130 Communications Handbook for Clinical Trials

Transcription

1 130 Commuicatios Hadbook for Cliical Trials

2 Chapter Commuicatig Sciece Clearly 8 Misuderstadigs about scietific research ca happe for may reasos. For example: I this chapter I. Why research is ecessary Scietists ofte use techical jargo. Some words such as sigificace ad trial have differet meaigs i a scietific cotext tha they do i everyday usage. II. III. Traslatig the laguage of cliical trials Demystifyig statistics Fudametal cocepts radomizatio, doubleblid trial, efficacy are ot commoly uderstood. Some terms like hazard ratio caot be easily traslated ito other laguages. IV. Five ways to avoid misuderstadigs Fortuately, whether you a researcher, commuity liaiso officer, or advocate, there are ways to make sure you are commuicatig scietific cocepts clearly. Aita Khemka Research teams ca reduce the chace of a misuderstadig by payig attetio to how commuities talk about these issues ad by followig some simple guidelies to commuicate more clearly. This chapter provides guidace o how to talk to differet audieces about cliical research. I Why research is ecessary Geoff Oliver Bugbee/IPM As someoe ivolved i cliical trials, you may take it for grated that medical research is importat. But may people do ot have a clear uderstadig of why cliical ad behavioral studies are eeded. Explaiig the eed for research is crucial for the clear commuicatio of scietific iformatio. Cliical trials ofte stregthe local laboratory capacity. A lab techicia works i the lab at the Mvita Cliic, a IPM research ceter, i Mombasa, Keya. A health worker i Tamil Nadu, Idia, speaks to me at a trai statio about HIV testig. 131

3 Cosider these guidelies whe you covey scietific ideas: Guidelie 1. Emphasize the health impact of your research. How will your study potetially beefit the health of the geeral public? Clearly statig the potetial health impact of the research is oe way to show how studies provide ecessary evidece for health itervetios. For example: This study is explorig how to develop a easy way for wome to protect themselves agaist HIV. Curretly, there is o malaria vaccie o the market. This study could help create a vaccie that could save millios of lives each year. Our research is tryig to fid out how well a ew drug ca reduce respiratory problems i childre with chroic asthma. If we fid out it works, this could help thousads of youg people participate more fully i daily activities. Guidelie 2. Show how your study fits ito the bigger picture of public health eeds ad research. Explaiig the coectio betwee your work ad the big picture of public health ca help others to see your team as part of the global commuity of scietists. People will come to appreciate that their ivolvemet i the study has value. For example, if you are about to start a HIV prevetio trial, you will eed to talk about HIV/ AIDS i the commuity perhaps by providig a simple explaatio of prevalece ad icidece. Begi by askig, How have people i your commuity (or tow, district, coutry) bee affected by the virus? Respod to their stories with iformatio about the umbers of people locally, atioally, ad globally who were ifected with the virus i the past year, are livig with HIV, or have died of AIDS. Explai how research has helped to fid better ways to care for people who are ifected with HIV by, for example, esurig the safety of drugs that are used for treatmet. Discuss how your study might address the epidemic i the commuity ad worldwide. Guidelie 3. Explai that all research asks a questio. Wheever you talk about a research study, poit out that the research team does ot kow what the results will be. All research tests a hypothesis, ad o matter what the result, the study will add to our kowledge about how to prevet or treat the disease. Whe commuities uderstad that o oe has the aswer, researchers ad commuity members ca appreciate their shared purpose ad feel solidarity with oe aother. For example: We do ot kow if this medicie works, so we are doig this study because we wat to fid out whether it ca help protect childre from diarrhea. We kow this vaccie protects mice agaist iflueza. Our study is tryig to fid out whether the vaccie ca also protect humas. 132 Commuicatios Hadbook for Cliical Trials

4 Aita Khemka To see if your messages are clear ad easy to uderstad, try them with people who fit the profile of your iteded audiece. Pictured here is a peer educator coductig a group discussio o HIV i New Delhi, Idia. Guidelie 4. Explai why the study is beig coducted i that particular commuity. Provide a hoest explaatio of why their commuity was chose. It is importat to explai that the scietists are tryig to solve a problem i the commuity. Commuities that are provided with a specific explaatio are less likely to feel that they are beig exploited by the study. I the case of HIV prevetio trials, for example, oe might say: Large-scale HIV prevetio studies must take place i settigs where the HIV icidece is high ad where prevetio is most eeded. We must esure that products work i this commuity ad are acceptable to residets. Studies must be coducted i areas where there are scietific istitutios ad traied research persoel. Commuities ad coutries hostig studies are cotributig to worldwide progress i prevetig HIV ifectios. Guidelie 5. Provide some backgroud iformatio about your field. Whether you are draftig a press release or preparig a talk for a Miistry of Health, you should be able to explai quickly the purpose ad cotext of your research, icludig the studies that came before. For example: Scietists have bee studyig microbicides for the past 20 years. We have bee gettig better at determiig what might work, ad we recetly discovered problems with certai approaches. This study is the latest step i this process. Guidelie 6. Outlie the process of cliical research. Few people uderstad how much effort, cost, ad prelimiary research is required before ivestigators lauch a large-scale cliical study. Although it is ot ecessary to explai the details about the phases of research, it ca be 133

5 helpful to metio that extesive lab work, aimal testig, ad studies ivolvig small groups of people are coducted for safety ad side effects log before a product or itervetio is tested o a large group of people. Most people ituitively uderstad that a treatmet must be show to be safe before it ca be show to be effective. Poitig out that this priciple is itegral to the structure of all cliical studies helps people to uderstad that scietists strive ot to harm ayoe who voluteers for a study. The research process itself is desiged to miimize risk to participats ad maximize the chace of success. As you explai cliical research, cosider the scietific literacy of your audiece. The same iformatio ca be preseted i may differet ways. The graphic examples below (Figures 8.1 to 8.5), which explai the phases of drug developmet ad cliical research, assume differet levels of reader sophisticatio. A sophisticated audiece ca apprehed a great deal of iformatio i a sigle image. For example, Figures 8.1 ad 8.2 explai the process of drug developmet, icludig the phases of a cliical trial, the success rates of products as they advace through each phase, ad the developmet timelie. Figure 8.1. Explaiig the process of drug discovery to a scietifically literate audiece Reprited with permissio from the Iteratioal Partership for Microbicides, Silver Sprig, MD, The Iteratioal Partership for Microbicides adapted the chart above to explai the process of drug discovery to their doors, a relatively sophisticated audiece. It highlights the umber of cadidate microbicides that are tested at each phase, illustratig that oly the most promisig products move forward ad oly oe safe ad effective product may emerge. Figure 8.2 explais the stages of research more fully. 134 Commuicatios Hadbook for Cliical Trials

6 Figure 8.2 These figures might be too complicated for may audieces. But similar iformatio ca be preseted i a much simpler way. The Global Campaig for Microbicides (GCM) uses a series of mix-ad-match slides to simplify these cocepts for oscietific audieces. The GCM slides demostrate simple ways to reiforce key cocepts, such as the duratio of drug developmet, ad illustrate some optios for providig more or less iformatio depedig o the audiece s scietific literacy. GCM s first slide (Figure 8.3) emphasizes that all experimetal products are tested i the laboratory ad i aimals before they are cosidered for testig i huma beigs. Figure 8.3. Logic of Drug Developmet First tested i the laboratory ad with aimals 1. Does it appear to work? 2. Does it appear safe? Oly the, tested i humas Oly if somethig is show to be safe does it go o to future steps 1. Is it safe i humas? Phase 1 &2 2. Does it work? Phase 3 The secod slide (Figure 8.4) reiforces this otio ad provides a little more iformatio about differet the phases of a cliical trial. 135

7 Figure 8.4. Microbicide, Vaccie & Drug Developmet I the lab Does it have activity agaist the virus or microbe? Does it hurt cells? Aimal Does it appear to prevet ifectio? Are their bad side effects? Huma (cliical) (Active product v. fake product) Phase 1: Is it safe for low risk idividuals to use Phase 2: Is it safe for use amog higher risk or sicker idividuals? Is there ay evidece that it may work? Phase 3: Does it really work to prevet or treat disease? 10+ Years A alterative slide (Figure 8.5) provides additioal iformatio o the duratio of each phase ad the reductio of viable products with each successive phase. Figure 8.5. Research Pipelie i products Laboratory Testig 2-6 Years 5 products 9 products Phase 1 (safety) 1 Year Phase 2 (Expaded safety) 2 Years 3 products Phase 2b/3 (effectiveess) 3.5 Years Phase 1 ad 2 trials amog HIV+, peile & rectal studies 10 + Years 10+ Years Guidelie 7. Frame research as servig the commo good. Wheever you talk about your study, emphasize the positive outcomes of medical research. For example, flu shots, medicatios to treat HIV, cotraceptive pills, tetaus shots, ad the eradicatio of smallpox are all public health successes of medical research. Emphasize that your study also hopes to fid aswers to health problems. Remid listeers that public health research has always bee a global effort. Highlight that the same product may be tested i umerous safety studies i the Uited States ad Europe ad the tested i Asia, South America, ad Africa i later-stage trials before it is approved for use ad implemeted at a coutry level. 136 Commuicatios Hadbook for Cliical Trials

8 II Traslatig the laguage of cliical studies The key to writig easy-to-read materials is to get outside of your ow head ad stop thikig about what you kow ad what you thik is importat, ad try to thik of it through somebody else s eyes ad what they will thik is importat to kow ad the write your materials with this audiece i mid. Aa Forbes, former Deputy Director, Global Campaig for Microbicides Researchers sometimes fear that simple explaatios dilute importat scietific cocepts. However, it is essetial to commuicate clearly ad credibly with oscietific audieces so that potetial participats, trial commuities, politicias, ad others will uderstad why their support is eeded. Liste to the laguage used by your audiece. Pay attetio to the patters of speech used by people who live ad work where your study is beig coducted. How do local staff members ad jouralists discuss the health issues you pla to study? What words or aalogies do they use? Jouralists care about readability, ad they are careful to use laguage to suit their audiece. I Keya, for example, jouralists ofte refer to the cut whe they write about male circumcisio because that is what Keyas call it. Scietists who are coductig research o male circumcisio ca take this ito accout whe they explai their work to commuity members. A cliicia at a cliic i Cambodia hadles blood specimes. Drawig ad storig blood has raised issues i some commuities. Commuicatig clearly about how blood is hadled i a cliical trial ca be a importat way to allay commuity cocers. 137 Jim Daiels

9 Box 8.1. Replacig jargo with everyday words Jargo Everyday laguage vagial itercourse coitally depedet disihibitio trasmissio acquisitio cocetratio level systemic toxicity serocovert accrual retetio termiate sex whe you have sex take more risks ifect become ifected with stregth side effects become HIV positive participats joiig the study participats stayig i the study ed Traslate scietific terms ito everyday laguage. You ca keep it simple without sacrificig the meaig of a cocept. Some people follow the two-syllable rule (Forbes 2009): questioig the use of all words that have more tha two syllables. Try to replace complicated words with shorter terms or with laguage that is more familiar. (See Box 8.1 for a example of how to replace jargo with everyday words.) You should also be alert to double meaigs. Eve the most commoly used terms i cliical studies ca be misiterpreted. Sometimes a seemigly eutral scietific word or phrase ca have egative cootatios to others or differet meaigs i a local laguage. This ca create stumblig blocks that iterfere with the implemetatio of a study. Box 8.2 demostrates three such istaces that may require a further explaatio from you. Cosider the use of images to tell your story. A illustratio ca do much to explai a cocept. Graphics ca help you trasced laguage differeces ad cultural barriers ad ca make complicated ideas easier to grasp. Of course, the same visual tool may ot be effective for every audiece. See Box 8.3 ad Figure 8.6 for examples of visual aids that are appropriate for lay audieces. 138 Commuicatios Hadbook for Cliical Trials

10 Performig plays is a excellet way to illustrate scietific cocepts. I this photo, youg wome i New Delhi, Idia, act out The Immue System Dace, a activity to help uderstad how HIV is trasmitted. Aita Khemka Box 8.2. Everyday words that ca mislead Come joi our trial! You hold a trial to decide if someoe is iocet or guilty of a crime. Am I i trouble? This is a Phase I safety trial of a ew HIV product. Oh good, the trial will help keep me safe from HIV! We have cesored 30 participats. Why were some participats cesored ad ot allowed to speak? 139

11 Box 8.3. Baobab trees used to explai serodiscordace The Parters i Prevetio (PIP) HIV/HSV Study erolled people who were i serodiscordat relatioships (where oe parter i the couple was HIV positive ad the other was HIV egative). The PIP team eeded to explai the cocept of serodiscordace i a way that could be uderstood by the study s participats i easter ad souther Africa. The team used a image of two baobab trees (left), oe of which is ifested with termites that ca destroy oe or both trees. Parters i Prevetio used the illustratio to show how HIV ca ifect oe or both parters, but that it caot be diagosed without testig. You should also cosider the use of software, such as PowerPoit, which allows you to use compellig photographs, drawigs, ad simple, colorful charts. A good slide has a miimal amout of text. If you use a graph or a chart, make sure that the axes ad the data are clearly labeled. Do ot read aloud from a slide; use it as a outlie, ot a script. Figure 8.6. Experiece of a Phase 3 Participat Family Plaig Codom plus placebo Recruitmet: Participat receives iformatio about the trial. INFORMED CONSENT to be SCREENED Screeig Visit 1: Educatio about the trial, HIV ad pregacy test, STD tests ad treatmet, baselie data collected Screeig Visit 2: Results of tests, couselig, reiforce educatio about trial INFORMED CONSENT to be ENROLLED Raqdomizatio: Participat assiged by chace to a group. Codom plus experimetal gel This slide from GCM provides a visual itroductio to civil society stakeholders of the otio of a radomized cotrolled trial from the perspective of a trial participat. Use props whe you preset scietific iformatio. Props ca help you explai cocepts i a egagig way. Props make a presetatio more iterestig ad memorable (see Box 8.4). 140 Commuicatios Hadbook for Cliical Trials

12 Katie West Slevi/GCM Tabita Mahlagei, commuity educator with the Aurum Istitute of South Africa, participates i a iteractive exercise, Uderstadig the HIV Life Cycle, with a group of trial site staff, CAB members, ad advocates durig a prevetio research literacy traiig coducted by the Global Campaig for Microbicides i Johaesburg, South Africa. Pay attetio to local cotext ad culture. The tools you use to explai your study must be relevat to the commuity. Multisite studies may eed to adapt materials to the eeds of each site (see Box 8.5). Box 8.4. Usig props to explai cliical trial cocepts Cocept Prop Exercise Lesso Placebo Two glasses of water, salt Brig out two glasses of water. Stir salt ito oly oe glass. The glasses will look the same, but oe ow has a active igrediet the salt. Double-blided Two glasses of water, sugar Brig out two glasses of water. Ask someoe from the audiece to pour the sugar i without ayoe else seeig them do it. Ask the audiece to guess which glass has sugar i it. A placebo is a word that refers to somethig that looks like medicie but is t, ad has o effect o the perso who takes it. Neither the participats or the researchers kow which participats are receivig the test drug ad which are receivig the placebo. Radomizatio Pait a cardboard box to look like a die, each side with a differet umber of dots from 1 to 6. Ask each perso to roll the die ad remember the umber that appears o top of the box. Divide the group accordig to these umbers: 1 to 3 o oe side of the room; 4 to 6 o the other. Whe people are radomly assiged to either the itervetio group or the placebo group of a study, the oly determiig factor is chace. 141

13 Box 8.5. The importace of field-testig materials: lessos leared from Orage Farm Whe staff members of the Bophelo Pele Male Circumcisio Project at Orage Farm, South Africa, bega a research study to determie whether adult medical male circumcisio would help to reduce the risk of HIV trasmissio, they were surprised to fid that may me did ot kow whether they were circumcised or ot. The staff quickly prited brochures with photographs of a fully circumcised peis ad a ucircumcised peis, so that me could see the differece. Some commuity members were disturbed seeig photographs of peises i materials. We asked for suggestios of other ways to explai the differeces, ad commuity members suggested that we use drawigs, which were less offesive to them, said Dirk Taljaard, project maager at the Bophelo Pele Male Circumcisio Project. The team immediately revised the materials, ad ow uses drawigs to show the aatomical differeces. Use stories ad aalogies to explai scietific cocepts. Years after people forget facts ad statistics, they will remember a good story, especially if it sparked a momet of uderstadig. Make sure that the aalogies you provide are culturally ad politically appropriate. Here are some examples of arratives that explai certai scietific cocepts: Hypothesis testig. Farmer Bataya has grow maize for five years, ad he ow wats to begi growig millet istead. He is ot sure if the fertilizer that helped to grow his maize will icrease his millet crops. The fertilizer might harm the millet or have o effect o the millet. To fid out for sure, Farmer Bataya must test the fertilizer o his fields. Farmer Bataya decides to plat two separate plots of lad with millet seed. He adds the fertilizer to the first plot ad othig to the secod plot. He ca ow compare the plots directly ad determie if the fertilizer helps the millet grow. If it does, he will apply the kowledge he has leared ad add fertilizer to both plots ext seaso. Moitorig by a Data Safety ad Moitorig Board (DSMB). A mother asks her daughter to make a meal. As the daughter cooks the meal, the mother opes the pot to check if all is goig well. Whe the food is ready, the mother tastes the food before servig the family. Although the daughter (the research team) is cookig the meal (ruig the study), the mother (the DSMB) is there to make sure the food is cooked properly. Differet stregths of the same product. Whe oe part of a trial that was testig a higher stregth of the PRO 2000 microbicide gel was stopped, may people could ot uderstad why a lower dose might work, whe a higher dose was ieffective. Ivestigators bega usig the aalogy of brewig a good pot of tea a popular beverage i most of Africa. They explaied that four tea bags will make the tea taste bitter, whereas tea made with oe bag tastes better. Protocol. A study protocol is like a recipe. Just as a recipe provides a list of igrediets ad the istructios for preparig a dish, research protocols provide all the elemets (product, populatio) ad the pla (study desig) for carryig out a study. 142 Commuicatios Hadbook for Cliical Trials

14 Traslate scietific cocepts ito local laguages. Eve high-level stakeholders who speak Eglish will appreciate hearig ews i their ow laguage. Whe briefig atioal govermet officials, cosider providig backgroud materials ot oly i the official atioal laguage, but i the mai local laguage. Whe traslatig techical termiology ito local laguages, allow eough time for the traslatio ad back-traslatio of importat materials. III Demystifyig statistics The use of umbers ca be challegig whe you wat to commuicate scietific iformatio. Statistics are ofte misreported or misiterpreted by jouralists ad the geeral public. Follow these rules to help them uderstad your study: Simplify umbers. Istead of sayig 51.2 percet, say about half. Be careful with fractios ad proportios. For example, if you say, A vaccie reduced risk by oe-third, may people jump to the coclusio, That must mea that two-thirds of people i the study got ifected! Use umbers ad umerical comparisos that people ca relate to their ow lives. For example: Three out of four wome of childbearig age i Provice Z told us that they curretly do ot wat to get pregat but they have o way to cotrol their fertility. Kow how to explai commo statistical terms. Cosider these examples: Statistical sigificace Short descriptio: If a result is reported as ot statistically sigificat, it meas that the fidig could be due to chace rather tha a real differece betwee groups. Loger explaatio: Whe researchers say that the differece betwee two groups is ot statistically sigificat, they mea that, give the umber of people i the study, they caot be cofidet that ay differece observed reflects a true differece betwee the two groups. This does ot mea that there was o differece. It meas oly that ay differece observed i the sample might be the result of chace. Scietists ted to say that a differece is ot statistically sigificat if the possibility that the differece is merely due to chace is greater tha 5 percet. Cofidece iterval Short descriptio: the rage of values withi which the true value is likely to be; the margi of error for a result. Loger explaatio: Because a trial must limit participatio to a subset of a much larger populace, it ca oly provide a result that is a estimate of what the true effect would be i the broader populatio. To assess the accuracy of this estimate, oe must look at the cofidece iterval, which provides the rage withi which the true effect is likely to lie. The arrower this rage, the more certai researchers are that the estimate is close to beig accurate ad that the same result would be see agai if the trial were repeated. As such, cofidece itervals 143

15 are importat for fully uderstadig the stregth ad reliability of the result, eve oe that is statistically sigificat. Elizabeth T. Robiso/FHI Trials typically use a 95 percet cofidece level (95% CI), meaig that there is a 95 percet chace that the true result lies withi the iterval. For example, if a trial demostrates that a product reduces HIV ifectios by 40 percet, ad the 95% CI is 22 percet to 68 percet, there is a 95 percet chace that the true effectiveess of the product is somewhere withi that rage. Explaiig statistical cocepts i a clear way is oe of the greatest challeges of commuicatig about sciece to lay audieces. Icidece ad prevalece The differece betwee these terms ca be cofusig. Icidece refers to the umber of ew cases of a disease or coditio i a specified time period for example, the umber of people who acquired a illess i a certai regio withi the past year. Icidece is ofte expressed as a percetage. The term is usually used for comparisos, to describe whether the ew cases of a disease are icreasig or decreasig. A researcher might say that the icidece of malaria i commuity X has rise because over the past 12 moths there were 500 ew cases of malaria i the commuity, whereas there were oly 400 ew cases i the previous year. If X commuity has 10,000 people, the icidece of malaria would be 5 percet (500/10,000). Prevalece refers to the total umber or proportio of old ad ew cases i a specified time period for example, the total umber of people i a regio who have a illess at the momet. For a chroic ifectious disease, it would iclude people who are ewly ifected ad people who have bee ifected for several years. Prevalece is ofte expressed as the umber of cases per 100,000 people. A researcher might say that the prevalece of HIV i a city of 1 millio people is 5,000 per 100,000 (or 5 percet) because their estimates suggest that 50,000 people i the city are curretly carryig the virus. It should also be oted that the icidece ad prevalece i a commuity ca be very differet. For example, a commuity may have a high prevalece (i.e., may people livig with HIV) but a low icidece (i.e., very few ew ifectios are occurrig, perhaps because of successful prevetio ad treatmet programs). 144 Commuicatios Hadbook for Cliical Trials

16 Box 8.6. Preset scietific results i simple, clear terms By Dr. Kawago Agot, Director, Impact Research ad Developmet Orgaizatio, ad Pricipal Ivestigator of the Bodo, Keya, site of the FEM-PrEP trial It is so importat to covey research results clearly ad simply. Cocepts like partial efficacy ca be particularly cofusig. This is somethig I have witessed may times. People are very creative i the way they apply math! For example, if a give treatmet is foud to be 50 percet effective, some people might iterpret this to mea that all they eed to do is take double the recommeded dose ad they would be fully protected. I 2007, I was part of a research team that published a scietific paper showig that medically performed male circumcisio is safe ad ca reduce me s risk of HIV ifectio durig vagial sex by about 60 percet (Bailey ad others 2007). Our study was oe of three that foud similar results. The fidigs were excitig, but explaiig them has bee a challege. Everyoe talks about male circumcisio providig 60 percet protectio, but ot everyoe uderstads what it meas. Our attempts at explaiig this statistic have revealed gross misuderstadigs. Oe iterpretatio we ofte hear is that if you have uprotected sex with a ifected parter te times, six of these times you will ot get HIV. Aother iterpretatio is that oce a ma is circumcised, it is okay to have sex with ifected wome as log as he stops or uses a codom after the sixth oe. After we aouced the study results, our research team held umerous dissemiatio meetigs with the media. We foud i oe media traiig workshop that the slides we were usig were difficult for jouralists to uderstad. Oe jouralist dismissed the results as ivalid because the percetage of protectio was ot exactly the same i all of the studies reducig the risk by 51 percet i oe, 59 percet i the secod, ad 60 percet i the third. To correct this misuderstadig, we took great care to emphasize that eve though the results appeared slightly differet i each of the three coutries where the research was coducted, the differece was egligible ad could be explaied by differeces i populatios targeted by the studies, ot differeces i the effect of circumcisio o HIV ifectio. After three radomized cliical trials showed that male circumcisio provides me partial protectio agaist HIV ifectio, the Govermet of Keya decided to expad male circumcisio services. Michael Stalker/FHI How we trai our commuity educators to explai partial protectio ca also be useful whe explaiig it to jouralists: Everyoe who egages i uprotected sex has a chace of gettig HIV whether they are circumcised or ot, but me who are circumcised have a lower chace of gettig HIV tha do me who are ot circumcised. We explai that i the research studies, circumcisio preveted 60 percet of the ifectios that would have occurred if the me remaied ucircumcised. I other words, 60 percet of all the ifectios that occur i me who are ot circumcised would be preveted if those me were circumcised. For me, this experiece with drastically iaccurate iterpretatios of scietific research has emphasized how importat it is for researchers to take the time to make sure they are commuicatig their results simply ad clearly. 145

17 IV Five ways to avoid misuderstadigs No oe ca guaratee that all audieces will uderstad your trial. However, here are five thigs you ca do to limit misuderstadigs or misiterpretatios of your study: 1. Limit the use of acroyms. Most people will ot be familiar with the acroyms you use i your work. If you must use a acroym, be sure to spell out the complete term o first use. 2. Use respectful laguage. Research protocols ofte use terms that carry scietific value but may seem dehumaizig to oscietists. For example, scietists sometimes refer to people who participate i a cliical trial as subjects. Use the words participats or voluteers to describe people who eroll i trials. These terms hoor their willigess ad effort to be ivolved i the trial. 3. Use eutral, straightforward laguage. Terms such as target group ad cotrol arm ca be cofusig or trigger egative resposes. Other terms such as serocoversio are too techical for lay audieces. See Box 8.7 for alteratives. Box Speak i ways that emphasize the huma face of trial participats Our study targets sex workers. Fewer ifectios were foud i the experimetal arm. May subjects were ocompliat ad deviated from the study protocol. Te percet of subjects serocoverted durig the trial. We cesored wome who became pregat durig the trial. Our study erolls sex workers. Fewer ifectios were foud amog commuity members who received the experimetal drug. Not all participats used the study product as directed. Te percet of the participats became HIV positive durig the study. The aalysis of HIV ifectios did ot iclude participats who became pregat durig the trial. 4. Use cosistet laguage. May study products ad itervetios have multiple ames, which ca cause cofusio. For example, the drug Viread is also kow as teofovir, ad some people refer to pre-exposure prophylaxis (PrEP) as a oral microbicide. Whe itroducig a ew product or cocept, it is importat to refer to it cosistetly with the same ame to avoid cofusig people. It may also be helpful to poit out the other terms that may be used to describe the same thig (such as Viread ad teofovir). 146 Commuicatios Hadbook for Cliical Trials

18 5. Avoid promisig more tha you ca deliver. Research has o guaratees, so you should preset realistic timelies ad expectatios. Use the coditioal tese with words such as could ad might whe you commuicate timelies ad possible scearios. Temper your descriptio of the study s goals with the realities of scietific research. Be positive about your research without overstatig its potetial. For example: We hope to release our results ext December. If this product works, it might help to save millios of lives. If the govermet approves this itervetio, we will be ready to lauch a ew program. Similarly, be coscious of the may iterpretatios of the terms you use. I everyday laguage, we ted to use may terms iterchageably ad words ca mea differet thigs to differet people. For example, whe talkig about prevetio, it is importat to make a clear distictio betwee absolute protectio a product that prevets ifectio 100 percet of the time i 100 percet of the people ad partial protectio a product that reduces the risk of ifectio i some people. Key poits to remember The first step to commuicatig clear iformatio about your scietific research is to take a step back ad explai the big picture. Remember to outlie the public health beefits ad process of cliical research, cotextualize the eed for your study, explai its purpose, ad address why this research is takig place i your particular commuity ad coutry. Cosider the scietific literacy, learig styles, ad cultural cotext of your audieces whe explaiig cliical research. Icorporate creative techiques to coect with your audieces. Images, graphs, props, theater, aalogies, stories, PowerPoit slides, role-plays, ad sogs are powerful commuicatios tools that ca help you explai ad simplify complex scietific cocepts. To limit misuderstadigs, traslate scietific terms ito everyday laguage, avoid jargo, simplify umbers, ad do ot promise more tha you ca deliver. 147