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Should the surgeon or the general practitioner (GP) follow up patients after surgery for colon cancer? A randomized controlled trial protocol focusing on quality of life, cost-effectiveness and serious clinical events.

ABSTRACT: All patients who undergo surgery for colon cancer are followed up according to the guidelines of the Norwegian Gastrointestinal Cancer Group (NGICG). These guidelines state that the aims of follow-up after surgery are to perform quality assessment, provide support and improve survival. In Norway, most of these patients are followed up in a hospital setting. We describe a multi-centre randomized controlled trial to test whether these patients can be followed up by their general practitioner (GP) without altering quality of life, cost effectiveness and/or the incidence of serious clinical events.Patients undergoing surgery for colon cancer with histological grade Dukes's Stage A, B or C and below 75 years of age are eligible for inclusion. They will be randomized after surgery to follow-up at the surgical outpatient clinic (control group) or follow-up by the district GP (intervention group). Both study arms comply with the national NGICG guidelines. The primary endpoints will be quality of life (QoL) (measured by the EORTC QLQ C-30 and the EQ-5D instruments), serious clinical events (SCEs), and costs. The follow-up period will be two years after surgery, and quality of life will be measured every three months. SCEs and costs will be estimated prospectively. The sample size was 170 patients.There is an ongoing debate on the best method of follow-up for patients with CRC. Due to a wide range of follow-up programmes and paucity of randomized trials, it is impossible to draw conclusions about the best combination and frequency of clinic (or family practice) visits, blood tests, endoscopic procedures and radiological examinations that maximize the clinical outcome, quality of life and costs. Most studies on follow-up of CRC patients have been performed in a hospital outpatient setting. We hypothesize that postoperative follow-up of colon cancer patients (according to national guidelines) by GPs will not have any impact on patients' quality of life. Furthermore, we hypothesize that there will be no increase in SCEs and that the incremental cost-effectiveness ratio will improve.This trial has been registered at ClinicalTrials.gov. The trial registration number is: NCT00572143.

SUBMITTER: Augestad KM

PROVIDER: S-EPMC2474836 | biostudies-literature | 2008 Jun

REPOSITORIES: biostudies-literature

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Should the surgeon or the general practitioner (GP) follow up patients after surgery for colon cancer? A randomized controlled trial protocol focusing on quality of life, cost-effectiveness and serious clinical events.

Augestad Knut M KM Vonen Barthold B Aspevik Ranveig R Nestvold Torunn T Ringberg Unni U Johnsen Roar R Norum Jan J Lindsetmo Rolv-Ole RO

BMC health services research 20080625

<h4>Background</h4>All patients who undergo surgery for colon cancer are followed up according to the guidelines of the Norwegian Gastrointestinal Cancer Group (NGICG). These guidelines state that the aims of follow-up after surgery are to perform quality assessment, provide support and improve survival. In Norway, most of these patients are followed up in a hospital setting. We describe a multi-centre randomized controlled trial to test whether these patients can be followed up by their general ...[more]

PMID: 18578856

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Project description:To assess whether colon cancer follow-up can be organised by general practitioners (GPs) without a decline in the patient's quality of life (QoL) and increase in cost or time to cancer diagnoses, compared to hospital follow-up.Randomised controlled trial.Northern Norway Health Authority Trust, 4 trusts, 11 hospitals and 88 local communities.Patients surgically treated for colon cancer, hospital surgeons and community GPs.24-month follow-up according to national guidelines at the community GP office. To ensure a high follow-up guideline adherence, a decision support tool for patients and GPs were used.Primary outcomes were QoL, measured by the global health scales of the European Organisation for Research and Treatment of Cancer QoL Questionnaire (EORTC QLQ C-30) and EuroQol-5D (EQ-5D). Secondary outcomes were cost-effectiveness and time to cancer diagnoses.110 patients were randomised to intervention (n=55) or control (n=55), and followed by 78 GPs (942 follow-up months) and 70 surgeons (942 follow-up months), respectively. Compared to baseline, there was a significant improvement in postoperative QoL (p=0.003), but no differences between groups were revealed (mean difference at 1, 3, 6, 9, 12, 15, 18, 21 and 24-month follow-up appointments): Global Health; ?-2.23, p=0.20; EQ-5D index; ?-0.10, p=0.48, EQ-5D VAS; ?-1.1, p=0.44. There were no differences in time to recurrent cancer diagnosis (GP 35 days vs surgeon 45 days, p=0.46); 14 recurrences were detected (GP 6 vs surgeon 8) and 7 metastases surgeries performed (GP 3 vs surgeon 4). The follow-up programme initiated 1186 healthcare contacts (GP 678 vs surgeon 508), 1105 diagnostic tests (GP 592 vs surgeon 513) and 778 hospital travels (GP 250 vs surgeon 528). GP organised follow-up was associated with societal cost savings (£8233 vs £9889, p<0.001).GP-organised follow-up was associated with no decline in QoL, no increase in time to recurrent cancer diagnosis and cost savings.ClinicalTrials.gov identifier NCT00572143.

Project description:ContextThe use of ethnic identifiers in health systems is recommended in several European countries as a means to identify and address heath inequities. There are barriers to implementation that have not been researched.ObjectiveThis study examines whether and how ethnicity data can be collected in Irish general practices in a meaningful and acceptable way.MethodsQualitative case study data generation was informed by Normalization Process Theory (NPT) constructs about 'sense' making and 'engagement'. It consisted of individual interviews and focus group discussions based on visual participatory techniques. There were 70 informants, including 62 general practitioner (GP) users of diverse ethnic backgrounds recruited through community organisations and eight GPs identified through an inter-agency steering group. Data were analysed according to principles of thematic analysis using NPT.ResultsThe link between ethnicity and health was often considered relevant because GP users grasped connections with genetic (skin colour, lactose intolerance), geographic (prevalence of disease, early years exposure), behavioural (culture/food) and social determinant (housing) factors. The link was less clear with religion. There was some scepticism and questions about how the collection of data would benefit GP consultations and concerns regarding confidentiality and the actual uses of these data (e.g. risk of discrimination, social control). For GPs, the main theme discussed was relevance: what added value would it bring to their consultations and was it was their role to collect these data? Their biggest concern was about data protection issues in light of the European Union (EU) General Data Protection Regulation (GDPR). The difficulty in explaining a complex concept such as 'ethnicity' in the limited time available in consultations was also worrying.ConclusionsImplementation of an ethnicity identifier in Irish general practices will require a strong rationale that makes sense to GP users, and specific measures to ensure that its benefits outweigh any potential harm. This is in line with both our participants' views and the EU GDPR.

Project description:ObjectivesThe I CARE study (Improving Care After colon canceR treatment in the Netherlands) aims to compare surgeon-led to general practitioner (GP)-led colon cancer survivorship care. Recruitment to the trial took longer than expected. In this descriptive study, recruitment is critically reviewed.SettingPatients were recruited from eight Dutch medical centres.ParticipantsPatients treated with curative intent for stages I-III colon cancer. Target patient sample size was calculated at 300.InterventionsPatients were randomised to surgeon-led (usual) versus GP-led care, with or without access to an eHealth application (Oncokompas).Outcome measuresBaseline characteristics of (non-)participants, reasons for non-participation and strategies to improve recruitment were reviewed.ResultsOut of 1238 eligible patients, 353 patients were included. Of these, 50 patients dropped out shortly after randomisation and before start of the intervention, resulting in a participation rate of 25%. Participants were on average slightly younger (68.1 years vs 69.3 years) and more often male (67% vs 50%) in comparison to non-participants. A total of 806 patients declined participation for reasons most often relating to research (57%), including the wish to remain in specialist care (31%) and too much effort to participate (12%). Some patients mentioned health (9%) and confrontation with the disease (5%) as a reason. In 43 cases, GPs declined participation, often related to the study objective, need for financial compensation and time restraints. The generally low participation rate led to concerns about reaching the target sample size. Methods to overcome recruitment challenges included changes to the original recruitment procedure and the addition of new study centres.ConclusionsChallenges were faced in the recruitment to a randomised trial on GP-led colon cancer survivorship care. Research on the transition of care requires sufficient time, funding and support base among patients and healthcare professionals. These findings will help inform researchers and policy-makers on the development of future practices.Trial registration numberNTR4860.

Project description:ObjectivesReminders in primary care administrative systems aim to help clinicians provide evidence-based care, prescribe safely and save money. However, increased use of reminders can lead to alert fatigue. Our study aimed to assess general practitioners' (GPs) and nurse practitioners' (NPs) views on electronic reminders in primary care.DesignA qualitative analysis using semistructured interviews.Setting and participantsFifteen GPs and NP based in general practices located in North-West London and Yorkshire, England.MethodsWe collected data on participants' views on: (1) perceptions of the value of information provided; (2) reminder-related behaviours and (3) how to improve reminders. We carried out a thematic analysis.ResultsParticipants were familiar with reminders in their clinical systems and felt many were important to support their clinical work. However, participants reported, on average, 70% of reminders were ignored. Four major themes emerged: (1) reaction to a reminder, which was mixed and varied by situation. (2) Factors influencing the decision to act on reminders, often related to experience, consultation styles and interests of participants. Time constraints, alert design, inappropriate presentation and litigation were also factors. (3) Negative consequences of using reminders were increased workload or costs and compromising GP and NPs behaviour. (4) Factors relating to improving users' engagement with reminders were prevention of unnecessary reminders through data linkage across healthcare administrative systems or the development of more intelligent algorithms. Participants felt training was vital to effectively manage reminders.ConclusionsGPs and NPs believe reminders are useful in supporting the provision of good quality patient care. Improving GPs and NPs' engagement with reminders centres on further developing their relevance to their clinical practice, which is personalised, considers cognitive workflow and suppresses inappropriate presentation.

Dataset Information

Should the surgeon or the general practitioner (GP) follow up patients after surgery for colon cancer? A randomized controlled trial protocol focusing on quality of life, cost-effectiveness and serious clinical events.

Publications

Should the surgeon or the general practitioner (GP) follow up patients after surgery for colon cancer? A randomized controlled trial protocol focusing on quality of life, cost-effectiveness and serious clinical events.

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