Patient and public involvement in the early stages of clinical trial development: a systematic cohort investigation Involving patients in setting priorities for healthcare improvement: a cluster randomized trial 'The public is too subjective': public involvement at different levels of health-care decision making. A multimedia intervention to enhance recruitment to clinical trials in primary care and community settings: process of development and evaluation Tensions in public health policy: patient engagement, evidence-based public health and health inequalities Improving the reporting of public health intervention research: advancing TREND and CONSORT. A randomized controlled trial of interventions to enhance patient-physician partnership, patient adherence and high blood pressure control among ethnic minorities and poor persons: study protocol NCT00123045 Expanding patient involvement in care. Effects on patient outcomes. Conducting experimental research in marginalised populations: clinical and methodological implications from a mixed-methods randomised controlled trial in Kenya Eliciting public preference for health-care resource allocation in South Korea. Patient-perceived satisfactory improvement (PPSI): Interpreting meaningful change in pain from the patient’s perspective 'More research needed': plugging gaps in the evidence base on health inequalities. Citizen Participation in Patient Prioritization Policy Decisions: An Empirical and Experimental Study on Patients' Characteristics The impact of advertising patient and public involvement on trial recruitment: embedded cluster randomised recruitment trial The impact of different modalities for activating patients in a community health center setting. Changes in enjoyment, self-efficacy, and motivation during a randomized trial to promote habitual physical activity adoption in bariatric surgery patients. Study design attributes influenced patients' willingness to participate in clinical research: a randomized vignette-based study.
Background R and omised controlled trials ( RCTs ) are considered particularly likely to benefit from patient and public involvement ( PPI ) . Decisions made by professional research ers at the outset may go on to have a significant impact on the potential for PPI contributions . Objective To increase knowledge of PPI within the early development of RCTs by systematic ally describing the reported level , nature and acceptability of proposed PPI to the funders . Methods Documentation from the outline application process for all RCTs that received funding from the Health Technology Assessment ( HTA ) Programme 2006–2010 was requested . For each application , data were extracted on trial characteristics , references to PPI in the development of the outline application and funding Board feedback , and plans for PPI in the full application and after the trial was funded . Results 110 applications were eligible with outline applications available for 90 ( 82 % ) . The cohort covered a wide range of interventions and conditions . 54 % ( 49/90 ) provided some information about PPI . 26 ( 28.9 % ) indicated PPI within the development of the outline application itself ; 32 ( 35.6 % ) planned involvement in the full application and 43 ( 48 % ) once the trial was funded . Recruitment at diagnosis and surgical interventions were less likely to describe PPI . Blinded trials and trials in which participants may receive placebo only , more frequently described PPI activity . The HTA commissioning Board feedback rarely referred to PPI . Conclusions Incorporation of PPI within the development of the outline application or specification of plans for future involvement was low . Funder requests for applicants to provide information on PPI and justification for its absence should be welcomed but further research is needed to identify the impact of this on its contributions to research . Comments on PPI by review ers should be directional rather than state that an increase is required . Challenges facing applicants in initiating PPI prior to funding need to be addressed Background Patients are increasingly seen as active partners in healthcare . While patient involvement in individual clinical decisions has been extensively studied , no trial has assessed how patients can effectively be involved in collective healthcare decisions affecting the population . The goal of this study was to test the impact of involving patients in setting healthcare improvement priorities for chronic care at the community level . Methods Design : Cluster r and omized controlled trial . Local communities were r and omized in intervention ( priority setting with patient involvement ) and control sites ( no patient involvement ) . Setting : Communities in a canadian region were required to set priorities for improving chronic disease management in primary care , from a list of 37 vali date d quality indicators . Intervention : Patients were consulted in writing , before participating in face-to-face deliberation with professionals . Control : Professionals established priorities among themselves , without patient involvement . Participants : A total of 172 individuals from six communities participated in the study , including 83 chronic disease patients , and 89 health professionals . Outcomes : The primary outcome was the level of agreement between patients ’ and professionals ’ priorities . Secondary outcomes included professionals ’ intention to use the selected quality indicators , and the costs of patient involvement . Results Priorities established with patients were more aligned with core generic components of the Medical Home and Chronic Care Model , including : access to primary care , self-care support , patient participation in clinical decisions , and partnership with community organizations ( p < 0.01 ) . Priorities established by professionals alone placed more emphasis on the technical quality of single disease management . The involvement intervention fostered mutual influence between patients and professionals , which result ed in a 41 % increase in agreement on common priorities ( 95%CI : + 12 % to + 58 % , p < 0.01 ) . Professionals ’ intention to use the selected quality indicators was similar in intervention and control sites . Patient involvement increased the costs of the prioritization process by 17 % , and required 10 % more time to reach consensus on common priorities . Conclusions Patient involvement can change priorities driving healthcare improvement at the population level . Future research should test the generalizability of these findings to other context s , and assess its impact on patient care . Trial registration The Netherl and s National Trial Register # NTR2496 There are a number of impulses towards public participation in health care decision making including instrumentalist , communitarian , educative and expressive impulses and the desire for increased accountability . There has , however , been little research looking systematic ally at the public 's preferences for being involved in particular types of rationing decisions , nor indeed , has there been a critical examination of the degree of involvement desired by the public . The research reported here uses findings from focus groups and in-depth interviews to explore these questions . Eight focus groups were conducted with a total of 57 informants , four amongst r and omly selected members of the public and four with informants from health and non-health related organisations . Nineteen interviews were conducted to allow the elaboration of focus group comments , to probe views more deeply and to pursue emerging themes . The findings show variations in the willingness of members of the public to be involved in health care decisions and consistency across the different forms of the public as represented by the focus groups with r and omly selected citizens and pre-existing organisations . There was a strong desire in all the groups for the public to be involved both at the system and programme levels , with much less willingness to be involved at the individual level . At the system and programme levels informants generally favoured consultation , without responsibility for decisions , but with the guarantee that their contribution would be heard and that decisions taken following consultation would be explained . At the patient level informants felt that the public should participate only by setting criteria for deciding between potential beneficiaries of treatment . The public has much to contribute , particularly at the system and programme levels , to supplement the inputs of health care professionals Results Nineteen review s were included . Multimedia interventions offer a platform for learning which can include study -specific information ( e.g. study purpose , risks ) , and generic information ( e.g. confidentiality ) . There was evidence that multimedia interventions improved various outcomes including perceived risk , personal choice and feeling informed . PPI forum members and qualitative experts developed study -specific components involving bespoke themes such as investigator details and benefits of participation , and generic information components including informed consent , r and omisation and confidentiality . Existing video clips of patients discussing their experiences of participation were carefully matched to these components This paper examines the proposition that there are considerable tensions between key strategies in health policy — namely , evidence -based approaches to population health improvement , reduction of health inequalities , and public and patient engagement — using ( 1 ) a critical analysis of the intersection of evidence -based public health , patient and public engagement , and health inequalities policies from a social constructionist perspective and ( 2 ) mathematical modelling of paternalistic and shared decision making in the management of hypertension in a r and om age and sex stratified community sample of residents of south east Northumberl and , UK . It is concluded that there may be unintended effects on population health of incongruities in major components of public health policy . Greater public and patient engagement may militate against the disease prevention goals of evidence -based policy , and may better engage sections of the population who already benefit from greater access and better health associated with social status and opportunity , serving to increase inequalities by further marginalising those already suffering from relative exclusion BACKGROUND Evidence -based public health decision-making depends on high quality and transparent accounts of what interventions are effective , for whom , how and at what cost . Improving the quality of reporting of r and omized and non-r and omized study design s through the CONSORT and TREND statements has had a marked impact on the quality of study design s. However , public health users of systematic review s have been concerned with the paucity of synthesized information on context , development and rationale , implementation processes and sustainability factors . METHODS This paper examines the existing reporting frameworks for research against information sought by users of systematic review s of public health interventions and suggests additional items that should be considered in future recommendations on the reporting of public health interventions . RESULTS Intervention model , theoretical and ethical considerations , study design choice , integrity of intervention/process evaluation , context , differential effects and inequalities and sustainability are often overlooked in reports of public health interventions . CONCLUSION Population health policy makers need synthesized , detailed and high quality a priori accounts of effective interventions in order to make better progress in tackling population morbidities and inequalities . Adding simple criteria to reporting st and ards will significantly improve the quality and usefulness of published evidence and increase its impact on public health program planning Background Disparities in health and healthcare are extensively documented across clinical conditions , setting s , and dimensions of healthcare quality . In particular , studies show that ethnic minorities and persons with low socioeconomic status receive poorer quality of interpersonal or patient-centered care than whites and persons with higher socioeconomic status . Strong evidence links patient-centered care to improvements in patient adherence and health outcomes ; therefore , interventions that enhance this dimension of care are promising strategies to improve adherence and overcome disparities in outcomes for ethnic minorities and poor persons . Objective This paper describes the design of the Patient-Physician Partnership ( Triple P ) Study . The goal of the study is to compare the relative effectiveness of the patient and physician intensive interventions , separately , and in combination with one another , with the effectiveness of minimal interventions . The main hypothesis is that patients in the intensive intervention groups will have better adherence to appointments , medication , and lifestyle recommendations at three and twelve months than patients in minimal intervention groups . The study also examines other process and outcome measures , including patient-physician communication behaviors , patient ratings of care , health service utilization , and blood pressure control . Methods A total of 50 primary care physicians and 279 of their ethnic minority or poor patients with hypertension were recruited into a r and omized controlled trial with a two by two factorial design . The study used a patient-centered , culturally tailored , education and activation intervention for patients with active follow-up delivered by a community health worker in the clinic . It also included a computerized , self- study communication skills training program for physicians , delivered via an interactive CD-ROM , with tailored feedback to address their individual communication skills needs . Conclusion The Triple P study will provide new knowledge about how to improve patient adherence , quality of care , and cardiovascular outcomes , as well as how to reduce disparities in care and outcomes of ethnic minority and poor persons with hypertension An intervention was developed to increase patient involvement in care . Using a treatment algorithm as a guide , patients were helped to read their medical record and coached to ask questions and negotiate medical decisions with their physicians during a 20-minute session before their regularly scheduled visit . In a r and omized controlled trial we compared this intervention with a st and ard educational session of equal length in a clinic for patients with ulcer disease . Six to eight weeks after the trial , patients in the experimental group reported fewer limitations in physical and role-related activities ( p less than 0.05 ) , preferred a more active role in medical decision-making , and were as satisfied with their care as the control group . Analysis of audiotapes of physician-patient interactions showed that patients in the experimental group were twice as effective as control patients in obtaining information from physicians ( p less than 0.05 ) . Results of the intervention included increased involvement in the interaction with the physician , fewer limitations imposed by the disease on patients ' functional ability , and increased preference for active involvement in medical decision-making ABSTRACT Experimental studies to test interventions for people living with HIV in low- and middle-income countries are essential to ensure appropriate and effective clinical care . The implication s of study participation on outcome data in such population s have been discussed theoretically , but rarely empirically examined . We aim ed to explore the effects of participating in a r and omised controlled trial conducted in an HIV clinic in Mombasa , Kenya . We report qualitative data from the Treatment Outcomes in Palliative Care trial , which evaluated the impact of a nurse-led palliative care intervention for HIV positive adults on antiretroviral therapy compared to st and ard care . Participants in both arms attended five monthly quantitative data collection appointments . Post-trial exit , 10 control and 20 intervention patients participated in semi-structured qualitative interviews , analysed using thematic analysis . We found benefit attributed to the compassion of the research team , social support , communication , completion of patient reported outcome measures ( PROMs ) and material support ( transport reimbursement ) . Being treated with compassion and receiving social support enabled participants to build positive relationships with the research team , which improved mental health and well-being . Open and non-judgmental communication made participants feel accepted . Participants described how repeated completion of the PROMs was a prompt for reflection , through which they began to help themselves and self-care . Participant reimbursements relieved financial hardship and enabled them to fulfil their social responsibilities , enhancing self-worth . These findings emphasise the importance of compassion , support and effective communication in the clinical encounter , particularly in stigmatised and isolated population s , and the potential of the integration of simple PROMs to improve patient outcomes . Participation in research has unexpected positive benefits for participants , which should be taken into account when design ing research in similar population s. Research ers should be aware of the effects of financial reimbursement and contact with research ers in isolated and impoverished communities OBJECTIVES To identify the principles the public considers important and the trade-offs between different values in health-care re source allocation practice s. METHODS This study approached the issue in both qualitative and quantitative ways . In a qualitative study , two focus groups discussed the issues of re source allocation in health care . To facilitate the discussion , a simple ranking task and a series of pairwise choice practice s were implemented . A discrete choice experiment survey question naire was also administered to a sample of the general population . Attributes and levels were determined through literature review s and the results from the focus group interview . We used a r and om-effect probit model to assess the effects of each attribute . RESULTS Through the focus group interviews , we found strong public support for the principle of equal opportunity . The participants thought that the severity of disease was the most important criterion when setting priorities . The majority supported the idea that the most disadvantaged should have the highest priority even when their health gains are less than those of others . The discrete choice experiment results showed that the severity of disease , health gains , and patients ' socioeconomic status significantly influence their choices , with each parameter having an expected sign . CONCLUSION The results showed that Koreans support not only health maximization but also equal opportunity , fair re source allocation , and e quality Abstract The assessment of clinical ly meaningful changes in  patient‐reported pain  has become increasingly important when interpreting results of clinical studies . However , proposed response criteria , such as the minimal clinical ly important difference , do not correspond with the growing need for information on truly meaningful , individual improvements . The aim of the present study was to investigate satisfactory improvements in pain from the patient ’s perspective . Data were collected in a 2‐week prospect i ve study of 181 arthritis patients treated with a local corticosteroid injection .  Baseline and follow‐up pain were assessed on 100 mm visual analogue scales for pain intensity ( VAS‐PI ) . At baseline , patients also marked a hypothetical level on a VAS‐PI representing a satisfactory improvement in pain . Patient‐perceived satisfactory improvement ( PPSI ) was constructed using a 5‐point categorical rating of change scale at follow‐up as the anchor . PPSI was associated with a minimal reduction of 30 mm or 55 % on the VAS‐PI . Since absolute change in pain associated with satisfactory improvement proved highly dependent on baseline pain , percent change scores performed better in classifying improved patients . The 55 % threshold for satisfactory improvement was consistent over the course of treatment and reasonably consistent across groups of patients . Our data suggest that PPSI is a clinical ly relevant and stable concept for interpreting truly meaningful improvements in pain from the individual perspective Policymakers and public health research ers have dem and ed better evidence of the effects of interventions on public health and health inequalities and have pointed to the relative absence of rigorous outcome evaluations in this area . While most of these commentators agree that health inequalities are a problem , the means of tackling them often seems to rest on poor evidential foundations . This is no longer surprising , as the problem has been well-documented and the solution probably seems clear : if there is not enough evidence , then obviously we need more ; and if the evidence is ‘ weak ’ , well , then , it just needs to be ‘ stronger ’ in future . The funding environment in the UK , at least , is supportive of the production of this new , stronger evidence , with several new funding initiatives which are aim ing to foster the production of new evaluations of public health interventions . However , it might be useful to consider further what ‘ more evidence ’ might look like ( that is , what sort of evidence is needed ) and how might it be ‘ stronger ’ than in the past and also to consider what additional challenges collecting this new evidence might bring . It is clear that evidence on the effectiveness and cost-effectiveness of public health interventions is often missing . Sometimes this is because policies are insufficiently subjected to outcome evaluation , perhaps because it is assumed that they are mostly beneficial and any positive outcomes can be taken as read . R and omized controlled trials of policies are particularly uncommon and there are a variety of real and perceived barriers to trials . This means that the public are frequently ‘ enrolled ’ in real-life policy ‘ experiments ’ without giving their explicit consent , or indeed without any real prospect of anyone learning anything substantial about the effects of those interventions . Although the experimental nature of most policies is generally unacknowledged , this is not always the Health systems worldwide are grappling with the need to control costs to maintain system viability . With the combination of worsening economic conditions , an aging population and reductions in tax revenues , the pressures to make structural changes are expected to continue growing . Common cost control mechanisms , e.g. curtailment of patient access and treatment prioritization , are likely to be adversely viewed by citizens . It seems therefore wise to include them in the decision making processes that lead up to policy changes . In the context of a multilevel iterative mixed- method design a quantitative survey representative of the German population ( N = 2031 ) was conducted to probe the acceptance of priority setting in medicine and to explore the practicability of direct public involvement . Here we focus on preferences for patients ' characteristics ( medical aspects , lifestyle and socio-economic status ) as possible criteria for prioritizing medical services . A question naire with closed response options was fielded to gain insight into attitudes toward broad prioritization criteria of patient groups . Furthermore , a discrete choice experiment was used as a rigorous approach to investigate citizens ' preferences toward specific criteria level in context of other criteria . Both the question naire and the discrete choice experiment were performed with the same sample . The citizens ' own health and social situation are included as explanatory variables . Data were evaluated using corresponding analysis , contingency analysis , logistic regression and a multinomial exploded logit model . The results show that some medical criteria are highly accepted for prioritizing patients whereas socio-economic criteria are rejected Background Patient and public involvement in research ( PPIR ) may improve trial recruitment rates , but it is unclear how . Where trials use PPIR to improve design and conduct , many do not communicate this clearly to potential participants . Better communication of PPIR might encourage patient enrolment , as trials may be perceived as more socially valid , relevant and trustworthy . We aim ed to evaluate the impact on recruitment of directly advertising PPIR to potential trial participants . Methods This is a cluster trial , embedded within a host trial ( ‘ EQUIP ’ ) recruiting service users diagnosed with severe mental illness . The intervention was informed by a systematic review , a qualitative study , social comparison theory and a stakeholder workshop including service users and carers . Adopting Participatory Design approaches , we co- design ed the recruitment intervention with PPIR partners using a leaflet to advertise the PPIR in EQUIP and sent potential participants invitations with the leaflet ( intervention group ) or not ( control group ) . Primary outcome was the proportion of patients enrolled in EQUIP . Secondary outcomes included the proportions of patients who positively responded to the trial invitation . Results Thirty-four community mental health teams were r and omised and 8182 service users invited . For the primary outcome , 4 % of patients in the PPIR group were enrolled versus 5.3 % of the control group . The intervention was not effective for improving recruitment rates ( adjusted OR = 0.75 , 95 % CI = 0.53 to 1.07 , p = 0.113 ) . For the secondary outcome of positive response , the intervention was not effective , with 7.3 % of potential participants in the intervention group responding positively versus 7.9 % of the control group ( adjusted OR = 0.74 , 95 % CI = 0.53 to 1.04 , p = 0.082 ) . We did not find a positive impact of directly advertising PPIR on any other outcomes . Conclusion To our knowledge , this is the largest ever embedded trial to evaluate a recruitment or PPIR intervention . Advertising PPIR did not improve enrolment rates or any other outcome . It is possible that rather than advertising PPIR being the means to improve recruitment , PPIR may have an alternative impact on trials by making them more attractive , acceptable and patient-centred . We discuss potential reasons for our findings and implication s for recruitment practice and research .Trial registration numbersIS RCT N , IS RCT N16488358 . Registered on 14 May 2014 . Study Within A Trial , SWAT-26 . Registered on 21 January 2016 OBJECTIVE Decision aids are design ed to assist patients in underst and ing their health care choices but lower SES population s are less activated and may not be prepared to benefit . Activating interventions may help prepare patients for using decision aids . METHODS We evaluated the impact of a decision aid video ( DA ) and the Patient Activation Intervention ( PAI ) on patient 's level of activation measured by the Patient Activation Measure ( PAM ) and their decision-making confidence measured by the decision self-efficacy ( DSE ) scale .  Patients were r and omized into control , PAI alone , DA alone , and DA+PAI groups . RESULTS PAM and DSE scores increased significantly in all groups with repeated measures . Restricting analyses to those with pre-intervention PAM scores at stages 1 or 2 , the change in PAM scores was significant only for the intervention groups . The change in DSE scores was significantly only in the DA group . CONCLUSION These findings provide support for the utility of the DA , the PAI , and the DA+PAI in activating lower SES individuals . The DA alone changed DSE scores in the least activated patients while the PAI and DA both changed PAM scores . PRACTICE IMPLICATION S Interventions directed at increasing patient engagement in their care may be useful particularly for less activated patients from lower SES population BACKGROUND The Bari-Active trial found that a physical activity ( PA ) intervention ( PAI ) , versus st and ard presurgical care control ( SC ) , produced significant increases in daily bout-related moderate-to-vigorous PA ( MVPA , in≥10-min bouts ) preoperatively . The present study examined whether PAI also produces superior improvements in psychological and /or motivational processes that may be important for PA adoption . OBJECTIVES Compare PAI and SC on baseline to postintervention changes in PA-related enjoyment , self-efficacy , and motivations , and examine whether greater bout-related MVPA changes are associated with greater improvements in these variables . SETTING University hospital , United States . METHODS Participants ( 87 % female ; body mass index = 45.0±6.5 kg/m(2 ) ) were r and omly assigned to 6 weeks of PAI ( n = 40 ) or SC ( n = 35 ) . PAI received weekly counseling sessions to increase daily walking exercise . At baseline and postintervention , both groups completed 7-day objective PA monitoring and question naires to evaluate changes in bout-related MVPA and PA enjoyment , self-efficacy , and motivation . RESULTS Retention was 84 % at postintervention . Intent-to-treat analyses showed that PAI on average reported more favorable changes than SC in PA enjoyment , self-efficacy , amotivation ( i.e. , lack of PA motivation ) , and identified and intrinsic regulations ( i.e. , more autonomous PA motivations ; P<.01 ) . In PAI completers ( n = 33 ) , changes in bout-related MVPA and psychological/motivational variables were unrelated . CONCLUSION PAI produced greater improvements in PA-related enjoyment , self-efficacy , and motivations  than SC . The lack of association between objective ly measured PA changes and psychological/motivational processes highlights the need for future research to identify which processes are most important for PA adoption and maintenance in bariatric surgery patients , and to determine whether the method used to measure PA affects the pattern of association OBJECTIVE To identify characteristics of clinical research projects that influence patients '  willingness to participate in research . STUDY DESIGN AND SETTING We surveyed all patients discharged during 1 month from a Swiss public teaching hospital . We described four hypothetical studies and asked patients whether they would agree to participate . We r and omly manipulated three study attributes in each vignette , using a factorial design . RESULTS All studies were not equally acceptable to the 1,277 respondents . A higher willingness to participate was found when a new drug had no side effects , no additional visit was required , balanced information was given , results were in the public domain , and the project was approved by a research ethics committee . In contrast , destruction of blood sample s at the end of the project , use of placebo controls , and r and om allocation to study arms were associated with a lower likelihood of participation . The origin of funds , financial reward , the need to complete a question naire , and clinical vs. economic purpose of the study did not influence willingness to participate . CONCLUSION Patients valued safety , convenience , oversight , and open communication in research . However , they were put off by some aspects that are valued by health care professionals . Educating the public about research methods may improve participation
The review revealed the most common stage for PPI was in research planning , and the most common level of involvement was collaboration .
Most studies did not provide evidence of effectiveness or elaborate on the impact of PPI , and they tended to report impact from the research er 's perspective .
Where impact was mentioned , this generally related to increased relevance to the community , empowerment of participants and alterations in study design .
OBJECTIVES Patient and public involvement ( PPI ) is argued to lead to higher quality health research , which is more relatable to and helps empower the public .
We synthesis ed the evidence to look for examples of PPI in health research in low/middle-income countries ( LMICs ) , looking at levels of involvement and impact .
Additionally , we considered the impact of who was undertaking the research on the level of involvement and reported impact .