General practice vs surgical-based follow-up for patients with colon cancer: randomised controlled trial.
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ABSTRACT:
SUBMITTER: Wattchow DA
PROVIDER: S-EPMC2361245 | biostudies-other | 2006 Apr
REPOSITORIES: biostudies-other
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Project description:General Practitioners (GPs) play an important role in the follow-up of patients after deliberate self-poisoning (DSP). The aim was to examine whether structured follow-up by GPs increased the content of, adherence to, and satisfaction with treatment after discharge from emergency departments.This was a multicentre, randomised trial with blinded assignment. Five emergency departments and general practices in the catchment area participated. 202 patients discharged from emergency departments after DSP were assigned. The intervention was structured follow-up by the GP over a 6-month period with a minimum of five consultations, accompanied by written guidelines for the GPs with suggestions for motivating patients to follow treatment, assessing personal problems and suicidal ideation, and availability in the case of suicidal crisis. Outcome measures were data retrieved from the Register for the control and payment of reimbursements to health service providers (KUHR) and by questionnaires mailed to patients and GPs. After 3 and 6 months, the frequency and content of GP contact, and adherence to GP consultations and treatment in general were registered. Satisfaction with general treatment received and with the GP was measured by the EUROPEP scale.Patients in the intervention group received significantly more consultations than the control group (mean 6.7 vs. 4.5 (p = 0.004)). The intervention group was significantly more satisfied with the time their GP took to listen to their personal problems (93.1% vs. 59.4% (p = 0.002)) and with the fact that the GP included them in medical decisions (87.5% vs. 54. 8% (p = 0.009)). The intervention group was significantly more satisfied with the treatment in general than the control group (79% vs. 51% (p = 0.026)).Guidelines and structured, enhanced follow-up by the GP after the discharge of the DSP patient increased the number of consultations and satisfaction with aftercare in general practice. Consistently with previous research, there is still a need for interventional studies.ClinicalTrials.gov Identifier: NCT01342809. Registered 18 April 2011.
| S-EPMC4604741 | biostudies-literature
Project description:ObjectiveTo examine the effectiveness of post-diagnosis dementia treatment and coordination of care by memory clinics compared with general practitioners.DesignMulticentre randomised controlled trial.SettingNine memory clinics and 159 general practitioners in the Netherlands.Participants175 patients with a new diagnosis of mild to moderate dementia living in the community and their informal caregivers.InterventionsUsual care provided by memory clinic or general practitioner.Main outcome measuresCaregiver rated quality of life of the patient measured with the quality of life in Alzheimer's disease instrument and self perceived burden of the informal caregiver measured with the sense of competence questionnaire (intention to treat analysis).ResultsThe quality of life of the patients in the memory clinic group was 0.5 (95% confidence interval -0.7 to 1.6) points higher than in the general practitioner group. Caregivers' burden was 2.4 (-5.8 to 1.0) points lower in the memory clinic group than in the general practitioner group.ConclusionNo evidence was found that memory clinics were more effective than general practitioners with regard to post-diagnosis treatment and coordination care for patients with dementia. Without further evidence on the effectiveness of these modalities, other arguments, such as cost minimisation, patients' preferences, or regional health service planning, can determine which type of dementia care is offered.Trial registrationClinical trials NCT00554047.
| S-EPMC3352696 | biostudies-literature
Project description:There are no universally accepted guidelines for the follow-up of individuals with cutaneous melanoma. Furthermore, to date, there have been no randomised controlled trials of different models of melanoma follow-up care. This randomised controlled trial was conducted to evaluate the effects of GP-led melanoma follow-up on patient satisfaction, follow-up guideline compliance, anxiety and depression, as well as health status.A randomised controlled trial of GP-led follow-up of cutaneous melanoma was conducted over a period of 1 year with assessment by self-completed questionnaires and review of general practice-held medical records at baseline and 12 months later. It took place in 35 general practices in North-east Scotland. Subjects were 142 individuals (51.4% women 48.6% men; mean (s.d.) age 59.2 (15.2) years previously treated for cutaneous melanoma and free of recurrent disease. The intervention consisted of protocol-driven melanoma reviews in primary care, conducted by trained GPs and supported by centralised recall, rapid access pathway to secondary care and a patient information booklet. The main outcome measure was patient satisfaction measured by questionnaire. Secondary outcomes were adherence to guidelines, health status measured by Short Form-36 and the Hospital Anxiety and Depression Scale.There were significant improvements in 5 out of 15 aspects of patient satisfaction during the study year in those receiving GP-led melanoma follow-up (all P<or=0.01). The intervention group was significantly more satisfied with 7 out of 15 aspects of care at follow-up after adjustment for potential confounders. There was significantly greater adherence to guidelines in the intervention group during the study year. There was no significant difference in health status or anxiety and depression between intervention and control groups at either baseline or outcome.GP-led follow-up is feasible, engenders greater satisfaction in those patients who receive it, permits closer adherence to guidelines and does not result in adverse effects on health status or anxiety and depression when compared with traditional hospital-based follow-up for melanoma.
| S-EPMC2869159 | biostudies-other
Project description:To assess whether systematic follow-up by general practitioners (GPs) of cases of deliberate self-poisoning (DSP) by their patients decreases psychiatric symptoms and suicidal behaviour compared with current practice.Randomised clinical trial with two parallel groups.General practices in Oslo and the eastern part of Akershus County.Patients aged 18-75 years admitted to hospital for DSP. We excluded patients diagnosed with psychoses, without a known GP, those not able to complete a questionnaire, and patients admitted to psychiatric in-patient care or other institutions where their GP could not follow them immediately after discharge.The GPs received a written guideline, contacted the patients and scheduled a consultation within one week after discharge, and then provided regular consultations for six months. We randomised the patients to either intervention (n = 78) or treatment as usual (n = 98).Primary outcome measure was the Beck Scale for Suicide Ideation (SSI). Secondary outcomes were Beck Depression Inventory (BDI) and Beck Hopelessness Scale (BHS), self-reported further self-harm and treatment for DSP in a general hospital or an emergency medical agency (EMA). We assessed patients on entry to the trial and at three and six months. We collected data from interviews, self-report questionnaires, and hospital and EMA medical records.There were no significant differences between the groups in SSI, BDI, or BHS mean scores or change from baseline to three or six months. During follow-up, self-reported DSP was 39.5% in the intervention group vs. 15.8% in controls (P = 0.009). Readmissions to general hospitals were similar (13% in both groups (P = 0.963), while DSP episodes treated at EMAs were 17% in the intervention group and 7% in the control group (P = 0.103).Structured follow-up by GPs after an episode of DSP had no significant effect on suicide ideation, depression or hopelessness. There was no significant difference in repeated episodes of DSP in hospitals or EMAs. However, the total number of incidents of deliberate self-harm reported by the patients was significantly higher in the intervention group.Trial registration ClinicalTrials.gov Identifier: NCT01342809.
| S-EPMC4667913 | biostudies-literature
Project description:BackgroundThe CORONIS trial reported differences in short-term maternal morbidity when comparing five pairs of alternative surgical techniques for caesarean section. Here we report outcomes at 3 years follow-up.MethodsThe CORONIS trial was a pragmatic international 2 × 2 × 2 × 2× 2 non-regular fractional, factorial, unmasked, randomised controlled trial done at 19 sites in Argentina, Chile, Ghana, India, Kenya, Pakistan, and Sudan. Pregnant women were eligible if they were to undergo their first or second caesarean section through a planned transverse abdominal incision. Women were randomly assigned by a secure web-based allocation system to one intervention from each of the three assigned pairs. All investigators, surgeons, and participants were unmasked to treatment allocation. In this follow-up study, we compared outcomes at 3 years following blunt versus sharp abdominal entry, exteriorisation of the uterus for repair versus intra-abdominal repair, single versus double layer closure of the uterus, closure versus non-closure of the peritoneum, and chromic catgut versus polyglactin-910 for uterine repair. Outcomes included pelvic pain; deep dyspareunia; hysterectomy and outcomes of subsequent pregnancies. Outcomes were assessed masked to the original trial allocation. This trial is registered with the Current Controlled Trials registry, number ISRCTN31089967.FindingsBetween Sept 1, 2011, and Sept 30, 2014, 13,153 (84%) women were followed-up for a mean duration of 3·8 years (SD 0·86). For blunt versus sharp abdominal entry there was no evidence of a difference in risk of abdominal hernias (adjusted RR 0·66; 95% CI 0·39-1·11). We also recorded no evidence of a difference in risk of death or serious morbidity of the children born at the time of trial entry (0·99, 0·83-1·17). For exteriorisation of the uterus versus intra-abdominal repair there was no evidence of a difference in risk of infertility (0·91, 0·71-1·18) or of ectopic pregnancy (0·50, 0·15-1·66). For single versus double layer closure of the uterus there was no evidence of a difference in maternal death (0·78, 0·46-1·32) or a composite of pregnancy complications (1·20, 0·75-1·90). For closure versus non-closure of the peritoneum there was no evidence of a difference in any outcomes relating to symptoms associated with pelvic adhesions such as infertility (0·80, 0·61-1·06). For chromic catgut versus polyglactin-910 sutures there was no evidence of a difference in the main comparisons for adverse pregnancy outcomes in a subsequent pregnancy, such as uterine rupture (3·05, 0·32-29·29). Overall, severe adverse outcomes were uncommon in these settings.InterpretationAlthough our study was not powered to detect modest differences in rare but serious events, there was no evidence to favour one technique over another. Other considerations will probably affect clinical practice, such as the time and cost saving of different approaches.FundingUK Medical Research Council and the Department for International Development.
| S-EPMC4930950 | biostudies-literature
Project description:Randomised controlled clinical trials typically have a relatively brief in-trial follow-up period which can underestimate safety signals and fail to detect long-term hazards, which may take years to appear. Extended follow-up after the scheduled closure of the trial allows detection of both persistent or enhanced beneficial effects following cessation of study treatment (i.e. a legacy effect) and the emergence of possible adverse effects (e.g. development of cancer).A systematic review was conducted following PRISMA guidelines to qualitatively compare post-trial follow-up methods used in large randomised controlled trials. Five bibliographic databases, including Medline and the Cochrane Library, and one trial registry were searched. All large randomised controlled trials (more than 1000 adult participants) published from March 2006 to April 2017 were evaluated. Two reviewers screened and extracted data attaining >?95% concordance of papers checked. Assessment of bias in the trials was evaluated using the Cochrane Risk of Bias tool.Fifty-seven thousand three hundred and fifty-two papers were identified and 65 trials which had post-trial follow-up (PTFU) were included in the analysis. The majority of trials used more than one type of follow-up. There was no evidence of an association between the retention rates of participants in the PTFU period and the type of follow-up used. Costs of PTFU varied widely with data linkage being the most economical. It was not possible to assess associations between risk of bias during the in-trial period and proportions lost to follow-up during the PTFU period.Data captured during the post-trial follow-up period can add scientific value to a trial. However, there are logistical and financial barriers to overcome. Where available, data linkage via electronic registries and records is a cost-effective method which can provide data on a range of endpoints.Not applicable for PROSPERO registration.
| S-EPMC5975470 | biostudies-other
Project description:IntroductionThrough addressing main barriers to the uptake of long-acting reversible contraceptives (LARCs) among Australian women, the Australian Contraceptive ChOice pRoject (ACCORd) trialled an educational intervention targeting general practitioners (GPs) and provided those in the intervention group with a rapid referral service for quick insertion. The cluster randomised controlled trial resulted in greater uptake of LARC in the intervention group. This protocol paper describes a longitudinal follow-up to the ACCORd Study to assess the long-term efficacy and cost-effectiveness of the intervention.Methods and analysisWomen participants (patients of ACCORd GPs) completed a baseline, 6-month and 12-month survey. These participants will be invited to complete an additional follow-up survey 3 years post completion of their baseline interview. Based on the original ACCORd Study tools, the online survey will address long-term outcomes including contraceptive continuation rates and reproductive history, any unintended pregnancies, satisfaction and concerns with their current contraceptive method, and an assessment of quality of life. We will analyse data using binary regression models with generalised estimating equations and robust standard errors to account for clustering.DiscussionDemonstration of sustained use, effectiveness at reducing unwanted pregnancies and cost-effectiveness of this strategy among this cohort of Australian primary care patients, will strengthen the policy and programme urgency of addressing wider dissemination of these strategies and replicating the study elsewhere.Ethics and disseminationThe ACCORd Study received approval from the Monash University Human Research Ethics Committee: CF16/188-201000080. Additionally, an amendment to conduct this 3-year longitudinal follow-up survey has been approved. The trial follow-up outcomes will be disseminated through formal academic pathways, including journal articles, national and international conferences and reports as well as using more 'mainstream' strategies such as seminars, workshops and media engagement. Additionally, outcomes will be communicated through policy briefs to Australian state and federal governments.Trail registration numberThis trial is registered with the Australian and New Zealand Trials Registry ACTRN12615001346561. Recruitment and data collection have been completed for the baseline, 6-month and 12-month surveys. Data collection for the 3-year survey commenced in August 2019.
| S-EPMC7509957 | biostudies-literature
Project description:BackgroundSCORE is the first randomised controlled trial (RCT) to examine shared oncologist and general practitioner (GP) follow-up for survivors of colorectal cancer (CRC). SCORE aimed to show that shared care (SC) was non-inferior to usual care (UC) on the EORTC QLQ-C30 Global Health Status/Quality of Life (GHQ-QoL) scale to 12 months.MethodsThe study recruited patients from five public hospitals in Melbourne, Australia between February 2017 and May 2021. Patients post curative intent treatment for stage I-III CRC underwent 1:1 randomisation to SC and UC. SC replaced two oncologist visits with GP visits and included a survivorship care plan and primary care management guidelines. Assessments were at baseline, 6 and 12 months. Difference between groups on GHQ-QoL to 12 months was estimated from a mixed model for repeated measures (MMRM), with a non-inferiority margin (NIM) of -10 points. Secondary endpoints included quality of life (QoL); patient perceptions of care; costs and clinical care processes (CEA tests, recurrences). Registration ACTRN12617000004369p.Findings150 consenting patients were randomised to SC (N = 74) or UC (N = 76); 11 GPs declined. The mean (SD) GHQ-QoL scores at 12 months were 72 (20.2) for SC versus 73 (17.2) for UC. The MMRM mean estimate of GHQ-QoL across the 6 month and 12 month follow-up was 69 for SC and 73 for UC, mean difference -4.0 (95% CI: -9.0 to 0.9). The lower limit of the 95% CI did not cross the NIM. There was no clear evidence of differences on other QoL, unmet needs or satisfaction scales. At 12 months, the majority preferred SC (40/63; 63%) in the SC group, with equal preference for SC (22/62; 35%) and specialist care (22/62; 35%) in UC group. CEA completion was higher in SC. Recurrences similar between arms. Patients in SC on average incurred USD314 less in health costs versus UC patients.InterpretationSC seems to be an appropriate and cost-effective model of follow-up for CRC survivors.FundingVictorian Cancer Agency and Cancer Australia.
| S-EPMC10716007 | biostudies-literature
Project description:BackgroundIntermittent claudication (IC) is a classic symptom of peripheral arterial disease, and strongly associated with coronary heart disease and cerebrovascular disease. Treatment of IC and secondary prevention of vascular events include best medical treatment (BMT), changes in lifestyle, most importantly smoking cessation and increased physical exercise, and in appropriate cases surgery. A person-centred and health promotion approach might facilitate breaking barriers to lifestyle changes and increasing adherence to secondary prevention therapy. The FASTIC study aims to evaluate a nurse-led, person-centred, health-promoting follow-up programme compared with standard follow-up by a vascular surgeon after surgical treatment for IC.MethodsThe FASTIC-study is a multicentre randomised controlled clinical trial. Patients will be recruited from two hospitals in Stockholm, Sweden after surgical treatment of IC through open and/or endovascular revascularisation and will be randomly assigned into two groups. The intervention group is offered a nurse-led, person-centred, health-promoting programme, which includes two telephone calls and three visits to a vascular nurse the first year after surgical treatment. The control group is offered standard care, which consists of a visit to a vascular surgeon 4-8 weeks after surgery and a visit to the outpatient clinic 1 year after surgical treatment. The primary outcome is adherence to BMT 1 year after surgical treatment and will be measured using The Swedish Prescribed Drug Registry. Clinical assessments, biomarkers, and questionnaires will be used to evaluate several secondary outcomes, such as predicted 10-year risk of cardiovascular and cerebrovascular events, health-related quality of life, and patients' perceptions of care quality.DiscussionThe FASTIC study will provide important information about interventions aimed at improving adherence to medication, which is an unexplored field among patients with IC. The study will also contribute to knowledge on how to implement person-centred care in a clinical context.Trial registrationClinicalTrials.govNCT03283358, registration date 06/13/2016.
| S-EPMC7271447 | biostudies-literature
Project description:PurposeThe aim of this study was to determine if there were any differences in health-related outcomes and physical activity (PA) between the two OptiTrain exercise groups and usual care (UC), 2 years post-baseline.MethodsThe OptiTrain study was a three-arm randomised controlled trial comparing 16 weeks of concurrent aerobic high-intensity interval training (HIIT) and progressive resistance exercise (RT-HIIT) or concurrent HIIT and continuous moderate-intensity aerobic exercise (AT-HIIT) to UC in 206 patients with breast cancer undergoing chemotherapy. Eligible participants were approached 2 years following baseline to assess cancer-related fatigue, quality of life, symptoms, muscle strength, cardiorespiratory fitness, body mass, PA, sedentary behaviour, and sick leave.ResultsThe RT-HIIT group reported lower total cancer-related fatigue, (- 1.37, 95% CI - 2.70, - 0.04, ES = - 0.06) and cognitive cancer-related fatigue (- 1.47, 95% CI - 2.75, - 0.18, ES = - 0.28), and had higher lower limb muscle strength (12.09, 95% CI 3.77, 20.40, ES = 0.52) than UC at 2 years. The AT-HIIT group reported lower total symptoms (- 0.23, 95% CI - 0.42, - 0.03, ES = - 0.15), symptom burden (- 0.30, 95% CI - 0.60, - 0.01, ES = - 0.19), and body mass - 2.15 (- 3.71, - 0.60, ES = - 0.28) than UC at 2 years.ConclusionAt 2 years, the exercise groups were generally experiencing positive differences in cancer-related fatigue (RT-HIIT), symptoms (AT-HIIT), and muscle strength (RT-HIIT) to UC. The findings provide novel evidence that being involved in an exercise program during chemotherapy can have long-term benefits for women with breast cancer, but that strategies are needed to create better pathways to support patients to maintain physical activity levels.Trial registrationClinicaltrials.gov registration number: NCT02522260. Trial registered on 9 June 2015. https://clinicaltrials.gov/ct2/show/NCT02522260 . Retrospectively registered.
| S-EPMC6534518 | biostudies-literature