency' with bladder (sensitivity 13.3%) or prostatic (sensitivity 32.1%) cancer, or to uterine body (sensitivity 14.3%) cancer, 'Unexpected genital bleeding' with uterine cancer (cervix, sensitivity 20.0%, uterine body, sensitivity 71.4%). 'Distended abdomen, bloating' had sensitivity 62.5% (based on eight cases of ovarian cancer). In ovarian cancer, increased abdominal circumference and a palpable tumour also were important diagnostic elements. Specificity for 'Macroscopic haematuria' was 99.8% (99.7-99.8). PPV > 3% was noted for 'Macroscopic haematuria' and bladder or renal cancer combined, for bladder cancer in male patients. In males aged 55-74, PPV = 7.1% for 'Macroscopic haematuria' and bladder cancer. Abdominal pain was an infrequent symptom in urogenital cancers. CONCLUSIONS: Most types of urogenital cancer present with rather specific symptoms. If the GP considers ovarian cancer, increased abdominal circumference should be actively determined. Several cases were clarified through the GP's clinical examination, or laboratory investigations.

Symptoms and signs of colorectal cancer, with differences between proximal and distal colon cancer: a prospective cohort study of diagnostic accuracy in primary care.

BACKGROUND: In an abdominal symptom study in primary care in six European countries, 511 cases of cancer were recorded prospectively among 61,802 patients 16 years and older in Norway, Denmark, Sweden, Netherlands, Belgium and Scotland. Colorectal cancer is one of the main types of cancer associated with abdominal symptoms; hence, an in-depth subgroup analysis of the 94 colorectal cancers was carried out in order to study variation in symptom presentation among cancers in different anatomical locations. METHOD: Initial data capture was by completion of standardised forms containing closed questions about symptoms recorded during the consultation. Follow-up data were provided by the GP after diagnosis, based on medical record data made after the consultation. GPs also provided free text comments about the diagnostic procedure for individual patients. Fisher's exact test was used to analyse differences between groups. RESULTS: Almost all symptoms recorded could indicate colorectal cancer. 'Rectal bleeding' had a specificity of 99.4% and a PPV of 4.0%. Faecal occult blood in stool (FOBT) or anaemia may indicate gastrointestinal bleeding: when these symptoms and signs were combined, sensitivity reached 57.5%, with 69.2% for cancer in the distal colon. For proximal colon cancers, none of 18 patients had 'Rectal bleeding' at the initial consultation, but three of the 18 did so at a later consultation. 'Abdominal pain, lower part', 'Constipation' and 'Distended abdomen, bloating' were less specific and also less sensitive than 'Rectal bleeding', and with PPV between 0.7% and 1.9%. CONCLUSIONS: Apart from rectal bleeding, single symptoms did not reach the PPV 3% NICE threshold. However, supplementary information such as a positive FOBT or persistent symptoms may revise the PPV upwards. If a colorectal cancer is suspected by the GP despite few symptoms, the total clinical picture may still reach the NICE PPV threshold of 3% and justify a specific referral.

Development and implementation of a nurse-led allergy clinic model in primary care: feasibility trial protocol.

In the United Kingdom, there are acknowledged short comings in allergy care provision for patients seen in primary care. There is a lack of allergy training for healthcare professionals and this leads to inappropriate referrals to the limited number of allergy specialists. The primary aims of this study are to assess the feasibility of delivering and evaluating a new nurse-led allergy service in primary care, measured by recruitment, retention and quality of life. This is a single arm feasibility trial in which up to 250 participants referred to the nurse-led allergy clinic will receive the intervention and complete 6-12 weeks follow-up before being referred back to their usual care. Primary outcomes for this study will be establishment of clinics, recruitment and retention rates, and estimates of change in disease-specific quality of life measures. Secondary outcomes will be acceptability of the new service to participants/carers and healthcare professionals. A sample of participants and professional stakeholders will take part in more in-depth semi-structured qualitative interviews. Data from this feasibility trial will be used to inform plans for a pilot randomised controlled trial of nurse-led allergy clinics.

Comparing the content and quality of video, telephone, and face-to-face consultations: a non-randomised, quasi-experimental, exploratory study in UK primary care.

BACKGROUND: Growing demands on primary care services have led to policymakers promoting video consultations (VCs) to replace routine face-to-face consultations (FTFCs) in general practice. AIM: To explore the content, quality, and patient experience of VC, telephone (TC), and FTFCs in general practice. DESIGN AND SETTING: Comparison of audio-recordings of follow-up consultations in UK primary care. METHOD: Primary care clinicians were provided with video-consulting equipment. Participating patients required a smartphone, tablet, or computer with camera. Clinicians invited patients requiring a follow-up consultation to choose a VC, TC, or FTFC. Consultations were audio-recorded and analysed for content and quality. Participant experience was explored in post-consultation questionnaires. Case notes were reviewed for NHS resource use. RESULTS: Of the recordings, 149/163 were suitable for analysis. VC recruits were younger, and more experienced in communicating online. FTFCs were longer than VCs (mean difference +3.7 minutes, 95% confidence interval [CI] = 2.1 to 5.2) or TCs (+4.1 minutes, 95% CI = 2.6 to 5.5). On average, patients raised fewer problems in VCs (mean 1.5, standard deviation [SD] 0.8) compared with FTFCs (mean 2.1, SD 1.1) and demonstrated fewer instances of information giving by clinicians and patients. FTFCs scored higher than VCs and TCs on consultation-quality items. CONCLUSION: VC may be suitable for simple problems not requiring physical examination. VC, in terms of consultation length, content, and quality, appeared similar to TC. Both approaches appeared less 'information rich' than FTFC. Technical problems were common and, though patients really liked VC, infrastructure issues would need to be addressed before the technology and approach can be mainstreamed in primary care.

Acceptability, benefits, and challenges of video consulting: a qualitative study in primary care.

BACKGROUND: People increasingly communicate online, using visual communication mediums such as Skype and FaceTime. Growing demands on primary care services mean that new ways of providing patient care are being considered. Video consultation (VC) over the internet is one such mode. AIM: To explore patients' and clinicians' experiences of VC. DESIGN AND SETTING: Semi-structured interviews in UK primary care. METHOD: Primary care clinicians were provided with VC equipment. They invited patients requiring a follow-up consultation to an online VC using the Attend Anywhere web-based platform. Participating patients required a smartphone, tablet, or video-enabled computer. Following VCs, semi-structured interviews were conducted with patients (n = 21) and primary care clinicians (n = 13), followed by a thematic analysis. RESULTS: Participants reported positive experiences of VC, and stated that VC was particularly helpful for them as working people and people with mobility or mental health problems. VCs were considered superior to telephone consultations in providing visual cues and reassurance, building rapport, and improving communication. Technical problems, however, were common. Clinicians felt, for routine use, VCs must be more reliable and seamlessly integrated with appointment systems, which would require upgrading of current NHS IT systems. CONCLUSION: The visual component of VCs offers distinct advantages over telephone consultations. When integrated with current systems VCs can provide a time-saving alternative to face-to-face consultations when formal physical examination is not required, especially for people who work. Demand for VC services in primary care is likely to rise, but improved technical infrastructure is required to allow VC to become routine. However, for complex or sensitive problems face-to-face consultations remain preferable.

Developing and testing of a screening tool to predict people without IgE-mediated allergy: a quantitative analysis of the predictive value of a screening tool.

BACKGROUND: Consultations in primary care for allergies are common. It can be difficult to differentiate between IgE-mediated (atopic) symptoms - which respond to allergen-specific interventions - and those that are non-atopic, without performing objective tests that are largely unavailable in UK general practice. AIM: To develop and test a screening tool that can accurately discriminate between atopic and non-atopic individuals. DESIGN AND SETTING: A validation study that took place in 2012 in adult volunteers aged >16 years in Scotland. METHOD: A questionnaire screening tool was developed using questions from a large cohort study and through consultation with experts. Participants answered the questions and had skin prick tests for four aeroallergens (house dust mite, cat, dog, and mixed grasses). Participants were classified as atopic if any average wheal diameter was ≥3 mm bigger than the negative control. Sensitivity, specificity, and positive and negative predictive values of individual and combinations of questions were calculated. RESULTS: In all, 143 participants completed the questionnaire and underwent skin prick testing. Of these, 81 (56.6%) were atopic. Negative predictive values for the individual questions ranged from 48.2% (55 not atopic out of 114 negative answers) to 72.0% (18/25). An optimum combination of four questions was identified, in which a negative answer to all four questions was reported by 24 participants, 21 (87.5%) of whom were not atopic. CONCLUSION: The authors have identified a set of questions that correctly predict negative skin prick tests to common aeroallergens 88% of the time. These may be useful to exclude patients who do not warrant further investigation and who can reliably be advised that allergen avoidance is neither necessary nor helpful.

Patient-reported outcome measures for asthma: a systematic review.

BACKGROUND: Patient-reported outcome measures (PROMs) are measures of the outcome of treatment(s) reported directly by the patient or carer. There is increasing international policy interest in using these to assess the impact of clinical care. AIMS: To identify suitably validated PROMs for asthma and examine their potential for use in clinical settings. METHODS: We systematically searched MEDLINE, EMBASE and Web of Science databases from 1990 onwards to identify PROMs for asthma. These were critically appraised, then narratively synthesised. We also identified the generic PROMs commonly used alongside asthma-specific PROMs. RESULTS: We identified 68 PROMs for asthma, 13 of which were selected through screening as being adequately developed to warrant full-quality appraisal: 8 for adults, 4 for children and 1 for a child's caregiver. The PROMs found to be sufficiently well validated to offer promise for use in clinical settings were the Asthma Quality of Life Questionnaire (AQLQ) and mini-AQLQ for adults, and Pediatric Asthma Quality of Life Questionnaire for children. Rhinasthma was considered promising in simultaneously assessing the impact of asthma and rhinitis in those with coexistent disease. We identified 28 generic PROMs commonly used in conjunction with asthma-specific instruments. CONCLUSIONS: We identified asthma PROMs that offer the greatest potential for use in clinical settings. Further work is needed to assess whether these are fit-for-purpose for use in clinical practice with individual patients. In particular, there is a need to ensure these are validated for use in clinical settings, acceptable to patients, caregivers and clinicians, and yield meaningful outcomes.

Adolescent seasonal allergic rhinitis and the impact of health-care professional training: cluster randomised controlled trial of a complex intervention in primary care.

BACKGROUND: Seasonal allergic rhinitis is typically poorly managed, particularly in adolescents, in whom it is responsible for considerable morbidity. Our previous work has demonstrated that if poorly controlled this can impair educational performance. AIM: The primary aim of this trial was to assess the impact of a primary care-based professional training intervention on clinical outcomes in adolescents with seasonal allergic rhinitis. METHODS: Cluster trial in which UK general practice staff were randomised to a short, intensive workshop on the evidence-based management of seasonal allergic rhinitis. The primary outcome measure was the change in the validated Rhinoconjunctivitis Quality of Life Questionnaire with Standardized Activities (RQLQ(S)) score between baseline and 6 weeks post intervention (minimal clinically important difference=0.5). Secondary outcome measures of interest included health-care professionals' knowledge and confidence in managing seasonal allergic rhinitis, number of seasonal allergic rhinitis-related consultations, relevant treatments prescribed and symptom scores. RESULTS: Thirty-eight general practices were randomised (20 in the intervention arm) and 246 patients (50.2% males, mean age 15 years) were included in the primary outcome analysis. Health-care professionals' knowledge and confidence of the clinical management of seasonal allergic rhinitis improved. This did not, however, result in clinically or statistically significant improvements in RQLQ(S): -0.15, (95% confidence interval, -0.5 to +0.2). There were no differences in consultation frequency, treatments issued for seasonal allergic rhinitis or symptom scores. CONCLUSIONS: Although associated with increases in professionals' self-assessed confidence and understanding of seasonal allergic rhinitis management, this intensive training workshop did not translate into improvements in adolescents' disease-specific quality of life or a reduction in rhinitis symptoms.

Continuing cancer screening later in life: attitudes and intentions among older adults in England.

BACKGROUND: the rise in life expectancy, together with age-related increase in the incidence of most cancers, has led to mounting interest in cancer screening in older people. In England, routine invitations stop and an 'opt-in' (individual request) process is available from ages 71 to 76 years for breast and colorectal screening respectively. Little is known about public attitudes towards age-stoppage policy. OBJECTIVE: this study examined public attitudes to current stoppage policy, information preferences and intentions to request screening beyond the age of routine invitations. SAMPLE: participants (n = 927; age 60-74 years) were recruited as part of a TNS Research International survey and took part in home-based, computer-assisted interviews. METHODS: measures included: (i) attitudes towards current stoppage policy, (ii) preference for communications about screening after the end of the routine invitation period and (iii) intention to opt-in. RESULTS: the majority of respondents (78%) did not agree with age-based stoppage policies. Most (83%) wanted a strong recommendation to opt-in after this age, although the number who thought they would follow such a recommendation was much lower (27%). A majority of participants (54%) thought information on screening at older ages should come from their general practitioner (GP). CONCLUSION: this survey indicates that older people in England wish to continue to be actively invited for cancer screening, although only a minority think that they would ultimately take up the offer. Primary care may play a role in negotiating a shared decision that is based on individual circumstances.

Investigating the effectiveness of the Mediterranean diet in pregnant women for the primary prevention of asthma and allergy in high-risk infants: protocol for a pilot randomised controlled trial.

BACKGROUND: Over recent decades there has been a substantial increase in asthma and allergic disease especially in children. Given the high prevalence, and the associated high disease burden and costs, there is a need to identify effective strategies for the primary prevention of asthma and allergy. A recent systematic review of the literature found strong supportive epidemiological evidence for a protective role of the Mediterranean diet, which now needs to be confirmed through formal experimental studies. This pilot trial in pregnant women aims to establish recruitment, retention and acceptability of a dietary intervention, and to assess the likely impact of the intervention on adherence to a Mediterranean diet during pregnancy. METHODS/DESIGN: This study was a pilot, two-arm, randomised controlled trial in a sample population of pregnant women at high risk of having a child who will develop asthma or allergic disease. DISCUSSION: The work ultimately aims to contribute to improving health outcomes through seeking to reduce the incidence of asthma and allergic problems. This pilot trial will prove invaluable in informing the subsequent planned large-scale, parallel group, randomised controlled trial.

Protocol for the adolescent hayfever trial: cluster randomised controlled trial of an educational intervention for healthcare professionals for the management of school-age children with hayfever.

BACKGROUND: Seasonal allergic rhinitis (hayfever) is common and can contribute to a considerable reduction in the quality of life of adolescents. This study aims to examine the effectiveness of standardised allergy training for healthcare professionals in improving disease-specific quality of life in adolescents with hayfever. METHODS/DESIGN: Adolescents with a history of hayfever registered in general practices in Scotland and England were invited to participate in a cluster randomised controlled trial. The unit of randomisation is general practices.The educational intervention for healthcare professionals consists of a short standardised educational course, which focuses on the management of allergic rhinitis. Patients in the intervention arm of this cluster randomised controlled trial will have a clinic appointment with their healthcare professional who has attended the training course. Patients in the control arm will have a clinic appointment with their healthcare professional and will receive usual care. The primary outcome measure is the change in the Rhinoconjunctivitis Quality of Life Questionnaire with Standardised Activities (RQLQ(S)) score between baseline and six weeks post-intervention in the patient intervention and control groups. Secondary outcome measures relate to healthcare professionals' understanding and confidence in managing allergic rhinitis, changes in clinical practice, numbers of consultations for hayfever and adolescent exam performance.A minimum of 11 practices in each arm of the trial (10 patients per cluster) will provide at least 80% power to demonstrate a minimal clinically important difference of 0.5 in RQLQ(S) score at a significance level of 5% based on an Intraclass Correlation Coefficient (ICC) of 0.02. DISCUSSION: At the time of submission, 24 general practices have been recruited (12 in each arm of the trial) and the interventions have been delivered. Follow-up data collection is complete. 230 children consented to take part in the trial; however complete primary outcome data are only available for 160. Further recruitment of general practices and patients will therefore take place in the summer of 2010. TRIAL REGISTRATION: Current Controlled Trials ISRCTN95538067.

Early treatment with prednisolone or acyclovir in Bell's palsy.

BACKGROUND: Corticosteroids and antiviral agents are widely used to treat the early stages of idiopathic facial paralysis (i.e., Bell's palsy), but their effectiveness is uncertain. METHODS: We conducted a double-blind, placebo-controlled, randomized, factorial trial involving patients with Bell's palsy who were recruited within 72 hours after the onset of symptoms. Patients were randomly assigned to receive 10 days of treatment with prednisolone, acyclovir, both agents, or placebo. The primary outcome was recovery of facial function, as rated on the House-Brackmann scale. Secondary outcomes included quality of life, appearance, and pain. RESULTS: Final outcomes were assessed for 496 of 551 patients who underwent randomization. At 3 months, the proportions of patients who had recovered facial function were 83.0% in the prednisolone group as compared with 63.6% among patients who did not receive prednisolone (P<0.001) and 71.2% in the acyclovir group as compared with 75.7% among patients who did not receive acyclovir (adjusted P=0.50). After 9 months, these proportions were 94.4% for prednisolone and 81.6% for no prednisolone (P<0.001) and 85.4% for acyclovir and 90.8% for no acyclovir (adjusted P=0.10). For patients treated with both drugs, the proportions were 79.7% at 3 months (P<0.001) and 92.7% at 9 months (P<0.001). There were no clinically significant differences between the treatment groups in secondary outcomes. There were no serious adverse events in any group. CONCLUSIONS: In patients with Bell's palsy, early treatment with prednisolone significantly improves the chances of complete recovery at 3 and 9 months. There is no evidence of a benefit of acyclovir given alone or an additional benefit of acyclovir in combination with prednisolone. (Current Controlled Trials number, ISRCTN71548196 [controlled-trials.com].).

Recruitment and retention in a multicentre randomised controlled trial in Bell's palsy: a case study.

BACKGROUND: It is notoriously difficult to recruit patients to randomised controlled trials in primary care. This is particularly true when the disease process under investigation occurs relatively infrequently and must be investigated during a brief time window. Bell's palsy, an acute unilateral paralysis of the facial nerve is just such a relatively rare condition. In this case study we describe the organisational issues presented in setting up a large randomised controlled trial of the management of Bell's palsy across primary and secondary care in Scotland and how we managed to successfully recruit and retain patients presenting in the community. METHODS: Where possible we used existing evidence on recruitment strategies to maximise recruitment and retention. We consider that the key issues in the success of this study were; the fact that the research was seen as clinically important by the clinicians who had initial responsibility for recruitment; employing an experienced trial co-ordinator and dedicated researchers willing to recruit participants seven days per week and to visit them at home at a time convenient to them, hence reducing missed patients and ensuring they were retained in the study; national visibility and repeated publicity at a local level delivered by locally based principal investigators well known to their primary care community; encouraging recruitment by payment to practices and reducing the workload of the referring doctors by providing immediate access to specialist care; good collaboration between primary and secondary care and basing local investigators in the otolarnygology trial centres RESULTS: Although the recruitment rate did not meet our initial expectations, enhanced retention meant that we exceeded our planned target of recruiting 550 patients within the planned time-scale. CONCLUSION: While difficult, recruitment to and retention within multi-centre trials from primary care can be successfully achieved through the application of the best available evidence, establishing good relationships with practices, minimising the workload of those involved in recruitment and offering enhanced care to all participants. Primary care trialists should describe their experiences of the methods used to persuade patients to participate in their trials when publishing their results.